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New FDA Drug Approvals - March 2025

sulopenem etzadroxil and probenecid

Orlynvah

Pharmaceutical company: Iterum Therapeutics

Pharmacologic classification: Penem antibiotic and renal tubular transport inhibitor

Therapeutic classification: Antibiotic

AVAILABLE FORMS

Tablets: 500 mg sulopenem etzadroxil and 500 mg probenecid

INDICATIONS AND DOSAGES

Uncomplicated UTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in patients with limited or no alternative oral antibacterial treatment

Adult females: One tablet PO b.i.d. for 5 days.

CONTRAINDICATIONS AND CAUTIONS

  • Contraindicated in patients with a history of hypersensitivity to sulopenem, probenecid, or other beta-lactams. Serious hypersensitivity reactions, including anaphylaxis and skin reactions, have been reported with beta-lactam antibacterial drugs. Severe hypersensitivity reactions, including anaphylaxis, have occurred with the use of probenecid.
  • Evaluate the patient for a history of hypersensitivity reactions to other carbapenems, cephalosporins, penicillins, or other beta-lactams, because cross-sensitivity has been reported.
  • Contraindicated in patients with known blood dyscrasias or uric acid kidney stones.
  • Use isn't recommended in patients with creatinine clearance less than 15 mL/minute.
  • This drug may cause Clostridioides difficile-associated diarrhea, ranging in severity from mild diarrhea to fatal colitis, which may occur more than 2 months after administration. If c. difficile-associated diarrhea is suspected or confirmed, the drug may need to be discontinued, and appropriate treatment begun.
  • Use cautiously in patients with a history of gout. To avoid exacerbation of gout, ensure appropriate therapy for gout is initiated during treatment with sulopenem and probenecid.
  • This drug isn't indicated for initial treatment or for step-down treatment after IV therapy of complicated infections.
  • Safety and effectiveness in children haven't been established.
  • Dialyzable drug: Unknown.

PREGNANCY-LACTATION-REPRODUCTION

  • Studies on the use of sulopenem during pregnancy are inadequate. Maternal and fetal toxicity occurred in animal studies. Probenecid crosses the placental barrier.
  • This drug is likely present in human milk. Use cautiously during breastfeeding.

INTERACTIONS

Drug-drug. Indomethacin, naproxen: May increase the level of these drugs and the risk of adverse effects. Adjust dosage of these drugs.
Ketoprofen: May increase ketoprofen level. Avoid use together.
Ketorolac tromethamine: May increase ketorolac level. Use together is contraindicated.
Lorazepam: May increase lorazepam level. Adjust lorazepam dosage.
Methotrexate: May increase methotrexate level. If use together can't be avoided, monitor closely for methotrexate-related adverse effects.
OAT3 inhibitors (losartan, atorvastatin, ibuprofen, furosemide): May increase sulopenem level. If use together can't be avoided, closely monitor for adverse reactions.
Oral sulfonylureas (glyburide, amaryl, glipizide): May increase antidiabetic effect. Monitor closely for hypoglycemia and adjust sulfonylurea dosage, as needed.
Rifampin: May increase rifampin level. Monitor closely for rifampin-related adverse effects.


ADVERSE REACTIONS

CNS: headache.
GI: diarrhea, nausea, vomiting, abdominal pain.
GU: vulvovaginal mycotic infection.
 

Reactions in bold italics are life-threatening.
 

Released: March 2025

Nursing Drug Handbook

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New FDA Drug Approvals Archive

New FDA Drug Approvals - July 2022
ganaxoloneZtalmyPharmaceutical company: Marinus PharmaceuticalsPharmacologic classification:Neuroactive steroid GABA type A receptor positive modulatorTherapeutic classification:AnticonvulsantControlled substance schedule: PendingAVAILABLE FORMSOral suspension: 50 mgINDICATIONS AND DOSAGESSeizures associated with cyclin-dependent kinase-like 5 deficiency disorderPatients age 2 and older weighing over 28 kg: Initially, 150 mg t.i.d. (450 mg daily). Titrate to 300 mg t.i.d., then 450 mg t.i.d. to the maximum dosage of 600 mg t.i.d. (1,800 mg daily) based on tolerability. Titrate no more frequently than every 7 days.Patients age 2 and older weighing 28 kg or less: Initially, 6 mg/kg t.i.d. (18 mg/kg/day). Titrate to 11 mg/kg t.i.d., then 16 mg/kg t.i.d. to the maximum dosage of 21 mg/kg t.i.d. (63 mg/kg/daily) based on tolerability.Adjust-a-dose: When discontinuing ganaxolone, decrease the dose gradually, when possible, to minimize the risk of increased seizure frequency and status epilepticus. For those with hepatic impairment, monitor for adverse reactions; reduce dose as needed.CONTRAINDICATIONS AND CAUTIONSUse cautiously in those with hepatic impairment, or with depression.Alert: Anticonvulsant drugs may increase the risk of suicidality as soon as the first week of treatment.This drug has the potential for abuse. Physical dependence risk hasn’t been determined, but abrupt discontinuation of anticonvulsant drugs isn’t recommended because of the risk of seizures.Safety and effectiveness in children under age 2 haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONEnroll patients in pregnancy exposure registry at 1-888-233-2334 or https://www.aedpregnancyregistry.org/. There are no adequate and well-controlled studies during pregnancy.This drug is excreted in human milk. The effects on milk production and the breastfed infant are unknown. Use cautiously during breastfeeding.INTERACTIONSDrug-drug. CNS depressants (opioids, antidepressants): may cause somnolence and sedation. Use cautiously together when driving or operating machinery.Strong or moderate CYP450 inducers (anticonvulsant drugs [carbamazepine, phenytoin, phenobarbital, primidone], rifampin): May decrease ganaxolone levels. Avoid use together. If use together is unavoidable, consider increased ganaxolone dosage; don’t exceed maximum daily dose. In patients on a stable ganaxolone dosage who are initiating or increasing the dosages of enzyme-inducing anticonvulsant drugs, ganaxolone dosage may need to be increased; don’t exceed maximum daily dose.Drug-lifestyle. Alcohol use: May increase somnolence and sedation. Use caution when driving or operating machinery.ADVERSE REACTIONSCNS: seizures, somnolence, pyrexia, sedation.EENT: nasal congestion.GI: salivary hypersecretion.Musculoskeletal: gait disturbance.Respiratory: upper respiratory infection, bronchitis.Other: seasonal allergy, flulike syndrome.Reactions in bold italics are life-threatening.Released: July 2022Nursing Drug Handbook© 2022 Wolters KluwermitapivatPyrukyndPharmaceutical company: Agios PharmaceuticalsPharmacologic classification:Pyruvate kinase activatorTherapeutic classification:Hemolysis inhibitorAVAILABLE FORMSTablets: 5 mg, 20 mg, 50 mgINDICATIONS AND DOSAGESHemolytic anemia in those with pyruvate kinase (PK) deficiencyAdults: Initially, 5 mg PO b.i.d. for 4 weeks. If hemoglobin remains below normal range or the patient required a transfusion within the last 8 weeks, increase to 20 mg b.i.d. for 4 weeks. If hemoglobin remains below normal range or patient required a transfusion within the last 8 weeks, increase to 50 mg b.i.d. If hemoglobin decreases during maintenance therapy of 5 mg or 20 mg b.i.d., consider titrating up to maximum of 50 mg b.i.d. Discontinue if there is no benefit by 24 weeks.Adjust-a-dose: If used with moderate CYP3A inhibitors, maximum mitapivat dose is 20 mg b.i.d. If use with moderate CYP3A inducers is unavoidable, titrate mitapivat beyond 50 mg b.i.d., but don’t exceed a maximum of 100 mg b.i.d.For those with adverse reaction, intolerability, or for hemoglobin above normal, reduce dose to the next lower dose level, 20 mg b.i.d. or 5 mg b.i.d. Taper the dose gradually to discontinue the drug. If the risk to the patient is greater than the risk of acute hemolysis because of sudden withdrawal of the drug, stop the drug without tapering.CONTRAINDICATIONS AND CAUTIONSAvoid use in those with moderate or severe hepatic impairment.Safety and effectiveness in children haven’t been determined.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate and well-controlled studies during pregnancy. Use cautiously during pregnancy.Untreated PK deficiency during pregnancy may precipitate acute hemolysis, preterm labor, miscarriage, and severe anemia requiring frequent transfusion. Additionally, preeclampsia and severe hypertension have been reported.Patients using hormonal contraception should use an alternative nonhormonal method or add a barrier method during treatment.There are no data on the safety of breastfeeding. Consider the benefits of breastfeeding, clinical need of the drug to the mother, and potential adverse effects on the infant.INTERACTIONSDrug-drug. CYP3A substrates (midazolam, hormonal contraceptives like ethinyl estradiol), CYP2B6 substrates, CYP2C substrates, UGT1A1 substrates): May decrease substrate level. Monitor for loss of therapeutic effect of substrates with narrow therapeutic index. Use of alternative nonhormonal contraceptive or adding a barrier method of contraception is recommended.Moderate CYP3A inducers (efavirenz): May decrease mitapivat levels. Consider alternative therapy. If use together is unavoidable, monitor hemoglobin and titrate beyond 50 mg b.i.d., if necessary, but don’t exceed a maximum recommended dose of 100 mg b.i.d.Moderate CYP3A inhibitors (fluconazole): May increase mitapivat levels, and risk of adverse reactions. Monitor hemoglobin. Don’t titrate mitapivat beyond 20 mg b.i.d.P-glycoprotein (P-gp) substrates: May increase levels of drugs that are P-gp substrates. Monitor for adverse reactions of P-gp substrates with narrow therapeutic index.Strong CYP3A inducers (rifampin): May decrease mitapivat levels. Avoid use together.Strong CYP3A inhibitors (itraconazole): May increase mitapivat levels and risk of adverse reactions. Avoid use together.ADVERSE REACTIONSCNS: paresthesia.CV: hot flush, flushing, hypertension, arrhythmia.EENT: oropharyngeal pain, dry mouth.GI: gastroenteritis, constipation.Hematologic: acute hemolysis.Metabolic: hypertriglyceridemia, increased urate level, estrone and estradiol decreases in males, testosterone increases in males.Musculoskeletal: back pain, arthralgia, musculoskeletal pain.Other: breast discomfort.Reactions in bold italics are life-threatening.Released: July 2022Nursing Drug Handbook© 2022 Wolters KluweroteseconazoleVivjoaPharmaceutical company: Mycovia PharmaceuticalsPharmacologic classification:Azole antifungalTherapeutic classification:AntifungalAVAILABLE FORMSCapsules: 150 mgINDICATIONS AND DOSAGESReduce incidence of recurrent vulvovaginal candidiasis (RVVC) in patients with a history of RVVC who are not of reproductive potentialAdult: 600 mg PO as a single dose on day 1, then 450 mg as a single dose on day 2, then beginning day 14, give 150 mg every 7 days for 11 weeks (weeks 2 through 12). Or, if given in combination with fluconazole; on day 1, day 4, and day 7, give fluconazole 150 mg PO; then on days 14 through 20, give oteseconazole 150 mg once daily; then beginning day 28, give oteseconazole 150 mg PO every 7 days for 11 weeks (weeks 4 through 14).CONTRAINDICATIONS AND CAUTIONSContraindicated in patients hypersensitive to the drug or its components.Safety and efficacy have not been established in females who are premenarchal.This drug is not recommended for use in patients with moderate or severe hepatic impairment (Child-Pugh class B or C) or in patients with severe renal impairment or end-stage renal disease with or without dialysis.Use cautiously in older adults.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm based on animal studies. The drug’s exposure window is about 690 days (5 half-lives).This drug is contraindicated in patients of reproductive potential (biological females who are not postmenopausal or who don’t have another reason for permanent infertility [tubal ligation, hysterectomy, salpingo-oophorectomy]) and during pregnancy.This drug is contraindicated during breastfeeding.INTERACTIONSDrug-drug. Breast cancer resistance protein substrates (rosuvastatin): May increase level and adverse effects of substrate. Use the lowest possible starting dose of the substrate or consider reducing the dose of the substrate drug. Monitor for adverse effects.ADVERSE REACTIONSCNS: headache.GI: nausea, dyspepsia.GU: dysuria, menorrhagia, metrorrhagia, vulvovaginal burning, discomfort, or pain.Other: hot flush.Reactions in bold italics are life-threatening.Released: July 2022Nursing Drug Handbook© 2022 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - May 2022
abrocitinibCibinqoPharmaceutical company: Pfizer, Inc.Pharmacologic classification:Janus kinase (JAK) inhibitorTherapeutic classification:ImmunomodulatorAVAILABLE FORMSTablets: 50 mg, 100 mg, and 200 mgINDICATIONS AND DOSAGESRefractory, moderate-to-severe atopic dermatitis not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisableAdults: 100 mg PO once daily. If inadequate response after 12 weeks, may increase to 200 mg once daily. Discontinue if there is an inadequate response after increasing to 200 mg once daily.Adjust-a-dose: For patients with moderate renal impairment (eGFR 30 to 59 mL/min) or patients who are known or suspected CYP2C19 poor metabolizers, reduce dosage to 50 mg once daily; if inadequate response after 12 weeks, may double the dose. Refer to the manufacturer’s instructions for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: This drug may increase the risk of serious bacterial, fungal, viral, and opportunistic infections leading to hospitalization or death. The most frequently reported serious infections were herpes simplex, herpes zoster, and pneumonia. Avoid use in those with active, serious infection, including localized infections. Consider the risk and benefits of use in those with chronic or recurrent infection.Don’t give to patients with active tuberculosis (TB). Consider anti-TB treatment in patients with previously untreated latent TB, history of active TB if an adequate course of treatment can’t be confirmed, and in patients with a negative latent TB test but who have risk factors for TB infection.Black Box Warning: Patients age 50 and older with rheumatoid arthritis (RA) and at least one CV risk factor treated with a JAK inhibitor have an increased risk of major adverse CV events, including all-cause mortality. A higher rate of major adverse CV events (MACE) (CV death, MI, stroke) and thrombosis (pulmonary embolism, venous, arterial) have occurred with JAK inhibitors compared with TNF blockers in patients with RA. Patients who are current or past smokers are at additional risk. Discontinue the drug in patients who have MI, stroke, or symptoms of thrombosis. Abrocitinib isn’t approved for use in RA patients.Black Box Warning: Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. Patients with RA treated with JAK inhibitors have a higher rate of malignancies (excluding nonmelanoma skin cancer) compared with TNF blockers. Patients who are current or past smokers are at increased risk.Black Box Warning: Serious and sometimes fatal thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated with JAK inhibitors. Use cautiously in patients at increased risk for thrombosis after first carefully considering the risks and benefits.Use isn’t recommended for patients with active hepatitis B or hepatitis C.Avoid use in patients with severe (Child Pugh C) hepatic impairment.Use cautiously in patients with moderate renal impairment.Use not recommended in patients with severe renal impairment (eGFR 15 to 29 mL/min) or end-stage renal disease, platelet count less than 150,000/mm3, absolute lymphocyte count less than 500/mm3, ANC less than 1,000/mm3 or hemoglobin less than 8 g/dL.Use cautiously in older adults and patients who are CYP2C19 poor metabolizers.Safety and effectiveness in children haven’t been determined.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate and well-controlled studies in pregnant women. Enroll women exposed to this drug during pregnancy in the pregnancy exposure registry at 1-877-311-3770.There are no data on the safety of breastfeeding. Advise against breastfeeding during treatment with abrocitinib and for one day after the last dose (approximately 5 to 6 elimination half-lives).This drug may impair female fertility.INTERACTIONSDrug-drug. Antiplatelet drugs (clopidogrel, prasugrel, ticagrelor [excluding low-dose aspirin]): May increase risk of bleeding with thrombocytopenia. Contraindicated during the first 3 months of treatment.Moderate to strong CYP2C19 and CYP2C9 inhibitors (fluconazole): May increase abrocitinib levels. Avoid use with drugs that are moderate to strong inhibitors of both CYP2C19 and CYP2C9.Other JAK inhibitors, biologic immunomodulators, or immunosuppressants: May enhance immunosuppressant effect. Avoid use together.P-glycoprotein (P-gp) substrates (digoxin, dabigatran): May increase P-gp substrate levels and risk of adverse reactions of the substrate where small increases may lead to serious or life-threatening toxicities. Monitor closely or dose titrate P-gp substrate.Strong CYP2C19 and CYP2C9 inducers (rifampin): May decrease abrocitinib levels. Avoid use together.Strong CYP2C19 inhibitors (fluvoxamine): May increase abrocitinib levels. Reduce dosage of abrocitinib.Vaccines: May diminish therapeutic effect of inactivated vaccines and increase risk of infection from live vaccines. Complete immunizations, including herpes zoster, following current guidelines prior to start of therapy. Avoid live vaccines immediately prior to, during, and immediately after therapy.Drug-lifestyle. Smoking:Increased risk of malignancies and CV events. Discourage smoking.Sun Exposure: Increased risk of malignancies. Limit exposure to sunlight and UV light.ADVERSE REACTIONSCNS: headache, dizziness, fatigue.CV: hypertension.EENT: nasopharyngitis, oropharyngeal pain.GI: nausea, vomiting, gastroenteritis, upper abdominal pain, abdominal discomfort.GU: UTI.Hematologic: thrombocytopenia.Metabolic: increased creatine kinase.Skin: acne, impetigo, contact dermatitis.Other: herpes simplex, herpes zoster, flulike symptoms, infections.Reactions in bold italics are life-threatening.Released: May 2022Nursing Drug Handbook© 2022 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - April 2022
cabotegravirApretude, VocabriaPharmaceutical company: ViiV HealthcarePharmacologic classification:HIV-1 integrase strand transfer inhibitorTherapeutic classification:AntiretroviralAVAILABLE FORMSInjection (extended-release): 600 mg/3 mL single-dose vialTablets: 30 mgINDICATIONS AND DOSAGESShort-term treatment of HIV-1 infection in combination with rilpivirine in patients who are virologically suppressed (HIV­1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirineAdults (lead-in therapy): 30 mg PO daily in combination with oral rilpivirine for at least 28 days as oral lead-in therapy to assess tolerability of cabotegravir prior to starting cabotegravir and rilpivirine extended-release injections. Take last oral dose on the same day cabotegravir and rilpivirine injections are started.Adults (bridging therapy): 30 mg PO daily in combination with oral rilpivirine for up to 2 months as oral bridging therapy for patients who plan to miss a scheduled injection visit by more than 7 days. The first dose of oral bridging therapy should begin about 1 month after the last cabotegravir and rilpivirine injection for patients on the monthly dosing schedule, and about 2 months after the last injections for patients on the every-2-month dosing schedule. Continue oral dosing until the day the injections are restarted.Short-term preexposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk patientsAdults and adolescents age 12 and older weighing at least 35 kg (lead-in therapy): One tablet PO daily for 1 month (at least 28 days) as oral lead-in therapy prior to starting cabotegravir extended-release injections. Take last oral dose on the same day cabotegravir injections are started or within 3 days.Adults and adolescents age 12 and older weighing at least 35 kg (bridging therapy): One tablet PO daily to replace one every 2-month injection as oral bridging therapy for patients who plan to miss cabotegravir injection by more than 7 days. The first dose of oral bridging therapy should begin about 2 months after the last cabotegravir injection and continued until injections are restarted or within 3 days. An alternate oral PrEP regimen is recommended for duration of more than 2 months.PrEP to reduce the risk of sexually acquired HIV-1 infection in at-risk patients with or without an oral lead-in with oral cabotegravirAdults and adolescents age 12 and older weighing at least 35 kg: Initially, 600 mg IM on the last day of or within 3 days after oral lead-in therapy, if used, followed by a second injection one month later. Continue with injections every 2 months thereafter.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients hypersensitive to the drug or its components.Cabotegravir is contraindicated for PrEP in patients with unknown or positive HIV-1 status. Monotherapy with cabotegravir isn’t a complete regimen for HIV-1 treatment.Black Box Warning: There is a risk of drug resistance with use for HIV PrEP in patients with undiagnosed HIV-1 infection. Drug-resistant variants have been identified in patients with undiagnosed HIV-1 infections with use of cabotegravir injections. Black Box Warning: Prior to starting cabotegravir (oral or IM) for PrEP and prior to each subsequent injection, test for HIV-1 infections using an FDA approved or cleared test for the diagnosis of acute primary HIV-1 infections. Patients who become infected with HIV-1 while receiving injections for PrEP must transition to a complete HIV-w treatment regimen.Black Box Warning: Don’t initiate this drug for PrEP unless negative infections status in confirmed.The time from initiation of HIV-1 PrEP to maximal protection is unknown.Use of this drug for PrEP is part of a comprehensive prevention strategy, including adherence to the drug schedule and safer sex practices.Serious or severe hypersensitivity reactions have occurred with other integrase inhibitors and may occur with cabotegravir. Treatment should be discontinued if signs or symptoms of hypersensitivity reactions develop.Use cautiously in patients with underlying liver disease or marked elevations in transaminases prior to treatment. Hepatoxicity has been reported in patients with or without known preexisting hepatic disease or other risk factors.Residual extended-release formulation of this drug may remain in circulation for up to 12 months or longer.Use cautiously in older adults and patients with severe or end-stage renal disease. Use in severe hepatic impairment hasn’t been studied.The safety and efficacy of cabotegravir for the treatment of HIV-1 infection in children, and for HIV-1 PrEP in children younger than age 12 or weighing less than 35 kg hasn’t been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONUse of cabotegravir during pregnancy hasn’t been evaluated. Use of cabotegravir injections isn’t recommended for use in patients planning to become pregnant. Risks and benefits of treatment should be discussed with individuals of childbearing potential or who are pregnant.Enroll pregnant women exposed to this drug during pregnancy in the Antiretroviral Pregnancy Registry (1-800-258-4263).Women with HIV-1 infection shouldn’t breastfeed due to the potential risk of HIV-1 transmission to the infant.For uninfected women taking cabotegravir for PrEP, assess the risks and benefits of treatment while breastfeeding. Extended-release formulation may be found in human milk 12 months or more after discontinuing the drug.INTERACTIONSDrug-drug. Antacids containing aluminum, magnesium, or calcium carbonate: Concomitant use may decrease the absorption of oral cabotegravir. Administer antacid products at least 2 hours before or 4 hours after taking cabotegravir.Methadone: May decrease methadone level. Monitor patient and adjust methadone dose as needed.Other antiretroviral drugs:Other antiretrovirals shouldn’t be used with cabotegravir when used as monotherapy for PrEP or in combination with rilpivirine for treatment of HIV-1.Rifabutin: May decrease cabotegravir level when given with extended-release injection. When used together, the second injection of extended-release cabotegravir should be given 2 weeks after the initial dose, and maintenance doses given monthly while on rifabutin.Strong inducers of UGT1A1 or 1A9 (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine): May significantly decrease cabotegravir levels and cause loss of virologic response. Use together is contraindicated.ADVERSE REACTIONSCNS: asthenia, depression, depressed mood, mood swings, headache, fever, sleep disorders, dizziness, somnolence, fatigue, abnormal dreams.GI: diarrhea, nausea, abdominal pain, flatulence, vomiting, decreased appetite.Hepatic: hepatoxicity.Musculoskeletal: myalgia, back pain.Respiratory: upper respiratory infection.Other: suicidality, injection site reactions.Reactions in bold italics are life-threatening.Released: April 2022Nursing Drug Handbook© 2022 Wolters KluwerdaridorexantQuviviqPharmaceutical company: Idorsia PharmaceuticalsPharmacologic classification:Orexin receptor antagonistTherapeutic classification:HypnoticControlled substance schedule: PendingAVAILABLE FORMSTablets: 25 mg, 50 mgINDICATIONS AND DOSAGESInsomnia characterized by difficulties with sleep onset or sleep maintenanceAdults: 25 to 50 mg PO no more than once per night 30 minutes before going to bed and at least 7 hours until planned awakening.Adjust-a-dose: For moderate hepatic impairment (Child Pugh 7 to 9) or coadministered with moderate CYP3A4 inhibitor, maximum dosage is 25 mg once per night.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with narcolepsy.Use in severe hepatic impairment isn’t recommended.Use cautiously in patients with psychiatric disorders; hypnotics may worsen depression, or suicidal ideation or behavior.Use cautiously in patients with a history of abuse or addiction to alcohol or other drugs.Use cautiously in patients with compromised respiratory function.Evaluate patients for comorbid diseases as cause of insomnia prior to starting daridorexant or if insomnia persists after 7 to 10 days.Use cautiously in older adults as they are more prone to CNS effects and falls.Safety and effectiveness haven’t been established in children.Sleep paralysis, hallucinations, and cataplexy-like symptoms (periods of leg weakness lasting from seconds to a few minutes and may not be associated with an identified triggering event [laughter or surprise]) may occur.Complex sleep behaviors (sleepwalking, sleep-driving, engaging in activities while not fully awake, including preparing and eating food, making phone calls, or having sex) may occur. If these occur, discontinue daridorexant immediately.Dialyzable drug: Unlikely.Overdose S&S: Somnolence, muscle weakness, cataplexy-like symptoms, sleep paralysis, disturbance in attention, fatigue, headache, constipation.PREGNANCY-LACTATION-REPRODUCTIONThere are no data available on safety of use during pregnancy. Health care providers are encouraged to register patients who are pregnant in a pregnancy exposure registry at 1-833-400-9611.There are no data on the presence of this drug in human milk, or its effects on breastfed infants or on milk production. This drug was present in animal milk and is likely to be present in human milk. Consider the mother’s need against the risk to the breastfed infant. Monitor breastfed infants for excessive sedation.INTERACTIONSDrug-drug. CNS depressants: May increase risk of CNS depression. Use with caution and consider dose decrease of daridorexant or CNS depressant.Strong and moderate CYP3A4 inducers: May reduce efficacy level of daridorexant. Avoid concomitant use together.Strong or moderate CYP3A4 inhibitors: May increase daridorexant level and risk of adverse reactions. Avoid concomitant use with strong CYP3A4 inhibitors. Decrease daridorexant dose to 25 mg once nightly with moderate CYP3A4 inhibitors.Drug-food. High-fat and high-calorie meal: May delay sleep onset if meal is consumed 30 minutes prior to taking daridorexant.Drug-lifestyle. Alcohol: May increase risk of CNS depression. Discourage use together.ADVERSE REACTIONSCNS: headache, somnolence or fatigue, dizziness.GI: nausea.Reactions in bold italics are life-threatening.Released: April 2022Nursing Drug Handbook© 2022 Wolters KluwerinclisiranLeqvioPharmaceutical company: NovartisPharmacologic classification:Proprotein convertase subtilisin kexin type 9 mRNA inhibitorTherapeutic classification:AntilipemicAVAILABLE FORMSInjection: 284 mg/1.5 mL (189 mg/mL) prefilled syringeINDICATIONS AND DOSAGESAdjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia or clinical atherosclerotic CV disease, in patients who require additional lowering of LDL cholesterolAdults: 284 mg subcut for one dose. Repeat dose at 3 months, then every 6 months thereafter.CONTRAINDICATIONS AND CAUTIONSUse of this drug hasn’t been studied in those with end-stage renal disease or severe hepatic impairment.The effect of this drug on CV morbidity and mortality hasn’t been determined.Safety and effectiveness in children haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate and well-controlled studies in women who are pregnant. This drug may cause fetal harm based on the mechanism of action.Discontinue the drug when pregnancy is recognized; consideration may be given to the therapeutic needs of the individual patient. Treatment of hyperlipidemia isn’t generally necessary during pregnancy.There are no data on the safety of this drug while breastfeeding. Consider the benefits of breastfeeding, the clinical need of the drug to the mother, and potential adverse effects on the infant.INTERACTIONSNone reported.ADVERSE REACTIONSGI: diarrhea.GU: UTI.Musculoskeletal: arthralgia, extremity pain.Respiratory: bronchitis, dyspnea.Skin: injection site reaction (pain, erythema, rash).Reactions in bold italics are life-threatening.Released: April 2022Nursing Drug Handbook© 2022 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - March 2022
asciminibScemblixPharmaceutical company: NovartisPharmacologic classification:Kinase inhibitorTherapeutic classification:AntineoplasticAVAILABLE FORMSTablets: 20 mg, 40 mgINDICATIONS AND DOSAGESPhiladelphia chromosome-positive chronic myeloid leukemia in chronic phase previously treated with two or more tyrosine kinase inhibitorsAdults: 80 mg PO once daily or 40 mg PO every 12 hours as long as clinical benefit is observed or until unacceptable toxicity.Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase with the T315I mutationAdults: 200 mg PO every 12 hours.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSThis drug may increase risk for hypersensitivity reactions, severe thrombocytopenia and neutropenia events, pancreatic toxicity, and hypertension.Cardiovascular toxicity, including arrhythmias, QT prolongation, ischemic cardiac and CNS conditions, arterial thrombotic and embolic events, and cardiac failure may occur. Patients with prior exposure to multiple tyrosine kinase inhibitors, preexisting cardiac conditions or CV risk factors are at increased risk.Safety and effectiveness in children haven’t been determined.Dialyzable drug: No.PREGNANCY-LACTATION-REPRODUCTIONThis drug can cause fetal harm. Advise females of reproductive potential of the risk to a fetus and to use effective contraception during treatment and for 1 week after the last dose.There are no data on the presence of asciminib or its metabolites in human milk, the effects on the breastfed child, or milk production. Advise women not to breastfeed during treatment and for 1 week after the last dose.This drug may impair fertility in females of reproductive potential. The reversibility of the effect is unknown.INTERACTIONSDrug-drug. Certain P-glycoprotein (P-gp) substrates: May increase plasma levels of P-gp substrates. Closely monitor patients treated with concomitant P-gp substrates where minimal changes in substrate level may lead to serious toxicities.CYP2C9 substrates (warfarin): May increase risk of adverse reactions of the substrate. Avoid coadministration of asciminib 80 mg total daily with CYP2C9 substrates where minimal changes in substrate level may lead to serious adverse reactions. If coadministration is unavoidable, reduce the substrate dose as recommended in its prescribing information. Avoid coadministration of asciminib 200 mg b.i.d. with sensitive substrates and substrates where minimal changes in substrate level may lead to serious adverse reactions. If coadministration is unavoidable, consider alternative therapy with a non-CYP2C9 substrate.CYP3A4 substrates (midazolam): May increase level of substrate and risk of adverse reactions. Closely monitor patients treated with asciminib 80 mg daily with concomitant use of CYP3A4 substrates where minimal changes in substrate level may lead to serious adverse reactions. Avoid coadministration of asciminib 200 mg b.i.d. with substrates where minimal changes in substrate level may lead to serious adverse reactions.Itraconazole oral solution containing hydroxypropyl-β-cyclodextrin: May reduce asciminib level, which may reduce its efficacy. Avoid concomitant use.Strong CYP3A4 inhibitors (clarithromycin): May increase asciminib level and increase the risk of adverse reactions. Closely monitor patients treated with asciminib at 200 mg b.i.d.ADVERSE REACTIONSCNS: fatigue, fever, headache, dizziness, peripheral neuropathy.CV: heart failure, hypertension,edema, hemorrhage, QT interval prolongation, arrhythmia, palpitations.EENT: blurred vision, dry eye.GI: nausea, diarrhea, abdominal pain, vomiting, constipation, pancreatitis, increased lipase and amylase.GU: UTI, increased creatinine.Hematologic: thrombocytopenia, neutropenia, febrile neutropenia, lymphopenia, anemia.Hepatic: increased ALT, increased AST, hyperbilirubinemia.Metabolic: increased triglycerides, dyslipidemia, hypothyroidism, increased creatine kinase, hypophosphatemia, hypocalcemia, hypercholesterolemia, hypokalemia, hyperuricemia.Musculoskeletal: musculoskeletal pain, arthralgia.Respiratory: upper respiratory infection, cough, dyspnea, pleural effusion, pneumonia.Skin: rash, pruritis, hypersensitivity reaction.Reactions in bold italics are life-threatening.Released: March 2022Nursing Drug Handbook© 2022 Wolters KluwermaribavirLivtencityPharmaceutical company: Takeda PharmaceuticalsPharmacologic classification:Kinase inhibitorTherapeutic classification:AntiviralAVAILABLE FORMSTablets: 200 mgINDICATIONS AND DOSAGESPost-transplant cytomegalovirus (CMV) infection or disease that is refractory to treatment with ganciclovir, valgaciclovir, cidofovir or foscarnetAdults and children age 12 and older and weighing at least 35 kg: 400 mg PO b.i.d.Adjust-a-dose: If coadministered with carbamazepine, increase maribavir to 800 mg PO b.i.d.; if coadministered with phenytoin or phenobarbital, increase maribavir to 1,200 mg PO b.i.d.CONTRAINDICATIONS AND CAUTIONSVirologic failure due to resistance can occur during and after treatment, usually within 4 to 8 weeks after treatment discontinuation.Safety and effectiveness in children younger than 12 and weighing less than 35 kg haven’t been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONNo adequate human data are available to establish whether this drug poses a risk in pregnancy.It’s unknown if this drug has any effects on nursing; consider clinical need for the drug and any potential adverse effects to the breastfed child.INTERACTIONSDrug-drug. Carbamazepine, phenytoin, phenobarbital: May decrease maribavir levels; increase maribavir dosage if taking concurrently.Cyclosporine, everolimus, sirolimus, tacrolimus: May increase concentrations of immunosuppressant; monitor for increased drug levels and adverse effects. Adjust immunosuppressant dose as needed.Digoxin: May increase digoxin levels; monitor digoxin level and adjust digoxin as needed.Ganciclovir, valganciclovir: May decrease viral activity of these drugs; don’t give together.Rifabutin, rifampin: May decrease maribavir efficacy; don’t give together. Rosuvastatin: May increase statin concentrations; monitor patient closely for adverse effects, especially myopathy and rhabdomyolysis. Strong CYP3A4 inducers (except for carbamazepine, phenytoin, and phenobarbital): May decrease maribavir levels; avoid concurrent use.Substrates of CYP3A, P-glycoprotein and BCRP (midazolam, fexofenadine, glyburide, cimetidine): May cause clinically relevant increase in plasma concentrations of substrate; avoid concurrent use.Drug-herb. St. John’s wort: May decrease maribavir efficacy; don’t give together.ADVERSE REACTIONSCNS: fatigue, taste disturbance.GI: nausea, diarrhea, vomiting.GU: acute kidney injury.Hematologic: neutropenia, anemia.Other: recurrence of underlying CMV infection or CMV disease.Reactions in bold italics are life-threatening.Released: March 2022Nursing Drug Handbook© 2022 Wolters KluwervosoritideVoxzogoPharmaceutical company: BioMarin MedicalPharmacologic classification:Human C type natriuretic peptide analogTherapeutic classification:Growth factorAVAILABLE FORMSInjection: 0.4 mg, 0.56 mg, 1.2 mg single-dose vialINDICATIONS AND DOSAGESIncrease linear growth in patients with achondroplasia with open epiphysesChildren age 5 and older: 0.24 to 0.8 mg subcut once daily, based on actual body weight. See prescribing information for dosing table.Adjust-a-dose: Adjust dose every 3 to 6 months, according to actual body weight. Permanently discontinue upon confirmation of no further growth potential, indicated by closure of epiphyses.CONTRAINDICATIONS AND CAUTIONSUse in those with significant cardiac or vascular disease hasn’t been studied.Avoid use in those with eGFR less than 60 mL/min/1.73 m2.Some dosage forms may contain polysorbate 80.Safety and effectiveness in children younger than age 5 haven’t been established.This drug isn’t indicated for use in adults.Dialyzable drug: No.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate and well-controlled studies in pregnant women.There are no data on the safety of breast-feeding. Consider benefits of breastfeeding, clinical need of the drug to the mother, and potential adverse effects on the infant. There are no data on fertility.INTERACTIONSDrug-drug. Antihypertensives: May increase hypotensive effect. Use cautiously together.ADVERSE REACTIONSCNS: dizziness, fatigue.CV: hypotension.EENT: ear pain.GI: vomiting, diarrhea, gastroenteritis.Musculoskeletal: arthralgia.Skin: dry skin, injection site erythema, swelling, urticaria, pain, bruising, pruritus, hemorrhage, discoloration, or induration.Other: flulike symptoms, seasonal allergy.Reactions in bold italics are life-threatening.Released: March 2022Nursing Drug Handbook© 2022 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - January 2022
atogepantQuliptaPharmaceutical company: AbbViePharmacologic classification:Calcitonin gene-related peptide receptor antagonistTherapeutic classification:Antimigraine drugAVAILABLE FORMSTablets: 10 mg; 30 mg; 60 mgINDICATIONS AND DOSAGESPrevention of episodic migraine headachesAdults: 1 tablet PO once daily.Adjust-a-dose: If taking with a strong CYP3A4 inhibitor, the recommended dose is 10 mg PO once daily. If taking with a strong or moderate CYP3A4 inducer, the recommended dose is 30 mg or 60 mg PO once daily. If taking with an OATP inhibitor, the recommended dose is 10 mg or 30 mg PO once daily. If severe renal impairment or end-stage renal disease (creatinine clearance less than 30 mL/min), the recommended dose is 10 mg PO once daily.CONTRAINDICATIONS AND CAUTIONSAvoid use in patients with severe hepatic impairment (Child-Pugh class C).Use cautiously in older adults. Initiate therapy at lowest dose.Safety and effectiveness in children haven’t been determined.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONIt isn’t known if this drug causes fetal harm. Use during pregnancy only if clearly indicated and the benefit outweighs the fetal risk. Women with migraine headaches may be at increased risk for preeclampsia and gestational hypertension.It isn’t known if this drug appears in human milk. Use cautiously in women who are breastfeeding.INTERACTIONSDrug-drug. OATP inhibitors (cyclosporine, rifampin): May increase level of atogepant. Adjust atogepant dose.Strong or moderate CYP3A4 inducers (carbamazepine, efavirenz, etravirine, rifampin, phenytoin): May decrease level of atogepant. Adjust atogepant dose.Strong CYP3A4 inhibitors (clarithromycin, ketoconazole, itraconazole): May increase level of atogepant. Adjust atogepant dose.Drug-herb. St. John’s wort: May decrease level of atogepant. Adjust atogepant dose.ADVERSE REACTIONSCNS: fatigue, somnolence.GI: nausea, constipation, decreased appetite.Hepatic: increased transaminase levels.Metabolic: weight loss.Reactions in bold italics are life-threatening.Released: January 2022 Nursing Drug Handbook © 2022 Wolters Kluwer avacopanTavneosPharmaceutical company: ChemoCentryx, Inc.Pharmacologic classification:Complement inhibitorTherapeutic classification:ImmunomodulatorAVAILABLE FORMSCapsules: 10 mgINDICATIONS AND DOSAGESAdjunctive treatment for severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy including glucocorticoidsAdults: 30 mg PO b.i.d. with food.Adjust-a-dose: When used with strong CYP3A4 inhibitors, reduce dose to 30 mg once daily. If AST or ALT increase to greater than 3 times the upper limit of normal (ULN), consider pausing avacopan. If AST or ALT increases to greater than 5 times ULN, or AST or ALT increases to 3 times ULN with elevation of bilirubin to more than 2 times ULN, discontinue drug until avacopan-induced liver injury is ruled out.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with serious hypersensitivity reaction to avacopan or to any of its components.May cause serious liver injury, transaminase elevations and hepatobiliary events, including serious and life-threatening events.Not recommended for use in patients with active, untreated, or uncontrolled chronic liver disease (hepatitis B, hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis.Reactivation of latent hepatitis B infection and hypersensitivity reactions, including angioedema can occur.Serious and fatal infections have been reported. Avoid use in patients with an active, serious infection.Use cautiously in patients with chronic or recurrent infection, tuberculosis (TB) exposure, history of serious or opportunistic infections, underlying conditions that predispose them to infection, or who have lived or traveled in areas of endemic TB or mycoses.Safety and effectiveness in children haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no adequate data to inform the use of avacopan during pregnancy or breastfeeding; use only if the benefits outweigh the fetal risk.INTERACTIONSDrug-drug. CYP3A4 substrates (midazolam): May increase adverse reactions. Monitor patient closely and consider dose reduction of sensitive CYP3A4 substrates with narrow therapeutic window.Strong and moderate CYP3A4 inducers (rifampin): May decrease level of avacopan. Avoid use together.Strong CYP3A4 inhibitors (itraconazole): May increase level of avacopan. Reduce avacopan dose to 30 mg PO once daily.Drug-herb. St. John’s wort: May decrease level of avacopan. Avoid use together.ADVERSE REACTIONSCNS: headache, fatigue, dizziness, paresthesia.CV: hypertension.GI: nausea, diarrhea, vomiting, upper abdominal pain.GU: increase in creatinine.Hepatic: liver enzyme abnormalities.Skin: rash.Other: angioedema.Reactions in bold italics are life-threatening.Released: January 2022 Nursing Drug Handbook © 2022 Wolters Kluwer mobocertinibExkivityPharmaceutical company: Takeda Pharmaceuticals AmericaPharmacologic classification:Kinase inhibitorTherapeutic classification:AntineoplasticAVAILABLE FORMSCapsules: 40 mgINDICATIONS AND DOSAGESLocally advanced or metastatic non–small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, with progression on or after platinum-based chemotherapyAdults:160 mg PO daily, until disease progression or unacceptable toxicity.Adjust-a-dose: See the manufacturer’s information for toxicity-related dose reductions. If use with a concomitant moderate CYP3A inhibitor can’t be avoided, reduce mobocertinib dose by approximately 50% and monitor QTc interval more frequently. After moderate CYP3A inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the drug at the dose prior to CYP3A initiation.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: This drug can cause life-threatening heart rate-corrected QT (QTc) prolongation, including torsades de pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation.Black Box Warning: Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors, as these may further prolong the QTc.Black Box Warning: Withhold, dose reduce, or permanently discontinue this drug based on the severity of QTc prolongation.This drug can increase the risk of interstitial lung disease/pneumonitis, which can be fatal.This drug increases the risk of cardiac toxicity, including decreased ejection fraction, cardiomyopathy, and heart failure.This drug may cause diarrhea, leading to dehydration or electrolyte imbalance, with or without renal impairment.Safety and effectiveness of this drug in children haven’t been established.Use cautiously in older adults as there may be a higher incidence and severity of adverse reactions.Recommended dosage hasn’t been determined for patients with severe renal or hepatic impairment.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm. Females of reproductive potential must use effective nonhormonal contraception during treatment and for 1 month after the last dose, and males with female partners of reproductive potential must use effective contraception during treatment with and for 1 week after the last dose.Due to the potential for adverse reactions in a child who is breastfed, women should not breastfeed during treatment and for 1 week after the last dose.This drug may impair fertility.INTERACTIONSDrug-drug. CYP3A substrates (midazolam): May decrease level of substrate; consider increasing substrate dosage if possible.Black Box Warning: Drugs that prolong the QTc interval (haloperidol, thioridazine, amiodarone, procainamide, lithium, ciprofloxacin, methadone, SSRIs, tricyclic antidepressants): May significantly increase risk of QTc prolongation; avoid use together. If use together is unavoidable, monitor QTc carefully.Hormonal contraceptives: May decrease level of contraceptive and cause therapeutic failure. Avoid use together.Strong and moderate CYP3A inducers (rifampin, efavirenz): May decrease mobocertinib level and antitumor activity; avoid concomitant use.Black Box Warning: Strong or moderate CYP3A inhibitors (itraconazole, ketoconazole): May increase mobocertinib level; avoid use together. If concomitant use can’t be avoided, reduce mobocertinib dose, monitor the QTc interval more frequently with ECGs, and monitor patients for increased risk of adverse reactions.Drug-herb. St. John’s wort: May decrease mobocertinib level; discourage use together.Drug-food. Grapefruit, grapefruit juice: May increase drug level; discourage intake during treatment.ADVERSE REACTIONSCNS: headache, fever, fatigue, peripheral neuropathy.CV: QTc prolongation, atrial fibrillation, hypertension, heart failure, edema.EENT: ocular toxicity.GI: diarrhea, stomatitis, vomiting, decreased appetite, nausea, abdominal pain, gastroesophageal reflux disease, dyspepsia.GU: acute kidney injury.Hematologic: leukocytopenia, anemia.Metabolic: weight loss, increased amylase, increased lipase, hypokalemia, increased creatinine, hypomagnesemia.Musculoskeletal: pain.Respiratory: interstitial lung disease, pneumonitis, cough, upper respiratory infection, dyspnea, rhinorrhea, pleural effusion.Skin: rash, paronychia, dry skin, pruritus, alopecia, hand-foot syndrome.Reactions in bold italics are life-threatening.Released: January 2022 Nursing Drug Handbook © 2022 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - December 2021
difelikefalinKorsuvaPharmaceutical company: Vifor, Inc.Pharmacologic classification:Kappa opioid receptor agonistTherapeutic classification:Miscellaneous CNS agentAVAILABLE FORMSInjection: 65 mcg/1.3 mL (50 mcg/mL)INDICATIONS AND DOSAGESModerate-to-severe pruritus associated with chronic kidney disease in those undergoing hemodialysisAdults: 0.5 mcg/kg IV bolus injection into venous line of dialysis circuit at the end of each hemodialysis treatment.CONTRAINDICATIONS AND CAUTIONSThis drug isn’t recommended for use in those on peritoneal dialysis or in those with severe hepatic impairment.Safety and effectiveness in children haven’t been established.Dialyzable drug: Yes.Overdose S&S: Dizziness, somnolence, mental status changes, paresthesia, fatigue, hypertension, vomiting.PREGNANCY-LACTATION-REPRODUCTIONThere are limited human data on use in women who are pregnant. Use only if clearly needed.There are no data on the presence of this drug in human milk, its effects on breastfed infants, or on milk production. Consider the benefits to the mother versus the risks to the infant from the drug or the underlying maternal condition.INTERACTIONSDrug-drug. CNS depressants, sedating antihistamines, opioids: May increase the risk of CNS adverse reactions. Use cautiously together.ADVERSE REACTIONSCNS: dizziness, gait disturbances, headache, somnolence, mental status change.GI: diarrhea, nausea.Metabolic: hyperkalemia.Reactions in bold italics are life-threatening.Released: December 2021Nursing Drug Handbook© 2021 Wolters Kluwer  maralixibatLivmarliPharmaceutical company: Mirum Pharmaceuticals, Inc.Pharmacologic classification:Ileal bile acid transporter (IBAT) inhibitorTherapeutic classification:Miscellaneous GI drugAVAILABLE FORMSOral solution: 9.5 mg/mLINDICATIONS AND DOSAGESCholestatic pruritus in patients with Alagille syndrome (ALGS)Adults and children age 1 and older: Initially 190 mcg/kg PO once daily. After one week, increase dose to 380 mcg/kg once daily, as tolerated. Maximum dose is 28.5 mg (3 mL) daily in patients weighing 70 kg or more.Adjust-a-dose: Decrease dose or interrupt therapy for liver function study abnormalities or GI adverse reactions. Once the liver study abnormalities either return to baseline or stabilize at a new baseline value, consider restarting at 190 mcg/kg, and increase as tolerated. If liver function study abnormalities or GI reactions recur, or symptoms consistent with clinical hepatitis, portal hypertension, or hepatic decompensation (variceal hemorrhage, ascites, hepatic encephalopathy) occur, discontinue therapy.CONTRAINDICATIONS AND CAUTIONSSafety and effectiveness in patients with ALGS with clinically significant portal hypertension or decompensated cirrhosis haven’t been established.Safety and effectiveness in patients age 65 and older and children less than age 1 haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONPatients with ALGS can have fat-soluble vitamin (FSV) deficiency as part of their disease and maralixibat may reduce absorption of FSV. Increased maternal supplementation of FSVs during pregnancy and lactation may be needed.Maternal use at the recommended dose is not expected to result in measurable fetal exposure because systemic absorption is low, but it may decrease fetal absorption of FSV.There are no data on the presence of this drug in human milk, its effects on the breastfed infant or on milk production. Breastfeeding is not expected to result in exposure of the infant to maralixibat at the recommended dose.INTERACTIONSDrug-drug. Bile acid binding resins (cholestyramine, colesevelam, colestipol): May bind to maralixibat in the GI tract. Give bile acid binding resin at least 4 hours before or 4 hours after maralixibat.OATP2B1 substrates (statins): May decrease absorption of the OATP2B1 substrate. Monitor effect of the substrate.ADVERSE REACTIONSGI: diarrhea, vomiting, nausea, GI bleeding, abdominal pain.Hepatic: increased liver function studies.Metabolic: FSV deficiency.Musculoskeletal: bone fracture.Reactions in bold italics are life-threatening.Released: December 2021Nursing Drug Handbook© 2021 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - November 2021
belumosudilRezurockPharmaceutical company: Kadmon PharmaceuticalsPharmacologic classification:Kinase inhibitorTherapeutic classification:ImmunomodulatorAVAILABLE FORMSTablets: 200 mgINDICATIONS AND DOSAGESChronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapyAdults and children age 12 and older: 200 mg PO daily with food until progression of chronic GVHD requires new systemic therapy.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments. When coadministered with strong CYP3A inducers or proton pump inhibitors, increase dosage of belumosudil to 200 mg b.i.d.CONTRAINDICATIONS AND CAUTIONSUse in patients with preexisting severe renal or hepatic impairment hasn’t been studied.The safety and effectiveness in children younger than age 12 haven’t been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm. Advise pregnant females of fetal risk.No data are available on the presence of this drug in human milk or its effects on breastfed children or milk production. Because of the potential for serious adverse reactions, breastfeeding during treatment and for at least one week after the last dose isn’t recommended.Females of reproductive potential and males with female partners of reproductive potential should use effective contraception during treatment and for at least one week after the last dose.This drug may cause reversible impairment of fertility in females and males.INTERACTIONSDrug-drug. Proton pump inhibitors (rabeprazole, omeprazole): May decrease belumosudil level and reduce its efficacy. Increase belumosudil dose to 200 mg b.i.d.Strong CYP3A inducers (rifampin):May decrease belumosudil level and reduce its efficacy. Increase belumosudil dose to 200 mg b.i.d.ADVERSE REACTIONSCNS: asthenia, fever, headache.CV: edema, hypertension, hypotension, hemorrhage.EENT: nasal congestion.GI: nausea, diarrhea, abdominal pain, dysphagia, decreased appetite.GU: elevated creatinine, renal failure.Hematologic: lymphocytopenia, anemia, thrombocytopenia, neutropenia.Hepatic: increased GGT, increased alkaline phosphatase, increased ALT.Metabolic: hypophosphatemia, hypocalcemia, hyperkalemia.Musculoskeletal: musculoskeletal pain, muscle spasm, arthralgia.Respiratory: dyspnea, cough.Skin: rash, pruritus.Other: infection (including bacterial and viral).Reactions in bold italics are life-threatening.Released: November 2021Nursing Drug Handbook© 2021 Wolters Kluwer  finerenoneKerendiaPharmaceutical company: Bayer PharmaceuticalsPharmacologic classification:Mineralocorticoid receptor antagonistTherapeutic classification:Miscellaneous renal drugAVAILABLE FORMSTablets: 10 mg, 20 mgINDICATIONS AND DOSAGESTo reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, nonfatal MI, and hospitalization for heart failure in patients with chronic kidney disease associated with type 2 diabetesAdults: Initially,10 mg or 20 mg PO once daily based on eGFR and serum potassium thresholds. Don’t initiate treatment if serum potassium is more than 5.0 mEq/L. If eGFR is 60 mL/min/1.73 m2 or more, start at 20 mg once daily; if eGFR is 25 to less than 60 mL/min/1.73 m2, start at 10 mg once daily. If starting with 10 mg, increase dosage after 4 weeks to the target dose of 20 mg once daily, based on eGFR and serum potassium thresholds.Adjust-a-dose: Adjust dosage as needed based on every 4-week potassium and eGFR level results. If current serum potassium is 4.8 mEq/L or less and patient is on 10 mg daily, increase to 20 mg daily, except if eGFR has decreased by more than 30% compared to previous measurement; if so, maintain 10 mg dose. If on 20 mg dose already, stay at 20 mg daily.If current serum potassium is more than 4.8 to 5.5 mEq/L and patient is on 10 mg daily, stay at 10 mg daily; if on 20 mg dose already, stay at 20 mg daily.If current serum potassium is more than 5.5 mEq/L and patient is on 10 mg daily, hold and consider restarting at 10 mg once daily when serum potassium is 5.0 mEq/L or less; if on 20-mg dose already, hold and restart at 10 mg once daily when serum potassium is 5.0 mEq/L or less.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with adrenal insufficiency.This drug is not recommended if eGFR is less than 25 mL/min/1.73 m2.This drug increases the risk of hyperkalemia, especially in patients with decreased kidney function and those with higher baseline potassium and risk factors for hyperkalemia (concomitant drugs that increase serum potassium or impair its excretion). If serum potassium levels are more than 4.8 to 5.0 mEq/L, initiation may be considered with additional serum potassium monitoring within the first 4 weeks based on clinical judgement and serum potassium levels.Avoid use in patients with severe hepatic impairment (Child Pugh C), and consider additional potassium monitoring in patients with moderate hepatic impairment (Child Pugh B).This drug is not approved for use in pediatric patients.Use cautiously in older adults.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThis drug has not been studied in patients who are pregnant.Breastfeeding is not recommended during treatment and for at least 1 day after the last dose of the drug.INTERACTIONSDrug-drug. Drugs that may increase potassium (ACE inhibitors, angiotensin-receptor blockers, potassium sparing diuretics): May increase retention of potassium; monitor potassium levels frequently.Moderate (erythromycin) and weak (amiodarone) CYP3A inhibitors: May increase finerenone level and risk of adverse reactions; use cautiously together and monitor potassium.Strong (rifampicin) or moderate (efavirenz) CYP3A inducers: May decrease finerenone level; avoid concurrent use.Strong CYP3A inhibitors (itraconazole): May significantly increase finerenone level; use together is contraindicated.Drug-herb. St. John’s wort:May decrease finerenone level; use together cautiously.Drug-food. Grapefruit or grapefruit juice: May increase finerenone level; discourage use together.ADVERSE REACTIONSCV: hypotension.Metabolic: hyperkalemia, hyponatremia.Reactions in bold italics are life-threatening.Released: November 2021Nursing Drug Handbook© 2021 Wolters Kluwer  odevixibatBylvayPharmaceutical company: Albireo PharmaPharmacologic classification:Bile acid transporter inhibitorTherapeutic classification:Miscellaneous GI drugAVAILABLE FORMSCapsules: 400 mcg, 1,200 mcgOral pellets: 200 mcg, 600 mcgINDICATIONS AND DOSAGESPruritus in patients with progressive familial intrahepatic cholestasisAdults and children age 3 months and older:40 mcg/kg PO daily with morning meal. If there is no improvement in pruritus after 3 months, increase dose in 40 mcg/kg increments up to 120 mcg/kg PO daily. Maximum total daily dose is 6 mg.Adjust-a-dose: Interrupt the drug if new onset liver function test (LFT) abnormalities or symptoms of clinical hepatitis are observed. Once LFTs return to baseline or stabilize at a new baseline, restart at 40 mcg/kg/day and increase dose as tolerated and appropriate. Consider permanent discontinuation if LFT abnormalities recur. Interrupt drug if persistent diarrhea occurs. Restart at 40 mcg/kg/day when diarrhea resolves and increase dose as tolerated and appropriate. If diarrhea persists and no alternate etiology is identified, discontinue treatment.CONTRAINDICATIONS AND CAUTIONSPatients who are exclusively on liquid food should not use odevixibat, including children who only take liquids (human milk, formula).This drug may not be effective in PFIC type 2 patients with ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump protein (BSEP-3).Efficacy and safety in patients with clinically significant portal hypertension and in patients with decompensated cirrhosis haven’t been established.Fat-soluble vitamin deficiency may develop or worsen. Monitor vitamin levels (A, D, E) and INR (for vitamin K activity) and supplement as indicated.The safety and effectiveness of this drug in patients less than 3 months or greater than 65 years of age have not been established.Dialyzable drug: Unlikely.PREGNANCY-LACTATION-REPRODUCTIONThere are no human data on use in pregnant women. Based on data from animal reproduction studies, in utero exposure may cause fetal harm, including cardiac malformations. Use only if clearly needed.There are no data on the presence of this drug in human milk or its effects on breastfed infants or on milk production. This drug has low absorption following oral administration, and breastfeeding is not expected to result in exposure of the infant at recommended doses.Monitor fat-soluble vitamin levels and increase fat-soluble vitamin intake if deficiency is observed during lactation.INTERACTIONSDrug-drug. Bile acid binding resins (cholestyramine, colesevelam, colestipol): May bind odevixibat in the gut and reduce efficacy. Administer binding resin at least 4 hours before or 4 hours after odevixibat.ADVERSE REACTIONSGI: diarrhea, vomiting, abdominal pain.Hepatic: increased transaminases, hyperbilirubinemia, cholelithiasis.Metabolic: fat-soluble vitamin deficiency, dehydration.Musculoskeletal: fracture.Other: splenomegaly.Reactions in bold italics are life-threatening.Released: November 2021Nursing Drug Handbook© 2021 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - October 2021
relugolix–estradiol–norethindrone acetateMyfembreePharmaceutical company: Myovant Sciences GmbH and PfizerPharmacologic classification: Gonadotropin-releasing hormone receptor antagonist/estrogen/ progestinTherapeutic classification: Hormonal agentAVAILABLE FORMSTablets: relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mgINDICATIONS AND DOSAGESManagement of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal womenAdults: One tablet PO daily for up to 24 months.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: This drug increases the risk of thrombotic or thromboembolic disorders, including pulmonary embolism, deep vein thrombosis, stroke, and MI, especially in women at increased risk for these events.Black Box Warning: This drug is contraindicated in women with current or a history of thrombotic or thromboembolic disorders, and in women at increased risk for these events, including women over age 35 who smoke, or women with uncontrolled hypertension, dyslipidemia, vascular disease, or obesity.Contraindicated in women at high risk for arterial, venous thrombotic, or thromboembolic disorder (cerebrovascular disease, coronary artery disease, peripheral vascular disease, thrombogenic valvular or thrombogenic rhythm diseases of the heart, inherited or acquired hypercoagulopathies, or headaches with focal neurologic symptoms or migraine headaches with aura if over age 35).Contraindicated for use in patients with known osteoporosis, current or history of breast cancer or other hormone-sensitive malignancies, increased risk for hormone-sensitive malignancies, known hepatic impairment or disease, undiagnosed abnormal uterine bleeding, or hypersensitivity to any of the drugs in the product.Discontinue the drug immediately if an arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs, or if a hormone-sensitive malignancy is diagnosed.Stop the drug if sudden unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions occurs, and evaluate for retinal vein thrombosis immediately.Treatment duration is limited to 24 months. This drug may cause decreases in bone mineral density (BMD) that may not be completely reversible. Baseline and periodic BMD assessments are recommended. Assess risk-benefit for women with additional risk factors for bone loss.This drug may contribute to depression, mood disorders, or suicidal ideation.Use cautiously in women with well-controlled hypertension; continue to monitor blood pressure and stop the drug if blood pressure rises significantly.Use cautiously in women with a history of cholestatic jaundice related to past estrogen use or pregnancy.Use cautiously in patients with prediabetes, diabetes, and hypertriglyceridemia. This drug may decrease glucose tolerance and increase cholesterol and triglyceride levels.This drug may cause uterine fibroid prolapse or expulsion; advise patients to seek medical attention for severe uterine bleeding.This drug may cause alopecia; discontinue the drug if hair loss becomes a concern.Safety and effectiveness in children have not been established.Dialyzable drug: Unknown.Overdose S&S: Nausea, vomiting, breast tenderness, abdominal pain, drowsiness, fatigue, and withdrawal bleeding.PREGNANCY-LACTATION-REPRODUCTIONThis drug is contraindicated in pregnancy. Females who are pregnant and exposed to the drug are encouraged to call the Myfembree Pregnancy Exposure Registry at 1-(855)-428-0707.This drug can cause early pregnancy loss; exclude pregnancy before initiating treatment.This drug may delay the ability to recognize pregnancy because it alters menstrual bleeding. Perform testing if pregnancy is suspected and discontinue the drug if pregnancy is confirmed.Advise women of reproductive potential to use effective non-hormonal contraception during treatment with the drug and for 1 week after the final dose. Avoid concomitant use of hormonal contraceptives.This drug is likely to be present in human milk. Weigh the benefits against the risk of adverse effects to the breastfed child.INTERACTIONSDrug-drug. Combined P-glycoprotein (P-gp) and strong CYP3A inducers (rifampin): May decrease concentrations of relugolix, estradiol, or norethindrone; avoid concurrent use.Estrogen-containing contraception: May increase estrogen levels, risk of estrogen-associated adverse events, and decrease efficacy of relugolix, estradiol, and norethrindrone. Avoid concurrent use.P-gp inhibitors (erythromycin): May increase relugolix concentrations; avoid concurrent use or if cannot discontinue P-gp inhibitor, separate doses by 6 hours and monitor for adverse reactions.Drug-herb. St. John’s wort: May decrease concentrations of relugolix, estradiol, or norethindrone. Discourage use together.Drug-lifestyle. Black Box Warning: Smoking: Smoking increases the risk of thromboembolic disorders and vascular events, especially in those over age 35. Discourage smoking.ADVERSE REACTIONSCNS: depression, mood disorders, irritability, anxiety.CV: hypertension, hot flush.GI: dyspepsia.GU: abnormal uterine bleeding, loss of libido.Musculoskeletal: bone loss.Skin: alopecia, hyperhidrosis or night sweats.Other: hypersensitivity, breast cyst.Reactions in bold italics are life-threatening.Released: October 2021 Nursing Drug Handbook© 2021 Wolters Kluwer Download these updates as a PDF
New FDA Drug Approvals - September 2021
ibrexafungerpBrexafemmePharmaceutical company: Scynexis, Inc.Pharmacologic classification:Triterpenoid antifungalTherapeutic classification:AntifungalAVAILABLE FORMSTablets: 150 mgINDICATIONS AND DOSAGESTreatment of patients with vulvovaginal candidiasisAdults and postmenarchal pediatric females: 300 mg (two 150-mg tablets) PO administered approximately 12 hours apart (in the morning and in the evening) for one day, for a total daily dosage of 600 mg (total of 4 tablets for one course of therapy).Adjust-a-dose: If taking a concomitant strong CYP3A inhibitor, administer one 150-mg tablet approximately 12 hours apart (in the morning and in the evening) for 1 day (total of 2 tablets for one course of therapy).CONTRAINDICATIONS AND CAUTIONSContraindicated in pregnancy or in patients hypersensitive to the drug or its components.Safety has not been established in premenarchal pediatric females.Dialyzable drug: No.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm; use is contraindicated in pregnancy.Verify the pregnancy status in females of reproductive potential prior to initiating treatment.If this drug is inadvertently administered during pregnancy or if pregnancy is detected within 4 days after a patient receives the drug, pregnant women exposed to the drug and health care providers should report pregnancies to Scynexis, Inc. at 1-888-982-SCYX (7299).There is no information regarding this drug’s presence in human breast milk; weigh the risk to the breastfed child.Advise females of reproductive potential to use effective contraception during treatment and for 4 days after the last dose.INTERACTIONSDrug-drug. Strong CYP3A inhibitors (ketoconazole, itraconazole): May significantly increase ibrexafungerp level; reduce ibrexafungerp dosage.Strong/moderate CYP3A inducers (rifampin, carbamazepine, phenytoin, long-acting barbiturates, bosentan, efavirenz, or etravirine): May significantly reduce ibrexafungerp level; avoid use together.Drug-herb. St. John’s wort: May significantly reduce ibrexafungerp level; discourage use together.ADVERSE REACTIONSCNS: dizziness.GI: diarrhea, nausea, abdominal pain, vomiting, flatulence.GU: dysmenorrhea, vaginal bleeding.Hepatic: elevated transaminases.Musculoskeletal: back pain.Skin: rash.Other: hypersensitivity reaction.Reactions in bold italics are life-threatening.Released: September 2021Nursing Drug Handbook© 2021 Wolters KluwerDownload these updates as a PDF
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