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New FDA Drug Approvals - July 2025

guselkumab

Tremfya

Pharmaceutical company: Janssen Biotech, Inc

Pharmacologic classification: Immunomodulators

Therapeutic classification: Interleukin 23 receptor antagonists


AVAILABLE FORMS

Injection (IV): 200 mg/20 ml single-dose vial
Injection (subcut): 100 mg/1 mL single-dose patient-controlled injector, or prefilled pen or syringe; 200 mg/2 mL single dose prefilled pen or syringe


INDICATIONS AND DOSAGES

Moderate to severely active Crohn disease

Adults Induction dose of 200-mg IV infusion or 400 mg subcut (given as two consecutive injections of 200 mg each) at week 0, week 4, and week 8. Then, maintenance doses of either 100 mg subcut at week 16, then every 8 weeks thereafter; or 200 mg subcut at week 12, then every 4 weeks thereafter. Use the lowest effective recommended dosage to maintain therapeutic response.

Moderate to severe plaque psoriasis

Adults 100 mg subcut at week 0, week 4, and every 8 weeks thereafter.

Active psoriatic arthritis

Adults 100 mg subcut at week 0, week 4, and every 8 weeks thereafter. May be administered alone or in combination with a conventional disease-modifying antirheumatic drug such as methotrexate.

Moderate to severe ulcerative colitis

Adults Induction dose of 200 mg IV infusion at week 0, week 4, and week 8. Then, maintenance doses of either 100 mg subcut at week 16, then every 8 weeks thereafter, or 200 mg subcut at week 12, then every 4 weeks thereafter. Use the lowest effective recommended dosage to maintain therapeutic response.


ADVERSE REACTIONS

CNS: fatigue, headache.
GI: abdominal pain, diarrhea, gastroenteritis.
Hematologic: neutropenia.
Hepatic: increased LFTs.
Musculoskeletal: arthralgia.
Respiratory: bronchitis, URI.
Skin: rash, tinea infections.
Other: herpes simplex infections, injection site reactions.
 

INTERACTIONS

Drug-drug.. CYP450 substrates with a narrow therapeutic index (phenytoin, repaglinide warfarin): May alter substrate levels. Monitor for therapeutic effect or drug concentration and consider dosage adjustment as needed.
Live vaccines: May increase risk of infections. Avoid use together.


CONTRAINDICATIONS AND CAUTIONS

  • Contraindicated in patients with serious hypersensitivity to the drug or any of its components.
  • Treatment shouldn't be started in patients with active infections until the infection resolves or is adequately treated.
  • Use cautiously in patients with a chronic infection or history of recurrent infection due to increased risk of infection.
  • Drug induced liver toxicity has been reported. Consider other treatment options in patients with acute liver disease or cirrhosis.
  • Safety and effectiveness of this drug haven't been established in children.
  • Dialyzable drug: Unlikely.


PREGNANCY-LACTATION-REPRODUCTION

  • Studies during pregnancy are inadequate. Humanized monoclonal antibodies, like guselkumab, cross the placenta.
  • Patient enrollment in pregnancy exposure registry is encouraged. (www.mothertobaby.org/ongoing-study/tremfya-guselkumab, 1-866-626-6847).
  • It's unknown if this drug appears in human milk or how drug affects milk production or infants who are breastfed. Weigh benefit to patient against risk to infant before use.
Reactions in bold italics are life-threatening.

Released: July 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer

 

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New FDA Drug Approvals Archive

New FDA Drug Approvals - July 2025
guselkumabTremfyaPharmaceutical company: Janssen Biotech, IncPharmacologic classification: ImmunomodulatorsTherapeutic classification: Interleukin 23 receptor antagonistsAVAILABLE FORMSInjection (IV): 200 mg/20 ml single-dose vialInjection (subcut): 100 mg/1 mL single-dose patient-controlled injector, or prefilled pen or syringe; 200 mg/2 mL single dose prefilled pen or syringeINDICATIONS AND DOSAGESModerate to severely active Crohn diseaseAdults Induction dose of 200-mg IV infusion or 400 mg subcut (given as two consecutive injections of 200 mg each) at week 0, week 4, and week 8. Then, maintenance doses of either 100 mg subcut at week 16, then every 8 weeks thereafter; or 200 mg subcut at week 12, then every 4 weeks thereafter. Use the lowest effective recommended dosage to maintain therapeutic response.Moderate to severe plaque psoriasisAdults 100 mg subcut at week 0, week 4, and every 8 weeks thereafter.Active psoriatic arthritisAdults 100 mg subcut at week 0, week 4, and every 8 weeks thereafter. May be administered alone or in combination with a conventional disease-modifying antirheumatic drug such as methotrexate.Moderate to severe ulcerative colitisAdults Induction dose of 200 mg IV infusion at week 0, week 4, and week 8. Then, maintenance doses of either 100 mg subcut at week 16, then every 8 weeks thereafter, or 200 mg subcut at week 12, then every 4 weeks thereafter. Use the lowest effective recommended dosage to maintain therapeutic response.ADVERSE REACTIONSCNS: fatigue, headache.GI: abdominal pain, diarrhea, gastroenteritis.Hematologic:neutropenia.Hepatic: increased LFTs.Musculoskeletal: arthralgia.Respiratory: bronchitis, URI.Skin: rash, tinea infections.Other: herpes simplex infections, injection site reactions.  INTERACTIONSDrug-drug.. CYP450 substrates with a narrow therapeutic index (phenytoin, repaglinide warfarin): May alter substrate levels. Monitor for therapeutic effect or drug concentration and consider dosage adjustment as needed.Live vaccines: May increase risk of infections. Avoid use together.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with serious hypersensitivity to the drug or any of its components.Treatment shouldn't be started in patients with active infections until the infection resolves or is adequately treated.Use cautiously in patients with a chronic infection or history of recurrent infection due to increased risk of infection.Drug induced liver toxicity has been reported. Consider other treatment options in patients with acute liver disease or cirrhosis.Safety and effectiveness of this drug haven't been established in children.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONStudies during pregnancy are inadequate. Humanized monoclonal antibodies, like guselkumab, cross the placenta.Patient enrollment in pregnancy exposure registry is encouraged. (www.mothertobaby.org/ongoing-study/tremfya-guselkumab, 1-866-626-6847).It's unknown if this drug appears in human milk or how drug affects milk production or infants who are breastfed. Weigh benefit to patient against risk to infant before use. Reactions in bold italics are life-threatening.Released: July 2025Nursing Drug Handbook© 2025 Wolters Kluwer  Download these updates as a PDF
New FDA Drug Approvals - June 2025
crinecerfontCrenessityPharmaceutical company: Neurocrine Biosciences, Inc.Pharmacologic classification: Corticotropin-releasing factor (CRF) type 1 receptor antagonistsTherapeutic classification: endocrine-metabolic agentsAVAILABLE FORMSCapsules: 25 mg; 50 mg; 100 mgOral solution: 50 mg/mLINDICATIONS AND DOSAGESAdjunctive treatment to glucocorticoid replacement to control androgens in classic congenital adrenal hyperplasiaAdults and children ages 4 years and older weighing 55 kg or more: 100 mg PO b.i.d. with morning and evening meals.Children ages 4 years and older weighing 20 kg to less than 55 kg: 50 mg PO b.i.d. with morning and evening meals.Children ages 4 years and older weighing 10 kg to less than 20 kg: 25 mg PO b.i.d. with morning and evening meals.Adjust-a-dose: If used together with a strong CYP3A4 inducer, double both the morning and evening dose. If used together with a moderate CYP3A4 inducer, double only the evening dose.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with hypersensitivity to crinecerfont or its components.Hypersensitivity reactions (throat tightness, angioedema, generalized rash) may occur.Continue glucocorticoids upon initiation of and during treatment with crinecerfont. Don't reduce the glucocorticoid dose below that required for cortisol replacement.Alert: Potentially fatal or life-threatening acute adrenal insufficiency or adrenal crisis may occur in patients with underlying adrenal insufficiency on inadequate daily glucocorticoid doses, especially in situations associated with increased cortisol need such as acute illness, serious trauma, or surgical procedures.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONStudies during pregnancy are inadequate.If a patient is pregnant or becomes pregnant while taking crinecerfont, report the drug exposure by calling 1-855-CRNSITY (1-855-276-7489).There are no data on the presence of crinecerfont in human milk or its effects on the breastfed infant or on milk production. Before initiating breastfeeding, consider patient's clinical need and risk to the infant.Monitor breastfed infants for signs of adrenal insufficiency (weakness, decreased feeding, weight loss).INTERACTIONSDrug-drug. Moderate and strong 3YP3A4 inducers (rifampin, ketoconazole): May decrease crinecerfont level and efficacy. Increase crinecerfont dosage according to manufacturer's instructions.ADVERSE REACTIONSCNS: fatigue, headache, dizziness, suicidal ideation.EENT: nasal congestion, epistaxis.GI: decreased appetite, abdominal pain.Hematologic:neutropenia.Musculoskeletal: arthralgia, back pain, myalgia.Reactions in bold italics are life-threatening.  Released: June 2025Nursing Drug Handbook© 2025 Wolters Kluwer  suzetrigineJournavxPharmaceutical company: Vertex Pharmaceuticals Inc.Pharmacologic classification: Sodium channel blockersTherapeutic classification: AnalgesicsAVAILABLE FORMSTablets: 50 mgINDICATIONS AND DOSAGESModerate to severe acute painAdults: Initially, 100 mg PO. Starting 12 hours after the initial dose, 50 mg PO every 12 hours.Adjust-a-dose: For patients taking moderate CYP3A inhibitors or with Child-Pugh Class B liver impairment, initially 100 mg PO. Starting 12 hours after the initial dose, 50 mg PO every 12 hours for doses 2, 3, and 4. Thereafter, starting 12 hours after dose 4, 50 mg PO every 24 hours.CONTRAINDICATIONS AND CAUTIONSAvoid use in patients with Child-Pugh Class C liver impairment.Use cautiously in patients with Child-Pugh Class B liver impairment due to higher systemic exposure.Avoid use in patients with eGFR less than 15 mL/minute.The safety and effectiveness of suzetrigine has not been established in children.Use for the shortest duration consistent with treatment goals. Use hasn't been studied beyond 14 days.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONStudies during pregnancy are inadequate. Based on animal studies, drug may cause fetal harm.Patients using hormonal contraceptives containing progestins other than levonorgestrel and norethindrone should use an additional nonhormonal contraceptive or use alternative contraceptives during treatment and for 28 days after discontinuation of suzetrigine.It isn't known whether drug appears in human milk or how drug affects milk production or infants who are breastfed. Weigh benefit to patient against risk to infant before use.Drug may reversibly impact the fertility of patients of childbearing potential.INTERACTIONSDrug-drug. Progestins other than levonorgestrel and norethindrone: May decrease level of hormonal contraceptive. Use of nonhormonal contraception, intrauterine system or ethinyl estradiol and norethindrone or levonorgestrel during treatment and for 28 days after discontinuation of suzetrigine is recommended.Sensitive CYP3A substrates (midazolam) or CYP3A substrates where minimal changes in levels may lead to loss of efficacy (tacrolimus, warfarin): May reduce level of CYP3A substrate which may reduce efficacy. Refer to CYP3A substrate manufacturer instructions for dosing instruction and modification when initiating or discontinuing suzetrigine.Strong and moderate CYP3A inducers (carbamazepine, phenytoin, dexamethasone): May decrease suzetrigine and active metabolite levels and decrease their efficacy. Avoid concomitant use.Strong or moderate CYP3A inhibitors (ketoconazole lopinavir, amiodarone, cimetidine): May increase suzetrigine and active metabolite levels and increase risk of adverse reactions. Use with strong CYP3A inhibitors is contraindicated. Reduce suzetrigine dose when used with moderate CYP3A inhibitors.Drug-herb.St. John's wort: May decrease suzetrigine and active metabolite levels and decrease their efficacy. Discourage use together.Drug-food.Grapefruit, grapefruit juice: May increase suzetrigine level and risk of adverse reactions. Discourage use together.ADVERSE REACTIONSGI: nausea, vomiting.GU: decreased eGFR.Metabolic: increased CK level.Musculoskeletal: muscle spasms.Skin: pruritis, rash.Reactions in bold italics are life-threatening.  Released: June 2025Nursing Drug Handbook© 2025 Wolters Kluwer  treosulfanGrafapexPharmaceutical company: Medexus Pharma, Inc.Pharmacologic classification: Alkylating agentsTherapeutic classification: ImmunosuppressantsAVAILABLE FORMSPowder for injection: 1 g; 5 g single-dose vialsINDICATIONS AND DOSAGESA preparative agent, in combination with fludarabine, for allogeneic hematopoietic stem cell transplantation in patients with myelodysplastic syndrome or acute myeloid leukemiaAdults and children ages 1 and older: 10 g/m2 IV infusion daily for three days beginning on Day -4 through Day -2 before stem cell transplantation. Give fludarabine 30 mg/m2 IV infusion daily on Days -6 through Day -2.CONTRAINDICATIONS AND CAUTIONSBoxed Warning: Treosulfan causes severe and prolonged myelosuppression at recommended dosage. Hematopoietic stem cell transplantation is required to prevent potentially fatal complications of prolonged myelosuppression. Monitor hematologic laboratory parameters.Contraindicated in patients with hypersensitivity to any component of the drug product.Don't begin the preparative regimen without an available stem cell donor.Seizures have occurred in patients treated with treosulfan.An increase in skin disorders (rash, dermatitis) was observed when patients received sodium bicarbonate-containing hydration during treosulfan infusion.Alert:Treosulfan is carcinogenic and genotoxic with an increased risk of secondary malignancy. This risk is increased in patients with Fanconi anemia and other DNA breakage disorders. The safety and efficacy of treosulfan have not been established for patients with these disorders.Safety and effectiveness in children younger than 1 year haven't been established.Dialyzable drug: Unlikely.Overdose S&S: Severe myelosuppression and prolonged pancytopenia, mucositis, skin toxicity, nausea, vomiting, gastritis.PREGNANCY-LACTATION-REPRODUCTIONMay cause fetal harm; drug is genotoxic and affects dividing cells. Advise patients of fetal risk.Patients of childbearing potential should use effective contraception during treatment and for 6 months following the last dose.Male patients with partners of childbearing potential should use effective contraception during treatment and for 3 months after the last dose.It's unknown if treosulfan or its metabolites are excreted in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, breastfeeding isn't recommended during treatment with treosulfan and for 1 week after the last dose.May cause temporary or permanent infertility.INTERACTIONSDrug-drug. CYP2C19 substrates (midazolam, quinidine, sirolimus) or CYP3A4 substrates (phenytoin, warfarin) where minimal changes in levels may lead to toxicity: May increase level of substrates and cause serious or life-threatening toxicity. Monitor patient closely.ADVERSE REACTIONSCNS: fever, headache, fatigue, insomnia, confusion, agitation, paresthesia, dizziness, pain.CV: edema, HTN, hypotension, hemorrhage, tachycardia, HF, pericardial effusion, flushing, embolism.EENT: pharyngeal/laryngeal inflammation, oropharyngeal pain, dysphonia, oral pain, dry mouth, vertigo.GI: stomatitis, nausea, vomiting, diarrhea, abdominal pain, constipation, gastritis, dyspepsia, dysphagia, abdominal distension, decreased appetite.GU: increased creatinine, AKI, hematuria, urinary tract pain.Hematologic: febrile neutropenia, neutropenia, anemia, thrombocytopenia.Hepatic: increased LFTs, liver toxicity.Metabolic: decreased or increased weight, impaired glucose tolerance.Musculoskeletal: pain.Respiratory: pneumonitis, pleural effusion, dyspnea, cough, hiccups.Skin: rash, dermatitis, hand-foot syndrome, pruritus, erythema, dermatitis, skin hyperpigmentation, dry skin.Other: secondary malignancies, benign neoplasms, infection, chills, injection site reactions.Reactions in bold italics are life-threatening.  Released: June 2025Nursing Drug Handbook© 2025 Wolters Kluwer  vanzacaftor, tezacaftor, and deutivacaftorAlyftrekPharmaceutical company: Vertex Pharmaceuticals Inc.Pharmacologic classification: Cystic fibrosis transmembrane regulator proteinTherapeutic classification: Miscellaneous respiratory drugsAVAILABLE FORMSTablets: vanzacaftor 4 mg, tezacaftor 20 mg, and deutivacaftor 50 mg; vanzacaftor 10 mg, tezacaftor 50 mg, and deutivacaftor 125 mgINDICATIONS AND DOSAGESCystic fibrosis in patients who have at least one responsive mutation in the CFTR geneAdults and children ages 12 and older: Two tablets of vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg PO once daily.Children ages 6 to less than 12 years weighing 40 kg or more: Two tablets of vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg PO once daily.Children ages 6 to less than 12 years weighing less than 40 kg: Three tablets of vanzacaftor 4 mg/tezacaftor 20 mg/deutivacaftor 50 mg PO once daily.Adjust-a-dose: Refer to manufacturer's instructions for administration with strong or moderate CYP3A inhibitors.CONTRAINDICATIONS AND CAUTIONSBoxed Warning: Elevated transaminases have been observed. Serious and potentially fatal drug-induced liver injury and liver failure were reported in patients taking a drug containing elexacaftor, tezacaftor, and ivacaftor, which contains the same or similar active ingredients as vanzacaftor, tezacaftor, and deutivacaftor. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of elexacaftor/tezacaftor/ivacaftor.Boxed Warning: Vanzacaftor, tezacaftor, and deutivacaftor shouldn't be used in patients with Child-Pugh Class C liver impairment. Use isn't recommended in patients with Child-Pugh Class B liver impairment and should only be considered when there is a clear medical need, and the benefit outweighs the risk. If used, monitor patients closely.Use in patients with eGFR less than 30L/minute/1.73 m2 only if benefits outweigh risks.Hypersensitivity reactions, including anaphylaxis, have been reported with drugs containing elexacaftor, tezacaftor or ivacaftor.Non-congenital lens opacities have been reported in children treated with drugs containing ivacaftor (a CFTR protein). Baseline and follow-up ophthalmological examinations are recommended.Safety and effectiveness of Alyftrek in children younger than 6 years of age have not been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONStudies during pregnancy are inadequate. It isn't known if drug will cause fetal harm.There are no data on the presence of vanzacaftor, tezacaftor, or deutivacaftor or their metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. It is likely that the drug is present in human milk. Consider benefits of breastfeeding with the clinical needs of the patient and potential adverse effects in the infant.INTERACTIONSDrug-drug. BCRP substrates (cimetidine, glyburide, prazosin) CYP2C9 substrates (losartan, ibuprofen), P-gp substrates (apixaban, digoxin, tacrolimus): May increase substrate level and risk of substrate-related adverse reactions. Monitor for substrate-related adverse reactions.Strong or moderate CYP3A inducers (carbamazepine, phenytoin, rifampin): May decrease levels of vanzacaftor, tezacaftor, and deutivacaftor and reduce effectiveness. Use together isn't recommended.Strong or moderate CYP3A inhibitors (erythromycin, ketoconazole, imatinib): May increase levels of vanzacaftor, tezacaftor, and deutivacaftor and the risk of adverse reactions. If use together can't be avoided, reduce the dose of vanzacaftor, tezacaftor, and deutivacaftor per manufacturer recommendations.Warfarin: May increase warfarin level. Monitor INR more frequently.Drug-food.Grapefruit, grapefruit juice: May increase level of vanzacaftor, tezacaftor and deutivacaftor and increase the risk of adverse reactions. Discourage use together.ADVERSE REACTIONSCNS: headache, fatigue.CV: increased BP.EENT: cataracts, nasopharyngitis, oropharyngeal pain, sinus congestion.Hepatic: increased transaminase levels.Metabolic: increased CK level.Respiratory: cough, URI.Skin: rash.Other: flu-like symptoms.Reactions in bold italics are life-threatening.  Released: June 2025Nursing Drug Handbook© 2025 Wolters Kluwer  Download these updates as a PDF
New FDA Drug Approvals - May 2025
revumenibRevuforjPharmaceutical company: Syndax PharmaceuticalsPharmacologic classification: Menin inhibitorTherapeutic classification: AntineoplasticAVAILABLE FORMSTablets: 25 mg, 110 mg, 160 mgINDICATIONS AND DOSAGESRelapsed or refractory acute leukemia with a lysine methyltransferase 2A gene translocationAdults and children ages 1 year and older weighing 40 kg or more: 270 mg PO b.i.d., or 160 mg PO b.i.d. if taken with strong CYP3A4 inhibitors, until disease progression, unacceptable toxicity, or for a minimum of 6 months.Adults and children ages 1 and older weighing less than 40 kg: 160 mg/m2 PO b.i.d., or 95 mg/m2 PO b.i.d. if taken with strong CYP3A4 inhibitors, until disease progression, unacceptable toxicity, or for a minimum of 6 months.Adjust-a-dose: If a strong CYP3A4 inhibitor is discontinued, increase the revumenib dose after at least 5 half-lives of the inhibitor to the recommended dosage without strong CYP3A4 inhibitors. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSBoxed Warning: This drug may cause potentially fatal differentiation syndrome. Symptoms include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusion, rapid weight gain or peripheral edema, acute kidney injury, and hypotension. Prior to initiating medication, reduce WBC count to less than 25 Gi/L. If differentiation syndrome is suspected, immediately start corticosteroid therapy and continuous hemodynamic monitoring until resolution. Interrupt medication if severe signs or symptoms persist more than 48 hours after the start of systemic corticosteroids, or if life-threatening symptoms occur. Restart steroids immediately if differentiation syndrome recurs after tapering the steroids. The median time to onset is 10 days.Alert: Revumenib can cause QT interval prolongation. Use cautiously in those with congenital QT prolongation, electrolyte imbalances, or heart failure.Concurrent use of standard intrathecal chemotherapy prophylaxis is recommended for those at risk for central nervous system relapse.Safety and effectiveness in children less than age 1 haven't been established.Older adults may have a greater incidence of QTc prolongation and edema compared to younger individuals.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm.Advise male and female patients of reproductive potential to use effective contraception during treatment and for 4 months after the last dose.It's unknown if this drug is present in human milk. Due to the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 1 week after the last dose.This drug may impair fertility.INTERACTIONSDrug-drug. Drugs that prolong QTc interval (amiodarone, clarithromycin, haloperidol): May increase risk of QT prolongation and its adverse reactions. Avoid use together; if not possible, obtain ECGs when initiating, during use, and as needed.Strong CYP3A4 inhibitors (itraconazole, posaconazole): May increase revumenib levels and cause adverse reactions. Reduce revumenib dosage as directed.Strong or moderate CYP3A4 inducers (dexamethasone, phenytoin, rifampin): May decrease revumenib levels, and increase risk of QT prolongation. Avoid use together.Drug-herb.St. John's wort: May decrease revumenib levels and increase risk of QT prolongation. Discourage use together.ADVERSE REACTIONSCNS: fatigue, headache, paresthesia, taste disorder, syncope.CV: hemorrhage, thrombosis, QT prolongation, edema, heart failure, pericardial effusion, ventricular tachycardia, cardiac arrest.EENT: cataract.GI: nausea, diarrhea, constipation, decreased appetite, abdominal pain.GU: kidney impairment, increased creatinine levels.Hematologic: febrile neutropenia, leukocytosis.Hepatic: increased AST, ALT, alkaline phosphatase levels.Metabolic: hyperphosphatemia, hypophosphatemia, hyperparathyroidism, hyperkalemia, hypokalemia, hypercholesterolemia, hypercalcemia, hyponatremia, hypertriglyceridemia.Musculoskeletal: pain.Respiratory: respiratory failure.Skin: rash.Other: infection, differentiation syndrome, hypersensitivity reaction.Reactions in bold italics are life-threatening.  Released: May 2025Nursing Drug Handbook© 2025 Wolters Kluwer  Download these updates as a PDF
New FDA Drug Approvals - April 2025
acoramidisAttrubyPharmaceutical company: BridgeBio Pharma, Inc.Pharmacologic classification: Transthyretin stabilizerTherapeutic classification: Miscellaneous cardiac drugAVAILABLE FORMSTablets: 356 mgINDICATIONS AND DOSAGESCardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis to reduce cardiovascular death and cardiovascular-related hospitalizationAdults: 712 mg PO b.i.d.CONTRAINDICATIONS AND CAUTIONSSafety and effectiveness in children haven't been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONUse during pregnancy hasn't been adequately studied. Use cautiously during pregnancy if the patient benefits outweigh the fetal risk.Report pregnancies during therapy to BridgeBio at 1-844-550-2246.It isn't known whether this drug appears in human milk or how the drug affects milk production or infants who are breastfed. Weigh the benefit to the patient against the risk to the infant before use.INTERACTIONSDrug-drug. CYP2C9 substrates (diclofenac, phenytoin, tamoxifen, tolbutamide, warfarin): May increase substrate level. Monitor therapy more frequently.UDP-glucuronosyltransferases and strong CYP3A inducers (glucocorticoids, rifampin, carbamazepine, phenobarbital, phenytoin): May decrease acoramidis level. Avoid use together.ADVERSE REACTIONSGI: diarrhea, upper abdominal pain.GU: increased creatinine, decreased estimated GFR.  Reactions in bold italics are life-threatening.  Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer  landiololRapiblykPharmaceutical company: AOP Orphan PharmaceuticalsPharmacologic classification: Beta blockerTherapeutic classification: AntiarrhythmicAVAILABLE FORMSPowder for injection: 280 mg in a single-dose vialINDICATIONS AND DOSAGESShort-term reduction of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutterAdults: Initially, 9 mcg/kg/minute continuous IV infusion. Adjust infusion rate every 10 minutes, as needed, for heart rate control in increments of 9 mcg/kg/minute. Maximum, 36 mcg/kg/minute dose.Adjust-a-dose: For patients with impaired cardiac function, start at 1 mcg/kg/minute continuous IV infusion. Adjust infusion rate every 15 minutes, as needed, in increments of 1 mcg/kg/minute. Maximum, 36 mcg/kg/minute. Titrate cautiously in patients with Child-Pugh class A liver impairment. To transition to a PO beta-blocker, reduce the infusion rate by 50% 10 minutes after the PO dose. Discontinue landiolol if heart rate control is maintained for at least 1 hour.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients hypersensitive to the drug or any of its components.Contraindicated in patients with severe sinus bradycardia, sick sinus syndrome, heart block greater than first degree, decompensated heart failure, cardiogenic shock, or pulmonary hypertension.This drug may depress myocardial contractility and precipitate heart failure and cardiogenic shock.Use cautiously in patients at risk for hypotension, including those with hemodynamic compromise or hypovolemia, or in those on interacting medications.Use cautiously in patients with first-degree AV block, sinus node dysfunction, or conduction disorders. This drug may increase the risk of bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest.Use cautiously in patients with reactive airway disease, diabetes, hypoglycemia, Prinzmetal angina, pheochromocytoma, and peripheral circulatory disorders.Use cautiously in patients with Child-Pugh class A liver impairment. Avoid use in Child-Pugh class B or C liver impairment.Use cautiously in patients with kidney impairment. This drug may cause hyperkalemia and hyperkalemic renal tubular acidosis.Patients at risk for anaphylactic reactions may be more reactive to allergen exposure and may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.Safety and effectiveness of this drug haven't been established in children.Dialyzable drug: Unknown.Overdose S&S: Bradycardia, AV block, junctional rhythms, intraventricular conduction delays, decreased cardiac contractility, hypotension, cardiac failure including cardiogenic shock, cardiac arrest, pulseless electrical activity, respiratory depression, seizures, sleep and mood disturbances, fatigue, lethargy, coma, bronchospasm, hyperkalemia, hypoglycemia.PREGNANCY-LACTATION-REPRODUCTIONStudies during pregnancy are inadequate. Avoid used during pregnancy.This drug crosses the placenta. Monitor neonates exposed to landiolol during pregnancy and labor for hypotension, hypoglycemia, bradycardia, and respiratory depression.It's unknown if this drug is excreted in human milk. Other beta-antagonists are detected in human milk. Monitor the breastfed infant for bradycardia and other symptoms of beta blockade, such as lethargy and hypoglycemia.INTERACTIONSDrug-drug. Catecholamine-depleting drugs (reserpine, MAO inhibitors): May have an additive effect when given with landiolol and increase the risk of hypotension, bradycardia-related vertigo, syncope, or postural hypotension. Avoid use together.Negative inotropes and medications that slow heart rate or cardiac conduction (calcium channel blockers [verapamil], beta blockers): May increase risk of bradycardia or heart block. Avoid use together.Positive inotropes, vasoconstrictors (digoxin, dobutamine): May decrease heart rate and blood pressure lowering effect of landiolol. Avoid use together.Sympathomimetics (dopamine, epinephrine, isoproterenol): May decrease heart rate lowering effect of landiolol. Avoid use together.ADVERSE REACTIONSCV: hypotension, bradycardia.Reactions in bold italics are life-threatening.  Released: April 2025Nursing Drug Handbook© 2025 Wolters Kluwer  Download these updates as a PDF
New FDA Drug Approvals - March 2025
sulopenem etzadroxil and probenecidOrlynvahPharmaceutical company: Iterum TherapeuticsPharmacologic classification: Penem antibiotic and renal tubular transport inhibitorTherapeutic classification: AntibioticAVAILABLE FORMSTablets: 500 mg sulopenem etzadroxil and 500 mg probenecidINDICATIONS AND DOSAGESUncomplicated UTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in patients with limited or no alternative oral antibacterial treatmentAdult females: One tablet PO b.i.d. for 5 days.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with a history of hypersensitivity to sulopenem, probenecid, or other beta-lactams. Serious hypersensitivity reactions, including anaphylaxis and skin reactions, have been reported with beta-lactam antibacterial drugs. Severe hypersensitivity reactions, including anaphylaxis, have occurred with the use of probenecid.Evaluate the patient for a history of hypersensitivity reactions to other carbapenems, cephalosporins, penicillins, or other beta-lactams, because cross-sensitivity has been reported.Contraindicated in patients with known blood dyscrasias or uric acid kidney stones.Use isn't recommended in patients with creatinine clearance less than 15 mL/minute.This drug may cause Clostridioides difficile-associated diarrhea, ranging in severity from mild diarrhea to fatal colitis, which may occur more than 2 months after administration. If c. difficile-associated diarrhea is suspected or confirmed, the drug may need to be discontinued, and appropriate treatment begun.Use cautiously in patients with a history of gout. To avoid exacerbation of gout, ensure appropriate therapy for gout is initiated during treatment with sulopenem and probenecid.This drug isn't indicated for initial treatment or for step-down treatment after IV therapy of complicated infections.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONStudies on the use of sulopenem during pregnancy are inadequate. Maternal and fetal toxicity occurred in animal studies. Probenecid crosses the placental barrier.This drug is likely present in human milk. Use cautiously during breastfeeding.INTERACTIONSDrug-drug. Indomethacin, naproxen: May increase the level of these drugs and the risk of adverse effects. Adjust dosage of these drugs.Ketoprofen: May increase ketoprofen level. Avoid use together.Ketorolac tromethamine: May increase ketorolac level. Use together is contraindicated.Lorazepam: May increase lorazepam level. Adjust lorazepam dosage.Methotrexate: May increase methotrexate level. If use together can't be avoided, monitor closely for methotrexate-related adverse effects.OAT3 inhibitors (losartan, atorvastatin, ibuprofen, furosemide): May increase sulopenem level. If use together can't be avoided, closely monitor for adverse reactions.Oral sulfonylureas (glyburide, amaryl, glipizide): May increase antidiabetic effect. Monitor closely for hypoglycemia and adjust sulfonylurea dosage, as needed.Rifampin: May increase rifampin level. Monitor closely for rifampin-related adverse effects.ADVERSE REACTIONSCNS: headache.GI: diarrhea, nausea, vomiting, abdominal pain.GU: vulvovaginal mycotic infection.  Reactions in bold italics are life-threatening.  Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer  Download these updates as a PDF
New FDA Drug Approvals - January 2025
palopegteriparatideYorvipathPharmaceutical company: Ascendis PharmaPharmacologic classification: Parathyroid hormone analogTherapeutic classification: Endocrine & metabolic agentAVAILABLE FORMSInjection (prefilled pens): 168 mcg/0.56 mL delivering doses of 6, 9, or 12 mcg; 294 mcg/0.98 mL delivering doses of 15, 18, or 21 mcg; 420 mcg/1.4 mL delivering doses of 24, 27, or 30 mcgINDICATIONS AND DOSAGESHypoparathyroidismAdults: Initially, 18 mcg subcut once daily. Adjust in 3-mcg increments or decrements, to maintain serum calcium within normal range without the need for active vitamin D or therapeutic calcium doses. Don't increase dosage more often than every 7 days or decrease dosage more often than every 3 days. The recommended dosage range is 6 to 30 mcg once daily. Maximum, 30 mcg daily.Adjust-a-dose:  Adjust palopegteriparatide, active vitamin D, and calcium supplements based on albumin-corrected serum calcium and vitamin D level, according to the manufacturer's instructions. If albumin-corrected serum calcium is 12 mg/dL or greater, withhold palopegteriparatide for 2 to 3 days and then recheck serum calcium. If adequate response is not achieved with a maximum dosage of 30 mcg, consider adding or restarting calcium or active vitamin D therapy, or seek other treatment options.CONTRAINDICATIONS AND CAUTIONSContraindicated in those with severe hypersensitivity to the drug or its excipients.Due to the risk of osteosarcoma, this drug isn't recommended in patients with open epiphyses, unexplained elevations of alkaline phosphatase, bone metastases or a history of skeletal malignancies, history of external beam or implant radiation therapy involving the skeleton, hereditary disorders predisposing to osteosarcoma, or metabolic bone diseases other than hypoparathyroidism, including Paget disease of bone.This drug isn't approved for acute postsurgical hypoparathyroidism.Serious hypercalcemia requiring hospitalization has occurred with palopegteriparatide. The risk is highest after starting or increasing the dose of this drug but may occur at any time.Serious hypocalcemia has occurred with palopegteriparatide. The risk is highest when the drug is abruptly discontinued but may occur at any time.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies in pregnant patients. Hypocalcemia may cause an increased rate of spontaneous abortion, premature and dysfunctional labor, possibly fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica, and neonatal seizures.If the patient is or becomes pregnant while on this drug, health care providers should report exposure by calling 1-844-442-7236.Infants born to mothers with hypocalcemia should be monitored for signs of hypocalcemia or hypercalcemia, including neuromuscular irritability (myotonic jerks, seizures), apnea, cyanosis, and cardiac arrhythmias.There are no adequate studies of the use of this drug during breastfeeding, so use cautiously. Infants should be monitored for hypercalcemia or hypocalcemia.INTERACTIONSDrug-drug. Digoxin: May predispose patients who develop hypercalcemia to digitalis toxicity or may reduce digoxin efficacy if hypocalcemia is present. Use together cautiously. Measure digoxin levels, serum calcium, and monitor for digitalis toxicity. Adjust digoxin or palopegteriparatide dose as needed.Drugs that affect serum calcium (lithium, thiazide diuretics, estrogens): May alter palopegteriparatide efficacy. Measure serum calcium more frequently and adjust dose as needed, especially after these drugs are initiated, discontinued, or dose-adjusted.ADVERSE REACTIONSCNS: headache, dizziness, presyncope, syncope, vertigo.CV: orthostatic hypotension, palpitations, postural orthostatic tachycardiac syndrome.EENT: oropharyngeal pain.GI: diarrhea.Metabolic: hypercalcemia.Musculoskeletal: back, flank, or spinal pain.Skin: injection site reactions.Reactions in bold italics are life-threatening.  Released: January 2025Nursing Drug Handbook© 2025 Wolters Kluwer  xanomeline and trospium chlorideCobenfyPharmaceutical company: Bristol Myers-SquibbPharmacologic classification: Anticholinergic and cholinergic agonistsTherapeutic classification: AntipsychoticsAVAILABLE FORMSCapsules:  50 mg xanomeline and 20 mg trospium; 100 mg xanomeline and 20 mg trospium; 125 mg xanomeline and 30 mg trospiumINDICATIONS AND DOSAGESSchizophreniaAdults: Initially, 50 mg xanomeline and 20 mg trospium PO b.i.d. for at least 2 days, then increase to 100 mg xanomeline and 20 mg trospium b.i.d. for at least 5 days. May increase to a maximum dosage of 125 mg xanomeline and 30 mg trospium b.i.d. based on tolerance and response.Adjust-a-dose:  For older adults, consider a slower titration and maximum dosage of 100 mg xanomeline and 20 mg trospium b.i.d.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with a history of hypersensitivity to xanomeline or trospium chloride. Angioedema has been reported with trospium chloride.Contraindicated in patients with urinary retention, Child-Pugh class B or C liver impairment, gastric retention, or untreated narrow-angle glaucoma.Use cautiously in older adults, patients with significant bladder outlet obstruction or incomplete bladder emptying (BPH, diabetic cystopathy) as they may be at an increased risk for urinary retention.Not recommended in patients with Child-Pugh class A liver impairment, estimated GFR less than 60 mL/minute, or active biliary disease, such as symptomatic gallstones.This drug may decrease GI motility. Use cautiously in patients with GI obstructive disorders, ulcerative colitis, intestinal atony, or myasthenia gravis because of the risk of gastric retention.Use cautiously in patients with narrow-angle glaucoma as pupillary dilation may occur triggering an acute angle closure attack.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONStudies during pregnancy are inadequate. Consider the risks of untreated schizophrenia to the patient (relapse, hospitalization, suicide, preterm birth) and the risk to the fetus. Maternal and fetal toxicity were seen in animal studies.Encourage patient enrollment in pregnancy exposure registry (1-866-961-2388 or https://womensmentalhealth.org/research/pregnancyregistry/atypicalantipsychotic/).No data are available on the presence of this drug in human milk, the effects on the breastfed infant, or on milk production. This drug is likely excreted in human milk. Consider the benefit of breastfeeding, the mother's clinical need for the drug, and potential adverse effects on the breastfed infant.INTERACTIONSDrug-drug. Antimuscarinic drugs (diphenhydramine, scopolamine): May increase the frequency or severity of adverse reactions. Monitor for anticholinergic adverse reactions.Drugs eliminated by active tubular secretion (cephalosporins, quinolone antibiotics, diuretics, antidiabetic agents, antiviral agents, some chemotherapy agents): May increase levels of trospium and the other drug competing for this elimination pathway. Use cautiously together and monitor for adverse reactions of both drugs.Oral sensitive CYP3A4 substrates (amiodarone, cyclosporine, warfarin) or P-gp substrates (digoxin, diltiazem, morphine, sirolimus): May increase level of substrates. Use cautiously together and monitor for adverse reactions of the substrates.Orally administered drugs: May decrease GI motility and alter absorption of some other oral drugs. Adjust dose of concomitantly administered drugs, as clinically needed.Strong inhibitors of CYP2D6 (paroxetine, bupropion): May increase xanomeline level. Use cautiously together and monitor for adverse reactions.ADVERSE REACTIONSCNS: dizziness, somnolence, extrapyramidal symptoms.CV: hypertension, tachycardia, orthostatic hypotension.EENT: dry mouth, blurred vision, salivary hypersecretion.GI: nausea, dyspepsia, constipation, vomiting, abdominal pain, diarrhea, gastroesophageal reflux disease.GU: urinary retention, UTI.Hepatic: elevated liver enzymes.Respiratory: cough.Reactions in bold italics are life-threatening.  Released: January 2025Nursing Drug Handbook© 2025 Wolters KluwerDownload these updates as a PDF 
New FDA Drug Approvals - December 2024
deuruxolitinibLeqselviPharmaceutical company: Sun Pharmaceutical IndustriesPharmacologic classification: Janus kinase (JAK) inhibitorTherapeutic classification: ImmunomodulatorAVAILABLE FORMSTablets:  8 mgINDICATIONS AND DOSAGESSevere alopecia areataAdults: 8 mg PO b.i.d.Adjust-a-dose:  Avoid or interrupt treatment for an absolute lymphocyte count less than 500 cells/mm3, absolute neutrophil count (ANC) less than 1,000 cells/mm3, hemoglobin less than 8 g/dL, or if the patient develops a serious or opportunistic infection. Begin or resume treatment when the absolute lymphocyte count is at least 500 cells/mm3, ANC is at least 1,000 cells/mm3, hemoglobin is at least 8 g/dL, or the infection is controlled.CONTRAINDICATIONS AND CAUTIONSThis drug is contraindicated for use in patients who are CYP2C9 poor metabolizers.Boxed Warning: This drug increases the risk of serious bacterial, fungal, viral, and opportunistic infections, including tuberculosis (TB), that may lead to hospitalization or death. Use isn't recommended in patients with active TB.Use cautiously in patients with a chronic or recurrent infection, a history of serious or opportunistic infections, or underlying conditions that may predispose to infection; or in patients who have been exposed to TB or who have resided or traveled in areas of endemic TB or endemic mycoses. Avoid use in patients with active, serious infections, including localized infections.Boxed Warning: A higher rate of all-cause mortality, including sudden CV death, was observed with another JAK inhibitor compared to tumor necrosis factor (TNF) blockers in the treatment of rheumatoid arthritis (RA). Deuruxolitinib isn't approved for use in RA.Boxed Warning: Malignancies have been reported with deuruxolitinib. Higher rates of lymphomas and lung cancers occurred with another JAK inhibitor versus TNF blockers in RA patients.Use cautiously in patients with a known malignancy (other than successfully treated nonmelanoma skin cancer), or in patients who develop a malignancy. Nonmelanoma skin cancers have been reported.Boxed Warning: Higher rates of major adverse CV events (CV death, MI, stroke) were observed with another JAK inhibitor compared to TNF blockers in patients with RA. Discontinue the drug if MI or stroke occurs.Use cautiously in patients with CV risk factors, and in current or past smokers.Boxed Warning: Thrombosis has occurred in patients treated with deuruxolitinib. Increased incidence of pulmonary embolism, and venous and arterial thrombosis has occurred with another JAK inhibitor versus TNF blockers. Avoid the drug in patients at increased risk for thrombosis.Use isn't recommended in patients with active hepatitis B or C virus.This drug isn't recommended for use in patients with an eGFR less than 30 mL/minute or Child-Pugh class C liver impairment.Safety and effectiveness in children haven't been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm. Pregnancy prevention is recommended. Report pregnancy to the manufacturer at 1-800-818-4555.It's unknown if this drug is present in human milk, or if the drug affects milk production or infants who are breastfed. Breastfeeding isn't recommended during treatment and for 1 day after the last dose.INTERACTIONSDrug-drug.Live vaccines: May enhance adverse effects and decrease therapeutic effect of live vaccines. Avoid live vaccines immediately before and during treatment.Moderate or strong CYP2C9 inhibitors (fluconazole, gemfibrozil): May increase deuruxolitinib level and risk of adverse effects. Use together is contra indicated.Potent immunosuppressants (other JAK inhibitors, biologic immunomodulators, cyclosporine): May increase immunosuppressive effects and risk for infection. Use together isn't recommended.Strong CYP3A, moderate or strong CYP2C9 inducers (rifampin, phenobarbital, dexamethasone): May decrease deuruxolitinib level and therapeutic effect. Avoid use together.Drug-herb. St. John's wort: May decrease drug level. Discourage use together.ADVERSE REACTIONSCNS: headache, fatigue.EENT: nasopharyngitis.Hematologic: anemia, neutropenia, lymphopenia, thrombocytosis.Metabolic: increased creatine kinase level, hyperlipidemia, weight gain.Skin: acne, skin and soft tissue infection.Other: herpes infection.Reactions in bold italics are life-threatening.  Released: December 2024Nursing Drug Handbook© 2024 Wolters Kluwer  vorasidenibVoranigoPharmaceutical company: Servier PharmaceuticalsPharmacologic classification: Isocitrate dehydrogenase (IDH)-1 and IDH-2 inhibitorsTherapeutic classification: AntineoplasticAVAILABLE FORMSTablets:  10 mg; 40 mgINDICATIONS AND DOSAGESGrade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, subtotal resection, or gross total resectionAdults and children ages 12 and older weighing 40 kg or more: 40 mg PO once daily until disease progression or unacceptable toxicity occurs.Children age 12 and older weighing less than 40 kg: 20 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. Permanently discontinue vorasidenib if the patient is unable to tolerate 10 mg once daily.CONTRAINDICATIONS AND CAUTIONSThis drug may cause elevations in liver transaminase levels and lead to liver failure, liver necrosis, and autoimmune hepatitis.Use cautiously in patients with creatine clearance of 40 mL/minute or less, patients on dialysis, or patients with Child-Pugh class C liver impairment; safety and effectiveness haven't been studied.Safety and effectiveness in children younger than age 12 haven't been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm.Females of reproductive potential and males with female partners of reproductive potential should use effective nonhormonal contraception during treatment and for 3 months after the last dose.It isn't known whether this drug appears in human milk or how the drug affects milk production or infants who are breastfed. Because of the risk of adverse reactions in the breastfed child, breastfeeding isn't recommended during treatment and for 2 months after the last dose.This drug may impair fertility. Effects weren't reversible in animal studies.INTERACTIONSDrug-drug. CYP3A substrates (amiodarone, sirolimus, warfarin): May decrease level of CYP3A substrate. Avoid use together where a minimal change in substrate level may lead to decreased therapeutic effect.Hormonal contraceptives: May decrease level of contraceptive and lead to contraceptive failure or increased breakthrough bleeding. If use together can't be avoided, use additional nonhormonal contraceptive methods.Moderate CYP1A2 inducers (phenytoin, rifampicin): May decrease vorasidenib level and antitumor activity. Avoid use together.Moderate or strong CYP1A2 inhibitors (ciprofloxacin, fluvoxamine): May increase vorasidenib level. Avoid use together. If use together can't be avoided, monitor for adverse reactions and adjust vorasidenib dose per manufacturer's instructions.Drug-lifestyle.Smoking (tobacco): May decrease vorasidenib level and antitumor activity. Discourage use together.ADVERSE REACTIONSCNS: fatigue, headache, seizures.GI: diarrhea, nausea, constipation, abdominal pain, decreased appetite.GU: increased creatinine.Hematologic: increased hemoglobin, decreased lymphocytes, decreased leukocytes, neutropenia, thrombocytopenia.Hepatic: increased liver function studies.Metabolic: hyperglycemia, hypocalcemia, hypophosphatemia, hyperkalemia.Musculoskeletal: pain.Other: COVID-19.Reactions in bold italics are life-threatening.  Released: December 2024Nursing Drug Handbook© 2024 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - November 2024
sofpironiumSofdraPharmaceutical company: Botanix PharmaceuticalsPharmacologic classification: AnticholinergicTherapeutic classification: Dermatologic agentAVAILABLE FORMSGel: 12.45%INDICATIONS AND DOSAGESPrimary axillary hyperhidrosisAdults and children ages 9 and older: Apply one pump actuation to each underarm once daily at bedtime.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with conditions exacerbated by anticholinergic effects, such as glaucoma, paralytic ileus, unstable CV status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, and Sjőgrens syndrome.Use cautiously in patients with a history of, or current, urinary retention.Transient blurred vision may occur, impairing the ability to perform activities that require clear vision.Safety and effectiveness in patients with kidney or liver impairment, or in children younger than 9 years haven't been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONStudies during human pregnancy are inadequate to inform risk. Adverse events were observed in some animal reproduction studies.This drug was found in animal milk during studies. It isn't known if the drug appears in human milk or how the drug affects milk production or infants who are breastfed. Weigh the benefits to the patient against the risk to the infant before use.INTERACTIONSDrug-drug.Anticholinergic agents (atropine, scopolamine, diphenhydramine):May increase anticholinergic adverse effects. Avoid use together.Strong CYP2D6 inhibitors (fluoxetine, bupropion): May increase sofpironium level and risk of anticholinergic adverse effects. Avoid use together.Drug-lifestyle.High environmental temperatures: May increase risk of heat-related illness. Avoid use if not sweating in hot or very warm environments.ADVERSE REACTIONSCNS: headache.CV: hypertension.EENT: dry mouth, blurred vision, mydriasis, dry eyes.GU: urinary retention.Respiratory: upper respiratory infection, viral upper respiratory infection.Skin: application site erythema, dermatitis, pruritus, irritation, exfoliation, rash, folliculitis, dryness, or pain.Other: flulike symptoms.Reactions in bold italics are life-threatening.  Released: November 2024Nursing Drug Handbook© 2024 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - October 2024
imetelstatRyteloPharmaceutical company: Geron CorporationPharmacologic classification: Oligonucleotide telomerase inhibitorTherapeutic classification: AntineoplasticAVAILABLE FORMSPowder for injection (preservative-free): 47-mg, 188-mg single-dose vialsINDICATIONS AND DOSAGESLow- to intermediate-risk myelodysplastic syndromes in patients with transfusion-dependent anemia requiring 4 or more RBC units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agentsAdults: 7.1-mg/kg IV infusion every 4 weeks. Discontinue if the need for RBC transfusions doesn't decrease after 24 weeks of treatment (six doses) or for unacceptable toxicity.Adjust-a-dose:  Grade 3 or 4 adverse reactions may require temporary dose delay, dose reductions, or treatment discontinuation. Refer to the manufacturer's instructions for toxicity-related dosage adjustments. CONTRAINDICATIONS AND CAUTIONSUse of this drug hasn't been established in patients with creatinine clearance of less than 30 mL/minute or Child-Pugh class C liver impairment.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause embryo-fetal harm. Avoid use during pregnancy. Patients of childbearing potential should use effective contraception during treatment and for 1 week after the last dose.Because of the risk to breastfed children, breastfeeding isn't recommended during treatment and for 1 week after the last dose.This drug may cause reversible fertility impairment in patients of childbearing potential.INTERACTIONSNone reported by the manufacturer.ADVERSE REACTIONSCNS: fatigue, headache, syncope.CV: HF, hemorrhage, atrial arrhythmia.EENT: epistaxis.Hematologic: neutropenia, leukopenia, thrombocytopenia, prolonged PTT, hematoma.Hepatic: increased liver function studies.Musculoskeletal: arthralgia, myalgia, fracture.Other: sepsis, infection, COVID-19, infusion-related reactions.Reactions in bold italics are life-threatening.  Released: October 2024Nursing Drug Handbook© 2024 Wolters Kluwerceftobiprole medocarilZevteraPharmaceutical company: Basilea Pharmaceutica InternationalPharmacologic classification: CephalosporinTherapeutic classification: AntibioticAVAILABLE FORMSPowder for injection: 667-mg single-dose vialsINDICATIONS AND DOSAGESStaphylococcus aureus bloodstream infections, including right-sided infective endocarditisAdults: 667 mg IV every 6 hours on days 1 to 8, then every 8 hours on day 9 and thereafter. May treat for up to 42 days.Acute bacterial skin and skin structure infections (ABSSSI) caused by strains of Staphylococcus aureus, Streptococcus pyogenes, and Klebsiella pneumoniaeAdults: 667 mg IV every 8 hours for 5 to 14 days.Community-acquired bacterial pneumonia (CABP) caused by strains of Staphylococcus aureus, Streptococcus pneumoniae (methicillin-susceptible isolates), Haemophilus influenzae, H. parainfluenzae, Escherichia coli, and K. pneumoniaeAdults: 667 mg IV every 8 hours for 5 to 14 days.Children ages 12 to less than 18 years: 13.3 mg/kg (up to 667 mg/dose) every 8 hours for 7 to 14 days.Children ages 3 months to less than 12 years: 20 mg/kg (up to 667 mg/dose) every 8 hours for 7 to 14 days.Adjust-a-dose (for CABP): Refer to the manufacturer's instructions for dosage adjustments for children ages 2 to less than 18 years old with kidney impairment. Dosage adjustments for children less than 2 years of age with any degree of kidney impairment haven't been established.Adjust-a-dose(for all indications): For adults with creatinine clearance (CrCl) greater than 150 mL/minute, increase dosage to 667 mg every 6 hours. For adults with CrCl less than 15 mL/minute including patients on hemodialysis, decrease dosage to 333 mg every 24 hours. For adults with CrCl of 15 to less than 50 mL/minute, refer to the manufacturer's instructions for dosage adjustments based on indication and CrCl.CONTRAINDICATIONS AND CAUTIONSContraindicated for use in patients with known history of severe hypersensitivity to this drug or other cephalosporins.This drug isn't indicated for treatment of ventilator-associated bacterial pneumonia. Increased mortality has been reported.Serious and sometimes fatal hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving beta-lactam antibacterial drugs.Seizures and other CNS reactions have been reported especially in patients with a history of epilepsy or lack of dose adjustment for kidney impairment. Ensure patients with known seizure disorders continue anticonvulsant therapy.Don't use this drug in the absence of proven or strongly suspected bacterial infection as the risk of drug-resistant bacteria increases and the patient is unlikely to benefit from treatment.Safety and effectiveness for the treatment of Staphylococcus aureus blood stream infections and ABSSSI in children haven't been established.Dialyzable drug: Yes.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies during pregnancy. Use during pregnancy only if the benefit outweighs fetal risk.It isn't known if this drug appears in human milk, or how the drug affects milk production or infants who are breastfed. Weigh the benefit to the patient against the risk to the infant before use.INTERACTIONSDrug-drug. OATP1B1 and OATP1B3 substrates (statins, repaglinide, olmesartan, enalapril, some chemotherapeutic agents): May increase substrate level. Use together is not recommended.ADVERSE REACTIONSCNS: fever, headache, dizziness, altered sense of taste, seizures, insomnia.CV: hypertension, phlebitis.GI: nausea, vomiting, diarrhea, abdominal pain.GU: increased creatinine levels.Hematologic: anemia, leukopenia.Hepatic: increased liver enzymes, hyperbilirubinemia.Metabolic: hypokalemia, hyponatremia.Respiratory: dyspnea, pleuritis, aggravated pneumonia.Skin: injection site reactions, rash, pruritus, urticaria.Other: fungal infection, hypersensitivity reactions including angioedema and anaphylaxis, death.Reactions in bold italics are life-threatening.  Released: October 2024Nursing Drug Handbook© 2024 Wolters KluwerDownload these updates as a PDF
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