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New FDA Drug Approvals - November 2023

avacincaptad pegol

Izervay

Pharmaceutical company: Iveric Bio, Inc.

Pharmacologic classification: Complement C5 inhibitor

Therapeutic classification: Ophthalmic agent
 

AVAILABLE FORMS

Intravitreal solution: 20 mg/mL single-dose vial
 

INDICATIONS AND DOSAGES

Geographic atrophy secondary to age-related macular degeneration (AMD)

Adults: 2 mg (0.1 mL) by intravitreal injection to each affected eye once per month (approximately 28 days, plus or minus 7 days) for up to 12 months.
 

CONTRAINDICATIONS AND CAUTIONS

  • Contraindicated in those with ocular or periocular infections, or active intraocular inflammation.
  • Intravitreal injections may be associated with endophthalmitis and retinal detachment. Aseptic injection technique must be used to minimize the risk of endophthalmitis.
  • Use of this drug was associated with increased incidence of neovascular (wet) AMD.
  • Transient increased intraocular pressure (IOP) has been observed following intravitreal injection.
  • Dialyzable drug: Unknown.
 

PREGNANCY-LACTATION-REPRODUCTION

  • There are no adequate studies during pregnancy. Use cautiously during pregnancy.
  • It isn't known if this drug appears in human milk. Use cautiously during breastfeeding.
 

INTERACTIONS

None reported.
   

ADVERSE REACTIONS

EENT: conjunctival hemorrhage, increased IOP, blurred vision, choroidal neovascularization, neovascular AMD, eye pain, vitreous floaters, blepharitis.

Reactions in bold italics are life-threatening.
 

Released: November 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer

lotilaner

Xdemvy

Pharmaceutical company: Tarsus Pharmaceuticals

Pharmacologic classification: Ectoparasiticide

Therapeutic classification: Antiparasitic
 

AVAILABLE FORMS

Ophthalmic solution: 0.25%
 

INDICATIONS AND DOSAGES

Demodex blepharitis

Adults: Instill one drop in each eye b.i.d. (approximately 12 hours apart) for 6 weeks.
 

CONTRAINDICATIONS AND CAUTIONS

  • Safety and effectiveness in children haven't been established.
  • Dialyzable drug: Unknown.
 

PREGNANCY-LACTATION-REPRODUCTION

  • There are no adequate studies on use during pregnancy or breastfeeding. Systemic exposure by ophthalmic route is limited. Use cautiously during pregnancy or breastfeeding.
 

INTERACTIONS

None reported.

 

ADVERSE REACTIONS
EENT: stinging and burning at instillation site, eyelid cyst, bacterial eyelid infection, corneal inflammation.

Reactions in bold italics are life-threatening.
 

Released: November 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer
 

ritlecitinib

Litfulo

Pharmaceutical company: Pfizer

Pharmacologic classification: Kinase inhibitor

Therapeutic classification: Immunosuppressant
 

AVAILABLE FORMS

Capsule: 50 mg
 

INDICATIONS AND DOSAGES

Severe alopecia areata

Adults and children age 12 and older: 50 mg PO once daily.
 

Adjust-a-dose: Discontinue this drug if platelet count is less than 50,000/mm3 or if absolute lymphocyte count (ALC) is less than 500/mm3. May restart once ALC returns above this value.

 

CONTRAINDICATIONS AND CAUTIONS

  • Contraindicated in patients with known hypersensitivity to ritlecitinib or its components. Hypersensitivity reactions, such as anaphylaxis, urticaria, and rash have been reported.
  • Boxed Warning: This drug increases the risk of serious bacterial, fungal, viral, and opportunistic infections leading to hospitalization or death. Interrupt treatment if serious infection occurs until the infection is controlled.
  • Boxed Warning: This drug shouldn't be given to patients with active tuberculosis (TB). Avoid use in patients with active, serious infections.
  • Use cautiously in patients with chronic or recurrent infection, who have been exposed to TB, have a history of serious infection or opportunistic infection, who have resided or traveled in areas of endemic TB or mycoses, or with underlying conditions that may predispose them to infection.
  • Viral reactivation, including cases of herpes zoster, has occurred.
  • Boxed Warning: A higher rate of all-cause mortality, including sudden CV death, and major adverse CV events (MI, stroke) occurred with another janus kinase (JAK) inhibitor versus tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis (RA). This drug isn't approved for use in patients with RA.
  • Use cautiously in patients who are current or former smokers and with other CV risk factors.
  • Boxed Warning: Malignancies have occurred in patients treated with this drug. A higher rate of lymphomas and lung cancers have occurred with another JAK inhibitor versus TNF blockers in patients with RA.
  • Nonmelanoma skin cancer has been observed. Use cautiously in patients with a known malignancy other than successfully treated nonmelanoma skin cancer or cervical cancer. Patients who currently smoke or previously smoked may have an increased risk of malignancy.
  • Boxed Warning: Thrombosis has occurred in patients treated with this drug. An increased incidence of pulmonary embolism, and venous and arterial thrombosis occurred with another JAK inhibitor versus TNF blockers. Avoid this drug in patients who may be at increased risk for thrombosis.
  • This drug isn't recommended in patients with Child-Pugh class C liver impairment, hepatitis B or hepatitis C.
  • Safety and effectiveness in children younger than age 12 haven't been established.
  • Use cautiously in older adults who generally have a higher incidence of infections.
  • Dialyzable drug: Unknown.
 

PREGNANCY-LACTATION-REPRODUCTION

  • Studies during pregnancy are inadequate. It's unknown if this drug causes harm to a fetus. Report pregnancies to the pregnancy exposure registry at 1-877-390-2940.
  • There is no data on the appearance of this drug in human milk, but the drug is present in animal milk. Because of potential adverse effects, breastfeeding isn't recommended during treatment and for 14 hours after the last dose.
 

INTERACTIONS

Drug–drug. CYP3A inducers (rifampin): May decrease ritlecitinib level. Use together isn't recommended.
CYP3A substrates (midazolam), CYP1A2 substrates (clozapine, theophylline, zolpidem): Increases substrate level and risk of adverse reactions. Monitor patient closely and adjust substrate dosage as needed.
JAK inhibitors, biologic immunomodulators, potent immunosuppressants (cyclosporine): May enhance adverse reactions of immunosuppressants. Avoid use together.
Live vaccines: May increase risk of vaccine-associated infection and diminish therapeutic effect of vaccine. Avoid live vaccines just prior to and during treatment.
Drug–food. Caffeine: May increase risk of adverse reactions of caffeine. Use together cautiously.

ADVERSE REACTIONS

CNS: dizziness, headache, fever.
GI: diarrhea, stomatitis.
Hematologic: decreased RBC count.
Metabolic: increased CK level.
Skin: acne, rash, urticaria, folliculitis, atopic dermatitis.
Other: herpes zoster, infection.

Reactions in bold italics are life-threatening.
 

Released: November 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer

Download these updates as a PDF

New FDA Drug Approvals Archive

New FDA Drug Approvals - November 2023
avacincaptad pegolIzervayPharmaceutical company: Iveric Bio, Inc.Pharmacologic classification: Complement C5 inhibitorTherapeutic classification: Ophthalmic agent  AVAILABLE FORMSIntravitreal solution: 20 mg/mL single-dose vial  INDICATIONS AND DOSAGESGeographic atrophy secondary to age-related macular degeneration (AMD)Adults: 2 mg (0.1 mL) by intravitreal injection to each affected eye once per month (approximately 28 days, plus or minus 7 days) for up to 12 months.  CONTRAINDICATIONS AND CAUTIONSContraindicated in those with ocular or periocular infections, or active intraocular inflammation.Intravitreal injections may be associated with endophthalmitis and retinal detachment. Aseptic injection technique must be used to minimize the risk of endophthalmitis.Use of this drug was associated with increased incidence of neovascular (wet) AMD.Transient increased intraocular pressure (IOP) has been observed following intravitreal injection.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies during pregnancy. Use cautiously during pregnancy.It isn't known if this drug appears in human milk. Use cautiously during breastfeeding.   INTERACTIONS None reported.     ADVERSE REACTIONSEENT: conjunctival hemorrhage, increased IOP, blurred vision, choroidal neovascularization, neovascular AMD, eye pain, vitreous floaters, blepharitis.Reactions in bold italics are life-threatening.  Released: November 2023Nursing Drug Handbook© 2023 Wolters KluwerlotilanerXdemvyPharmaceutical company: Tarsus PharmaceuticalsPharmacologic classification: EctoparasiticideTherapeutic classification: Antiparasitic  AVAILABLE FORMSOphthalmic solution: 0.25%  INDICATIONS AND DOSAGESDemodex blepharitisAdults: Instill one drop in each eye b.i.d. (approximately 12 hours apart) for 6 weeks.  CONTRAINDICATIONS AND CAUTIONSSafety and effectiveness in children haven't been established.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies on use during pregnancy or breastfeeding. Systemic exposure by ophthalmic route is limited. Use cautiously during pregnancy or breastfeeding.   INTERACTIONSNone reported.   ADVERSE REACTIONSEENT: stinging and burning at instillation site, eyelid cyst, bacterial eyelid infection, corneal inflammation.Reactions in bold italics are life-threatening.  Released: November 2023Nursing Drug Handbook© 2023 Wolters Kluwer  ritlecitinibLitfuloPharmaceutical company: PfizerPharmacologic classification: Kinase inhibitorTherapeutic classification: Immunosuppressant  AVAILABLE FORMSCapsule: 50 mg  INDICATIONS AND DOSAGESSevere alopecia areataAdults and children age 12 and older: 50 mg PO once daily.  Adjust-a-dose: Discontinue this drug if platelet count is less than 50,000/mm3 or if absolute lymphocyte count (ALC) is less than 500/mm3. May restart once ALC returns above this value. CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with known hypersensitivity to ritlecitinib or its components. Hypersensitivity reactions, such as anaphylaxis, urticaria, and rash have been reported.Boxed Warning: This drug increases the risk of serious bacterial, fungal, viral, and opportunistic infections leading to hospitalization or death. Interrupt treatment if serious infection occurs until the infection is controlled.Boxed Warning: This drug shouldn't be given to patients with active tuberculosis (TB). Avoid use in patients with active, serious infections.Use cautiously in patients with chronic or recurrent infection, who have been exposed to TB, have a history of serious infection or opportunistic infection, who have resided or traveled in areas of endemic TB or mycoses, or with underlying conditions that may predispose them to infection.Viral reactivation, including cases of herpes zoster, has occurred.Boxed Warning: A higher rate of all-cause mortality, including sudden CV death, and major adverse CV events (MI, stroke) occurred with another janus kinase (JAK) inhibitor versus tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis (RA). This drug isn't approved for use in patients with RA.Use cautiously in patients who are current or former smokers and with other CV risk factors.Boxed Warning: Malignancies have occurred in patients treated with this drug. A higher rate of lymphomas and lung cancers have occurred with another JAK inhibitor versus TNF blockers in patients with RA.Nonmelanoma skin cancer has been observed. Use cautiously in patients with a known malignancy other than successfully treated nonmelanoma skin cancer or cervical cancer. Patients who currently smoke or previously smoked may have an increased risk of malignancy.Boxed Warning: Thrombosis has occurred in patients treated with this drug. An increased incidence of pulmonary embolism, and venous and arterial thrombosis occurred with another JAK inhibitor versus TNF blockers. Avoid this drug in patients who may be at increased risk for thrombosis.This drug isn't recommended in patients with Child-Pugh class C liver impairment, hepatitis B or hepatitis C.Safety and effectiveness in children younger than age 12 haven't been established.Use cautiously in older adults who generally have a higher incidence of infections.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONStudies during pregnancy are inadequate. It's unknown if this drug causes harm to a fetus. Report pregnancies to the pregnancy exposure registry at 1-877-390-2940.There is no data on the appearance of this drug in human milk, but the drug is present in animal milk. Because of potential adverse effects, breastfeeding isn't recommended during treatment and for 14 hours after the last dose.   INTERACTIONSDrug–drug.CYP3A inducers (rifampin): May decrease ritlecitinib level. Use together isn't recommended.CYP3A substrates (midazolam), CYP1A2 substrates (clozapine, theophylline, zolpidem): Increases substrate level and risk of adverse reactions. Monitor patient closely and adjust substrate dosage as needed.JAK inhibitors, biologic immunomodulators, potent immunosuppressants (cyclosporine): May enhance adverse reactions of immunosuppressants. Avoid use together.Live vaccines: May increase risk of vaccine-associated infection and diminish therapeutic effect of vaccine. Avoid live vaccines just prior to and during treatment.Drug–food.Caffeine: May increase risk of adverse reactions of caffeine. Use together cautiously.ADVERSE REACTIONSCNS: dizziness, headache, fever.GI: diarrhea, stomatitis.Hematologic: decreased RBC count.Metabolic: increased CK level.Skin: acne, rash, urticaria, folliculitis, atopic dermatitis.Other: herpes zoster, infection.Reactions in bold italics are life-threatening.  Released: November 2023Nursing Drug Handbook© 2023 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - October 2023
nirmatrelvir–ritonavirPaxlovidPharmaceutical company: PfizerPharmacologic classification: Protease inhibitorsTherapeutic classification: Antivirals  AVAILABLE FORMSTablets: 150 mg nirmatrelvir copackaged with 100 mg ritonavir  INDICATIONS AND DOSAGESMild-to-moderate coronavirus disease 2019 (COVID-19) in patients at high risk for progression to severe COVID-19, including hospitalization or deathAdults: 300 mg nirmatrelvir PO with 100 mg ritonavir PO taken together b.i.d. for 5 days.  Adjust-a-dose: For eGFR of 30 to less than 60 mL/minute, 150 mg nirmatrelvir PO with 100 mg ritonavir PO taken together b.i.d. for 5 days.CONTRAINDICATIONS AND CAUTIONSContraindicated with drugs primarily metabolized by CYP3A and for which elevated levels are associated with serious or life-threatening reactions, and drugs that are strong CYP3A inducers where significantly reduced nirmatrelvir or ritonavir levels may be associated with loss of virologic response and possible resistance.Boxed Warning: Consider the benefit of PAXLOVID treatment in reducing hospitalization and death, and whether the risk of drug-to-drug interactions for the patient can be appropriately managed.Nirmatrelvir–ritonavir isn't approved for preexposure or postexposure prevention of COVID-19.Contraindicated in patients with a history of significant hypersensitivity reactions (toxic epidermal necrolysis or Stevens-Johnson syndrome) to nirmatrelvir or ritonavir or any other components of the product. Anaphylaxis, severe cutaneous adverse reactions, and other hypersensitivity reactions have been reported.Transaminase elevations, hepatitis, and jaundice have occurred in patients receiving ritonavir. Use cautiously in patients with preexisting liver disease, liver enzyme abnormalities, or hepatitis. This drug isn't recommended in patients with Child-Pugh class C liver impairment.This drug isn't recommended in patients with GFR less than 30 mL/minute or patients on kidney replacement therapy.There may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.Use cautiously in older adults.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONStudies on use of nirmatrelvir or ritonavir during pregnancy are inadequate. Use cautiously during pregnancy.There are patient and fetal risks associated with untreated COVID-19.It's unknown if nirmatrelvir is excreted in human milk. Ritonavir is present in human milk. Use cautiously during pregnancy.Patients with COVID-19 who are breastfeeding should follow clinical guidelines to avoid exposing their infants to COVID-19.Ritonavir may reduce the efficacy of combined hormonal contraceptives. Use an effective alternative contraceptive or an additional barrier method of contraception during treatment.   INTERACTIONSAlert: Nirmatrelvir with ritonavir has the potential for significant interactions with many drugs. Consult a drug interaction resource or pharmacist for additional information. Drug-drug. Alpha 1-adrenoreceptor antagonists (alfuzosin, tamsulosin): May increase levels of the antagonist and risk of hypotension. Avoid use together. Coadministration with alfuzosin is contraindicated.Antiarrhythmics (amiodarone, disopyramide, dronedarone, flecainide, lidocaine [systemic], propafenone, quinidine): May increase antiarrhythmic level. Use together with disopyramide or lidocaine cautiously with therapeutic level monitoring, if available. Use with amiodarone, dronedarone, flecainide, propafenone, or quinidine is contraindicated.Antibacterials (clarithromycin, erythromycin): May increase level of antibacterial. Refer to antibacterial prescribing information.Anticancer drugs (abemaciclib, ceritinib, dasatinib, encorafenib, ibrutinib, ivosidenib, neratinib, nilotinib, venetoclax, vinblastine, vincristine):May increase level of the anticancer drug. Avoid coadministration of encorafenib or ivosidenib due to risk of serious adverse events, including QT interval prolongation. Avoid use with neratinib, venetoclax or ibrutinib. Coadministration of vincristine and vinblastine may lead to significant hematologic or GI adverse effects.Anticoagulants (apixaban, dabigatran and rivaroxaban, warfarin): May increase risk of bleeding and anticoagulant level. May increase or decrease warfarin level. Closely monitor INR when used with warfarin. Avoid use with rivaroxaban. Reduce dose of dabigatran and apixaban or avoid concomitant use. Refer to anticoagulant prescribing information.Anticonvulsants (carbamazepine, phenobarbital, primidone, phenytoin): May cause loss of virologic response and possible resistance. Use together is contraindicated.Antifungals (isavuconazonium, itraconazole azole, ketoconazole, voriconazole): May increase isavuconazonium, itraconazole, ketoconazole, and nirmatrelvir–ritonavir levels. May decrease voriconazole level. Avoid use with voriconazole. Refer to antifungal prescribing information.Anti-HIV agents (bictegravir–emtricitabine–tenofovir, efavirenz, maraviroc, nevirapine, zidovudine): May alter anti-HIV agent level. Refer to anti-HIV agent prescribing information.Anti-HIV protease inhibitors (atazanavir, darunavir, tipranavir):  May increase protease inhibitor level. Refer to protease inhibitor prescribing information. Patients on ritonavir- or cobicistat-containing HIV regimens should continue treatment as indicated. Monitor for increased adverse events.Antimigraine medications (eletriptan, rimegepant, ubrogepant): May increase level of antimigraine medication. Use of eletriptan within 72 hours of Paxlovid is contraindicated due to risk for serious adverse reactions, including CV and cerebrovascular events. Coadministration of ubrogepant is contraindicated because of the risk for serious adverse reactions. Avoid use with rimegepant.Antimycobacterial (bedaquiline, rifabutin):  May increase level of antimycobacterial. Refer to antimycobacterial prescribing information.Antipsychotics (clozapine, lurasidone, pimozide, quetiapine): May increase level of antipsychotic. Refer to antipsychotic prescribing information.Apalutamide:  May decrease nirmatrelvir or ritonavir levels. Coadministration is contraindicated.Atorvastatin, rosuvastatin: May increase statin level. Consider temporary discontinuation of atorvastatin and rosuvastatin during treatment. Atorvastatin and rosuvastatin don't need to be withheld prior to or after completing Paxlovid.Bosentan: May increase bosentan level and decrease nirmatrelvir or ritonavir level. Discontinue bosentan at least 36 hours prior to initiation of Paxlovid.Bupropion: May decrease level of bupropion. Monitor for adequate antidepressant response.Calcium channel blockers (amlodipine, diltiazem, felodipine, nicardipine, nifedipine, verapamil): May increase level of calcium channel blocker. Monitor closely and consider decreasing the calcium channel dose.Cardiovascular agents (aliskiren, ticagrelor, vorapaxar): May increase level of CV agent. Avoid use together.Cilostazol: May increase cilostazol level. Decrease dose of cilostazol.Clonazepam: May increase clonazepam level. Decrease clonazepam dosage as indicated, and monitor therapy.Clopidogrel: May decrease level of clopidogrel active metabolite. Use together cautiously.Colchicine: May increase colchicine level and risk of serious reactions. Use together is contraindicated in patients with kidney or liver impairment.Corticosteroids metabolized by CYP3A (betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, triamcinolone):  May increase level of corticosteroid. Consider alternative corticosteroid (beclomethasone, prednisone, prednisolone).Cystic fibrosis transmembrane conductance regulator potentiators (ivacaftor, elexacaftor–tezacaftor–ivacaftor, tezacaftor–ivacaftor): May increase level of cystic fibrosis drug. Refer to prescribing information for dosage adjustment.Darifenacin: May increase darifenacin level. The darifenacin dose should not exceed 7.5 mg daily. Refer to darifenacin prescribing information.Digoxin: May increase digoxin level. Monitor digoxin level.Eplerenone, ivabradine: May increase level of these drugs. Use together is contraindicated.Ergot derivatives (dihydroergotamine, ergotamine, methylergonovine): May increase level of ergot derivative and risk for toxicity. Use together is contraindicated.Ethinyl estradiol: May decrease hormone level. Consider using an additional, nonhormonal method of contraception during the 5 days of treatment and until one menstrual cycle after stopping Paxlovid.Finerenone: May increase finerenone level. Use together is contraindicated.Flibanserin: May increase flibanserin level and risk of hypotension, syncope, and CNS depression. Use together is contraindicated.Hepatitis C direct acting antivirals (elbasvir–grazoprevir, glecaprevir–pibrentasvir, ombitasvir–paritaprevir–ritonavir–dasabuvir, sofosbuvir–velpatasvir–voxilaprevir): May increase level of antiviral. Avoid concomitant use with glecaprevir–pibrentasvir. Patients on ritonavir-containing hepatitis C virus (HCV) regimens should continue treatment as indicated. Monitor for increased drug adverse events with use together. Refer to HCV antiviral prescribing information.Immunosuppressants (cyclosporine, tacrolimus): May increase immunosuppressant level. Avoid concomitant use when close monitoring of immunosuppressant level is not feasible. If coadministered, adjust immunosuppressant dose and closely monitor immunosuppressant level and assess for adverse reactions.Immunosuppressant (voclosporin): May increase voclosporin level. Coadministration contraindicated due to potential for kidney toxicity.Ivabradine: May increase ivabradine level and risk for bradycardia or conduction disturbances. Use together is contraindicated.Janus kinase (JAK) inhibitors (tofacitinib, upadacitinib): May increase JAK inhibitor level. Adjust dose of tofacitinib. Dose adjustment for coadministration of upadacitinib depends on the upadacitinib indication. Refer to the JAK inhibitor prescribing information.Lomitapide: May increase risk for liver toxicity and GI adverse reactions. Use together is contraindicated.Lovastatin, simvastatin: May increase statin level and risk for myopathy. Use together is contraindicated.Lumacaftor–ivacaftor: May decrease levels of nirmatrelvir or ritonavir. Use together is contraindicated.Methadone: May decrease methadone level. Monitor methadone-maintained patients closely for evidence of withdrawal and adjust methadone dose accordingly.mTOR inhibitors (everolimus, sirolimus): May increase mTOR inhibitor level. Avoid use together.Neuropsychiatric agents (aripiprazole, brexpiprazole, cariprazine, iloperidone, lumateperone, pimavanserin, suvorexant): May increase level of neuropsychiatric agent. Avoid use of suvorexant. Adjust dose of aripiprazole, brexpiprazole, cariprazine, iloperidone, lumateperone, pimavanserin.Opioid analgesics (fentanyl, hydrocodone, oxycodone, meperidine): May increase opioid level. Closely monitor for therapeutic and adverse opioid effects including potentially fatal respiratory depression. Consider decreasing opioid dosage.Opioid antagonists (naloxegol): May increase naloxegol level. Use together is contraindicated due to the potential for opioid withdrawal.PDE5 inhibitors for erectile dysfunction (avanafil, sildenafil, tadalafil, vardenafil): May increase PDE5 inhibitor level. Don't use with avanafil. Adjust dose of sildenafil, tadalafil, and vardenafil. Refer to inhibitor prescribing information.PDE5 inhibitors (sildenafil, tadalafil): May increase PDE5 inhibitor level. Use of sildenafil is contraindicated for pulmonary hypertension because of potential for sildenafil-associated adverse events. Avoid use with tadalafil for pulmonary hypertension.sGC stimulator (riociguat): May increase riociguat level. Dosage adjustment of riociguat recommended when used for pulmonary hypertension.Ranolazine: May increase ranolazine level. Use is contraindicated because of the potential for serious or life-threatening reactions.Salmeterol: May increase salmeterol level and risk of CV adverse events (QT prolongation, palpitations, sinus tachycardia). Avoid use together.Saxagliptin: May increase saxagliptin level. Decrease dose of saxagliptin. Refer to saxagliptin prescribing information.Silodosin: May increase silodosin level and risk of postural hypotention. Use together is contraindicated.Sedative-hypnotics (oral midazolam, triazolam): May increase benzodiazepine level. Use together is contraindicated.Sedative-hypnotics (buspirone, clorazepate, diazepam, flurazepam, parenteral midazolam, zolpidem): May increase sedative-hypnotic level. Consider dose decrease and monitor for adverse events. Coadministration of parenteral midazolam should be done in a setting with monitoring and appropriate medical management in case of respiratory depression or prolonged sedation.Trazodone: May increase trazodone level and its adverse reactions (nausea, dizziness, hypotension, syncope). Consider decreasing trazodone dose.Tolvaptan: May increase tolvaptan level and risk for dehydration, hypovolemia, and hyperkalemia. Use together is contraindicated.Drug-herb. St. John's wort:  May decrease drug level. Use together is contraindicated due to potential loss of virologic response and possible resistance.ADVERSE REACTIONSCNS: altered taste, headache, malaise.CV: hypertension.GI: diarrhea, abdominal pain, nausea, vomiting.Hepatic: transaminase elevations, hepatitis, jaundice.Skin: toxic epidermal necrolysis, Stevens-Johnson syndrome. .Other: hypersensitivity reactions, anaphylaxis.Reactions in bold italics are life-threatening.  Released: October 2023Nursing Drug Handbook© 2023 Wolters KluwersotagliflozinInpefaPharmaceutical company: Lexicon PharmaceuticalsPharmacologic classification: Sodium-glucose cotransporter 2 inhibitorTherapeutic classification: Antidiabetic  AVAILABLE FORMSTablets: 200 mg; 400 mg  INDICATIONS AND DOSAGESTo reduce the risk of CV death, hospitalization for heart failure (HF), and urgent HF visits in patients with HF or with type 2 diabetes, chronic kidney disease, and other CV risk factorsAdults: 200 mg PO daily. After at least 2 weeks, may increase to 400 mg PO once daily, as tolerated.Adjust-a-dose: Decrease to 200 mg PO daily, as necessary, based on tolerance.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with a history of serious hypersensitivity reaction to sotagliflozin.This drug isn't recommended in patients with Child-Pugh class B or C liver impairment.Use cautiously in patients with a history of pancreatitis or pancreatic surgery, acute febrile illness, reduced caloric intake, ketogenic diet, surgery, insulin dose reduction, volume depletion, and alcohol abuse, which are risk factors for ketoacidosis.Patients with eGFR less than 60 mL/min/1.73 m2, older adults, or patients taking loop diuretics may be at increased risk for volume depletion. This may manifest as symptomatic hypotension or acute transient changes in creatinine.This drug can significantly increase the risk of diabetic ketoacidosis. Blood glucose may be lower than typically expected for diabetic ketoacidosis (less than 250 mg/dL).Serious UTIs, including pyelonephritis and urosepsis, and necrotizing fasciitis (Fournier gangrene) of the perineum, have been reported.Safety and effectiveness in patients with an eGFR less than 25 mL/min/1.73 m2 or on dialysis are not known.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies during pregnancy. Based on animal data showing kidney effects, this drug isn't recommended during the second and third trimesters of pregnancy.There are no data on the presence of this drug in human milk, its effects on the breastfed infant or on milk production. Since kidney maturation occurs in utero and during the first 2 years of life, there may be risk to the developing kidneys. Breastfeeding isn't recommended while taking this drug.   INTERACTIONSDrug-drug.Digoxin: May increase digoxin level. Monitor digoxin level.Insulin, insulin secretagogues: May increase risk of hypoglycemia. Monitor glucose and decrease dose of insulin or insulin secretagogue as needed.Lithium: May decrease lithium level. Monitor lithium level frequently during initiation of and changes in sotagliflozin therapy.Loop diuretics (furosemide, torsemide): May increase risk for volume depletion. Use cautiously together.Rifampin: May decrease sotagliflozin level. Monitor clinical effect.Drug-food. May increase sotagliflozin level. Take drug not more than 1 hour before the first meal of the day.   ADVERSE REACTIONSCNS: dizziness.GI diarrhea.GU UTI, genital mycotic infection.Metabolic diabetic ketoacidosis, hypoglycemia,volume depletion.  Reactions in bold italics are life-threatening.  Released: October 2023Nursing Drug Handbook© 2023 Wolters Kluwer  Download these updates as a PDF
New FDA Drug Approvals - September 2023
fezolinetantVeozahPharmaceutical company: Astellas PharmaPharmacologic classification: Neurokinin 3 receptor antagonistTherapeutic classification: Menopause drug  AVAILABLE FORMSTablets: 45 mg  INDICATIONS AND DOSAGESModerate to severe vasomotor symptoms due to menopauseAdults: 45 mg PO once daily.  CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with known cirrhosis, severe kidney impairment or kidney failure.Safety and efficacy in children haven't been established.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONThere are no data on the risks associated with the use of this drug during pregnancy.It's unknown if this drug appears in human milk.   INTERACTIONSDrug-drug. CYP1A2 inhibitors (cimetidine, ciprofloxacin, fluvoxamine): May increase fezolinetant level. Use together is contraindicated.  ADVERSE REACTIONSCNS: insomnia.GI: abdominal pain, diarrhea.Hepatic: transaminase elevation.Musculoskeletal: back pain.Other: hot flash.Reactions in bold italics are life-threatening.  Released: September 2023Nursing Drug Handbook© 2023 Wolters KluwerperfluorohexyloctaneMieboPharmaceutical company: Bausch and LombPharmacologic classification: Semifluorinated alkaneTherapeutic classification: Miscellaneous ophthalmic drug  AVAILABLE FORMSOphthalmic solution:  100% multi-dose bottles  INDICATIONS AND DOSAGESDry eye diseaseAdults:  Instill one drop q.i.d. into affected eye(s).  CONTRAINDICATIONS AND CAUTIONSSafety and effectiveness in patients younger than age 18 have not been established.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies during pregnancy. Use cautiously during pregnancy.There are no data on the presence of this drug in human milk, its effects on breastfed infants, or on milk production. Use cautiously during breastfeeding.   INTERACTIONSNone reported by the manufacturer.  ADVERSE REACTIONSEENT: blurred vision, conjunctival redness.Reactions in bold italics are life-threatening.  Released: September 2023Nursing Drug Handbook© 2023 Wolters Kluwer  Download these updates as a PDF
New FDA Drug Approvals - July 2023
leniolisibJoenjaPharmaceutical company: Pharming HealthcarePharmacologic classification:Kinase inhibitorTherapeutic classification:ImmunomodulatorAVAILABLE FORMSCapsules: 70 mgINDICATIONS AND DOSAGESActivated phosphoinositide 3-kinase delta syndromeAdults and children age 12 and older weighing at least 45 kg: 70 mg PO b.i.d. 12 hours apart.  CONTRAINDICATIONS AND CAUTIONSUse in patients with Child-Pugh class B and C liver impairment hasn't been established and isn't recommended.Safety and effectiveness in children younger than age 12 or weighing less than 45 kg has not been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm.Patients of childbearing potential should use effective contraception during therapy and for 1 week after the last dose.There is no information on the presence of this drug in human milk. Due to the potential for adverse reactions in the infant, breastfeeding during treatment and for 1 week after the last dose isn't recommended.INTERACTIONSDrug-drug. BCRP, OATP1B1, OATPB13 substrates (methotrexate, rosuvastatin, pravastatin, prazosin)May increase level of substrate. Avoid use together.CYP1A2 substrates with a narrow therapeutic index (theophylline): May increase levels. Avoid use together.Live vaccines: Leniolisib may decrease vaccine effectiveness. Avoid use together.Moderate and strong CYP3A4 inducers (phenytoin, rifampin, efavirenz): May decrease leniolisib level. Avoid use together.Strong CYP3A4 inhibitors (clarithromycin, itraconazole, ketoconazole, ritonavir): May increase leniolisib level. Avoid use together.Drug-herb. St. John's wort: May decrease leniolisib level. Avoid use together.Drug-food. Grapefruit juice: May increase leniolisib level. Avoid use together.ADVERSE REACTIONSCNS: headache, fatigue, fever.CV: tachycardia.EENT: sinusitis.GI: diarrhea.Hematologic: neutropenia.Musculoskeletal: neck pain, back pain.Skin: atopic dermatitis, alopecia.Reactions in bold italics are life-threatening.Released: July 2023Nursing Drug Handbook© 2023 Wolters KluwertrofinetideDaybuePharmaceutical company: Acadia PharmaceuticalsPharmacologic classification: Glycine-proline-glutamate analogTherapeutic classification: Miscellaneous CNS agentAVAILABLE FORMSOral solution: 200 mg/mLINDICATIONS AND DOSAGESRett syndromeAdults and children age 2 and older weighing 50 kg or more: 12,000 mg (60 mL) PO b.i.d.Adults and children age 2 and older weighing 35 kg to less than 50 kg: 10,000 mg (50 mL) PO b.i.d.Adults and children age 2 and older weighing 20 kg to less than 35 kg: 8,000 mg (40 mL) PO b.i.d.Adults and children age 2 and older weighing 12 kg to less than 20 kg: 6,000 mg (30 mL) PO.Adults and children age 2 and older weighing 9 kg to less than 12 kg: 5,000 mg (25 mL) PO.Adjust-a-dose: Interrupt, reduce dose, or discontinue trofinetide for severe diarrhea, suspected dehydration, or significant weight loss.CONTRAINDICATIONS AND CAUTIONSUse in patients with moderate or severely reduced GFR is not recommended.Safety and effectiveness in children less than 2 years have not been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies in women who are pregnant. Use during pregnancy only if benefit outweighs risk to the fetus.It isn't known if this drug appears in human milk. Use cautiously during breastfeeding.INTERACTIONSDrug-drug. A CYP3A4 substrates (carbamazepine, midazolam): May increase level of substrate. Monitor sensitive substrates with a narrow therapeutic index.OATP1B1, OATP1B3 substrates (valproic acid, methotrexate): May increase level of substrate. Avoid concomitant use with substrates with a narrow therapeutic index.ADVERSE REACTIONSCNS: fever, seizures, anxiety, fatigue.EENT: nasopharyngitis.GI: diarrhea, vomiting, decreased appetite.Metabolic: weight loss.Reactions in bold italics are life-threatening.Released: July 2023Nursing Drug Handbook© 2023 Wolters Kluwer  zavegepantZavzpretPharmaceutical company: Pfizer, Inc.Pharmacologic classification: Calcitonin gene-related peptide receptor antagonistTherapeutic classification: Antimigraine drugAVAILABLE FORMSNasal spray: 10 mg per unit-dose deviceINDICATIONS AND DOSAGESAcute treatment of migraine with or without auraAdults: 10 mg as a single spray in one nostril, as needed. The maximum dosage is 10 mg in 24 hours.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with a history of hypersensitivity to the drug or any of its components.Hypersensitivity reactions, including facial swelling and urticaria, have occurred.Avoid use in patients with creatinine clearance of less than 30 mL/minute and Child-Pugh class C liver impairment.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no data on use during pregnancy. Pregnant patients with migraine may be at increased risk of preeclampsia and gestational hypertension.It isn't known if this drug appears in human milk. Use cautiously during breastfeeding.INTERACTIONSDrug-drug. Intranasal decongestants (azelastine, oxymetazoline): May decrease absorption of zavegepant. Avoid use together. If concomitant use is unavoidable, administer decongestants at least 1 hour after zavegepant.OATP1B3 inducers (clotrimazole, progesterone), sodium taurocholate cotransporting polypeptide (NTCP) inducers: May decrease zavegepant level. Avoid use together.OATP1B3 inhibitors (rifampin, clarithromycin), NTCP inhibitors (rifampin): May increase zavegepant level. Avoid use together.ADVERSE REACTIONSCNS: taste disorder.EENT: nasal discomfort.GI: nausea, vomiting.Reactions in bold italics are life-threatening.Released: July 2023Nursing Drug Handbook© 2023 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - June 2023
omaveloxoloneSkyclarysPharmaceutical company: Reata PharmaceuticalsPharmacologic classification:Nuclear factor(erythroid-derived 2) activatorTherapeutic classification:Miscellaneous CNS drugAVAILABLE FORMSCapsules: 50 mgINDICATIONS AND DOSAGESFriedreich ataxiaAdults and adolescents age 16 and older: 150 mg PO once daily on an empty stomach at least 1 hour before a meal.Adjust-a-dose: If use with a strong CYP3A4 inhibitor can't be avoided, reduce omaveloxolone to 50 mg once daily. If use with a moderate CYP3A4 inhibitor can't be avoided, or for patients with Child-Pugh class B liver impairment, reduce omaveloxolone to 100 mg once daily. If adverse reactions develop, further decrease dose to 50 mg once daily. Discontinue if adverse reactions occur at 50 mg dose.CONTRAINDICATIONS AND CAUTIONSMay worsen cardiac function. Use cautiously in patients with heart failure or cardiac disease.Avoid use in Child-Pugh class C liver impairment.Safety and effectiveness have not been established in children younger than age 16.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONBased on animal data, this drug may cause fetal harm.There are no data on presence of this drug in human milk. Effects on milk production and the breastfed infant are unknown. Use only if the benefit to the patient outweighs the risk to the infant.May decrease efficacy of hormonal contraceptives. Patients of childbearing potential should use an alternative contraceptive method or additional nonhormonal contraceptive (condoms) during concomitant use and for 28 days after discontinuation of omaveloxolone.INTERACTIONSDrug-drug. CYP3A4 substrates (midazolam), CYP2C8 substrates (repaglinide),BCRP and OATP1B1 substrates (rosuvastatin): May decrease level of substrate drug. Monitor for lack of efficacy.Hormonal contraceptives (pill, patch, ring, implant, and progestin-only pill): May decrease contraceptive effectiveness. Avoid concomitant use.Strong or moderate CYP3A4 inducers: May decrease omaveloxolone level and its effectiveness. Avoid concomitant use.Strong or moderate CYP3A4 inhibitors: May increase omaveloxolone level. Avoid concomitant use. If use can't be avoided, reduce omaveloxolone dose.Drug-herb. St. John's wort: May decrease omaveloxolone level. Avoid concomitant use.Drug-food. Grapefruit, grapefruit juice: May increase omaveloxolone level. Discourage concomitant use.  ADVERSE REACTIONSCNS: headache, fatigue.CV: increased B-type natriuretic peptide.EENT: oropharyngeal pain.GI: nausea, diarrhea, vomiting, abdominal pain, decreased appetite.Hepatic: increased liver enzymes.Metabolic: increased LDL-cholesterol, decreased HDL-cholesterol.Musculoskeletal: musculoskeletal pain, spasms, back pain.Skin: rash.Other: flulike syndrome.Reactions in bold italics are life-threatening.Released: June 2023Nursing Drug Handbook© 2023 Wolters KluwersparsentanFilspariPharmaceutical company: Travere TherapeuticsPharmacologic classification: Endothelin and angiotensin II receptor antagonistTherapeutic classification: Miscellaneous GU drugAVAILABLE FORMSTablets: 200 mg, 400 mgINDICATIONS AND DOSAGESReduce proteinuria in patients with primary immunoglobulin A nephropathy at risk for rapid disease progressionAdults: 200 mg PO once daily. After 14 days, increase to 400 mg PO once daily, as tolerated. Consider repeating titration when resuming drug after an interruption.Adjust-a-dose: Refer to the manufacturer's instructions for dosage adjustment and monitoring in patients developing transaminase elevations of more than 3 times the upper limit of normal (ULN). If treatment is withheld, don't resume in patients with symptoms of liver toxicity or liver enzyme levels and bilirubin that have not returned to pretreatment levels. Stop the drug permanently if ALT or AST is greater than 8 x ULN and no other cause is found.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: Prescribers, patients, and pharmacies must enroll in a REMS program due to risks of elevation in aminotransferases, hepatotoxicity and liver failure, and major birth defects.Alert: Avoid use in patients with any degree of liver impairment, including those with aminotransferase levels greater than 3 x ULN at baseline.This drug inhibits the renin-angiotensin-aldosterone system (RAAS) and may increase the risk of acute kidney injury.Use cautiously in those at risk for hypotension, in those with fluid retention, and in patients with advanced kidney disease, due to the risk of hyperkalemia. Use hasn't been evaluated in patients with heart failure.Safety and effectiveness in children haven't been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONBlack Box Warning: Use during pregnancy is contraindicated. This drug can cause major birth defects and fetal death if used during pregnancy. Initiate in patients of childbearing potential only after confirmation of a negative pregnancy test. Pregnancy testing is also required monthly during treatment, and one month after discontinuation.Patients who can become pregnant must use effective contraception before initiation, monthly during treatment, and for one month after discontinuation.Breastfeeding isn't recommended during treatment due to the risk of adverse reactions, such as hypotension, in breastfed infants.INTERACTIONSDrug-drug. Antacids and acid-reducing agents (histamine-2 [H2] antagonists, PPI): May decrease sparsentan level. Administer sparsentan 2 hours before or after antacids. Avoid concomitant use with H2 antagonists and PPIs.CYP2B6, 2C9, 2C19 substrates (bupropion): May decrease substrate level.Drugs that increase serum potassium (potassium-sparing diuretics, potassium supplements): May increase risk of hyperkalemia. Monitor potassium level. Monitor for substrate efficacy and consider dosage adjustment.Moderate CYP3A inhibitors (cyclosporine): May increase sparsentan level and the risk of adverse reactions. Monitor blood pressure, edema, potassium, and kidney function.NSAIDs (cyclooxygenase-2 inhibitors): May worsen kidney function. Monitor for signs of worsening kidney function.P-gp substrates (fexofenadine, digoxin) and BCRP substrates (glyburide, cimetidine, rosuvastatin): May increase substrate level and substrate-related adverse reactions. Avoid concomitant use of sensitive substrates.Alert: RAAS inhibitors (angiotensin receptor blockers, ACE inhibitors), endothelin receptor antagonists (bosentan, ambrisentan), aliskiren: May increase risk of hypotension, syncope, hyperkalemia, and decreased kidney function. Use together is contraindicated.Strong CYP3A inducers (rifampin): May decrease sparsentan level. Avoid use together.Strong CYP3A inhibitors (itraconazole): May increase sparsentan level. Avoid use together. If not possible, interrupt sparsentan.Drug-food. Potassium-containing salt substitutes: May cause hyperkalemia. Monitor potassium level.ADVERSE REACTIONSCNS: dizziness.CV: peripheral edema, hypotension, orthostatic hypotension.GU: acute kidney injury.Hematologic: anemia.Hepatic: transaminase elevations.Metabolic: hyperkalemia.Reactions in bold italics are life-threatening.Released: June 2023Nursing Drug Handbook© 2023 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - May 2023
daprodustatJesduvroqPharmaceutical company: GlaxoSmithKlinePharmacologic classification:Hypoxia-inducible factor prolyl hydroxylase inhibitorTherapeutic classification:HematopoieticAVAILABLE FORMSTablets: 1 mg; 2 mg; 4 mg; 6 mg; 8 mgINDICATIONS AND DOSAGESAnemia due to chronic kidney disease in patients who have been receiving dialysis for at least 4 monthsAdults not being treated with an erythropoiesis stimulating agent (ESA): If the pretreatment hemoglobin is less than 9 g/dL, give 4 mg PO once daily; if the pretreatment hemoglobin is 9 to 10 g/dL, give 2 mg PO once daily; if the pretreatment hemoglobin is greater than 10 to 11 g/dL, give 1 mg PO once daily.Adults being switched from an ESA: For patients switching from epoetin alfa, darbepoetin alfa, or ethoxy PEG-epoetin beta, refer to the manufacturer's instructions for daprodustat dosing instructions based on current ESA drug and dosage.Adjust-a-dose: Increase or decrease dose by one dose level at a time. Dose levels are 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 12 mg, 16 mg, and 24 mg. Decrease dose if hemoglobin increases rapidly by more than 1 g/dL over 2 weeks or 2 g/dL over 4 weeks, or if hemoglobin exceeds 11 g/dL. Don't increase the dose more frequently than every 4 weeks. If hemoglobin exceeds 12 g/dL, interrupt treatment. Restart at one dose level lower when hemoglobin drops to within the target range. Maximum dose is 24 mg once daily. Reduce daprodustat starting dose by half in patients on clopidogrel or a moderate CYP2C8 inhibitor, or with moderate hepatic impairment (Child-Pugh class B), except in patients whose starting dose is already 1 mg. Discontinue therapy if a clinically meaningful hemoglobin increase isn't achieved by 24 weeks.  CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: Daprodustat increases the risk of thrombotic vascular events (MI, stroke, venous thromboembolism, and vascular access thrombosis), that may be fatal.Alert: Patients with CV or cerebrovascular disease are at increased risk. Avoid use in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within 3 months prior to starting. A hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.Black Box Warning: Targeting hemoglobin greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with ESAs, which also increase erythropoietin levels. No trial has identified a hemoglobin target, daprodustat dose or dosing strategy that does not increase these risks. Use the lowest dose sufficient to reduce the need for RBC transfusion.Alert: Contraindicated in patients with uncontrolled hypertension. Hypertensive crises, including hypertensive encephalopathy and seizures, have been reported.This drug isn't indicated for use in patients not on dialysis as they may be at greater risk for CV mortality, stroke, thromboembolism, serious acute kidney injury, hospitalization for heart failure, and serious GI erosions.Use in severe hepatic impairment (Child-Pugh class C) isn't recommended.Patients with a preexisting history of heart failure are at increased risk of hospitalization for heart failure.Gastric or esophageal erosions, including GI bleeding and need for RBC transfusion, may occur. Use cautiously in patients at increased risk, including patients with a history of GI erosion or peptic ulcer disease, concomitant medications that increase the risk of GI erosion, current tobacco smoking, and current alcohol use.Use isn't recommended in patients with active malignancies. Increased hypoxia inducible factor-1 levels may be associated with unfavorable effects on cancer growth.This drug has not been shown to improve quality of life, fatigue, or patient well-being.Daprodustat is not a substitute for transfusion in patients requiring immediate correction of anemia.Safety and effectiveness in children haven't been established.Intentional drug abuse for its rewarding psychological or physiologic effects may be seen in athletes for the effects on erythropoiesis.Dialyzable drug: No.PREGNANCY-LACTATION-REPRODUCTIONThis drug is associated with adverse fetal outcomes in animal studies. Advise patients who are pregnant of the fetal risk.There are no data on the presence of daprodustat in human milk, the effects on the breastfed child, or effects on milk production. Due to serious adverse reactions of the drug, patients should not breastfeed during treatment and for 1 week after the final dose.INTERACTIONSDrug-drug. CYP2C8 inducers (rifampin): May decrease daprodustat level and decrease its efficacy. Monitor hemoglobin and adjust daprodustat dose when initiating or discontinuing CYP2C8 inducers.Moderate CYP2C8 inhibitors (clopidogrel): May increase daprodustat level. Reduce daprodustat starting dose when initiating treatment unless starting dose is already 1 mg. Monitor hemoglobin and adjust daprodustat dose when initiating or stopping CYP2C8 inhibitors.Strong CYP2C8 inhibitors (gemfibrozil): May increase level of daprodustat. Concomitant use in contraindicated.Drug-lifestyle. Tobacco smoking, alcohol use: May increase risk of gastric or esophageal erosions. Discourage use together.ADVERSE REACTIONSCNS: stroke, dizziness.CV: thrombotic vascular events (MI, deep vein thrombosis, pulmonary embolism, vascular access thrombosis), heart failure, hypertension..GI: GI erosion, abdominal pain.Other: hypersensitivity.Reactions in bold italics are life-threatening.Released: May 2023Nursing Drug Handbook© 2023 Wolters Kluwerlecanemab-irmbLeqembiPharmaceutical company: Eisai Inc. and BiogenPharmacologic classification: Amyloid beta-directed antibodyTherapeutic classification: Anti-Alzheimer drugAVAILABLE FORMSInjection: 200 mg/2 mL; 500 mg/5 mL single-use vialsINDICATIONS AND DOSAGESMild cognitive impairment or mild dementia stage of Alzheimer diseaseAdults: 10 mg/kg administered IV infusion over approximately one hour once every two weeks.Adjust-a-dose: See the manufacturer's instructions for dose reductions in the settings of amyloid-related imaging abnormalities-edema (ARIA-E) and -hemosiderin deposition (ARIA-H) based on symptom severity and magnetic resonance imaging findings.CONTRAINDICATIONS AND CAUTIONSAlert: ARIA may develop; monitor closely during the first 14 weeks of treatment. ARIA-E appears as brain edema or sulcal effusions. ARIA-H includes microhemorrhage and superficial siderosis, and usually occurs with ARIA-E. ARIA is usually asymptomatic but can rarely include seizure and status epilepticus.Risk of ARIA, including symptomatic ARIA, was increased in apolipoprotein E ε4 homozygotes compared to heterozygotes and noncarriers. Consider testing for APOE ε4 status prior to treatment.Use clinical judgment in considering whether to continue dosing in patients with recurrent ARIA-E.Alert: Intracerebral hemorrhage may rarely occur; use cautiously in patients with prior cerebral hemorrhage greater than 1 cm in greatest diameter, more than 4 microhemorrhages, superficial siderosis, evidence of vasogenic edema, evidence of cerebral contusion, aneurysm, vascular malformation, infective lesions, multiple lacunar infarcts or stroke involving a major vascular territory, or severe small vessel or white matter disease.Safety and effectiveness in children haven't been established. Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate data on use in pregnancy.There are no data on use during lactation. Weigh risks versus benefits.INTERACTIONSDrug-drug. Antithrombotics, thrombolytic agents, antiplatelets, anticoagulants: May increase risk of bleeding; use together cautiously. Consider withholding lecanemab-irmb temporarily if anticoagulant must be used for 4 weeks or less.ADVERSE REACTIONSCNS: headache, ARIA-E.CV: atrial fibrillation.EENT: cough.GI: diarrhea.Hematologic: lymphopenia.Other: infusion-related reactions.Reactions in bold italics are life-threatening.Released: May 2023Nursing Drug Handbook© 2023 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - April 2023
bexagliflozinBrenzavvyPharmaceutical company: TheracosBioPharmacologic classification:Sodium-glucose cotransporter 2 (SGLT2) inhibitorTherapeutic classification:AntidiabeticAVAILABLE FORMSTablets: 20 mgINDICATIONS AND DOSAGESAs adjunct to diet and exercise to improve glycemic control in type 2 diabetesAdults: 20 mg PO once daily in the morning.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients hypersensitive to this drug or any of its components and in patients on dialysis.This drug isn’t recommended in patients with eGFR less than 30 mL/min/1.73 m2 or type 1 diabetes mellitus. This drug has not been studied in severe hepatic impairment and isn’t recommended for use in this population.This drug may increase the risk of ketoacidosis. Use cautiously in patients with pancreatic insulin deficiency, caloric restriction, and alcohol use.Use cautiously in patients predisposed to need for amputation, including those with prior amputation, peripheral vascular disease, neuropathy, or diabetic foot ulcers. This drug may increase the risk of lower limb amputation due to infection, gangrene, ischemia, or osteomyelitis.This drug may cause a decrease in intravascular volume and cause symptomatic hypotension or acute transient changes in creatinine. Older adults, those with impaired kidney function (eGFR less than 60 mL/min/1.73 m2), low systolic blood pressure, or taking loop diuretics may be at increased risk. Acute kidney injury, some requiring hospitalization and dialysis, has been reported in patients receiving SGLT2 inhibitors.SGLT2 inhibitors (including bexagliflozin) may increase the risk of UTI, including urosepsis and pyelonephritis.Necrotizing fasciitis of the perineum (Fournier’s gangrene), a rare, serious, life-threatening necrotizing infection requiring urgent surgical intervention, has been reported in patients receiving SGLT2 inhibitors.This drug may increase the risk of genital mycotic infection. Patients with a history of genital mycotic infection or who are uncircumcised are at greater risk.The safety and effectiveness in children haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.Use of this drug isn’t recommended during the second and third trimesters of pregnancy based on animal data.There is no information regarding the presence of this drug in human milk, effects on the breastfed infant or on milk production. This drug may increase the risk of adverse reactions in a breastfed infant. Use isn’t recommended while breastfeeding.INTERACTIONSDrug-drug. Insulin and insulin secretagogues (glimepiride, glyburide, sulfonylurea agents): Increases the risk of hypoglycemia. When used together, decrease the insulin or insulin secretagogue dose as needed.Lithium: May decrease lithium level. Monitor lithium level more frequently upon initiation and discontinuation of bexagliflozin.UGT enzyme inducers (rifampicin, phenobarbital): May decrease bexagliflozin level and its efficacy. Consider adding another antihyperglycemic agent if necessary.ADVERSE REACTIONSGI: thirst.GU: increased urination,genital mycotic infection, UTI, vaginal pruritus, increased serum creatinine, decreased eGFR.Metabolic: volume depletion, hypoglycemia.Musculoskeletal: lower limb amputation.Skin: rash.Other: sepsis.Reactions in bold italics are life-threatening.Released: April 2023Nursing Drug Handbook© 2023 Wolters KluwerelacestrantOrserduPharmaceutical company: Stemline Therapeutics, Inc.Pharmacologic classification:Estrogen receptor antagonistTherapeutic classification:AntineoplasticAVAILABLE FORMSTablets: 86 mg, 345 mgINDICATIONS AND DOSAGESEstrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapyPostmenopausal females and adult males: 345 mg PO once daily until disease progression or unacceptable toxicity.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments. Reduce the dose to 258 mg once daily for patients with moderate hepatic impairment (Child-Pugh B). Avoid use in patients with severe hepatic impairment (Child-Pugh C). Avoid concomitant use with strong or moderate CYP3A4 inducers and inhibitors.CONTRAINDICATIONS AND CAUTIONSAvoid use in severe hepatic impairment (Child-Pugh C).Safety and effectiveness have not been established in children.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONBased on findings in animals and its mechanism of action, this drug can cause fetal harm.Females of reproductive potential and males with female partners of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.There are no data on the presence of this drug in human milk, its effects on milk production, or the breastfed child. Patients shouldn’t breastfeed during treatment and for 1 week after the last dose.Based on findings from animal studies, this drug may impair fertility.INTERACTIONSDrug-drug. BCRP substrates (rosuvastatin), p-glycoprotein substrates (digoxin): May increase the substrate level and the risk of adverse reactions. Reduce the dosage of the substrate per its product labeling.Strong and moderate CYP3A4 inducers (rifampin, efavirenz): May decrease elacestrant level and its effectiveness. Avoid use together.Strong and moderate CYP3A4 inhibitors (itraconazole, fluconazole): May increase elacestrant level and the risk of adverse reactions. Avoid use together.ADVERSE REACTIONSCNS: fatigue, headache, insomnia, dizziness.EENT: stomatitis.GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, decreased appetite, gastroesophageal reflux disease.Hepatic: abnormal liver function tests.Musculoskeletal: musculoskeletal pain.Metabolic: increased cholesterol, increased triglycerides, hyponatremia, increased creatinine.Hematologic: decreased hemoglobin.Respiratory: cough, dyspnea.Skin: rash.Other: hot flush.Reactions in bold italics are life-threatening.Released: April 2023Nursing Drug Handbook© 2023 Wolters KluwerlenacapavirSunlencaPharmaceutical company: Gilead Sciences, Inc.Pharmacologic classification:Capsid inhibitorTherapeutic classification:AntiretroviralAVAILABLE FORMSInjection: 463.5 mg/1.5 mL single-dose vialTablets: 300 mgINDICATIONS AND DOSAGESHIV-1 infection in combination with other antiretrovirals, in heavily treatment-experienced patients with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerationsInitiation option 1Adults: 927 mg subcut and 600 mg PO once on day 1. Then 600 mg PO once on day 2. Then begin maintenance regimen.Initiation option 2Adults: 600 mg PO once daily on days 1 and 2. Then 300 mg PO once on day 8.Then 927 mg subcut once on day 15. Then begin maintenance regimen.Maintenance regimenAdults: 927 mg subcut every 6 months (26 weeks) from the date of last injection. May give within 2 weeks before or after the 6 month target date.CONTRAINDICATIONS AND CAUTIONSUse cautiously in patients with severe hepatic impairment or kidney failure with replacement therapy.Immune reconstitution syndrome may occur in patients treated with combination antiretroviral therapy. Autoimmune disorders (Grave disease, polymyositis, Guillain-Barré syndrome, autoimmune hepatitis) may occur with immune reconstitution syndrome.Nonadherence to the medication regimen could lead to loss of virologic response and development of resistance.Safety and effectiveness in children have not been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONInsufficient data on use in pregnancy is available to determine risk.Health care providers are encouraged to register patients in the Antiretroviral Pregnancy Registry at 1-800-258- 4263.The Centers for Disease Control and Prevention recommends those with HIV-1 infection not to breastfeed. It’s unknown whether this drug is present in breast milk.INTERACTIONSAlert:Lenacapavir has the potential for significant interactions with many drugs. Consult a drug interactions resource for additional information.Drug-drug. Alert: Anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin): May decrease lenacapavir levels and increase risk for resistance. Use with carbamazepine or phenytoin is contraindicated. Use with oxcarbazepine or phenobarbital isn’t recommended. Consider use of alternative anticonvulsants.Alert: Antimycobacterials (rifabutin, rifampin, rifapentine): May decrease lenacapavir levels and increase risk for resistance. Use with rifampin is contraindicated. Use with rifabutin or rifapentine isn’t recommended.Antiretroviral agents (atazanavir–cobicistat, atazanavir–ritonavir, efavirenz, nevirapine, tipranavir–ritonavir): May alter lenacapavir level.Use of efavirenz, nevirapine, or tipranavir–ritonavir may decrease lenacapavir levels and increase risk for resistance. Use with atazanavir–cobicistat or atazanavir–ritonavir may increase lenacapavir levels. Concomitant administration with any of these agents isn’t recommended.Combined P-glycoprotein (P-gp), UGT1A1, and strong CYP3A inhibitors (cobicistat, atazanavir): May significantly increase lenacapavir levels. Use together isn’t recommended.Corticosteroids, systemic (dexamethasone, hydrocortisone/cortisone): may increase systemic corticosteroid levels and increase risk of Cushing syndrome and adrenal suppression. Initiate with lowest starting dose and titrate carefully while monitoring for safety.CYP3A substrates: Lenacapavir may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last subcut dose of lenacapavir, increasing the risk of adverse reactions. See prescribing information of sensitive CYP3A substrate for dosing with moderate inhibitors of CYP3A.Digoxin: May increase digoxin levels. Use cautiously and monitor digoxin therapeutic concentration.Direct oral anticoagulants (rivaroxaban, dabigatran, edoxaban): May increase direct oral anticoagulants. Refer to the anticoagulant prescribing information for administration with combined moderate CYP3A and P-gp inhibitors.Ergot derivatives (dihydroergotamine, ergotamine, methylergonovine): May increase levels of ergot derivatives. Use together isn’t recommended.HMG-CoA reductase inhibitors (lovastatin, simvastatin): May increase levels of these statins. Initiate statins at lowest starting dose and titrate carefully while monitoring for safety.Midazolam (oral), triazolam: May increase levels of these drugs. Use cautiously together.Moderate CYP3A inducers (efavirenz): May significantly decrease lenacapavir levels and increase risk of resistance to lenacapavir. Use together isn’t recommended.Naloxegol: May increase naloxegol level. Avoid use together; if unavoidable, decrease dosage of naloxegol and monitor for adverse reactions.Narcotic analgesic for treatment of opioid dependence (buprenorphine, methadone): Effects of coadministration are unknown. Carefully titrate the dose of buprenorphine or methadone to desired effect; use the lowest possible initial or maintenance dose. In patients currently taking buprenorphine or methadone, a dose adjustment may be needed when lenacapavir is started. Monitor clinical signs and symptoms.Narcotic analgesics metabolized by CYP3A (fentanyl, oxycodone): May increase levels of these narcotics. Monitor closely for effects and adverse reactions.PDE-5 inhibitors (sildenafil, tadalafil, vardenafil): When used for pulmonary arterial hypertension, use with lenacapavir and tadalafil isn’t recommended. When used for erectile dysfunction, refer to the prescribing information of PDE5 inhibitors for dose recommendations.Strong CYP3A inducers (rifampin): May significantly decrease lenacapavir levels and increase risk of resistance to lenacapavir. Use together is contraindicated.Tramadol: May increase tramadol levels. Consider a decrease in tramadol dose.Drug-herb. St. John’s wort: May decrease lenacapavir levels. Use together is contraindicated.ADVERSE REACTIONSGI: nausea.GU: elevated creatinine levels, glycosuria, proteinuria.Hepatic: increased AST, ALT, and direct bilirubin levels.Metabolic: hyperglycemia.Skin: injection site reactions (swelling, pain, discomfort, erythema, nodule, induration, pruritus, extravasation, mass, hematoma, edema, ulcer).Reactions in bold italics are life-threatening.Released: April 2023Nursing Drug Handbook© 2023 Wolters KluwerpirtobrutinibJaypircaPharmaceutical company: Eli Lilly and CompanyPharmacologic classification:Kinase inhibitorTherapeutic classification:AntineoplasticAVAILABLE FORMSTablets: 50 mg, 100 mgINDICATIONS AND DOSAGESRelapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitorAdults: 200 mg PO once daily until disease progression or unacceptable toxicity occurs.Adjust-a-dose:Refer to the manufacturer’s instructions for toxicity-related dosage adjustments. If severely reduced GFR (eGFR 15 to 29 mL/min) and the current dose is 200 mg once daily, reduce the dose to 100 mg once daily; otherwise reduce the dose by 50 mg. If the current dosage is 50 mg once daily, discontinue the drug. If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the pirtobrutinib dose by 50 mg. If the current dosage is 50 mg once daily, interrupt pirtobrutinib treatment for the duration of strong CYP3A inhibitor use. After discontinuation of a strong CYP3A inhibitor for 5 half-lives, resume the pirtobrutinib dose taken prior to initiating the inhibitor. If concomitant use with a moderate CYP3A inducer is unavoidable and the current dosage of pirtobrutinib is 200 mg once daily, increase the dose to 300 mg. If the current pirtobrutinib dose is 50 mg or 100 mg once daily, increase the dose by 50 mg.CONTRAINDICATIONS AND CAUTIONSFatal and serious bacterial, viral, fungal, and opportunistic infections have occurred. Consider prophylaxis (vaccinations, antimicrobials) in patients at increased risk for infections.Fatal and serious hemorrhage has occurred. Consider withholding the drug for 3 to 7 days pre- and post-surgery depending upon the type of surgery and risk of bleeding.Use cautiously in patients with cardiac risk factors (hypertension, previous arrhythmias); this drug may increase the risk of development of atrial fibrillation or flutter.Use cautiously in older adults.Safety and effectiveness of this drug have not been established in children.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONBased on animal studies, this drug can cause fetal harm.Females of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.There are no data on the presence of this drug in human milk or the effects on the breastfed child or milk production. Patients shouldn’t breastfeed during treatment and for 1 week after the last dose.INTERACTIONSDrug-drug. Antithrombotic agents (heparin, warfarin, apixaban): May increase risk of bleeding. Use cautiously together.CYP2C8 (repaglinide), CYP2C19 (omeprazole), CYP3A (midazolam), P-glycoprotein (digoxin), or BCRP (rosuvastatin) substrates: May increase level of sensitive substrates and the risk of substrate-related adverse reactions. Follow recommendations for sensitive substrates provided in their product labeling.Strong CYP3A inhibitors (itraconazole): May increase pirtobrutinib level and risk of adverse reactions. Avoid use together. If unavoidable, reduce the pirtobrutinib dose.Strong or moderate CYP3A inducers (rifampin, bosentan, efavirenz): May decrease pirtobrutinib level and efficacy. Avoid use together. If concomitant use is unavoidable, increase the dose of pirtobrutinib.Drug-lifestyle. Sunlight: May increase risk of new skin cancer or other cancers. Use sun protection.ADVERSE REACTIONSCNS: fatigue, fever, peripheral neuropathy, dizziness.CV: edema, hemorrhage, atrial fibrillation, atrial flutter.GI: diarrhea, constipation, abdominal pain, nausea.GU: increased creatinine level,Hematologic: bruising, anemia, neutropenia, thrombocytopenia, lymphocytopenia, transient lymphocytosis.Hepatic: increased transaminases, increased alkaline phosphatase.Metabolic: hypocalcemia, hypokalemia, hyponatremia, hyperkalemia, increased lipase.Musculoskeletal: musculoskeletal pain, arthritis, arthralgia.Respiratory: dyspnea, cough, pneumonia, upper respiratory infection, pleural effusion.Skin: rash.Other: sepsis, infection, second primary malignancy.Reactions in bold italics are life-threatening.Released: April 2023Nursing Drug Handbook© 2023 Wolters Kluwer Download these updates as a PDF
New FDA Drug Approvals - March 2023
adagrasibKrazatiPharmaceutical company: Mirati TherapeuticsPharmacologic classification: KRAS inhibitorTherapeutic classification: AntineoplasticAVAILABLE FORMSTablets: 200 mgINDICATIONS AND DOSAGESKRAS G12C-mutated locally advanced or metastatic non–small-cell lung cancer in patients who have received at least one prior systemic therapyAdults: 600 mg PO b.i.d. until disease progression or unacceptable toxicity.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments. First dose reduction for adverse reactions is to 400 mg PO b.i.d.; second dose reduction is to 600 mg PO daily. Permanently discontinue drug if patients can’t tolerate 600 mg per day.CONTRAINDICATIONS AND CAUTIONSThis drug may increase the risk of QTc interval prolongation and risk for tachyarrhythmias, torsades de pointes, and sudden death. Avoid use in patients with congenital QT syndrome.Use cautiously in patients with heart failure, bradyarrhythmias, electrolyte abnormalities, and patients unable to avoid taking medication known to prolong the Qt interval.Safety and effectiveness haven’t been established in children.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThere are no available data on the use of this drug during pregnancy.Because of the potential for adverse reactions in a breastfed child, patients shouldn’t breastfeed during treatment and for 1 week after the last dose.This drug may impair fertility.INTERACTIONSDrug-drug. Drugs that prolong QT interval (amiodarone, levofloxacin, fluoxetine, haloperidol, methadone): May prolong the QT interval. Avoid use together.Sensitive CYP2C9 or CYP2D6 substrates or P-glycoprotein substrates (warfarin, dextromethorphan, digoxin): May increase substrate level. Avoid use together where minimal concentration changes may lead to serious adverse reactions.Sensitive CYP3A4 substrates (midazolam): May increase CYP3A substrate level. Avoid use together.Strong CYP3A4 inducers (rifampin): May reduce adagrasib level. Avoid use together.Strong CYP3A4 inhibitors (itraconazole): May increase adagrasib level. Avoid concomitant use until adagrasib concentrations have reached steady state (after approximately 8 days).Drug-herb. St. John’s wort: May reduce adagrasib concentrations. Avoid use together.ADVERSE REACTIONSCNS: fatigue, dizziness, fever, mental status changes.CV: edema, QT prolongation, heart failure, hypotension, pulmonary embolism.GI: diarrhea, nausea, vomiting, constipation, abdominal pain, decreased appetite, GI bleeding, GI obstruction.GU: abnormal kidney function.Hematologic: anemia, leukopenia, lymphopenia, neutropenia, thrombocytopenia.Hepatic: hepatotoxicity, increased liver enzymes, decreased albumin.Metabolic: hyponatremia, hypokalemia, increased lipase, increased amylase, hypomagnesemia, dehydration, decreased weight.Musculoskeletal: musculoskeletal pain, muscular weakness.Respiratory: dyspnea, cough, pneumonia, interstitial lung disease, interstitial pneumonitis, hypoxia, pleural effusion, respiratory failure, pulmonary hemorrhage.Other: sepsis, sudden death.  Reactions in bold italics are life-threatening.Released: March 2023Nursing Drug Handbook© 2023 Wolters Kluwer olutasidenibRezlidhiaPharmaceutical company: Rigel Pharmaceuticals, Inc.Pharmacologic classification: Isocitrate dehydrogenase-1 (IDH1) inhibitorTherapeutic classification: AntineoplasticAVAILABLE FORMSCapsules: 150 mgINDICATIONS AND DOSAGESRelapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 mutationAdults: 150 mg PO b.i.d. until disease progression or unacceptable toxicity. If there is no disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response.Adjust-a-dose: Refer to the manufacturer’s instruction for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: Differentiation syndrome, which can be fatal, can occur. If differentiation syndrome is suspected, withhold drug and initiate corticosteroids and hemodynamic monitoring until symptoms resolve.This drug may increase the risk of hepatotoxicity. Use cautiously in patients with mild or moderate hepatic impairment. Use in patients with severe hepatic impairment hasn’t been established. Safety and effectiveness in children haven’t been established.Older adults have an increased risk of hepatotoxicity and hypertension compared to younger individuals.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm.It’s unknown if this drug is excreted in human milk. Patients shouldn’t breastfeed during and for 2 weeks after treatment.INTERACTIONSDrug-drug. Moderate or strong CYP3A inducers (phenytoin, dexamethasone, rifampin): May decrease olutasidenib levels. Avoid use together.Sensitive CYP3A substrates (digoxin, sirolimus): May decrease levels of substrates. Avoid concomitant use; if unavoidable, monitor for loss of therapeutic effects of these drugs.ADVERSE REACTIONSCNS: fatigue, malaise, fever, headache.CV: edema, hypertension.GI: nausea, constipation, mucositis, diarrhea, abdominal pain, vomiting, decreased appetite, gallbladder disorders.GU: increased creatinine.Hematologic: leukocytosis, increased lymphocytes.Hepatic: hepatotoxicity, elevated transaminases, increased bilirubin, increased alkaline phosphatase.Metabolic: hypokalemia, hypophosphatemia, increased lipase, increased uric acid, hyponatremia.Musculoskeletal: arthralgia.Respiratory: dyspnea, cough.Skin: rash.Other: differentiation syndrome. Reactions in bold italics are life-threatening.Released: March 2023Nursing Drug Handbook© 2023 Wolters Kluwer Download these updates as a PDF
New FDA Drug Approvals - January 2023
sodium phenylbutyrate and taurursodiolAlbrioza (Canadian), RelyvrioPharmaceutical company: AmylyxPharmacologic classification:Histone deacetylase inhibitor, hydrophilic bile acidTherapeutic classification:Miscellaneous CNS drugAVAILABLE FORMSOral suspension: 3 g sodium phenylbutyrate and 1 g taurursodiol in single-dose packetINDICATIONS AND DOSAGESAmyotrophic lateral sclerosisAdults: Initially, one packet PO daily for 3 weeks. Then, increase to the maintenance dose of one packet b.i.d.CONTRAINDICATIONS AND CAUTIONSAvoid use in those with moderate or severe hepatic impairment and abnormal kidney function.Use cautiously in those with disorders that interfere with bile acid circulation, disorders of enterohepatic circulation (biliary infection, active cholecystitis), severe pancreatic disorders (pancreatitis), and intestinal disorders that may alter concentrations of bile acids (ileal resection, regional ileitis).Use cautiously in patient’s sensitive to salt intake such as those with HF, abnormal kidney function, or other conditions associated with sodium retention because of the high sodium content of this drug.Safety and effectiveness in children haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no data on the use in pregnant patients.It’s unknown if this drug is present in human milk. The risks and benefits should be considered.INTERACTIONSDrug-drug. Aluminum-based antacids: May interfere with taurursodiol absorption. Avoid use together; consider other acid-lowering agents.Bile acid sequestering agents (cholestyramine, colestipol, colesevelam): May decrease taurursodiol absorption. Avoid use together. Consider alternative cholesterol-lowering agents.CYP1A2, CYP2B6, CYP3A4 substrates (ramelteon, bupropion, aminophylline): May decrease level of these isoenzymes. Avoid use to together when a small change in substrate plasma level may lead to serious toxicities or loss of efficacy.CYP2C8 and CYP2B6 substrates (repaglinide): May increase level of these substrates. Avoid use together when a small change in substrate plasma level may lead to serious toxicities or loss of efficacy.Histone deacetylace (HDAC) inhibitor (phenylbutyrate): May increase risk of adverse effects as this drug contains phenylbutyrate. Avoid use of other HDAC inhibitors, because of additive effects.Inhibitors of bile acid transporters (cyclosporine): May exacerbate accumulation of conjugated bile salts in the liver and result in clinical symptoms. Avoid use together; if concomitant use with strong inhibitor is necessary, use caution and monitor serum transaminases and bilirubin.OATP1B3 inhibitors (rifampicin, pioglitazone): May increase level of taurursodiol. Avoid use together.OAT1 substrates (adefovir, tenofovir, statins): May increase levels of OAT1 substrates. Avoid use of together.P-glycoprotein and BCRP substrates (digoxin, methotrexate, rosuvastatin): May increase levels of these substrates. Avoid use together when a small change in substrate levels may lead to serious toxicities or loss of efficacy with this drug.Probenecid: May affect kidney excretion of sodium phenylbutyrate metabolites. Avoid use together.Strong CYP3A4 inducers (phenytoin, rifampin): May decrease taurursodiol level. Monitor use together.ADVERSE REACTIONSCNS: Fatigue, dizziness.EENT: Salivary hypersecretion.GI: Diarrhea, abdominal pain, nausea.Respiratory: URI.Reactions in bold italics are life-threatening.Released: January 2023Nursing Drug Handbook© 2023 Wolters KluwerDownload these updates as a PDF
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