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New FDA Drug Approvals - December 2024

deuruxolitinib

Leqselvi

Pharmaceutical company: Sun Pharmaceutical Industries

Pharmacologic classification: Janus kinase (JAK) inhibitor

Therapeutic classification: Immunomodulator

AVAILABLE FORMS

Tablets:  8 mg

INDICATIONS AND DOSAGES

Severe alopecia areata

Adults: 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 CAUTIONS

  • This 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-REPRODUCTION

  • This 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.

INTERACTIONS

Drug-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 REACTIONS

CNS: 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

 

vorasidenib

Voranigo

Pharmaceutical company: Servier Pharmaceuticals

Pharmacologic classification: Isocitrate dehydrogenase (IDH)-1 and IDH-2 inhibitors

Therapeutic classification: Antineoplastic

AVAILABLE FORMS

Tablets:  10 mg; 40 mg

INDICATIONS AND DOSAGES

Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, subtotal resection, or gross total resection

Adults 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 CAUTIONS

  • This 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-REPRODUCTION

  • This 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.

INTERACTIONS

Drug-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 REACTIONS

CNS: 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

Download these updates as a PDF

New FDA Drug Approvals Archive

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
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
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