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New Drug Indications - June 2024

alectinib hydrochloride

Alecensa
Pharmaceutical company: Genentech

NEW INDICATION & DOSAGE
Adjuvant treatment in patients with resected anaplastic lymphoma kinase-positive non-small-cell lung cancer tumors (at least 4 cm or node-positive)
Adults: 600 mg PO b.i.d. for 2 years or until disease recurrence or unacceptable toxicity occurs.

Adjust-a-dose: For patients with Child-Pugh class C liver impairment, give 450 mg PO b.i.d. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

dolutegravir/lamivudine

Dovato
Pharmaceutical company: ViiV Healthcare

NEW INDICATION & DOSAGE
HIV-1 infection in patients with no antiretroviral treatment history and with no known substitutions associated with resistance to the individual components
Children age 12 and older weighing 25 kg or more: 1 tablet PO once daily. HIV-1 infection as replacement for a current stable antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) with no history of treatment failure and no known substitutions associated with resistance to the individual components
Children age 12 and older weighing 25 kg or more: 1 tablet PO once daily.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

hydroxyurea

Xromi
Pharmaceutical company: Rare Disease Therapeutics, Inc.

NEW FORMULATION
Oral solution: 100 mg/mL

NEW INDICATION & DOSAGE
To reduce frequency of painful crises and need for blood transfusions in patients with sickle cell anemia with recurrent moderate-to-severe painful crises
Children ages 6 months to younger than 2 years (Xromi): 15 mg/kg PO once daily. Monitor blood counts every 2 weeks. If blood counts are in acceptable range, may increase dosage by 5 mg/kg daily every 8 to 12 weeks until maximum tolerated dosage or 35 mg/kg daily. If blood counts are considered toxic, withhold drug until blood counts recover. Resume therapy after reducing dosage by 2.5 mg/kg to 5 mg/kg daily. See the manufacturer's instructions for blood count parameters.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

ravulizumab–cwvc

Ultomiris
Pharmaceutical company: Alexion Pharmaceuticals

NEW INDICATION & DOSAGE
Neuromyelitis optica spectrum disorder in patients who are anti-aquaporin-4 antibody positive
Adults weighing 100 kg or more: 3,000-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 3,600-mg IV infusion once every 8 weeks.
Adults weighing 60 to less than 100 kg: 2,700-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 3,300-mg IV infusion once every 8 weeks.
Adults weighing 40 to less than 60 kg: 2,400-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 3,000-mg IV infusion once every 8 weeks.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

iloperidone

Fanapt
Pharmaceutical company: Vanda Pharmaceuticals

NEW INDICATION & DOSAGE
Acute treatment of manic or mixed episodes associated with bipolar I disorder
Adults: Initially, 1 mg PO b.i.d. Increase dosage daily, as tolerated, according to the following schedule: 3 mg b.i.d. on day 2; 6 mg b.i.d. on day 3; 9 mg b.i.d. on day 4; 12 mg b.i.d. on day 5. Recommended daily dose, 12 mg b.i.d.

Adjust-a-dose:  For patients who are poor metabolizers of CYP2D6 and those taking CYP2D6 or CYP3A4 inhibitors, reduce dosage by 50%. Patients with Child-Pugh class B liver impairment may need dosage reduction if clinically indicated. Avoid use in patients with Child-Pugh class C liver impairment.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

risperidone

Risvan
Pharmaceutical company: Laboratorios Farmaceuticos Rovi

NEW FORMULATION
Injection (IM extended-release suspension): 75 mg; 100 mg single-dose kit

NEW INDICATION & DOSAGE
Schizophrenia
Adults: 75 mg or 100 mg IM once monthly after establishing tolerability with oral risperidone. For patients stable on 3 mg of PO risperidone daily, give 75 mg IM; or for patients stable on 4 mg of PO risperidone daily, give 100 mg IM starting one day after the last PO risperidone dose.

Adjust-a-dose:  Recommended dosage is 75 mg once monthly after titration to at least 3 mg PO risperidone in patients with kidney or liver impairment. Two to four weeks before starting a strong CYP2D6 inhibitor, decrease risperidone dosage to 75 mg once monthly, if applicable. If given with a strong CYP3A4 inducer, increase risperidone dosage from 75 mg to 100 mg once daily; additional oral risperidone may be considered in patients on 100-mg dose. Reevaluate dosage after discontinuing CYP3A4 inducer.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

tenofovir alafenamide

Vemlidy
Pharmaceutical company: Gilead Sciences

NEW INDICATION & DOSAGE
Chronic hepatitis B virus infection
Children age 6 and older weighing at least 25 kg: 25 mg PO daily.

Released: June 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

New Drug Indications Archive

New Drug Indications - September 2023
tapentadol hydrochlorideNucyntaPharmaceutical company: Collegium Pharmaceutical, Inc.NEW INDICATION & DOSAGEAcute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate (immediate-release)Children age 6 and older weighing 80 kg or more: 50 mg PO every 4 hours. May increase dosage to 75 mg every 4 hours, then 100 mg every 4 hours to maintain adequate analgesia, as tolerated. Maximum single dose, 100 mg.Children age 6 and older weighing 60 to 79 kg: 50 mg PO every 4 hours. May increase dosage to 75 mg every 4 hours to maintain adequate analgesia, as tolerated. Maximum single dose, 75 mg.Children age 6 and older weighing 40 to 59 kg: 50 mg PO every 4 hours. Maximum single dose, 50 mg.Adjust-a-dose: Maximum daily dose is 7.5 mg/kg/day (six 1.25-mg/kg doses over 24 hours). In children with a high BMI, maximum daily dose must not exceed the maximum dose for a body weight at the 97th percentile for a given age. Reduce dosage over time as acute pain decreases. Duration of treatment for children shouldn't exceed 3 days. Use in children with liver or kidney impairment isn't recommended.Released: September 2023Nursing Drug Handbook© 2023 Wolters Kluwer
New Drug Indications - August 2023
bezlotoxumabZinplavaPharmaceutical company: Merck Sharp & DohmeNEW INDICATION & DOSAGETo reduce recurrence of Clostridioides difficile infection (CDI) in patients receiving antibacterial treatment for CDI and who are at high risk for CDI recurrenceChildren age 1 and older: 10 mg/kg by IV infusion over 60 minutes as a one-time dose during antibacterial treatment for CDI.Released: August 2023Nursing Drug Handbook© 2023 Wolters KluwercolchicineLodocoPharmaceutical company: Agepha PharmaNEW FORMTablets: 0.5 mgNEW INDICATION & DOSAGETo reduce the risk of MI, stroke, coronary revascularization, and CV death in patients with established atherosclerotic disease or multiple risk factors for CV disease (Lodoco only)Adults: 0.5 mg PO once daily.Adjust-a-dose: Use is contraindicated in patients with creatinine clearance less than 15 mL/minute, Child-Pugh class C liver impairment, preexisting blood dyscrasias, or concurrent use of strong CYP3A4 or P-glycoprotein inhibitors.Released: August 2023Nursing Drug Handbook© 2023 Wolters Kluwerferric carboxymaltoseInjectaferPharmaceutical company: Daiichi-SankyoNEW INDICATION & DOSAGEIron deficiency in patients with New York Heart Association class II/III heart failure to improve exercise capacityAdults weighing at least 70 kg:  If hemoglobin (Hb) is 14 g/dL or less, give 1,000 mg IV on day 1. If Hb is more than 14 g/dL to less than 15 g/dL, give 500 mg IV on day 1. At week 6, give 1,000 mg if Hb is less than 10 g/dL or 500 mg if Hb is 10 to 14 g/dL. No additional dose is needed if Hb is greater than 14 g/dL at week 6.Adults weighing less than 70 kg:  If Hb is 14 g/dL or less, give 1,000 mg IV on day 1. If Hb is more than 14 g/dL to less than 15 g/dL, give 500 mg IV on day 1. At week 6, give 500 mg if Hb is less than 10 g/dL. No additional dose is needed if Hb is greater than 14 g/dL at week 6.Adjust-a-dose: Give addition maintenance dose of 500 mg IV at weeks 12, 24, and 36 if ferritin level is less than 100 ng/mL or ferritin is 100 to 300 ng/mL with transferrin saturation of less than 20%. May repeat treatment if iron deficiency recurs.Released: August 2023Nursing Drug Handbook© 2023 Wolters KluwerletermovirPrevymisPharmaceutical company: Merck Sharp & DohmeNEW INDICATION & DOSAGEProphylaxis of CMV disease in kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative)Adults: 480 mg administered once daily PO or IV infusion over 1 hour beginning day 0 to 7 posttransplant through 200 days posttransplant.Adjust-a-dose:  If the drug is administered with cyclosporine, decrease the dose to 240 mg PO or IV once daily. If cyclosporine is initiated after the start of letermovir, decrease the next dose of letermovir to 240 mg once daily. If cyclosporine is discontinued after the start of letermovir, increase the next dose of letermovir 480 mg once daily. If cyclosporine dosing is interrupted due to high cyclosporine level, no letermovir dosage adjustment is needed.Released: August 2023Nursing Drug Handbook© 2023 Wolters Kluwer  linaclotideLinzessPharmaceutical company: AbbVieNEW INDICATION & DOSAGEFunctional constipationChildren ages 6 to 17: 72 mcg PO once daily.Released: August 2023Nursing Drug Handbook© 2023 Wolters KluwerodevixibatBylvayPharmaceutical company: Albireo PharmaNEW INDICATION & DOSAGECholestatic pruritus in patients with Alagille syndromeAdults and children age 12 months and older: 120 mcg/kg PO once daily in the morning with a meal.Adjust-a-dose:  May decrease to 40 mcg/kg/day if intolerance occurs without other cause. Once tolerability stabilizes, increase to 120 mcg/kg/day. Interrupt therapy if new-onset liver function test abnormalities or signs and symptoms of hepatitis occur. Once liver function test values return to baseline or stabilize at new baseline, restart drug at 40 mcg/kg/day and increase dose as tolerated. Consider permanently stopping the drug if liver function test abnormalities recur. Discontinue the drug if hepatic decompensation (ascites, variceal hemorrhage, hepatic encephalopathy) occurs. Interrupt therapy if persistent diarrhea occurs. Restart drug at 40 mcg/kg/day when diarrhea resolves and increase dose as tolerated. Stop the drug if diarrhea persists and no alternative etiology is identified.Released: August 2023Nursing Drug Handbook© 2023 Wolters KluwerolaparibLynparzaPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGEDeleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisoloneAdults: 300 mg PO b.i.d., until disease progression or unacceptable toxicity occurs. Give in combination with a GnRH analogue or after bilateral orchiectomy. Recommended abiraterone dosage, 1,000 mg PO once daily in combination with prednisone or prednisolone 5 mg PO b.i.d. Refer to the abiraterone prescribing information for additional information.Released: August 2023Nursing Drug Handbook© 2023 Wolters Kluwer 
New Drug Indications - July 2023
avapritinibAyvakitPharmaceutical company: Blueprint MedicinesNEW INDICATION & DOSAGEIndolent systemic mastocytosis (ISM)Adults: 25 mg PO once daily.Adjust-a-dose: For Child-Pugh class C liver impairment, give 25 mg every other day. Avoid use with strong or moderate CYP3A inhibitors. This drug isn't recommended for ISM with platelet count less than 50 X 109/L.Released: July 2023Nursing Drug Handbook© 2023 Wolters KluwerbrexpiprazoleRexultiPharmaceutical company: OtsukaNEW INDICATION & DOSAGEAgitation associated with dementia due to Alzheimer diseaseAdults: Initially, 0.5 mg PO once daily on days 1 to 7. Increase to 1 mg PO once daily on days 8 to 14. Then, increase to target dose of 2 mg PO once daily on day 15. May increase to maximum daily dose of 3 mg after at least 2 weeks based on patient's response and tolerability.Adjust-a-dose: If Child-Pugh score is 7 or more or creatinine clearance is less than 60 mL/minute, maximum daily dose is 2 mg.Released: July 2023Nursing Drug Handbook© 2023 Wolters KluwerbuprenorphineBrixadiPharmaceutical company: Braeburn, Inc.NEW FORMULATIONSInjection (extended-release weekly): 8 mg/0.16 mL, 16 mg/0.32 mL, 24 mg/0.48 mL, 32 mg/0.64 mL prefilled syringesInjection (extended-release monthly): 64 mg/0.18 mL, 96 mg/0.27 mL, 128 mg/0.36 mL prefilled syringesINDICATION & DOSAGEModerate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine-containing product, or who are already being treated with buprenorphineAdults: Individualized dose based on tolerability or efficacy. After a test dose of 4 mg transmucosally to establish tolerance without withdrawal, begin weekly dosing subcut every 7 days. Or, in patients currently treated with other buprenorphine-containing products, switch to either weekly subcut dosing every 7 days or monthly dosing subcut every 28 days.Adjust-a-dose: May give weekly dose up to 2 days before or after the weekly time point. May give monthly dose up to 1 week before or after the monthly time point.Alert: Weekly and monthly formulations aren't interchangeable. Weekly formulation can't be combined to yield a monthly dose.Boxed Warning: Serious harm or death could result from IV administration of Brixadi. This drug is only available through a REMS program to prevent risk of IV self-administration.Released: July 2023Nursing Drug Handbook© 2023 Wolters KluwerescitalopramLexaproPharmaceutical company: AbbVieINDICATION & DOSAGEGeneralized anxiety disorderChildren age 7 and older: 10 mg PO once daily. May increase to 20 mg once daily after at least 2 weeks.Released: July 2023Nursing Drug Handbook© 2023 Wolters Kluwer  fluticasone furoate–vilanterol trifenatateBreo ElliptaPharmaceutical company: GlaxoSmithKlineNEW FORMULATIONSPowder for inhalation: Inhaler containing two double-foil blister strips of powder formulation: One strip contains fluticasone furoate 50 mcg/blister; the other contains vilanterol 25 mcg/blisterINDICATION & DOSAGEAsthmaAdolescents ages 12 to 17: 1 inhalation of 100 mcg fluticasone furoate–25 mcg vilanterol trifenatate once daily.Children ages 5 to 11: 1 inhalation of 50 mcg fluticasone furoate–25 mcg vilanterol trifenatate once daily.Released: July 2023Nursing Drug Handbook© 2023 Wolters KluweribuprofenCaldolorPharmaceutical company: Cumberland PharmaceuticalsINDICATION & DOSAGEMild to moderate pain; moderate to severe pain as an adjunct to opioid analgesics; fever reduction in childrenChildren age 3 months to less than 6 months: 10 mg/kg IV up to a maximum single dose of 100 mg. Infusion time must be at least 10 minutes.Released: July 2023Nursing Drug Handbook© 2023 Wolters KluwerivacaftorKalydecoPharmaceutical company: Vertex PharmaceuticalsNEW AVAILABLE FORMOral granules (unit-dose packets):: 5.8 mg, 13.4 mgINDICATION & DOSAGECystic fibrosis (CF) in patients who have one mutation in the CF transmembrane conductance regulator gene that's responsive to ivacaftor potentiation based on clinical data, in vitro assay data, or bothChildren age 2 months to younger than 4 months weighing 3 kg or more: 13.4 mg granules PO every 12 hours.Children age 1 month to younger than 2 months weighing 3 kg or more: 5.8 mg granules PO every 12 hours.  Adjust-a-dose: Use in children younger than age 6 months with any level of liver impairment isn't recommended. Use in children age 1 to younger than 6 months born earlier than a gestational age of 37 weeks hasn't been evaluated. Refer to the manufacturer's instructions for liver insufficiency, drug-interaction, and toxicity-related dose adjustments.Released: July 2023Nursing Drug Handbook© 2023 Wolters Kluwerpolatuzumab vedotin-piiqPolivyPharmaceutical company: GenentechINDICATION & DOSAGEPreviously untreated diffuse large B-cell lymphoma, not otherwise specified, or high-grade B-cell lymphoma in patients who have an International Prognostic Index score of 2 or greater, in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP)Adults: 1.8 mg/kg IV infusion every 21 days for six cycles. Give with R-CHP in any order after administration of prednisone on day 1 of each cycle. Prednisone is given on days 1 to 5 of each cycle. Give prophylactic granulocyte colony-stimulating factor.Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: July 2023Nursing Drug Handbook© 2023 Wolters KluwerupadacitinibRinvoqPharmaceutical company: AbbVieINDICATION & DOSAGEModerately to severely active Crohn disease in patients who have had an inadequate response or intolerance to one or more TNF blockersAdults: Induction dosage, 45 mg PO once daily for 12 weeks; then maintenance dosage, 15 mg daily. May increase maintenance dose to 30 mg for patients with refractory, severe, or extensive disease. Discontinue the drug if response with 30-mg dose is inadequate. Use the lowest effective dose needed to maintain response.Adjust-a-dose:  If the patient has eGFR of 15 to less than 30 mL/minute/1.73 m2 or Child-Pugh class A or B liver impairment or is taking strong CYP3A4 inhibitors, give induction dose of 30 mg for 12 weeks and maintenance dose of 15 mg once daily. This drug isn't recommended for use in combination with other JAK inhibitors, biological therapies for Crohn disease, or with potent immunosuppressants.Released: July 2023Nursing Drug Handbook© 2023 Wolters Kluwer
New Drug Indications - June 2023
New Drug Indications - May 2023
dabrafenibTafinlarPharmaceutical company: NovartisINDICATION & DOSAGEIn combination with trametinib for the treatment of low-grade glioma in patients with a BRAF V600E mutation who require systemic therapyChildren ages 1 to 17 weighing 51 kg or more: 150-mg capsules or suspension PO b.i.d.Children ages 1 to 17 weighing 38 to 50 kg: 100-mg capsules PO b.i.d.Children ages 1 to 17 weighing at least 26 to 37 kg: 75-mg capsules PO b.i.d.Children ages 1 to 17 weighing 8 to 50 kg: 20- to 130-mg oral solution PO b.i.d. based on body weight. See the manufacturer's instructions for recommended dosage table.  Adjust-a-dose: Refer to trametinib prescribing information for recommended dosing information. Refer to the manufacturer's instructions for toxicity-related dosage adjustments. Continue treatment until disease progression or unacceptable toxicity.Released: May 2023Nursing Drug Handbook© 2023 Wolters KluwermaralixibatLivmarliPharmaceutical company: Mirum PharmaceuticalsINDICATION & DOSAGE Cholestatic pruritus in patients with Alagille syndromeChildren age 3 months and older: Initially, 190 mcg/kg PO once daily. After 1 week, increase dosage 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 dosage or interrupt therapy for liver function test (LFT) abnormalities or GI adverse reactions. When LFT values return to baseline or stabilize at new baseline values, consider restarting at 190 mcg/kg, and increase as tolerated. If LFT abnormalities or GI reactions recur, or signs and symptoms consistent with clinical hepatitis, portal hypertension, or hepatic decompensation (variceal hemorrhage, ascites, hepatic encephalopathy) occur, discontinue therapy.Released: May 2023Nursing Drug Handbook© 2023 Wolters KluwersarilumabxKevzaraPharmaceutical company: Sanofi-Aventis and Regeneron PharmaceuticalsINDICATION & DOSAGEPolymyalgia rheumatica in patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taperAdults: 200 mg subcut once every 2 weeks in combination with a tapering course of corticosteroids or as monotherapy following discontinuation of corticosteroids.Adjust-a-dose: Discontinue the drug for ANC below 1,000/mm3, platelet count below 100,000 mm3, or AST or ALT levels above three times the upper limit of normal. Withhold treatment until infection is controlled if serious or opportunistic infection occurs.Released: May 2023Nursing Drug Handbook© 2023 Wolters Kluwertrametinib dimethyl sulfoxideMekinistPharmaceutical company: NovartisNEW FORMULATIONOral solution: 0.05 mg/1 mLINDICATION & DOSAGEIn combination with dabrafenib for treatment of low-grade glioma with a BRAF V600E mutation in patients who require systemic therapyChildren ages 1 to 17 weighing 51 kg or more: 2-mg tablet or solution PO daily.Children ages 1 to 17 weighing 38 to 50 kg: 1.5-mg tablet PO once daily.Children ages 1 to 17 weighing 26 to 37 kg: 1-mg tablet PO once daily.Children ages 1 to 17 weighing 8 to 50 kg: 0.3- to 1.6-mg oral solution PO daily based on body weight. See manufacturer's instructions for recommended dosage table.Adjust-a-dose: Refer to the dabrafenib prescribing information for recommended dosing information. Refer to the manufacturer's instructions for toxicity-related dosage adjustments. Continue treatment until disease progression or unacceptable toxicity.Released: May 2023Nursing Drug Handbook© 2023 Wolters Kluwer 
New Drug Indications - April 2023
abrocitinibCibinqoPharmaceutical company: Pfizer, Inc.NEW INDICATION & DOSAGERefractory, moderate-to-severe atopic dermatitis not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisableChildren age 12 and older: 100 mg PO once daily. May increase to 200 mg once daily if inadequate response after 12 weeks. Discontinue the drug if inadequate response after 200-mg dose increase. Can use with or without topical corticosteroids.Adjust-a-dose: For patients with moderate kidney impairment (eGFR of 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.Released: April 2023Nursing Drug Handbook© 2023 Wolters KluwerafliberceptEyleaPharmaceutical company: Regeneron Pharmaceuticals, Inc.NEW INDICATION & DOSAGERetinopathy of prematurityPreterm infants: 0.4 mg (0.01 mL) intravitreal injection. May be given bilaterally on the same day. May repeat injection in each eye. Interval between doses injected into the same eye should be at least 10 days.Released: April 2023Nursing Drug Handbook© 2023 Wolters Kluwerlanadelumab-flyoTakhzyroPharmaceutical company: Takeda Pharmaceuticals U.S.A.NEW INDICATION & DOSAGEPrevention of hereditary angioedema attacksChildren age 6 to less than 12 years: Initially, 150 mg subcut every 2 weeks. If the patient is attack-free for more than 6 months, may consider decreasing dosing to 150 mg subcut every 4 weeks.Children age 2 to less than 6 years: 150 mg subcut every 4 weeks.Released: April 2023Nursing Drug Handbook© 2023 Wolters KluwersildenafilRevatioPharmaceutical company: Viatris Specialty LLCNEW INDICATION & DOSAGETo improve exercise ability and delay clinical worsening in patients with World Health Organization group 1 pulmonary arterial hypertensionChildren ages 1 to 17 weighing more than 45 kg: 20 mg PO t.i.d. Dose may be titrated to a maximum dose of 40 mg t.i.d. based on symptoms and tolerability.Children ages 1 to 17 weighing 20 to 45 kg: 20 mg PO t.i.d.Children ages 1 to 17 weighing 20 kg or less: 10 mg PO t.i.d.Released: April 2023Nursing Drug Handbook© 2023 Wolters Kluwer 
New Drug Indications - March 2023
ceftazidime and avibactamAvycazPharmaceutical company: AbbVie NEW INDICATION & DOSAGEHospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible microorganisms (Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, or Haemophilus influenzae)Children 2 years to less than 18 years: 62.5 mg/kg IV every 8 hours over 2 hours for 7 to 14 days. Maximum dose is 2.5 g.Children age 6 months to less than 2 years: 62.5 mg/kg IV every 8 hours over 2 hours for 7 to 14 days.Children age 3 months to less than 6 months: 50 mg/kg IV every 8 hours over 2 hours for 7 to 14 days.Adjust-a-dose: For children age 2 and older with an eGFR of 31 to 50 mL/minute/1.73 m2, give 31.25 mg/kg to a maximum of 1.25 g every 8 hours; with an eGFR of 16 to 30 mL/minute/1.73 m2, give 23.75 mg/kg to a maximum of 0.94 g every 12 hours; with an eGFR of 6 to 15 mL/minute/1.73 m2, give 23.75 mg/kg to a maximum of 0.94 g every 24 hours, or with an eGFR  of 5 mL/minute/1.73m2 or less, give 23.75 mg/kg to a maximum of 0.94 g every 48 hours.  Dosing for children less than 2 years with abnormal kidney function hasn’t been established.Released: March 2023Nursing Drug Handbook© 2023 Wolters Kluwer dexmedetomidine HClPrecedexPharmaceutical company: Pfizer/Hospira, Inc. NEW INDICATION & DOSAGEProcedural sedation in patients who are nonintubatedChildren age 2 to less than 18 years: Loading infusion of 2 mcg/kg IV over 10 minutes followed by a maintenance infusion of 1.5 mcg/kg/hour and titrated to achieve desired clinical effect with dosage ranging from 0.5 to 1.5 mcg/kg/hour.Children age 1 month to less than 2 years: Loading infusion of 1.5 mcg/kg IV over 10 minutes followed by a maintenance infusion of 1.5 mcg/kg/hour and titrated to achieve desired clinical effect with dosage ranging from 0.5 to 1.5 mcg/kg/hour.Released: March 2023Nursing Drug Handbook© 2023 Wolters Kluwer pembrolizumabKeytrudaPharmaceutical company: Merck Sharp & Dohme NEW INDICATION & DOSAGEAdjuvant treatment following resection and platinum-based chemotherapy for patients with stage IB, II, or IIIA non–small-cell lung cancerAdults: 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks until disease recurrence or unacceptable toxicity occurs, or up to 12 months in patients without disease recurrence.Released: March 2023Nursing Drug Handbook© 2023 Wolters Kluwer risperidoneRykindoPharmaceutical company: Shandong Luye Pharmaceutical, Co. NEW FORMExtended-release injectable suspension: 12.5 mg, 25 mg, 37.5 mg, 50 mgNEW INDICATION & DOSAGEParenteral maintenance therapy for schizophrenia or bipolar I disorder (as monotherapy or as combination therapy with lithium or valproate)Adults: Establish tolerance to oral risperidone before giving IM. Give 25 mg IM into the buttock every 2 weeks, alternating injections between the two buttocks. Adjust dose no sooner than every 4 weeks based on effectiveness. The maximum dose is 50 mg IM every 2 weeks. Give oral risperidone for 7 days following the first injection.Adults switching from RisperDAL Consta: Continue the same IM dose beginning 4 weeks (no later than 5 weeks) after the last injection of RisperDAL Consta; oral risperidone supplementation isn't recommended.Adjust-a-dose: For patients with abnormal kidney function or hepatic impairment, titrate oral risperidone up to at least 2 mg before starting IM dose of 25 mg IM every 2 weeks and giving oral risperidone for 7 days following the first injection. May consider initial IM dose of 12.5 mg.When initiating therapy with CYP3A4 hepatic enzyme inducers, closely monitor the patient during first 4 to 8 weeks. A dosage increase or additional oral risperidone may need to be considered. On discontinuation of CYP3A4 inducers, reevaluate risperidone injection dosage and, if necessary, decrease dosage. Patients may be placed on a lower risperidone injection dosage between 2 and 4 weeks before the planned discontinuation of CYP3A4 inducers to adjust for the expected increase in risperidone plasma concentration.Released: March 2023Nursing Drug Handbook© 2023 Wolters Kluwer semaglutideWegovyPharmaceutical company: Novo Nordisk, Inc. NEW INDICATION & DOSAGEAdjunct to diet and exercise for long-term weight management in children with an initial BMI at the 95th percentile or greater for age and sex assigned at birthChildren age 12 and older: Initially, 0.25 mg subcut once weekly for 4 weeks, then increase to 0.5 mg for 4 weeks, then 1 mg for 4 weeks, then 1.7 mg for 4 weeks, then to 2.4 mg weekly maintenance dose.Adjust-a-dose: If any dose isn’t initially tolerated, delay dose escalation for 4 weeks. If 2.4-mg dose isn’t tolerated, decrease to 1.7 mg. If 1.7 mg isn’t tolerated, discontinue the drug.Released: March 2023Nursing Drug Handbook© 2023 Wolters Kluwer tucatinibTukysaPharmaceutical company: Seagen, Inc. NEW INDICATION & DOSAGEIn combination with trastuzumab in patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed after treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapyAdults: 300 mg PO b.i.d. approximately 12 hours apart until disease progression or unacceptable toxicity. Refer to the prescribing information for trastuzumab for additional information.Adjust-a-dose: For patients with severe hepatic impairment (Child-Pugh class C), reduce the dose to 200 mg b.i.d. Concomitant use of strong CYP2C8 inhibitors isn’t recommended; if use can’t be avoided, reduce tucatinib dose to 100 mg b.i.d. Refer to the prescribing information for toxicity-related dosage adjustments.Released: March 2023Nursing Drug Handbook© 2023 Wolters Kluwer zanubrutinibBrukinsaPharmaceutical company: BeiGene NEW INDICATION & DOSAGEChronic lymphocytic leukemia or small lymphocytic lymphomaAdults: 160 mg PO b.i.d. or 320 mg PO once daily. Continue treatment until disease progression or unacceptable toxicity occurs.Released: March 2023Nursing Drug Handbook© 2023 Wolters Kluwer 
New Drug Indications - February 2023
atezolizumab TecentriqPharmaceutical company:  GenentechNEW INDICATION & DOSAGE Unresectable or metastatic alveolar soft part sarcoma Adults:  840-mg IV infusion every 2 weeks, or 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks until disease progression or unacceptable toxicity occurs.Children age 2 and older:  15-mg/kg IV infusion (up to a maximum of 1,200 mg) every 3 weeks until disease progression or unacceptable toxicity occurs.Released: February 2023 Nursing Drug Handbook © 2023 Wolters Kluwer cariprazine VraylarPharmaceutical company:  AbbVieNEW INDICATION & DOSAGE Adjunctive therapy to antidepressants for the treatment of major depressive disorder Adults:  Initially, 1.5 mg PO once daily. May increase to 3 mg once daily on day 15 based on patient’s response and tolerability. Maximum dosage is 3 mg daily.Released: February 2023 Nursing Drug Handbook © 2023 Wolters Kluwer ibrexafungerp BrexafemmePharmaceutical company:  Scynexis, Inc.NEW INDICATION & DOSAGE Reduction of incidence of recurrent vulvovaginal candidiasis Adult and pediatric females who are postmenarchal:  300 mg (two 150 mg tablets) PO approximately 12 hours apart for 1 day for a total daily dosage of 600 mg monthly for 6 months.Adjust-a-dose:  If concomitantly used with strong CYP3A inhibitor, give one 150 mg tablet approximately 12 hours apart for 1 day for a total daily dosage of 300 mg monthly for 6 months.Released: February 2023 Nursing Drug Handbook © 2023 Wolters Kluwer tocilizumab ActemraPharmaceutical company:  GenentechNEW INDICATION & DOSAGE Coronavirus disease 2019 in patients who are hospitalized, receiving systemic corticosteroids, and who require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation Adults:  8 mg/kg IV infusion over 60 minutes. If clinical signs or symptoms worsen or don’t improve after the first dose, one additional dose may be given at least 8 hours after the initial infusion. Maximum recommended dosage is 800 mg/infusion.Adjust-a-dose:  Don’t initiate in patients with an ANC below 1,000 per mm 3 , platelet count below 50,000 mm 3 , or ALT or AST above 10 times the upper limit of normal.Released: February 2023 Nursing Drug Handbook © 2023 Wolters Kluwer
New Drug Indications - January 2023
brentuximab vedotinAdcetrisPharmaceutical company: Seagen, Inc.NEW INDICATION & DOSAGEPreviously untreated high-risk classical Hodgkin lymphoma, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamideChildren age 2 and older: 1.8 mg/kg IV over 30 minutes every 3 weeks until a maximum of 5 doses, disease progression, or unacceptable toxicity. Maximum dose is 180 mg. Give granulocyte colony stimulating factor beginning with cycle 1.Adjust-a-dose: Refer to prescribing information for chemotherapy agents for additional information.Released: January 2023Nursing Drug Handbook© 2023 Wolters Kluwercemiplimab-rwlcLibtayoPharmaceutical company: RegeneronNEW INDICATION & DOSAGELocally advanced or metastatic non–small-cell lung cancer with no EGFR, ALK or ROS1 aberrations as first-line treatment in combination with platinum‐based chemotherapyAdults: 350-mg IV infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity occurs.Adjust-a-dose: Refer to prescribing information for chemotherapy agents for additional information.Released: January 2023Nursing Drug Handbook© 2023 Wolters KluwercobimetinibCotellicPharmaceutical company: Genentech, Inc.NEW INDICATION & DOSAGEMonotherapy for histiocytic neoplasmAdults: 60 mg PO once daily for the first 21 days of a 28-day cycle until disease progression or unacceptable toxicity.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments. If concurrent short-term (14 days or less) use of a moderate CYP3A inhibitor is unavoidable in patients taking cobimetinib 60 mg, decrease cobimetinib dosage to 20 mg daily. Resume pervious dosage after inhibitor is discontinued. Use an alternative to the CYP3A inhibitor in patients taking less than 60 mg.Released: January 2023Nursing Drug Handbook© 2023 Wolters Kluwer dulaglutideTrulicityPharmaceutical company: LillyNEW INDICATION & DOSAGEAdjunct to diet and exercise to improve glycemic control in patients with type 2 diabetesChildren age 10 and older: 0.75 mg subcut one weekly. If after at least 4 weeks additional glycemic control is needed, may increase dosage to the maximum of 1.5 mg weekly.Released: January 2023Nursing Drug Handbook© 2023 Wolters Kluwer
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