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New Drug Indications - March 2023


ceftazidime and avibactam

Avycaz

Pharmaceutical company: AbbVie

 

NEW INDICATION & DOSAGE

Hospital-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 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


 

dexmedetomidine HCl

Precedex

Pharmaceutical company: Pfizer/Hospira, Inc.

 

NEW INDICATION & DOSAGE

Procedural sedation in patients who are nonintubated

Children 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 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


 

pembrolizumab

Keytruda

Pharmaceutical company: Merck Sharp & Dohme

 

NEW INDICATION & DOSAGE

Adjuvant treatment following resection and platinum-based chemotherapy for patients with stage IB, II, or IIIA non–small-cell lung cancer

Adults: 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 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


 

risperidone

Rykindo

Pharmaceutical company: Shandong Luye Pharmaceutical, Co.

 

NEW FORM

Extended-release injectable suspension: 12.5 mg, 25 mg, 37.5 mg, 50 mg

NEW INDICATION & DOSAGE

Parenteral 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 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


 

semaglutide

Wegovy

Pharmaceutical company: Novo Nordisk, Inc.

 

NEW INDICATION & DOSAGE

Adjunct 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 birth

Children 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 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


 

tucatinib

Tukysa

Pharmaceutical company: Seagen, Inc.

 

NEW INDICATION & DOSAGE

In 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 chemotherapy

Adults: 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 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer


 

zanubrutinib

Brukinsa

Pharmaceutical company: BeiGene

 

NEW INDICATION & DOSAGE

Chronic lymphocytic leukemia or small lymphocytic lymphoma

Adults: 160 mg PO b.i.d. or 320 mg PO once daily. Continue treatment until disease progression or unacceptable toxicity occurs.

Released: March 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer