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New Drug Indications - June 2022


alpelisib

Vijoice

Pharmaceutical company: Novartis

NEW INDICATION & DOSAGE

Severe manifestations of PIK3CA-related overgrowth spectrum requiring systemic therapy 

Adults: 250 mg PO once daily until disease progression or unacceptable toxicity occurs.

Children ages 6 to less than 18: Initially, 50 mg PO once daily. May increase after 24 weeks to 125 mg for response optimization. Continue until disease progression or unacceptable toxicity occurs.

Children ages 2 to less than 6: 50 mg PO once daily until disease progression or unacceptable toxicity occurs.

Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments.

Released: June 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


axicabtagene ciloleucel

Yescarta

Pharmaceutical company: Kite Pharma, Inc.

NEW INDICATION & DOSAGE

Large B-cell lymphoma that is refractory to or relapses within 12 months of first-line chemoimmunotherapy

Adults: Target dose is 2 × 106 CAR-positive viable T cells/kg of body weight (or a maximum of 2 × 108 CAR-positive viable T cells for patients weighing 100 kg or more).

Released: June 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


ceftolozane and tazobactam

Zerbaxa

Pharmaceutical company: Merck & Co.

NEW INDICATION & DOSAGE

Complicated intra-abdominal infections caused by Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, K. pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, S. constellatus, or S. salivarius treated concurrently with metronidazole

Birth to less than age 18: 30 mg/kg (up to maximum 1.5 g) IV every 8 hours for 5 to 14 days.

Adjust-a-dose: Use isn't recommended in children with eGFR 50 mL/min/1.73 m2 or less.

Complicated UTIs, including pyelonephritis, caused by Escherichia coli, K. pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa

Birth to less than age 18: 30 mg/kg (up to maximum 1.5 g) IV every 8 hours for 7 to 14 days.

Adjust-a-dose: Use isn't recommended in children with eGFR 50 mL/min/1.73 m2 or less.

Released: June 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


dexmedetomidine hydrochloride

Igalmi

Pharmaceutical company: Bioxcel Therapeutics

NEW FORM

Sublingual film: 120 mcg, 180 mcg

INDICATION & DOSAGE

Acute treatment of agitation associated with schizophrenia or bipolar I or II disorder

Adults: 120 mcg sublingually or buccally for mild or moderate, agitation; if agitation persists, may give up to two additional 60-mcg doses at least 2 hours apart. Or 180 mcg sublingually or buccally for severe agitation; if agitation persists, may give up to two additional 90-mcg doses at least 2 hours apart.

Adults age 65 or older: 120 mcg sublingually or buccally for mild, moderate, or severe agitation; if agitation persists, may give up to two additional 60-mcg doses at least 2 hours apart.

Adjust-a-dose: If mild or moderate hepatic impairment, give 90 mcg for mild or moderate agitation or 120 mcg for severe agitation. If severe hepatic impairment, give 60 mcg for mild or moderate agitation, or 90 mcg for severe agitation. If agitation persists in patients with hepatic impairment, may give up to two additional 60-mcg doses at least 2 hours apart. If systolic blood pressure (SBP) is less than 90 mm Hg, diastolic blood pressure (DBP) is less than 60 mm Hg, heart rate is less than 60 beats per minute or postural decrease in SBP is more than 20 mm Hg or DBP is more than 10 mm Hg after prior dose, don't repeat dose.

Released: June 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


fluticasone propionate

ArmonAir Digihaler

Pharmaceutical company: Teva Respiratory

NEW FORM

Oral inhalation powder: 30 mcg, 55 mcg, 113 mcg, 232 mcg

INDICATION & DOSAGE

As preventive maintenance of chronic asthma in patients requiring oral corticosteroids (ArmonAir Digihaler)

Adults and children age 12 and older not on an inhaled corticosteroid: 55 mcg by oral inhalation b.i.d. Patients with greater asthma severity may use 113 mcg or 232 mcg by oral inhalation b.i.d. Maximum dose is 232 mcg b.i.d.

Adults and children age 12 and older previously taking inhaled corticosteroids: 55 mcg, 113 mcg, or 232 mcg by oral inhalation b.i.d. based on asthma severity and strength of prior therapy. Maximum dose is 232 mcg b.i.d.

Children ages 4 to 11 not on an inhaled corticosteroid: 30 mcg by oral inhalation b.i.d. After 2 weeks, may increase dose to 55 mcg b.i.d.

Children ages 4 to 11 previously taking inhaled corticosteroids: 30 mcg or 55 mcg by oral inhalation b.i.d. based on asthma severity and strength of prior therapy. Doses above 55 mcg b.i.d. haven't been established in children ages 4 to 11.

Adjust-a-dose: For patients who don't respond adequately to starting dose after 2 weeks of therapy, an increased dose may improve control.

Released: June 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


rilpivirine

Edurant

Pharmaceutical company: Janssen Products

INDICATION & DOSAGE

In combination with cabotegravir for short-term treatment of HIV-1 infection in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen as an oral lead-in to assess tolerability of rilpivirine before use of cabotegravir and rilpivirine (Cabenuva) extended-release injectable suspensions

Adolescents age 12 and older weighing 35 kg or more: 25 mg PO once daily in combination with cabotegravir 30 mg PO once daily. Use oral lead-in dose for at least 28 days.

In combination with cabotegravir for short-term treatment of HIV-1 infection in patients with HIV-1 RNA less than 50 copies/mL who are on a stable oral therapy regimen but who will miss scheduled injections with cabotegravir and rilpivirine (Cabenuva) extended-release injectable suspensions by more than 7 days to up to 2 consecutive months

Adolescents age 12 and older and weighing 35 kg or more: 25 mg PO once daily in combination with cabotegravir 30 mg PO once daily starting about 1 month after the last injection and continuing until the day injection dosing is restarted. Refer to the Cabenuva prescribing information for dosing instructions.

Adjust-a-dose: For oral therapy with rilpivirine and cabotegravir of durations greater than 2 months, an alternative oral regimen is recommended, which may include rilpivirine.

Released: June 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer