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New Drug Indications - November 2024

certolizumab pegol

Cimzia
Pharmaceutical company: UCB, Inc.

NEW INDICATION & DOSAGE
Active polyarticular juvenile idiopathic arthritis
Adults and children ages 2 and older weighing 40 kg or more: 400 mg subcut at weeks 0, 2, and 4; then maintenance dose of 200 mg every 2 weeks.
Adults and children ages 2 and older weighing 20 to less than 40 kg: 200 mg subcut at weeks 0, 2, and 4; then maintenance dose of 100 mg every 2 weeks.
Adults and children ages 2 and older weighing 10 to less than 20 kg: 100 mg subcut at weeks 0, 2, and 4; then maintenance dose of 50 mg every 2 weeks.

Released: November 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

letermovir

Prevymis
Pharmaceutical company: Merck & Co.

NEW AVAILABLE FORM
Oral pellets: 20 mg; 120 mg packet

NEW INDICATION & DOSAGE
Prophylaxis of cytomegalovirus (CMV) infection and disease in CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT)
Children age 12 and older weighing at least 30 kg: 480 mg PO or IV infusion once daily through 100 days post-HSCT.
Children ages 6 months to younger than 12 years weighing 15 to less than 30 kg: 240 mg PO or 120-mg IV infusion once daily through 100 days post-HSCT.
Children ages 6 months to younger than 12 years weighing 7.5 to less than 15 kg: 120-mg oral pellets or 60-mg IV infusion once daily through 100 days post-HSCT.
Children ages 6 months to younger than 12 years weighing 6 to less than 7.5 kg: 80-mg oral pellets or 40-mg IV infusion once daily through 100 days post-HSCT.

Adjust-a-dose: May begin therapy between day 0 and day 28 post-HSCT. In patients at risk for late CMV infection and disease, may continue through 200 days post-HSCT. If coadministered with cyclosporine, decrease the dose to 240 mg PO or IV once daily in children age 12 and older weighing at least 30 kg; 120 mg in children younger than age 12 weighing 15 to less than 30 kg; 60 mg in children younger than age 12 weighing 7.5 to less than 15 kg; or 40 mg in children younger than age 12 weighing 6 to less than 7.5 kg. If initiating cyclosporine after start of letermovir, decrease the next dose of letermovir. If cyclosporine is discontinued after starting letermovir, increase the next dose of letermovir. If cyclosporine dosing is interrupted because of high cyclosporine level, no letermovir dose adjustment is needed.

Prophylaxis of CMV disease in patients who are kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative)
Adults and children ages 12 and older weighing at least 40 kg: 480 mg PO or IV infusion once daily through 200 days posttransplant.

Adjust-a-dose: May begin therapy between day 0 and day 7 posttransplant. If coadministered with cyclosporine, decrease the dose to 240 mg PO or IV once daily. If cyclosporine is initiated after start of letermovir, decrease the next dose of letermovir to 240 mg once daily. If cyclosporine is discontinued after starting letermovir, increase the next dose of letermovir to 480 mg once daily. If cyclosporine dosing is interrupted because of high cyclosporine level, no letermovir dose adjustment is needed.

Released: November 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

pembrolizumab

Keytruda
Pharmaceutical company: Merck & Co.

NEW INDICATION & DOSAGE
First-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma, in combination with pemetrexed and platinum chemotherapy
Adults: 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks until disease progression or unacceptable toxicity occurs, or up to 24 months in patients without disease progression. Give before chemotherapy when given the same day.
 

Released: November 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

ribociclib

Kisqali
Pharmaceutical company: Novartis

INDICATION & DOSAGE
Adjuvant treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative, stage II and III early breast cancer in patients at high risk for recurrence, in combination with an aromatase inhibitor
Adults: 400 mg PO once daily for 21 consecutive days followed by 7 days off therapy. Continue for 3 years, or until disease recurrence or unacceptable toxicity occurs. Refer to the aromatase inhibitor prescribing information for dosage and administration specifics.

Adjust-a-dose: For patients with early breast cancer and Child-Pugh class B or C liver impairment, no dose adjustment is necessary. If use with a strong CYP3A inhibitor can't be avoided, reduce ribociclib dose to 200 mg once daily; allow 5 half-lives of the inhibitor after discontinuation of the inhibitor before returning to the initial ribociclib dose.

Released: November 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

New Drug Indications Archive

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
New Drug Indications - December 2022
amifampridineFirdapsePharmaceutical company: Catalyst PharmaceuticalsNEW INDICATION & DOSAGELambert-Eaton myasthenic syndromeChildren age 6 and older weighing 45 kg or more (Firdapse): 15 to 30 mg/day PO in three to four divided doses. May increase by 5 mg daily every 3 or 4 days. Maximum single dose is 20 mg; maximum daily dose is 80 mg.Children age 6 and older weighing less than 45 kg (Firdapse): 5 to 15 mg/day PO in three to four divided doses. May increase by 2.5 mg daily every 3 or 4 days. Maximum single dose is 10 mg; maximum daily dose is 40 mg.Released: December 2022Nursing Drug Handbook© 2022 Wolters KluwerdupilumabDupixentPharmaceutical company: Sanofi RegeneronNEW INDICATION & DOSAGEPrurigo nodularisAdults: Initially, 600 mg subcut given as two 300-mg injections in different sites followed by 300 mg subcut every other week.Released: December 2022Nursing Drug Handbook© 2022 Wolters Kluwer durvalumabImfinziPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGEUnresectable hepatocellular carcinoma in combination with tremelimumab-actlAdults weighing 30 kg or more: Tremelimumab-actl 300 mg IV over 60 minutes as a single dose day 1 of cycle followed by a 1-hour observation period; then give durvalumab 1,500 mg IV the same day followed by 1,500 mg every 4 weeks as a single agent until disease progression or unacceptable toxicity occurs.Adults weighing less than 30 kg: Tremelimumab-actl 4 mg/kg over 60 minutes as a single dose day 1 of cycle 1 followed by a 1-hour observation period; then give durvalumab 20 mg/kg IV the same day followed by 20 mg/kg every 4 weeks as a single agent until disease progression or unacceptable toxicity occurs.Released: December 2022Nursing Drug Handbook© 2022 Wolters Kluwer selpercatinibRetevmoPharmaceutical company: Eli Lilly and CompanyNEW INDICATION & DOSAGELocally advanced or metastatic solid tumors with RET gene fusion in patients with progression on or following prior systemic treatment, or who have no alternative treatment optionsAdults weighing 50 kg or more: 160 mg PO b.i.d. until disease progression or unacceptable toxicity.Adults weighing less than 50 kg: 120 mg PO b.i.d. until disease progression or unacceptable toxicity.Released: December 2022Nursing Drug Handbook© 2022 Wolters Kluwer upadacitinibRinvoqPharmaceutical company: AbbVieNEW INDICATION & DOSAGEActive nonradiographic axial spondyloarthritis in patients with inadequate response or intolerance to TNF blocker therapyAdults: 15 mg PO daily.Adjust-a-dose: If serious infection develops, interrupt the drug until the infection is controlled. Interrupt therapy if ANC is less than 1,000 cells/mm3, or absolute lymphocyte count (ALC) is less than 500 cells/mm3, or hemoglobin level is less than 8 g/dL. May restart the drug once ANC, ALC, or hemoglobin level returns to above these values. If hepatic transaminase levels rise and drug-induced liver injury is suspected, interrupt therapy.Released: December 2022Nursing Drug Handbook© 2022 Wolters Kluwer
New Drug Indications - November 2022
durvalumabImfinziPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGEMetastatic or locally advanced biliary tract cancer in combination with gemcitabine and cisplatinAdults weighing 30 kg or more: 1,500-mg IV infusion every 3 weeks (21 days) for up to eight cycles in combination with chemotherapy, followed by 1,500 mg every 4 weeks as a single agent until disease progression or unacceptable toxicity occurs.Adults weighing less than 30 kg: 20-mg/kg IV infusion every 3 weeks (21 days) for up to eight cycles in combination with chemotherapy, followed by 20 mg/kg every 2 weeks as a single agent until disease progression or unacceptable toxicity occurs.Released: November 2022Nursing Drug Handbook© 2022 Wolters Kluwerlumacaftor and ivacaftorOrkambiPharmaceutical company: Vertex PharmaceuticalsNEW AVAILABLE FORMOral granules (single-dose packets):lumacaftor 150 mg and ivacaftor 188 mg; lumacaftor 100 mg and ivacaftor 125 mg; lumacaftor 75 mg and ivacaftor 94 mgINDICATION & DOSAGETreatment of cystic fibrosis in patients who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator geneChildren ages 1 to 2 and weighing 14 kg or greater: 1 granule packet (lumacaftor 150 mg and ivacaftor 188 mg) every 12 hours with fat-containing food.Children ages 1 to 2 and weighing 9 to less than 14 kg: 1 granule packet (lumacaftor 100 mg and ivacaftor 125 mg) every 12 hours with fat-containing food.Children ages 1 to 2 and weighing 7 to less than 9 kg: 1 granule packet (lumacaftor 75 mg and ivacaftor 94 mg) every 12 hours with fat-containing food.Released: November 2022Nursing Drug Handbook© 2022 Wolters Kluwer
New Drug Indications - October 2022
baloxavir marboxilXofluzaPharmaceutical company: GenentechNEW INDICATION & DOSAGETreatment of acute, uncomplicated influenza in patients who have been symptomatic for no more than 48 hours, who are otherwise healthyChildren age 5 and older weighing 80 kg or more: 80 mg PO as a single dose.Children age 5 and older weighing 20 to less than 80 kg: 40 mg PO as a single dose.Postexposure influenza prophylaxisChildren age 5 and older weighing 80 kg or more: 80 mg PO as a single dose.Children age 5 and older weighing 20 to less than 80 kg: 40 mg PO as a single dose.Children age 5 and older weighing less than 20 kg: 2 mg/kg PO as a single dose.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer  belimumabBenlystaPharmaceutical company: GlaxoSmithKlineNEW INDICATION & DOSAGEActive lupus nephritis in patients who are receiving standard therapyChildren age 5 and older: 10 mg/kg IV infusion every 2 weeks for first three doses, then every 4 weeks thereafter.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer  ibrutinibImbruvicaPharmaceutical company: Pharmacyclics and Janssen BiotechNEW INDICATION & DOSAGEChronic graft-versus-host disease (GVHD) after failure of one or more lines of systemic therapyChildren age 12 and older: 420 mg PO once daily until GVHD progresses, underlying malignancy recurs, unacceptable toxicity occurs, or patient no longer requires treatment.Children age 1 to less than 12 years: 240 mg/m2 PO once daily (maximum dose 420 mg) until GVHD progresses, underlying malignancy recurs, unacceptable toxicity occurs, or patient no longer requires treatment.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer  relugolix–estradiol–norethindrone acetateMyfembreePharmaceutical company: Myovant Sciences NEW INDICATION & DOSAGEManagement of moderate to severe pain associated with endometriosisAdults: 1 tablet PO daily for up to 24 months.Adjust-a-dose: If use with oral P-glycoprotein inhibitors can’t be avoided, give relugolix–estradiol–norethindrone acetate first, and separate dosing by at least 6 hours.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer  ustekinumabStelaraPharmaceutical company: Janssen BiotechNEW INDICATION & DOSAGEAcute psoriatic arthritisChildren ages 6 to 17 weighing more than 100 kg with coexistent moderate-to-severe plaque psoriasis: Initially, 90 mg subcut; repeat dose in 4 weeks, followed by maintenance dose of 90 mg subcut every 12 weeks.Children ages 6 to 17 weighing 60 kg or more: Initially, 45 mg subcut; repeat dose in 4 weeks, followed by maintenance dose of 45 mg subcut every 12 weeks.Children ages 6 to 17 weighing less than 60 kg: Initially, 0.75 mg/kg subcut; repeat dose in 4 weeks, followed by maintenance dose of 0.75 mg/kg subcut every 12 weeks.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer 
New Drug Indications - September 2022
crizotinibXalkoriPharmaceutical company: PfizerNEW INDICATION & DOSAGEUnresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumorAdults: 250 mg PO b.i.d.Adjust-a-dose: For creatinine clearance less than 30 mL/minute (not requiring dialysis), give 250 mg once daily. For preexisting moderate hepatic impairment, give 200 mg b.i.d. For preexisting severe hepatic impairment, give 250 mg once daily. For unavoidable concomitant use with strong CYP3A inhibitors, decrease crizotinib to 250 mg once daily. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Children age 1 and older: 280 mg/m2 PO b.i.d.Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments, dosage adjustments for renal or hepatic impairment, and for concomitant use of strong CYP3A inhibitors.Released: September 2022Nursing Drug Handbook© 2022 Wolters Kluwer phentermine and topiramateQsymiaPharmaceutical company: Vivus LLCNEW INDICATION & DOSAGEChronic weight management, as an adjunct to diet and increased physical activity in children with BMI in the 95th percentile or more standardized for age and sexChildren age 12 and older: Initially, 3.75 mg phentermine/23 mg topiramate PO every morning for 14 days; then increase to 7.5 mg phentermine/46 mg topiramate every morning. Evaluate weight loss after 12 weeks of therapy. If the child hasn't lost at least 3% of baseline BMI, escalate dose to 11.25 mg phentermine/69 mg topiramate every morning for 14 days, followed by 15 mg phentermine/92 mg topiramate every morning. Evaluate BMI 12 weeks after dose escalation. If the patient hasn't lost at least 5% of baseline BMI, discontinue the drug by decreasing the dose to every other day for at least 1 week before stopping therapy altogether.Adjust-a-dose: If the child's weight loss exceeds 0.9 kg/week, consider dose reduction. For patients with moderate renal impairment (creatinine clearance of 30 to less than 50 mL/minute), severe renal impairment (creatinine clearance less than 30 mL/minute), or moderate hepatic impairment (Child-Pugh class B), don't exceed 7.5 mg phentermine/46 mg topiramate once daily.Released: September 2022Nursing Drug Handbook© 2022 Wolters Kluwer stiripentolDiacomitPharmaceutical company: BiocodexNEW INDICATION & DOSAGESeizures associated with Dravet syndrome in patients taking clobazamChildren age 1 and older weighing 10 kg or more: 25 mg/kg PO b.i.d. or 16.67 mg/kg PO t.i.d.Children age 1 and older weighing 7 to less than 10 kg: 25 mg/kg PO b.i.d.Children age 6 months to younger than age 1 weighing 7 kg or more: 25 mg/kg PO b.i.d.Adjust-a-dose: If exact dosage can't be achieved with the available strengths, round to the nearest dosage, which is usually within 50 to 150 mg of the recommended 50 mg/kg/day. Maximum dose, 3,000 mg/day. If somnolence occurs, consider reducing clobazam dosage by 25%. If somnolence persists, consider decreasing clobazam dosage by an additional 25%. Consider adjusting the dosage of other concomitant anticonvulsants with sedating properties.Released: September 2022Nursing Drug Handbook© 2022 Wolters Kluwer 
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