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New FDA Drug Approvals - May 2025

revumenib

Revuforj

Pharmaceutical company: Syndax Pharmaceuticals

Pharmacologic classification: Menin inhibitor

Therapeutic classification: Antineoplastic


AVAILABLE FORMS

Tablets: 25 mg, 110 mg, 160 mg


INDICATIONS AND DOSAGES

Relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene translocation

Adults 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 CAUTIONS

  • Boxed 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-REPRODUCTION

  • This 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.


INTERACTIONS

Drug-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 REACTIONS

CNS: 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 2025

Nursing Drug Handbook

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New FDA Drug Approvals Archive

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
New FDA Drug Approvals - September 2024
vadadustatVafseoPharmaceutical company: Akebia TherapeuticsPharmacologic classification: Hypoxia-inducible factor prolyl hydroxylase inhibitorTherapeutic classification: HematopoieticAVAILABLE FORMSTablets: 150 mg, 300 mg, 450 mgINDICATIONS AND DOSAGESAnemia due to chronic kidney disease in patients who have been on dialysis for 3 months or moreAdults not being treated with an erythropoietin stimulating agent (ESA) or switching from an ESA: Initially, 300 mg PO once daily. May increase dose in increments of 150 mg no more frequently than once every 4 weeks to achieve or maintain hemoglobin (Hb) levels between 10 g/dL to 11 g/dL. Dosage may range from 150 to 600 mg daily.Adjust-a-dose:  If Hb rises more than 1 g/dL in 2 weeks or 2 g/dL in 4 weeks, interrupt or reduce the dose. If Hb exceeds 11 g/dL, withhold the drug until Hb is 11 g/dL or less, then resume at 150 mg less than the prior dose. During transition from an ESA, RBC transfusion or temporary ESA treatment may be considered if Hb falls below 9 g/dL or the response isn't acceptable. Pause vadadustat during ESA rescue treatment. When Hb is 10 g/dL or more, vadadustat may be restarted 2 days after the last dose of epoetin, 7 days after the last dose of darbepoetin alfa, or 14 days after the last dose of methoxy polyethylene glycol-epoetin beta. Resume vadadustat at the prior dose or 150 mg more than the prior dose and titrate according to the manufacturer's instructions. CONTRAINDICATIONS AND CAUTIONSBoxed Warning: This drug increases the risk of thrombotic vascular events, including venous thromboembolism, vascular access thrombosis, MI, stroke, and death. Targeting a Hb level greater than 11 g/dL may increase the risk of death, and arterial and venous thrombotic events. A target Hb level, dose of vadadustat, or dosing strategy that doesn't increase these risks hasn't been established. Use the lowest dose of the drug sufficient to reduce the need for RBC transfusion.Avoid use in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within 3 months prior to starting treatment.Contraindicated for use in patients with known hypersensitivity to the drug or any of its components.Contraindicated for use in patients with uncontrolled hypertension. Hypertensive crisis, including hypertensive encephalopathy and seizures have been reported.This drug may cause liver toxicity, generally within the first 3 months of treatment. Use isn't recommended in patients with cirrhosis or active, acute liver disease.Use cautiously in patients with a history of GI erosion and peptic ulcer disease. This drug increases the risk of GI erosions and related GI bleeding and the need for RBC transfusions.This drug may have unfavorable effects on cancer growth. Use isn't recommended in patients with active malignancies.This drug isn't indicated as a substitute for RBC transfusions for the immediate treatment of anemia, or for anemia due to chronic kidney disease in patients not on dialysis.This drug should be stopped if an appropriate increase in Hb isn't achieved after 24 weeks of treatment. Evaluate for and treat alternative explanations for poor response before restarting therapy.Safety and effectiveness in children haven't been established.Dialyzable drug: Approximately 16%.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies of this drug during pregnancy. Use only if benefits justify fetal risk.Breastfeeding isn't recommended during treatment and for 2 days after the last dose.INTERACTIONSDrug-drug.BCRP substrates (sulfasalazine): May increase substrate level. Monitor for adverse reactions related to BCRP substrate and refer to substrate prescribing information for dose modification, if needed.Drugs that increase risk of GI erosion (NSAIDs, mycophenolate): May increase risk of GI erosion. Monitor patients closely.Non-iron-containing phosphate binders (calcium acetate, sevelamer carbonate): May decrease vadadustat level. Give vadadustat at least 1 hour before or 2 hours after binding agent.OAT1 inhibitors (probenecid, rifampicin), OAT3 inhibitors (gemfibrozil, probenecid, teriflunomide): May increase vadadustat level. Monitor for too large or too rapid an increase in Hb response.OAT3 substrates (cefaclor, ceftizoxime, famotidine, furosemide, oseltamivir carboxylate, penicillin G, sitagliptin): May increase substrate level. Monitor for adverse reactions related to OAT3 substrate and refer to substrate prescribing information for dose modification, if needed.Oral iron supplements (ferrous sulfate, sodium ferrous citrate), iron-containing phosphate binders (ferric citrate, sucroferric oxyhydroxide): May decrease vadadustat level. Give vadadustat at least 1 hour before the supplement.Statins (rosuvastatin, simvastatin): May increase statin level and risk for adverse reactions. Limit rosuvastatin dosage to 5 mg daily. Starting dosage of simvastatin should be 5 mg daily and maximum dosage not to exceed 20 mg daily.Drug-lifestyle. Alcohol, tobacco: May increase risk of GI erosion. Discourage use together.ADVERSE REACTIONSCNS: seizures, stroke, headache, fatigue, dizziness.CV: MI, vascular access thrombosis, hypertension.GI: GI erosion, diarrhea, nausea, vomiting, abdominal pain.Respiratory: dyspnea.Other: dialysis-related complications.Reactions in bold italics are life-threatening.  Released: September 2024Nursing Drug Handbook© 2024 Wolters KluwerresmetiromRezdiffraPharmaceutical company: Madrigal PharmaceuticalsPharmacologic classification: Thyroid hormone receptor-beta agonistTherapeutic classification: Gastrointestinal drugAVAILABLE FORMSTablets: 60 mg, 80 mg, 100 mgINDICATIONS AND DOSAGESNoncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (stages F2 to F3) in conjunction with diet and exerciseAdults weighing 100 kg or more: 100 mg PO once daily.Adults weighing less than 100 kg: 80 mg PO once daily.Adjust-a-dose:  If used with moderate CYP2C8 inhibitors in patients weighing 100 kg or more, decrease the dosage to 80 mg once daily; in patients weighing less than 100 kg, decrease dosage to 60 mg once daily. CONTRAINDICATIONS AND CAUTIONSAvoid use in patients with Child-Pugh class B or C liver impairment due to increased exposure to the drug and the risk of adverse effects.Safety and effectiveness in patients with NASH cirrhosis haven't been established.Liver toxicity, cholelithiasis, acute cholecystitis, and obstructive pancreatitis have occurred in patients taking resmetirom.Safety and effectiveness in children or patients with a creatinine clearance less than 30 mL/minute haven't been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies on use of this drug during pregnancy to evaluate for drug-associated risk.Risks to the patient and fetus related to underlying NASH with liver fibrosis include gestational diabetes, hypertensive complications, preterm birth, and postpartum hemorrhage.Pregnancies should be reported to Madrigal Pharmaceuticals at 1-800-905-0324 or https://www.madrigalpharma.com/contact/.There is no information regarding the presence of this drug in human or animal 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. CYP2C8 substrates (pioglitazone): May increase substrate level. Monitor the patient closely.Moderate CYP2C8 inhibitors (clopidogrel): May increase resmetirom level. Reduce resmetirom dose per the manufacturer's recommendations.OATP1B1 and OATP1B3 inhibitors (cyclosporine): May increase resmetirom level. Use together isn't recommended.Some statins (atorvastatin, pravastatin, rosuvastatin, simvastatin): May increase the level of these statins. Limit daily dosage of atorvastatin and pravastatin to 40 mg. Limit daily dosage of rosuvastatin and simvastatin to 20 mg.Strong CYP2C8 inhibitors (gemfibrozil): May increase resmetirom level. Use together isn't recommended.ADVERSE REACTIONSCNS: altered sense of taste, depression, dizziness, vertigo.CV: arrhythmia, palpitations.GI: abdominal pain, abnormal feces, decreased appetite, constipation, diarrhea, flatulence, nausea, vomiting. GU: abnormal uterine bleeding.Hepatic: increased AST and ALT levels, hyperbilirubinemia.Metabolic: hypoglycemia.Musculoskeletal: tendinopathy.Skin: erythema, pruritus, rash, urticaria.Reactions in bold italics are life-threatening.  Released: September 2024Nursing Drug Handbook© 2024 Wolters KluwergivinostatDuvyzatPharmaceutical company: ITF TherapeuticsPharmacologic classification: Histone deacetylase inhibitorTherapeutic classification: Muscular dystrophy drugAVAILABLE FORMSOral suspension: 8.86 mg/mLINDICATIONS AND DOSAGESDuchenne muscular dystrophyAdults and children ages 6 and older weighing 60 kg or more: 53.2 mg (6 mL) PO b.i.d.Adults and children ages 6 and older weighing 40 kg to less than 60 kg: 44.3 mg (5 mL) PO b.i.d.Adults and children ages 6 and older weighing 20 kg to less than 40 kg: 31 mg (3.5 mL) PO b.i.d.Adults and children ages 6 and older weighing 10 kg to less than 20 kg: 22.2 mg (2.5 mL) PO b.i.d.Adjust-a-dose:  Refer to the manufacturer's instructions for toxicity-related dosage adjustments. Dosage modification may be necessary if platelet count is less than 150 x 109/L verified in two assessments one week apart; for moderate or severe diarrhea; or for fasting triglycerides greater than 300 mg/dL. Withhold the drug if QTc interval is greater than 500 msec or the change from baseline is greater than 60 msec. CONTRAINDICATIONS AND CAUTIONSThis drug may cause GI disturbances, myelosuppression and hypertriglyceridemia.This drug can cause QTc interval prolongation. Avoid use in patients at increased risk for ventricular arrythmias, including those with congenital long QT syndrome, coronary artery disease, electrolyte disturbance, or use with other medications that cause QT prolongation.Safety and effectiveness in children less than 6 years haven't been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no data available on use during pregnancy or breastfeeding as Duchenne muscular dystrophy predominately affects young males.INTERACTIONSDrug-drug.CYP3A4 substrates (midazolam, codeine, cyclosporine), OCT2 substrates (procainamide, cisplatin, gentamicin): May increase risk of adverse effects. Closely monitor patients when the drug is used in combination with orally administered substrates in which a slight change in substrate level may lead to toxicity.Drugs that prolong QTc interval (amiodarone, erythromycin, sertraline, haloperidol, methadone): May increase QTc prolongation. Avoid use together. If concomitant use can't be avoided, monitor ECG.Drug-herb.Herbs that prolong QTc interval (echinacea, ginseng, St. John's wort): May increase QTc prolongation. Discourage use together. ADVERSE REACTIONSCNS: fever, fatigue.CV: QTc prolongation.GI: diarrhea, abdominal pain, nausea, vomiting, constipation, decreased appetite.Hematologic: thrombocytopenia, neutropenia, anemia.Metabolic: hypertriglyceridemia, hypothyroidism.Musculoskeletal: myalgia, arthralgia.Skin: rash.Reactions in bold italics are life-threatening.  Released: September 2024Nursing Drug Handbook© 2024 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - August 2024
aprocitentanTryvioPharmaceutical company: Idorsia PharmaceuticalsPharmacologic classification: Endothelin receptor antagonistTherapeutic classification: AntihypertensiveAVAILABLE FORMSTablets (enteric-coated): 12.5 mgINDICATIONS AND DOSAGESHypertension in combination with other antihypertensive drugs in patients who are not adequately controlled on other agentsAdults: 12.5 mg PO once daily.CONTRAINDICATIONS AND CAUTIONSBoxed Warning: This drug is only available through the Tryvio REMS Program.Contraindicated in those hypersensitive to aprocitentan or any of its components, and patients who are pregnant.This drug may increase the risk of fluid retention. Use cautiously in older adults and in patients with heart failure or kidney impairment. Use is not recommended in patients with New Your Heart Association heart failure stage III to IV, unstable cardiac function, with N-terminal pro b-type natriuretic peptide greater than or equal to 500 pg/mL, eGFR less than 15 mL/minute, or in patients on dialysis.This drug may increase the risk of liver toxicity. Use is not recommended in patients with Child-Pugh class B or C liver impairment.This drug may increase the risk of anemia. Use is not recommended in patients with severe anemia.Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.Safety and effectiveness in children have not been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONBoxed Warning: Tryvio can cause major birth defects if used during pregnancy. In patients who can become pregnant, a negative pregnancy test must be obtained prior to initiation of treatment, monthly during treatment, and for one month after stopping aprocitentan. Discontinue the drug if pregnancy is detected.Boxed Warning: Patients who can become pregnant must use acceptable methods of contraception prior to initiation of treatment, during treatment, and for one month after discontinuation.This drug may be present in human milk and may cause serious adverse effects to the breastfed infant. Breastfeeding is not recommended during treatment.This drug may adversely affect spermatogenesis and male fertility. It's unknown if the effects on fertility are reversible.INTERACTIONSDrug-drug.Antihypertensive drugs: May increase hypotensive effects. Monitor the patient.ADVERSE REACTIONSCV: edema, fluid retention.Hematologic: anemia.Reactions in bold italics are life-threatening.  Released: August 2024Nursing Drug Handbook© 2024 Wolters Kluwercefepime and enmetazobactamExblifepPharmaceutical company: Allecra TherapeuticsPharmacologic classification: Combination cephalosporin and beta-lactamase inhibitorTherapeutic classification: AntibioticAVAILABLE FORMSPowder for injection: 2.5 g in a single-dose vial (2 g cefepime and 0.5 g enmetazobactam)INDICATIONS AND DOSAGESComplicated UTI, including pyelonephritis, caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complexAdults: 2.5-g IV infusion every 8 hours for 7 days and up to 14 days for patients with concurrent bacteremia.Adjust-a-dose:  If eGFR is 130 mL/minute or more, infuse 2.5 g IV every 8 hours over 4 hours. If eGFR is 30 to 59 mL/minute, infuse 1.25 g IV every 8 hours; if eGFR is 15 to 29 mL/minute, infuse 1.25 g IV every 12 hours; if eGFR is less than 15 mL/minute or the patient is receiving intermittent hemodialysis, give a loading dose of 1.25 g IV on the first day of treatment, followed by 0.625 g IV every 24 hours. CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with a history of serious hypersensitivity reactions to cefepime, enmetazobactam, or other beta-lactam antibacterial drugs.Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs.Use cautiously in patients with altered kidney function.Neurotoxicity has been reported during treatment with cefepime, including life-threatening or fatal episodes of encephalopathy, aphasia, myoclonus, seizures, and nonconvulsive status epilepticus, especially in patients with kidney impairment who didn't receive an appropriate dosage adjustment.Positive direct Coombs tests with or without hemolysis have been reported during treatment with cefepime. If hemolytic anemia develops, discontinue the drug and institute appropriate therapy.To reduce development of drug-resistant bacteria and maintain effectiveness of antibacterial drugs, use the drug only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.Safety and efficacy haven't been established in children.Use cautiously in older adults.Dialyzable drug: Yes.Overdose S&S:  encephalopathy, myoclonus, seizures, neuromuscular excitability, nonconvulsive status epilepticus.PREGNANCY-LACTATION-REPRODUCTIONThere are no available data with use in pregnancy.Positive Coombs test may be observed in newborns whose mothers have received cephalosporin antibacterial drugs during pregnancy.This drug appears in human milk; use cautiously during breastfeeding.INTERACTIONSDrug-drug.Aminoglycosides (gentamicin, tobramycin): May increase risk of kidney toxicity and ototoxicity. Monitor kidney function and hearing.Diuretics (furosemide): May increase risk of kidney toxicity. Monitor kidney function.ADVERSE REACTIONSCNS: headache.GI: diarrhea, vomiting, nausea.Hematologic: anemia.Hepatic: increased transaminase levels, bilirubinemia.Skin: infusion site reactions.Other: hypersensitivity reactions.Reactions in bold italics are life-threatening.  Released: August 2024Nursing Drug Handbook© 2024 Wolters KluwerDownload these updates as a PDF
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