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New FDA Drug Approvals - June 2024

iloprost

Aurlumyn

Pharmaceutical company: Eicos Sciences

Pharmacologic classification: Prostacyclin mimetic

Therapeutic classification: Vasodilator

AVAILABLE FORMS

Injection: 100 mcg/mL single-dose vial

INDICATIONS AND DOSAGES

Severe frostbite to reduce the risk of digit amputations

Adults: Continuous IV infusion over 6 hours daily for up to 8 consecutive days. Initially, 0.5 nanograms/kg/min IV infusion. Increase in increments of 0.5 nanograms/kg/min every 30 min, as tolerated, to maximum of 2 nanograms/kg/min. Repeat dose titration on days 2 and 3. From day 4 onward, start the infusion at the highest tolerated dose from the previous day, and adjust the rate as needed based on tolerability.

Adjust-a-dose: For patients with Child-Pugh class B or C liver impairment, initiate infusion at 0.25 nanograms/kg/min for 30 min, then titrate in 0.5 nanograms/kg/min increments every 30 min, as tolerated, to a maximum of 2 nanograms/kg/min. For patients with an estimated GFR less than 30 mL/min, initiate and titrate dosing as recommended. If the patient cannot tolerate the starting rate of 0.5 nanograms/kg/min, decrease to 0.25 nanograms/kg/min. If dose-limiting adverse reactions occur that cannot be tolerated, decrease the rate by 0.5 nanograms/kg/min every 30 min until tolerated. If a dose-limiting adverse reaction occurs during administration at the starting dose, discontinue the infusion and attempt reinitiation after the event has resolved or has been treated. If infusion is stopped at any point for a dose-limiting adverse event, reinitiate the infusion at a previously tolerated rate once the event has resolved. The maximum tolerated rate should be maintained for the remaining 6-hour daily infusion.

CONTRAINDICATIONS AND CAUTIONS

  • May cause symptomatic hypotension.
  • Use cautiously in patients with liver impairment.
  • Safety and efficacy in children have not been established.
  • Dialyzable drug: Unknown.

PREGNANCY-LACTATION-REPRODUCTION

  • There are no available data on the use of this drug during pregnancy.
  • There are no data on the presence of iloprost in human milk or its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions, breastfeeding should be avoided during treatment.

INTERACTIONS

Drug-drug. Antihypertensives, vasodilators: May cause additive hypotensive effects. Consider temporary discontinuation of concomitant vasodilator or other antihypertensive medications during iloprost administration.

ADVERSE REACTIONS

CNS: headache, dizziness.
CV: flushing, palpitations, tachycardia, hypotension.
GI: nausea, vomiting.
Musculoskeletal: jaw pain, myalgia.

Reactions in bold italics are life-threatening.
 

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

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New FDA Drug Approvals Archive

New FDA Drug Approvals - June 2024
iloprostAurlumynPharmaceutical company: Eicos SciencesPharmacologic classification: Prostacyclin mimeticTherapeutic classification: VasodilatorAVAILABLE FORMSInjection: 100 mcg/mL single-dose vialINDICATIONS AND DOSAGESSevere frostbite to reduce the risk of digit amputationsAdults: Continuous IV infusion over 6 hours daily for up to 8 consecutive days. Initially, 0.5 nanograms/kg/min IV infusion. Increase in increments of 0.5 nanograms/kg/min every 30 min, as tolerated, to maximum of 2 nanograms/kg/min. Repeat dose titration on days 2 and 3. From day 4 onward, start the infusion at the highest tolerated dose from the previous day, and adjust the rate as needed based on tolerability.Adjust-a-dose: For patients with Child-Pugh class B or C liver impairment, initiate infusion at 0.25 nanograms/kg/min for 30 min, then titrate in 0.5 nanograms/kg/min increments every 30 min, as tolerated, to a maximum of 2 nanograms/kg/min. For patients with an estimated GFR less than 30 mL/min, initiate and titrate dosing as recommended. If the patient cannot tolerate the starting rate of 0.5 nanograms/kg/min, decrease to 0.25 nanograms/kg/min. If dose-limiting adverse reactions occur that cannot be tolerated, decrease the rate by 0.5 nanograms/kg/min every 30 min until tolerated. If a dose-limiting adverse reaction occurs during administration at the starting dose, discontinue the infusion and attempt reinitiation after the event has resolved or has been treated. If infusion is stopped at any point for a dose-limiting adverse event, reinitiate the infusion at a previously tolerated rate once the event has resolved. The maximum tolerated rate should be maintained for the remaining 6-hour daily infusion.CONTRAINDICATIONS AND CAUTIONSMay cause symptomatic hypotension.Use cautiously in patients with liver impairment.Safety and efficacy in children have not been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no available data on the use of this drug during pregnancy.There are no data on the presence of iloprost in human milk or its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions, breastfeeding should be avoided during treatment.INTERACTIONSDrug-drug.Antihypertensives, vasodilators: May cause additive hypotensive effects. Consider temporary discontinuation of concomitant vasodilator or other antihypertensive medications during iloprost administration.ADVERSE REACTIONSCNS: headache, dizziness.CV: flushing, palpitations, tachycardia, hypotension.GI: nausea, vomiting.Musculoskeletal: jaw pain, myalgia.Reactions in bold italics are life-threatening.  Released: June 2024Nursing Drug Handbook© 2024 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - April 2024
berdazimerZelsuvmiPharmaceutical company: LNHC, Inc.Pharmacologic classification: Nitric oxide-releasing agentTherapeutic classification: AntiviralAVAILABLE FORMSGel: 10.3% berdazimer supplied as two tubes (Tube A contains 14 g berdazimer and Tube B contains 17 g hydrogel)INDICATIONS AND DOSAGESMolluscum contagiosumAdults and children age 1 and older: Mix 0.5-mL gel from Tube A and 0.5-mL gel from Tube B on the manufacturer-provided dosing guide. Immediately apply as an even, thin layer once daily to each molluscum contagiosum lesion for up to 12 weeks.CONTRAINDICATIONS AND CAUTIONSApplication site reactions, including allergic contact dermatitis, have occurred.Safety and effectiveness in children younger than 1 year haven't been established.Dialyzable drug: UnknownPREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies during pregnancy. Fetal risk is unknown.It isn't known whether drug appears in human milk. Before use during breastfeeding, consider the patient's need for therapy and the potential effects on the infant.INTERACTIONSNone reported by the manufacturer.ADVERSE REACTIONSCNS: fever.GI: vomiting.Respiratory: upper respiratory infection.Skin: application site pain, erythema, stinging, burning, pruritis, exfoliation, dermatitis, swelling, erosion, discoloration, vesicles, irritation, infection.Reactions in bold italics are life-threatening.  Released: April 2024Nursing Drug Handbook© 2024 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - March 2024
fruquintinibFruzaqlaPharmaceutical company: Takeda PharmaceuticalsPharmacologic classification: Kinase inhibitorTherapeutic classification: AntineoplasticAVAILABLE FORMSCapsules: 1 mg, 5 mg  INDICATIONS AND DOSAGESMetastatic colorectal cancer in patients previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapyAdults: 5 mg PO once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity occurs.Adjust-a-dose: For adverse reactions, first dosage reduction is to 4 mg PO once daily; second dosage reduction is to 3 mg PO once daily. Permanently discontinue the drug in patients unable to tolerate 3 mg PO once daily. Refer to the manufacturer's instructions for dosage adjustments related to adverse reactions. CONTRAINDICATIONS AND CAUTIONSThis drug can cause hypertension, including hypertensive crisis. Don't initiate treatment unless blood pressure is adequately controlled.This drug may increase the risk of serious or fatal hemorrhagic events, infections, or GI perforation or fistula.This drug can cause liver injury. Use isn't recommended in patients with Child-Pugh class C liver impairment. Fruquintinib has not been sufficiently studied in patients with Child-Pugh class B liver impairment.This drug can cause posterior reversible encephalopathy syndrome, resulting in subcortical vasogenic edema.Impaired wound healing can occur in patients who receive VEGF inhibitors.This drug may increase the risk of arterial thromboembolic events. Use cautiously when initiating therapy in patients with a recent history of thromboembolic events. The 1-mg capsules contain FD&C Yellow No. 5 (tartrazine) and Yellow No. 6 (sunset yellow FCF), which may cause allergic-type reactions (including bronchial asthma) in susceptible persons and is frequently seen in patients who also have aspirin hypersensitivity.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug can cause fetal harm. Patients and their partners of childbearing potential should use effective contraception during treatment and for 2 weeks after the last dose.Verify pregnancy status of patients of reproductive potential prior to initiating this drug.There are no data about this drug in human milk or its effects on a breastfed child or on milk production. Breastfeeding should be avoided during treatment and for 2 weeks after the last dose due to the potential for serious adverse reactions in the breastfed child.INTERACTIONSDrug-drug. Moderate CYP3A inducers (efavirenz): May decrease fruquintinib level. Avoid use together; if unavoidable, continue fruquintinib at recommended dosage.Strong CYP3A inducers (rifampin): May decrease fruquintinib level. Don't use together.Vaccines (inactivated): May diminish effect of vaccines. Give inactivated vaccines at least 2 weeks before stating fruquintinib when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 months after therapy is complete.Vaccines (live): May diminish vaccine effect and increase risk of vaccine-associated infection. Avoid use together.ADVERSE REACTIONSCNS: asthenia, fatigue.CV: hypertension, hemorrhage.EENT: dysphonia, epistaxis, throat pain.GI: stomatitis, abdominal pain, diarrhea, vomiting, GI hemorrhage, GI perforation, GI fistula, anorexia, intestinal obstruction.GU: proteinuria, UTI, proctalgia, increased creatinine levels.Hematologic:thrombocytopenia, anemia, lymphocytopenia, prolonged PTT.Hepatic: increased LFTs.Metabolic: hypothyroidism, hyperlipidemia, hyperglycemia, hypokalemia, hypocalcemia, hypoalbuminemia, hyponatremia, hypomagnesemia, hyperuricemia.Musculoskeletal: musculoskeletal pain, arthralgia, back pain.Respiratory: pneumonia, URI.Skin: palmar-plantar erythrodysesthesia, rash.Other: death.Reactions in bold italics are life-threatening.  Released: March 2024Nursing Drug Handbook© 2024 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - February 2024
capivasertibTruqapPharmaceutical company: AstraZenecaPharmacologic classification: Kinase inhibitorTherapeutic classification: Antineoplastic agentAVAILABLE FORMSTablets: 160 mg, 200 mg  INDICATIONS AND DOSAGESHormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations following progression while on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy, in combination with fulvestrantAdults: 400 mg PO b.i.d. (approximately 12 hours apart) for 4 days followed by 3 days off. Continue until disease progression or unacceptable toxicity occurs. Refer to the fulvestrant manufacturer's instructions for dosing information. For males and pre- and perimenopausal females, consider giving a luteinizing hormone-releasing hormone agonist according to standard clinical practice.Adjust-a-dose: For adverse reactions, the first dose reduction is 320 mg b.i.d. for 4 days followed by 3 days off. The second dose reduction is 200 mg b.i.d. for 4 days followed by 3 days off. Permanently discontinue capivasertib if patient is unable to tolerate the second dose reduction. Refer to the manufacturer's instructions for toxicity-related dosage adjustments. If giving with a strong or moderate CYP3A inhibitor, reduce capivasertib dosage to 320 mg PO b.i.d. for 4 days followed by 3 days off. When the CYP3A inhibitor is discontinued, resume the capivasertib dosage given before initiation of the inhibitor after 3 to 5 half-lives of the inhibitor. CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with severe hypersensitivity to capivasertib or any of its components.Severe hyperglycemia associated with ketoacidosis may occur. Safety and effectiveness in patients with type 1 diabetes or diabetes requiring insulin haven't been established.Cutaneous adverse reactions, such as erythema multiforme, palmar-plantar erythrodysesthesia and drug reaction with eosinophilia and systemic symptoms (DRESS), may occur and may be severe.This drug hasn't been studied in patients with creatinine clearance of 29 mL/minute or less, or bilirubin level more than 3 times the upper limit of normal (ULN) and any AST level.Use cautiously in patients with bilirubin level greater than 1.5 to 3 times the ULN and any AST level.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm.Female patients of reproductive potential should use effective contraception during treatment and for 1 month after the last dose.Male patients with female partners of reproductive potential should use effective contraception during treatment and for 4 months after the last dose.It isn't known whether this drug appears in human milk. Because of the risk to a breastfed child, breastfeeding isn't recommended during treatment.INTERACTIONSDrug-drug. Moderate and strong CYP3A inducers (phenytoin, rifampin, efavirenz): May decrease capivasertib level and effectiveness. Avoid use together.Moderate CYP3A inhibitors (erythromycin, fluconazole, verapamil): May increase capivasertib level and risk of adverse effects. Reduce capivasertib dosage and monitor patient.Strong CYP3A inhibitors (clarithromycin, itraconazole): May increase capivasertib level and risk of adverse effects. Avoid use together. If concomitant use can't be avoided, reduce capivasertib dosage and monitor patient.Drug-food.Grapefruit and grapefruit products: May increase drug level. Discourage use together.ADVERSE REACTIONSCNS: fatigue, headache, fever, dysgeusia.GI: diarrhea, nausea, stomatitis, vomiting, decreased appetite, dyspepsia.GU: UTI, increased creatinine level, kidney injury (acute kidney injury, kidney failure)Hematologic: anemia, lymphocytopenia, leukopenia, neutropenia, thrombocytopenia.Hepatic: increased ALT.Metabolic: hyperglycemia, increased triglycerides, decreased corrected calcium, hypokalemia.Respiratory: pneumonia.Skin: cutaneous reactions (butterfly rash, dermatitis, allergic dermatitis, dry skin, eczema, erythema multiforme, palmar-plantar erythrodysesthesia syndrome, pruritis, erythematous rash, maculopapular rash, papular rash, skin discoloration, skin fissures, skin ulcer, urticaria, purpura, drug eruption).Other: hypersensitivity reaction, second malignancy.Reactions in bold italics are life-threatening.  Released: February 2024Nursing Drug Handbook© 2024 Wolters KluwernirogacestatOgsiveoPharmaceutical company: SpringWorks TherapeuticsPharmacologic classification: Gamma secretase inhibitorTherapeutic classification: Antineoplastic  AVAILABLE FORMSTablets: 50 mg  INDICATIONS AND DOSAGESProgressing desmoid tumorsAdults: 150 mg PO b.i.d. until disease progression or unacceptable toxicity occurs.Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSThis drug may increase the risk of liver toxicity, nonmelanoma skin cancer, and electrolyte abnormalities.Safety and effectiveness have not been established in children. Widening of the epiphyseal growth plate has occurred in children with open growth plates treated with nirogacestat.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm.It's unknown if this drug is present in human milk. Because of the potential for serious adverse reactions on the breastfed child, breastfeeding is not recommended during treatment and for 1 week after the last dose.Patients should use effective contraception during treatment and for 1 week after the last dose.This drug may cause fertility impairment in males and females, and ovarian toxicity.INTERACTIONSDrug-drug. CYP2C19 substrates (carisoprodol, citalopram, diazepam, diphenhydramine, fluoxetine, omeprazole, pantoprazole, voriconazole): May decrease substrate level. Avoid use together if decreased level of substrate leads to decreased effectiveness. Refer to prescribing information for the substrate.CYP3A substrates (midazolam, amitriptyline, clarithromycin, cyclosporin, docetaxel, etoposide, mirtazapine, paclitaxel, tacrolimus, tamoxifen): May increase substrate level. Avoid use together if minimal changes in level may lead to serious adverse reaction.Gastric acid reducing agents (proton pump inhibitors, histamine-2 blockers): May decrease nirogacestat level. Avoid use together. If use cannot be avoided, give nirogacestat 2 hours before or 2 hours after antacid.Moderate or strong CYP3A inducers (carbamazepine, phenobarbital, phenytoin, primidone, rifampin, efavirenz): May decrease nirogacestat level. Avoid use together.Moderate or strong CYP3A inhibitors (amiodarone, cimetidine, itraconazole, clarithromycin, diltiazem, fluconazole, erythromycin, ketoconazole, lopinavir, nefazodone, voriconazole, verapamil): May increase nirogacestat level. Avoid use together.Drug-food.Grapefruit products, Seville oranges, starfruit: May increase nirogacestat level. Discourage use together.ADVERSE REACTIONSCNS: fatigue, headache.EENT: epistaxis.GI: diarrhea, nausea, stomatitis, abdominal pain.GU: ovarian toxicity, glycosuria, proteinuria.Hepatic: increased AST and ALT levels.Metabolic: hypophosphatemia, hypokalemia.Respiratory: cough, URI, dyspnea.Skin: rash, alopecia, folliculitis, skin abscesses with scarring, nonmelanoma skin cancer.Other: flulike illness.Reactions in bold italics are life-threatening.  Released: February 2024Nursing Drug Handbook© 2024 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - January 2024
etrasimodVelsipityPharmaceutical company: Pfizer, Inc.Pharmacologic classification: Sphingosine 1-phosphate (S1P) receptor modulatorTherapeutic classification: ImmunosuppressantAVAILABLE FORMSTablets: 2 mg  INDICATIONS AND DOSAGESModerately to severely active ulcerative colitisAdults: 2 mg PO once daily.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients who experienced MI, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure (HF) requiring hospitalization, or Class III or IV HF in the last 6 months.Contraindicated in patients with a history or presence of Mobitz type II second-degree or third-degree AV block, sick sinus syndrome, or SA block, unless the patient has a functioning pacemaker.This drug may result in a transient decrease in heart rate (HR) and AV conduction delays. Consider cardiology consultation prior to initiating treatment for patients with significant QT prolongation, arrythmias requiring treatment with Class Ia or Class III anti-arrhythmic drugs or QT-prolonging drugs, unstable ischemic heart disease, Class I or II HF, history of cardiac arrest, cerebrovascular disease, or uncontrolled hypertension, resting HR less than 50, history of symptomatic bradycardia, recurrent cardiogenic syncope, severe untreated sleep apnea, or history of Mobitz type I second-degree AV block, unless the patient has a functioning pacemaker.Alert: Life-threatening and rare, fatal infections have occurred in association with other S1P receptor modulators. Wait to initiate treatment in patients with an active infection until infection is resolved. Consider interrupting or stopping treatment if a serious infection develops.Progressive multifocal leukoencephalopathy (PML) has been reported in patients with multiple sclerosis (MS) treated with S1P receptor modulators. If suspected, treatment should be paused and discontinued if confirmed.Immune reconstitution inflammatory syndrome (IRIS) has been reported in patients with MS who developed PML while being treated with S1P receptor modulators and subsequently discontinued treatment. Symptom onset is generally within a few months after treatment discontinuation and presents as clinical decline that may be rapid, can lead to serious neurologic complications, or death, and is often associated with characteristic changes on MRI.This drug may increase the risk of infection. Patients without a confirmed history of varicella or who have not been fully vaccinated against varicella zoster virus should be tested for antibodies to varicella zoster virus before initiating treatment.Fatal cryptococcal meningitis and disseminated cryptococcal infections have been reported with S1P receptor modulators. If suspected, treatment should be paused, and the patient should undergo diagnostic evaluation.Use isn't recommended in patients with Child-Pugh class C liver impairment.This drug may increase the risk of macular edema or malignancy (including skin malignancy), may increase blood pressure, or cause a decline in pulmonary functionThis drug may increase the risk of developing posterior reversible encephalopathy syndrome. Delay in diagnosis and treatment may lead to permanent neurologic sequelae.If patients have received immunosuppressive or immunomodulating drugs prior to starting etrasimod, consider the half-life and mode of action of prior therapies as unintended additive immune system effects may occur.Lymphocyte counts take 4 to 5 weeks to return to normal range after stopping drug. If the patient is receiving concomitant immunosuppressants, they remain at increased risk for infectious complications up to 5 weeks after the last dose of etrasimod.Use isn't recommended in patients who are CYP2C9 poor metabolizers.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm. Patients of reproductive potential should use effective contraception during treatment with the drug and for one week following the last dose.There are no data on the presence of etrasimod in human milk. Animal studies suggest the drug is excreted in milk. Weigh risk versus benefit if use is necessary.Health care providers are encouraged to enroll patients in the Velsipity pregnancy exposure registry by calling 1-800-616-3791.INTERACTIONSDrug-drug.Antineoplastics, immunomodulators (cyclosporine), noncorticosteroid immunosuppressants (adalimumab, sirolimus): May increase immunosuppression. Avoid use together.Beta blockers (metoprolol), calcium channel blockers (amlodipine, verapamil): May increase bradycardic effects. Seek cardiologist's advice before initiating drugs that may further decrease HR.Combined strong CYP3A4, moderate CYP2C8, and moderate CYP2C9 inducer (rifampin): May decrease etrasimod level. Avoid use together.Class Ia and Class III antiarrhythmics (quinidine, procainamide, amiodarone, sotalol), QT-prolonging drugs (ciprofloxacin, ketoconazole, amitriptyline, haloperidol, methadone): May increase the risk of QT prolongation and torsades de pointes. Seek cardiologist's advice before use together.Live attenuated vaccines: May diminish the therapeutic effect of vaccine. Administer vaccine at least 4 weeks prior to starting etrasimod and avoid use during and for 5 weeks after treatment.Moderate to strong inhibitors of both CYP2C9 and CYP3A4 (fluconazole): May increase etrasimod level. Avoid use together.Drug-lifestyle.Sunlight, UV light: May increase risk of skin malignancy. Limit exposure to sunlight and UV light.  ADVERSE REACTIONSCNS: headache, dizziness.CV: hypertension, bradycardia.EENT: decreased visual acuity.GI: nausea.GU: UTI.Hepatic: elevated liver function tests.Metabolic: hypercholesterolemia.Musculoskeletal: arthralgia.Other: herpes viral infection.Reactions in bold italics are life-threatening.  Released: January 2024Nursing Drug Handbook© 2024 Wolters KluwermomelotinibOjjaaraPharmaceutical company: GlaxoSmithKlinePharmacologic classification: Kinase inhibitorTherapeutic classification: Immunosuppressant  AVAILABLE FORMSTablets: 100 mg, 150 mg, 200 mg  INDICATIONS AND DOSAGESIntermediate- or high-risk myelofibrosis in patients with anemiaAdults: 200 mg PO once daily.Adjust-a-dose: In patients with Child-Pugh class C liver impairment, reduce starting dose to 150 mg PO once daily. Refer to the manufacturer's instructions for toxicity-related dosage adjustments. Discontinue the drug in patients unable to tolerate 100 mg once daily.CONTRAINDICATIONS AND CAUTIONSThis drug may increase the risk of serious infections, which may be fatal. Don't initiate in patients with an active infection.May increase hepatitis B virus (HBV) load, with or without associated elevations in ALT or AST in patients with chronic HBV. If hepatitis B surface antigen or anti-HBc antibody is positive, consultation with a liver specialist should be considered. Chronic HBV infection should be treated and monitored according to clinical HBV guidelines.This drug may cause liver toxicity. Delay starting therapy in patients presenting with uncontrolled acute and chronic liver disease until apparent causes have been investigated and treated as clinically indicated.Kinase inhibitors may increase the risk of major adverse CV events, including CV death, MI, and stroke. Use cautiously in patients who currently smoke or have a history of smoking or other CV risk factors.Kinase inhibitors may increase the risk of thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis.Kinase inhibitors may increase the risk of lymphoma and other malignancies. Use cautiously in patients with known or new malignancy and patients who currently smoke or have a history of smoking.Safety and efficacy haven't been established in children.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm and should only be used during pregnancy if the benefits outweigh fetal risk.Patients of childbearing potential should use highly effective contraception during therapy and for at least 1 week after the last dose.There is no data on the appearance of this drug in human milk, but it has been reported as present in rat milk. Breastfeeding isn't recommended during treatment and for at least 1 week after the last dose.INTERACTIONSDrug-drug. BCRP substrates (rosuvastatin, methotrexate, glyburide, cimetidine): May increase exposure of substrate. Initiate rosuvastatin at 5 mg and do not increase to more than 10 mg once daily. Dose adjustment of other BCRP substrates may also be needed.OATP1B1/B3 inhibitors (cyclosporine, gemfibrozil, enalapril, cisplatin): Increases momelotinib level. Consider momelotinib dose modifications.Vaccines (inactivated): May diminish therapeutic effect of vaccine. Administer vaccines at least 2 weeks prior to initiating momelotinib or revaccinate at least 3 months after therapy is discontinued.Vaccines (live): May increase the risk of vaccine-associated infection and diminish the effect of vaccines. Avoid use together.  ADVERSE REACTIONSCNS: paresthesia, dizziness, headache, fever, syncope, fatigue, neuralgia, peripheral neuropathy, peripheral motor neuropathy, polyneuropathy.CV: arrhythmia, hypotension, hemorrhage, thrombosis, HF, peripheral edema, flushing.EENT: blurred visionGI: diarrhea, nausea, abdominal pain, vomiting.GU: kidney infection, UTI, acute kidney injury.Hematologic: thrombocytopenia, neutropenia.Hepatic: elevated liver enzymes.Musculoskeletal: extremity pain, back pain.Respiratory: pneumonia, cough, respiratory failure.Skin: pruritus, rash.Other: bacterial infection, viral infection, fungal infection, vitamin B1 deficiency.Reactions in bold italics are life-threatening.  Released: January 2024Nursing Drug Handbook© 2024 Wolters KluwerzilucoplanZilbrysqPharmaceutical company: UCB, Inc.Pharmacologic classification: Complement C5 inhibitorTherapeutic classification: Immunomodulator  AVAILABLE FORMSInjection: 16.6 mg/0.416 mL, 23 mg/0.574 mL, 32.4 mg/0.81 mL in single-dose prefilled syringes  INDICATIONS AND DOSAGESGeneralized myasthenia gravis in patients who are anti-acetylcholine receptor antibody-positiveAdults weighing 77 kg or more: 32.4 mg subcut once daily.Adults weighing 56 to less than 77 kg: 23 mg subcut once daily.Adults weighing less than 56 kg: 16.6 mg subcut once daily.  CONTRAINDICATIONS AND CAUTIONSBoxed Warning: Meningococcal infections have occurred in patients treated with complement inhibitors. These infections may rapidly become life-threatening or fatal if not recognized and treated early. Because of the risk, zilucoplan is available only through a REMS program.Boxed Warning: Meningococcal vaccination (for serogroups A, C, W, and Y, and serogroup B) should be completed or updated at least 2 weeks prior to administering the first dose of this drug, unless the risk of delaying therapy outweighs the risk of developing a meningococcal infection.If urgent therapy is indicated in a patient who is not up-to-date with meningococcal vaccines, the patient should receive meningococcal vaccines as soon as possible and receive antibacterial drug prophylaxis.Boxed Warning: Patients receiving zilucoplan are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination.Zilucoplan is contraindicated in patients with unresolved N. meningitidis infection.Patients may have increased susceptibility to infections caused by Streptococcus pneumoniae, Haemophilus influenzae, and N. gonorrhoeae. Administer vaccinations for the prevention of S. pneumoniae and H. influenzae type b according to the Advisory Committee on Immunization Practices guidelines. Even after vaccination, patients are at increased risk for infection due to these bacteria.Pancreatitis and pancreatic cysts have been reported.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONStudies during pregnancy are inadequate. Animal studies showed increased fetal risk.There are no data on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production. Use cautiously during breastfeeding.INTERACTIONSNone reported.  ADVERSE REACTIONSGI: nausea, vomiting, diarrhea.GU: UTI.Hepatic: increased lipase, increased amylase, pancreatitis, pancreatic cysts.Respiratory: upper respiratory infection.Skin: injection site reactions.Reactions in bold italics are life-threatening.  Released: January 2024Nursing Drug Handbook© 2024 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - December 2023
gepironeExxuaPharmaceutical company: Fabre-Kramer PharmaceuticalsPharmacologic classification: 5HT1A receptor agonistTherapeutic classification: Antidepressant  AVAILABLE FORMSTablets (extended-release): 18.2 mg, 36.3 mg, 54.5 mg, 72.6 mg  INDICATIONS AND DOSAGESMajor depressive disorderAdults: Start at 18.2 mg PO once daily. May increase to 36.3 mg once daily on day 4, 54.5 mg once daily after day 7, and 72.6 mg once daily after day 14 based on clinical response and tolerability. Maximum daily dose is 72.6 mg.  Adjust-a-dose: In older adults, patients with creatinine clearance less than 50 mL/minute or Child-Pugh class B liver impairment, maximum dosage is 36.3 mg once daily after day 7. In patients also receiving a moderate CYP3A4 inhibitor, reduce gepirone dosage by 50%.CONTRAINDICATIONS AND CAUTIONSBoxed Warning: There is an increased risk of suicidal thinking and behavior in children and young adults taking antidepressants. Closely monitor for worsening and emergence of suicidal thoughts and behaviors. This drug isn't approved for use in pediatric patients.Contraindicated in patients with hypersensitivity to gepirone or its components, patients with prolonged QTc interval greater than 450 msec at baseline, congenital long QT syndrome, or Child-Pugh class C liver impairment.This drug isn't approved for use in treating bipolar depression.This drug may precipitate a manic, mixed, or hypomanic episode, especially in patients with bipolar disorder or who have risk factors for bipolar disorder (family history of bipolar disorder, suicide, or depression).Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONStudies during pregnancy are inadequate. Health care providers are encouraged to register patients in the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.Consider the risk of untreated depression during pregnancy and postpartum with the risk of complications to the newborn upon delivery.Neonates exposed to serotonergic antidepressants in the third trimester may experience complications upon delivery, including respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremors, jitteriness, irritability, and constant crying that require prolonged hospitalization, respiratory support, and tube feeding. Exposure during late pregnancy may also increase the risk of persistent pulmonary hypertension, which is associated with substantial neonatal morbidity and mortality.There are no data on the presence of gepirone in human milk, the effects on the breastfed infant, or the effects on milk production. Use cautiously during breastfeeding and monitor for infant irritability, restlessness, excessive somnolence, decreased feeding, and weight loss.INTERACTIONSDrug-drug.CYP3A4 inducers (bosentan, phenytoin): May significantly decrease gepirone level. Avoid use together.Drugs that prolong the QTc interval (amiodarone, haloperidol, ciprofloxacin, methadone, amitriptyline): May increase QTc prolonging effects of gepirone and the risk of cardiac arrhythmias. Monitor patients with ECGs more frequently.MAO inhibitors (selegiline, phenelzine, linezolid, IV methylene blue): Increase the risk of serotonin syndrome. Use together or within 14 days is contraindicated.Moderate CYP3A4 inhibitors (erythromycin, diltiazem): May increase gepirone level. If use can't be avoided, reduce gepirone dosage by 50%.Serotonergic drugs (SSRIs, tricyclic antidepressants): May increase the risk of serotonin syndrome. If serotonin syndrome occurs, consider discontinuation of gepirone or concomitant serotonergic drugs.Strong CYP3A4 inhibitors (clarithromycin, indinavir, ketoconazole): May increase gepirone level. Use together is contraindicated.Drug-herb.St. John's wort: May decrease gepirone level. Discourage use together.  ADVERSE REACTIONSCNS: dizziness, lightheadedness, headache, fatigue, sedation, somnolence, insomnia, paresthesia, agitation, feeling jittery, lethargy, confusion, increased energy, feeling abnormal, hypoesthesia, poor quality sleep, thinking abnormalities.CV: palpitations, increased heart rate, peripheral edema.EENT: dry mouth, nasal congestion, nasopharyngitis.GI: nausea, diarrhea, vomiting, abdominal pain, dyspepsia, increased appetite, constipation.Metabolic: weight gain.Respiratory: upper respiratory infection, dyspnea.Skin: hyperhidrosis.Other: breast tenderness.Reactions in bold italics are life-threatening.  Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwermotixafortideAphexdaPharmaceutical company: BioLineRxPharmacologic classification: CXCR4 inhibitorTherapeutic classification: Hematopoietic  AVAILABLE FORMSLyophilized powder for injection: 62 mg single-dose vial  INDICATIONS AND DOSAGESTo mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma in combination with filgrastim (G-CSF)Adults: 1.25 mg/kg actual body weight subcut 10 to 14 hours prior to the initiation of the first apheresis. A second dose can be administered 10 to 14 hours prior to a third apheresis, if necessary. Filgrastim 10 mcg/kg subcut must be administered once daily for 4 days prior to the first dose of motixafortide and on each day prior to apheresis.  CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with a history of serious hypersensitivity reaction to this drug.Anaphylactic shock and hypersensitivity reactions may occur. Premedicate all patients. Administer in a setting where personnel and therapies are available for immediate treatment of reactions.This drug may mobilize leukemic cells, contaminating the apheresis product, and should not be used in patients with leukemia.Tumor cells may be released from marrow and collected in the leukapheresis product during stem cell mobilization with motixafortide and filgrastim. The effect of potential reinfusion of tumor cells is unknown.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm. Patients of reproductive potential should use effective contraception during and for 8 days after treatment.It's unknown if this drug is present in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential serious adverse reactions in the breastfed child, breastfeeding is not recommended during the treatment and for 8 days after the final dose.   INTERACTIONSDrug-drug.Negative chronotropic drugs (beta blockers): May increase risk of hypotension if hypersensitivity reaction occurs. Replace beta blocker with nonchronotropic drug when appropriate.   ADVERSE REACTIONSCNS: paresthesia, fever, dizziness, tremor.CV: flushing, hypertension.EENT: ear swelling.GI: nausea.Metabolic:hypokalemia.Musculoskeletal: back pain.Skin: injection site reactions (pain, erythema, pruritis, bruising, discomfort, induration, mass, nodule, rash, swelling, urticaria, cellulitis), pruritis, urticaria, rash, erythema, exfoliative dermatitis.Other: hypersensitivity reactions, chills.Reactions in bold italics are life-threatening.  Released: December 2023Nursing Drug Handbook© 2023 Wolters Kluwer  palovaroteneSohonosPharmaceutical company: IPSEN Biopharmaceuticals, Inc.Pharmacologic classification: Retinoic acid receptor agonistTherapeutic classification: Metabolic agent  AVAILABLE FORMSCapsules: 1 mg, 1.5 mg, 2.5 mg, 5 mg, 10 mg  INDICATIONS AND DOSAGESReduction in the volume of new heterotopic ossification in patients with fibrodysplasia ossificans progressiva (FOP)Adults and children age 14 and older: Daily dosing regimen: 5 mg PO daily. Stop daily dosing when flare-up dosing begins. Flare-up dosing is 20 mg PO daily for 4 weeks, followed by 10 mg PO daily for 8 weeks (for a total of 12 weeks), even if symptoms resolve earlier, then return to daily dosing of 5 mg.Children ages 8 to 13 (females) and ages 10 to 13 (males) weighing 60 kg or more: Follow adult dosing.Children ages 8 to 13 (females) and ages 10 to 13 (males) weighing 40 to 59.9 kg: Daily dosing: 4 mg PO daily. Flare-up dosing: 15 mg PO daily weeks 1 to 4, then 7.5 mg PO daily weeks 5 to 12.Children ages 8 to 13 (females) and ages 10 to 13 (males) weighing 20 to 39.9 kg: 3 mg PO daily. Flare-up dosing: 12.5 mg PO daily weeks 1 to 4, then 6 mg PO daily weeks 5 to 12.Children ages 8 to 13 (females) and ages 10 to 13 (males) weighing 10 to 19.9 kg: 25 mg PO daily. Flare-up dosing: 10 mg PO daily weeks 1 to 4, then 5 mg PO daily weeks 5 to 12.Adjust-a-dose: Administer the initial flare-up dosage once daily for 4 weeks, then administer the lower flare-up dosage once daily for 8 weeks (for a total of 12 weeks of flare-up treatment), even if symptoms resolve earlier, then return to daily dosing. If, during flare-up treatment, the patient experiences marked worsening of the original flare-up site or another flare-up at a new location, restart the 12-week flare-up dosing with the week 1 to 4 dose. For flare-up symptoms that have not resolved at the end of the 12-week period, the week 5 to 12 flare-up dose may be extended in 4-week intervals and continued until the flare-up symptoms resolve. If new flare-up symptoms occur after daily dosing is resumed, flare-up dosing may be restarted.If the patient requires dosage reduction for adverse reactions during either daily dosing or flare-up dosing, refer to the manufacturer's instructions. May reduce dosage further or discontinue temporarily or permanently if adverse reactions don't improve. Subsequent flare-up dosing should be initiated at the last previously tolerated dose. If concomitant use with moderate CYP3A inhibitors is necessary, reduce palovarotene dose by half; see manufacturer's instructions for specifics.  CONTRAINDICATIONS AND CAUTIONSContraindicated in patients hypersensitive to retinoids, or to any component of this drug.Boxed Warning: Premature epiphyseal closure occurs in growing pediatric patients treated with this drug. Close monitoring is recommended.Mucocutaneous adverse reactions, including dry skin, dry lips, pruritis, rash, alopecia, erythema, skin exfoliation, photosensitivity reactions, and dry eye have occurred. This may increase the risk of skin and soft tissue infections, particularly paronychia and decubitus ulcer. Dosage reduction may be required.May increase bone toxicity, including reductions in bone mass and spontaneous osteoporosis and fracture. Bone spurs and calcification of tendons or ligaments may also occur, especially with long-term use at high doses.May increase the risk of decreased vertebral bone mineral content and bone density, and vertebral fractures (T4 to L4).Depression, anxiety, mood alterations and suicidal thoughts and behaviors may occur.Night blindness may occur and make driving at night hazardous.The safety and effectiveness for the treatment of FOP have not been established in female children younger than age 8 or male children younger than age 10.This drug isn't recommended for use in patients with Child-Pugh class B or C liver impairment, or those with creatinine clearance 15 to 29 mL/min.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONBoxed Warning: This drug may cause fetal harm and is contraindicated during pregnancy. Because of the risk of teratogenicity and to minimize fetal exposure, this drug is to be administered only if conditions for pregnancy prevention are met.Negative serum pregnancy test required at least 1 week prior to initiating therapy, periodically during treatment, and one month after treatment discontinuation.Females of reproductive potential must use an effective method of contraception at least 1 month prior to treatment, during treatment, and for 1 month after the last dose.If pregnancy occurs during treatment, discontinue the drug immediately and refer the patient to an obstetrician/gynecologist experienced in reproductive toxicity.It's unknown if this drug crosses into human milk. Breastfeeding isn't recommended during treatment and for at least 1 month after the last dose.Palovarotene is present in semen, but at levels unlikely to affect fetal development.   INTERACTIONSDrug-drug. Strong or moderate CYP3A4 inhibitors (ketoconazole, erythromycin): May increase palovarotene concentrations. Avoid use together. If moderate inhibitors are used, reduce palovarotene dose by 50%.Strong or moderate CYP3A4 inducers (rifampicin): May decrease palovarotene concentrations. Avoid use together.Tetracyclines: May increase risk of benign intracranial hypertension. Avoid use together.Vitamin A: May cause additive effects and risk of hypervitaminosis A. Avoid use together.Drug-food.Grapefruit, pomelo, or juices containing these fruits: May increase palovarotene levels. Don't use together.Drug-lifestyle.Sun exposure: May increase risk of mucocutaneous adverse reactions and photosensitivity. Avoid excessive sun exposure or artificial UV light. Sunscreen, protective clothing, and sunglasses should be used when exposure is unavoidable.  ADVERSE REACTIONSCNS: headache, migraine, fatigue.CV: peripheral edema.EENT: dry eye.GI: nausea.Hepatic: increased ALT levels.Metabolic: hypertriglyceridemia.Musculoskeletal: premature epiphyseal closure, arthralgia, extremity pain, back pain, musculoskeletal pain, myalgia.Skin: dry skin, dry lips, pruritus, rash, alopecia, erythema, skin peeling.Other: hypersensitivity. Reactions in bold italics are life-threatening.  Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - November 2023
avacincaptad pegolIzervayPharmaceutical company: Iveric Bio, Inc.Pharmacologic classification: Complement C5 inhibitorTherapeutic classification: Ophthalmic agent  AVAILABLE FORMSIntravitreal solution: 20 mg/mL single-dose vial  INDICATIONS AND DOSAGESGeographic atrophy secondary to age-related macular degeneration (AMD)Adults: 2 mg (0.1 mL) by intravitreal injection to each affected eye once per month (approximately 28 days, plus or minus 7 days) for up to 12 months.  CONTRAINDICATIONS AND CAUTIONSContraindicated in those with ocular or periocular infections, or active intraocular inflammation.Intravitreal injections may be associated with endophthalmitis and retinal detachment. Aseptic injection technique must be used to minimize the risk of endophthalmitis.Use of this drug was associated with increased incidence of neovascular (wet) AMD.Transient increased intraocular pressure (IOP) has been observed following intravitreal injection.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies during pregnancy. Use cautiously during pregnancy.It isn't known if this drug appears in human milk. Use cautiously during breastfeeding.   INTERACTIONS None reported.     ADVERSE REACTIONSEENT: conjunctival hemorrhage, increased IOP, blurred vision, choroidal neovascularization, neovascular AMD, eye pain, vitreous floaters, blepharitis.Reactions in bold italics are life-threatening.  Released: November 2023Nursing Drug Handbook© 2023 Wolters KluwerlotilanerXdemvyPharmaceutical company: Tarsus PharmaceuticalsPharmacologic classification: EctoparasiticideTherapeutic classification: Antiparasitic  AVAILABLE FORMSOphthalmic solution: 0.25%  INDICATIONS AND DOSAGESDemodex blepharitisAdults: Instill one drop in each eye b.i.d. (approximately 12 hours apart) for 6 weeks.  CONTRAINDICATIONS AND CAUTIONSSafety and effectiveness in children haven't been established.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies on use during pregnancy or breastfeeding. Systemic exposure by ophthalmic route is limited. Use cautiously during pregnancy or breastfeeding.   INTERACTIONSNone reported.   ADVERSE REACTIONSEENT: stinging and burning at instillation site, eyelid cyst, bacterial eyelid infection, corneal inflammation.Reactions in bold italics are life-threatening.  Released: November 2023Nursing Drug Handbook© 2023 Wolters Kluwer  ritlecitinibLitfuloPharmaceutical company: PfizerPharmacologic classification: Kinase inhibitorTherapeutic classification: Immunosuppressant  AVAILABLE FORMSCapsule: 50 mg  INDICATIONS AND DOSAGESSevere alopecia areataAdults and children age 12 and older: 50 mg PO once daily.  Adjust-a-dose: Discontinue this drug if platelet count is less than 50,000/mm3 or if absolute lymphocyte count (ALC) is less than 500/mm3. May restart once ALC returns above this value. CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with known hypersensitivity to ritlecitinib or its components. Hypersensitivity reactions, such as anaphylaxis, urticaria, and rash have been reported.Boxed Warning: This drug increases the risk of serious bacterial, fungal, viral, and opportunistic infections leading to hospitalization or death. Interrupt treatment if serious infection occurs until the infection is controlled.Boxed Warning: This drug shouldn't be given to patients with active tuberculosis (TB). Avoid use in patients with active, serious infections.Use cautiously in patients with chronic or recurrent infection, who have been exposed to TB, have a history of serious infection or opportunistic infection, who have resided or traveled in areas of endemic TB or mycoses, or with underlying conditions that may predispose them to infection.Viral reactivation, including cases of herpes zoster, has occurred.Boxed Warning: A higher rate of all-cause mortality, including sudden CV death, and major adverse CV events (MI, stroke) occurred with another janus kinase (JAK) inhibitor versus tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis (RA). This drug isn't approved for use in patients with RA.Use cautiously in patients who are current or former smokers and with other CV risk factors.Boxed Warning: Malignancies have occurred in patients treated with this drug. A higher rate of lymphomas and lung cancers have occurred with another JAK inhibitor versus TNF blockers in patients with RA.Nonmelanoma skin cancer has been observed. Use cautiously in patients with a known malignancy other than successfully treated nonmelanoma skin cancer or cervical cancer. Patients who currently smoke or previously smoked may have an increased risk of malignancy.Boxed Warning: Thrombosis has occurred in patients treated with this drug. An increased incidence of pulmonary embolism, and venous and arterial thrombosis occurred with another JAK inhibitor versus TNF blockers. Avoid this drug in patients who may be at increased risk for thrombosis.This drug isn't recommended in patients with Child-Pugh class C liver impairment, hepatitis B or hepatitis C.Safety and effectiveness in children younger than age 12 haven't been established.Use cautiously in older adults who generally have a higher incidence of infections.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONStudies during pregnancy are inadequate. It's unknown if this drug causes harm to a fetus. Report pregnancies to the pregnancy exposure registry at 1-877-390-2940.There is no data on the appearance of this drug in human milk, but the drug is present in animal milk. Because of potential adverse effects, breastfeeding isn't recommended during treatment and for 14 hours after the last dose.   INTERACTIONSDrug–drug.CYP3A inducers (rifampin): May decrease ritlecitinib level. Use together isn't recommended.CYP3A substrates (midazolam), CYP1A2 substrates (clozapine, theophylline, zolpidem): Increases substrate level and risk of adverse reactions. Monitor patient closely and adjust substrate dosage as needed.JAK inhibitors, biologic immunomodulators, potent immunosuppressants (cyclosporine): May enhance adverse reactions of immunosuppressants. Avoid use together.Live vaccines: May increase risk of vaccine-associated infection and diminish therapeutic effect of vaccine. Avoid live vaccines just prior to and during treatment.Drug–food.Caffeine: May increase risk of adverse reactions of caffeine. Use together cautiously.ADVERSE REACTIONSCNS: dizziness, headache, fever.GI: diarrhea, stomatitis.Hematologic: decreased RBC count.Metabolic: increased CK level.Skin: acne, rash, urticaria, folliculitis, atopic dermatitis.Other: herpes zoster, infection.Reactions in bold italics are life-threatening.  Released: November 2023Nursing Drug Handbook© 2023 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - October 2023
nirmatrelvir–ritonavirPaxlovidPharmaceutical company: PfizerPharmacologic classification: Protease inhibitorsTherapeutic classification: Antivirals  AVAILABLE FORMSTablets: 150 mg nirmatrelvir copackaged with 100 mg ritonavir  INDICATIONS AND DOSAGESMild-to-moderate coronavirus disease 2019 (COVID-19) in patients at high risk for progression to severe COVID-19, including hospitalization or deathAdults: 300 mg nirmatrelvir PO with 100 mg ritonavir PO taken together b.i.d. for 5 days.  Adjust-a-dose: For eGFR of 30 to less than 60 mL/minute, 150 mg nirmatrelvir PO with 100 mg ritonavir PO taken together b.i.d. for 5 days.CONTRAINDICATIONS AND CAUTIONSContraindicated with drugs primarily metabolized by CYP3A and for which elevated levels are associated with serious or life-threatening reactions, and drugs that are strong CYP3A inducers where significantly reduced nirmatrelvir or ritonavir levels may be associated with loss of virologic response and possible resistance.Boxed Warning: Consider the benefit of PAXLOVID treatment in reducing hospitalization and death, and whether the risk of drug-to-drug interactions for the patient can be appropriately managed.Nirmatrelvir–ritonavir isn't approved for preexposure or postexposure prevention of COVID-19.Contraindicated in patients with a history of significant hypersensitivity reactions (toxic epidermal necrolysis or Stevens-Johnson syndrome) to nirmatrelvir or ritonavir or any other components of the product. Anaphylaxis, severe cutaneous adverse reactions, and other hypersensitivity reactions have been reported.Transaminase elevations, hepatitis, and jaundice have occurred in patients receiving ritonavir. Use cautiously in patients with preexisting liver disease, liver enzyme abnormalities, or hepatitis. This drug isn't recommended in patients with Child-Pugh class C liver impairment.This drug isn't recommended in patients with GFR less than 30 mL/minute or patients on kidney replacement therapy.There may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.Use cautiously in older adults.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONStudies on use of nirmatrelvir or ritonavir during pregnancy are inadequate. Use cautiously during pregnancy.There are patient and fetal risks associated with untreated COVID-19.It's unknown if nirmatrelvir is excreted in human milk. Ritonavir is present in human milk. Use cautiously during pregnancy.Patients with COVID-19 who are breastfeeding should follow clinical guidelines to avoid exposing their infants to COVID-19.Ritonavir may reduce the efficacy of combined hormonal contraceptives. Use an effective alternative contraceptive or an additional barrier method of contraception during treatment.   INTERACTIONSAlert: Nirmatrelvir with ritonavir has the potential for significant interactions with many drugs. Consult a drug interaction resource or pharmacist for additional information. Drug-drug. Alpha 1-adrenoreceptor antagonists (alfuzosin, tamsulosin): May increase levels of the antagonist and risk of hypotension. Avoid use together. Coadministration with alfuzosin is contraindicated.Antiarrhythmics (amiodarone, disopyramide, dronedarone, flecainide, lidocaine [systemic], propafenone, quinidine): May increase antiarrhythmic level. Use together with disopyramide or lidocaine cautiously with therapeutic level monitoring, if available. Use with amiodarone, dronedarone, flecainide, propafenone, or quinidine is contraindicated.Antibacterials (clarithromycin, erythromycin): May increase level of antibacterial. Refer to antibacterial prescribing information.Anticancer drugs (abemaciclib, ceritinib, dasatinib, encorafenib, ibrutinib, ivosidenib, neratinib, nilotinib, venetoclax, vinblastine, vincristine):May increase level of the anticancer drug. Avoid coadministration of encorafenib or ivosidenib due to risk of serious adverse events, including QT interval prolongation. Avoid use with neratinib, venetoclax or ibrutinib. Coadministration of vincristine and vinblastine may lead to significant hematologic or GI adverse effects.Anticoagulants (apixaban, dabigatran and rivaroxaban, warfarin): May increase risk of bleeding and anticoagulant level. May increase or decrease warfarin level. Closely monitor INR when used with warfarin. Avoid use with rivaroxaban. Reduce dose of dabigatran and apixaban or avoid concomitant use. Refer to anticoagulant prescribing information.Anticonvulsants (carbamazepine, phenobarbital, primidone, phenytoin): May cause loss of virologic response and possible resistance. Use together is contraindicated.Antifungals (isavuconazonium, itraconazole azole, ketoconazole, voriconazole): May increase isavuconazonium, itraconazole, ketoconazole, and nirmatrelvir–ritonavir levels. May decrease voriconazole level. Avoid use with voriconazole. Refer to antifungal prescribing information.Anti-HIV agents (bictegravir–emtricitabine–tenofovir, efavirenz, maraviroc, nevirapine, zidovudine): May alter anti-HIV agent level. Refer to anti-HIV agent prescribing information.Anti-HIV protease inhibitors (atazanavir, darunavir, tipranavir):  May increase protease inhibitor level. Refer to protease inhibitor prescribing information. Patients on ritonavir- or cobicistat-containing HIV regimens should continue treatment as indicated. Monitor for increased adverse events.Antimigraine medications (eletriptan, rimegepant, ubrogepant): May increase level of antimigraine medication. Use of eletriptan within 72 hours of Paxlovid is contraindicated due to risk for serious adverse reactions, including CV and cerebrovascular events. Coadministration of ubrogepant is contraindicated because of the risk for serious adverse reactions. Avoid use with rimegepant.Antimycobacterial (bedaquiline, rifabutin):  May increase level of antimycobacterial. Refer to antimycobacterial prescribing information.Antipsychotics (clozapine, lurasidone, pimozide, quetiapine): May increase level of antipsychotic. Refer to antipsychotic prescribing information.Apalutamide:  May decrease nirmatrelvir or ritonavir levels. Coadministration is contraindicated.Atorvastatin, rosuvastatin: May increase statin level. Consider temporary discontinuation of atorvastatin and rosuvastatin during treatment. Atorvastatin and rosuvastatin don't need to be withheld prior to or after completing Paxlovid.Bosentan: May increase bosentan level and decrease nirmatrelvir or ritonavir level. Discontinue bosentan at least 36 hours prior to initiation of Paxlovid.Bupropion: May decrease level of bupropion. Monitor for adequate antidepressant response.Calcium channel blockers (amlodipine, diltiazem, felodipine, nicardipine, nifedipine, verapamil): May increase level of calcium channel blocker. Monitor closely and consider decreasing the calcium channel dose.Cardiovascular agents (aliskiren, ticagrelor, vorapaxar): May increase level of CV agent. Avoid use together.Cilostazol: May increase cilostazol level. Decrease dose of cilostazol.Clonazepam: May increase clonazepam level. Decrease clonazepam dosage as indicated, and monitor therapy.Clopidogrel: May decrease level of clopidogrel active metabolite. Use together cautiously.Colchicine: May increase colchicine level and risk of serious reactions. Use together is contraindicated in patients with kidney or liver impairment.Corticosteroids metabolized by CYP3A (betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, triamcinolone):  May increase level of corticosteroid. Consider alternative corticosteroid (beclomethasone, prednisone, prednisolone).Cystic fibrosis transmembrane conductance regulator potentiators (ivacaftor, elexacaftor–tezacaftor–ivacaftor, tezacaftor–ivacaftor): May increase level of cystic fibrosis drug. Refer to prescribing information for dosage adjustment.Darifenacin: May increase darifenacin level. The darifenacin dose should not exceed 7.5 mg daily. Refer to darifenacin prescribing information.Digoxin: May increase digoxin level. Monitor digoxin level.Eplerenone, ivabradine: May increase level of these drugs. Use together is contraindicated.Ergot derivatives (dihydroergotamine, ergotamine, methylergonovine): May increase level of ergot derivative and risk for toxicity. Use together is contraindicated.Ethinyl estradiol: May decrease hormone level. Consider using an additional, nonhormonal method of contraception during the 5 days of treatment and until one menstrual cycle after stopping Paxlovid.Finerenone: May increase finerenone level. Use together is contraindicated.Flibanserin: May increase flibanserin level and risk of hypotension, syncope, and CNS depression. Use together is contraindicated.Hepatitis C direct acting antivirals (elbasvir–grazoprevir, glecaprevir–pibrentasvir, ombitasvir–paritaprevir–ritonavir–dasabuvir, sofosbuvir–velpatasvir–voxilaprevir): May increase level of antiviral. Avoid concomitant use with glecaprevir–pibrentasvir. Patients on ritonavir-containing hepatitis C virus (HCV) regimens should continue treatment as indicated. Monitor for increased drug adverse events with use together. Refer to HCV antiviral prescribing information.Immunosuppressants (cyclosporine, tacrolimus): May increase immunosuppressant level. Avoid concomitant use when close monitoring of immunosuppressant level is not feasible. If coadministered, adjust immunosuppressant dose and closely monitor immunosuppressant level and assess for adverse reactions.Immunosuppressant (voclosporin): May increase voclosporin level. Coadministration contraindicated due to potential for kidney toxicity.Ivabradine: May increase ivabradine level and risk for bradycardia or conduction disturbances. Use together is contraindicated.Janus kinase (JAK) inhibitors (tofacitinib, upadacitinib): May increase JAK inhibitor level. Adjust dose of tofacitinib. Dose adjustment for coadministration of upadacitinib depends on the upadacitinib indication. Refer to the JAK inhibitor prescribing information.Lomitapide: May increase risk for liver toxicity and GI adverse reactions. Use together is contraindicated.Lovastatin, simvastatin: May increase statin level and risk for myopathy. Use together is contraindicated.Lumacaftor–ivacaftor: May decrease levels of nirmatrelvir or ritonavir. Use together is contraindicated.Methadone: May decrease methadone level. Monitor methadone-maintained patients closely for evidence of withdrawal and adjust methadone dose accordingly.mTOR inhibitors (everolimus, sirolimus): May increase mTOR inhibitor level. Avoid use together.Neuropsychiatric agents (aripiprazole, brexpiprazole, cariprazine, iloperidone, lumateperone, pimavanserin, suvorexant): May increase level of neuropsychiatric agent. Avoid use of suvorexant. Adjust dose of aripiprazole, brexpiprazole, cariprazine, iloperidone, lumateperone, pimavanserin.Opioid analgesics (fentanyl, hydrocodone, oxycodone, meperidine): May increase opioid level. Closely monitor for therapeutic and adverse opioid effects including potentially fatal respiratory depression. Consider decreasing opioid dosage.Opioid antagonists (naloxegol): May increase naloxegol level. Use together is contraindicated due to the potential for opioid withdrawal.PDE5 inhibitors for erectile dysfunction (avanafil, sildenafil, tadalafil, vardenafil): May increase PDE5 inhibitor level. Don't use with avanafil. Adjust dose of sildenafil, tadalafil, and vardenafil. Refer to inhibitor prescribing information.PDE5 inhibitors (sildenafil, tadalafil): May increase PDE5 inhibitor level. Use of sildenafil is contraindicated for pulmonary hypertension because of potential for sildenafil-associated adverse events. Avoid use with tadalafil for pulmonary hypertension.sGC stimulator (riociguat): May increase riociguat level. Dosage adjustment of riociguat recommended when used for pulmonary hypertension.Ranolazine: May increase ranolazine level. Use is contraindicated because of the potential for serious or life-threatening reactions.Salmeterol: May increase salmeterol level and risk of CV adverse events (QT prolongation, palpitations, sinus tachycardia). Avoid use together.Saxagliptin: May increase saxagliptin level. Decrease dose of saxagliptin. Refer to saxagliptin prescribing information.Silodosin: May increase silodosin level and risk of postural hypotention. Use together is contraindicated.Sedative-hypnotics (oral midazolam, triazolam): May increase benzodiazepine level. Use together is contraindicated.Sedative-hypnotics (buspirone, clorazepate, diazepam, flurazepam, parenteral midazolam, zolpidem): May increase sedative-hypnotic level. Consider dose decrease and monitor for adverse events. Coadministration of parenteral midazolam should be done in a setting with monitoring and appropriate medical management in case of respiratory depression or prolonged sedation.Trazodone: May increase trazodone level and its adverse reactions (nausea, dizziness, hypotension, syncope). Consider decreasing trazodone dose.Tolvaptan: May increase tolvaptan level and risk for dehydration, hypovolemia, and hyperkalemia. Use together is contraindicated.Drug-herb. St. John's wort:  May decrease drug level. Use together is contraindicated due to potential loss of virologic response and possible resistance.ADVERSE REACTIONSCNS: altered taste, headache, malaise.CV: hypertension.GI: diarrhea, abdominal pain, nausea, vomiting.Hepatic: transaminase elevations, hepatitis, jaundice.Skin: toxic epidermal necrolysis, Stevens-Johnson syndrome. .Other: hypersensitivity reactions, anaphylaxis.Reactions in bold italics are life-threatening.  Released: October 2023Nursing Drug Handbook© 2023 Wolters KluwersotagliflozinInpefaPharmaceutical company: Lexicon PharmaceuticalsPharmacologic classification: Sodium-glucose cotransporter 2 inhibitorTherapeutic classification: Antidiabetic  AVAILABLE FORMSTablets: 200 mg; 400 mg  INDICATIONS AND DOSAGESTo reduce the risk of CV death, hospitalization for heart failure (HF), and urgent HF visits in patients with HF or with type 2 diabetes, chronic kidney disease, and other CV risk factorsAdults: 200 mg PO daily. After at least 2 weeks, may increase to 400 mg PO once daily, as tolerated.Adjust-a-dose: Decrease to 200 mg PO daily, as necessary, based on tolerance.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with a history of serious hypersensitivity reaction to sotagliflozin.This drug isn't recommended in patients with Child-Pugh class B or C liver impairment.Use cautiously in patients with a history of pancreatitis or pancreatic surgery, acute febrile illness, reduced caloric intake, ketogenic diet, surgery, insulin dose reduction, volume depletion, and alcohol abuse, which are risk factors for ketoacidosis.Patients with eGFR less than 60 mL/min/1.73 m2, older adults, or patients taking loop diuretics may be at increased risk for volume depletion. This may manifest as symptomatic hypotension or acute transient changes in creatinine.This drug can significantly increase the risk of diabetic ketoacidosis. Blood glucose may be lower than typically expected for diabetic ketoacidosis (less than 250 mg/dL).Serious UTIs, including pyelonephritis and urosepsis, and necrotizing fasciitis (Fournier gangrene) of the perineum, have been reported.Safety and effectiveness in patients with an eGFR less than 25 mL/min/1.73 m2 or on dialysis are not known.Safety and effectiveness in children haven't been established.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies during pregnancy. Based on animal data showing kidney effects, this drug isn't recommended during the second and third trimesters of pregnancy.There are no data on the presence of this drug in human milk, its effects on the breastfed infant or on milk production. Since kidney maturation occurs in utero and during the first 2 years of life, there may be risk to the developing kidneys. Breastfeeding isn't recommended while taking this drug.   INTERACTIONSDrug-drug.Digoxin: May increase digoxin level. Monitor digoxin level.Insulin, insulin secretagogues: May increase risk of hypoglycemia. Monitor glucose and decrease dose of insulin or insulin secretagogue as needed.Lithium: May decrease lithium level. Monitor lithium level frequently during initiation of and changes in sotagliflozin therapy.Loop diuretics (furosemide, torsemide): May increase risk for volume depletion. Use cautiously together.Rifampin: May decrease sotagliflozin level. Monitor clinical effect.Drug-food. May increase sotagliflozin level. Take drug not more than 1 hour before the first meal of the day.   ADVERSE REACTIONSCNS: dizziness.GI diarrhea.GU UTI, genital mycotic infection.Metabolic diabetic ketoacidosis, hypoglycemia,volume depletion.  Reactions in bold italics are life-threatening.  Released: October 2023Nursing Drug Handbook© 2023 Wolters Kluwer  Download these updates as a PDF
New FDA Drug Approvals - September 2023
fezolinetantVeozahPharmaceutical company: Astellas PharmaPharmacologic classification: Neurokinin 3 receptor antagonistTherapeutic classification: Menopause drug  AVAILABLE FORMSTablets: 45 mg  INDICATIONS AND DOSAGESModerate to severe vasomotor symptoms due to menopauseAdults: 45 mg PO once daily.  CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with known cirrhosis, severe kidney impairment or kidney failure.Safety and efficacy in children haven't been established.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONThere are no data on the risks associated with the use of this drug during pregnancy.It's unknown if this drug appears in human milk.   INTERACTIONSDrug-drug. CYP1A2 inhibitors (cimetidine, ciprofloxacin, fluvoxamine): May increase fezolinetant level. Use together is contraindicated.  ADVERSE REACTIONSCNS: insomnia.GI: abdominal pain, diarrhea.Hepatic: transaminase elevation.Musculoskeletal: back pain.Other: hot flash.Reactions in bold italics are life-threatening.  Released: September 2023Nursing Drug Handbook© 2023 Wolters KluwerperfluorohexyloctaneMieboPharmaceutical company: Bausch and LombPharmacologic classification: Semifluorinated alkaneTherapeutic classification: Miscellaneous ophthalmic drug  AVAILABLE FORMSOphthalmic solution:  100% multi-dose bottles  INDICATIONS AND DOSAGESDry eye diseaseAdults:  Instill one drop q.i.d. into affected eye(s).  CONTRAINDICATIONS AND CAUTIONSSafety and effectiveness in patients younger than age 18 have not been established.Dialyzable drug: Unknown.   PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate studies during pregnancy. Use cautiously during pregnancy.There are no data on the presence of this drug in human milk, its effects on breastfed infants, or on milk production. Use cautiously during breastfeeding.   INTERACTIONSNone reported by the manufacturer.  ADVERSE REACTIONSEENT: blurred vision, conjunctival redness.Reactions in bold italics are life-threatening.  Released: September 2023Nursing Drug Handbook© 2023 Wolters Kluwer  Download these updates as a PDF
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