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New Drug Indications - August 2022


brexanolone

Zulresso

Pharmaceutical company: Sage Therapeutics

NEW INDICATION & DOSAGE

Postpartum depression

Women age 15 and older: Give as continuous IV infusion over a total of 60 hours, titrating dose as follows: 0 to 4 hours, 30 mcg/kg/hour; 4 to 24 hours, increase infusion rate to 60 mcg/kg/hour; 24 to 52 hours, increase infusion rate to 90 mcg/kg/hour or consider a dose of 60 mcg/kg/hour if higher infusion rate isn't tolerated; 52 to 56 hours, decrease infusion rate to 60 mcg/kg/hour; 56 to 60 hours, decrease infusion rate to 30 mcg/kg/hour.

Adjust-a-dose: For excessive sedation, stop infusion until symptoms resolve and resume at the same or lower infusion rate.

Released: August 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

 


brolucizumab-dbll

Beovu

Pharmaceutical company: Novartis

NEW INDICATION & DOSAGE

Diabetic macular edema

Adults: 6-mg intravitreal injection every 6 weeks (every 39 to 45 days) for five doses, then every 8 to 12 weeks thereafter.

Released: August 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

 


dabrafenib mesylate

Tafinlar

Pharmaceutical company: Novartis

NEW INDICATION & DOSAGE

Unresectable or metastatic solid tumors with BRAF V600E mutation as detected by an FDA-approved test in patients who have progressed after prior therapy and have no satisfactory alternative treatment options, in combination with trametinib

Adults and children ages 6 to 17 weighing 51 kg or more: 150 mg PO b.i.d. Continue until disease progression or unacceptable toxicity occurs.

Children ages 6 to 17 weighing 38 to 50 kg: 100 mg PO b.i.d. Continue until disease progression or unacceptable toxicity occurs.

Children ages 6 to 17 weighing 26 to 37 kg: 75 mg PO b.i.d. Continue until disease progression or unacceptable toxicity occurs.

Adjust-a-dose: Refer to the trametinib prescribing information for recommended trametinib dosing information. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.

Released: August 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

 


dupilumab

Dupixent

Pharmaceutical company: Regeneron

NEW INDICATION & DOSAGE

Moderate-to-severe atopic dermatitis not adequately controlled with topical therapy or when those therapies aren't advisable

Children ages 6 months to 5 years weighing 15 to less than 30 kg: 300 mg subcut every 4 weeks.

Children ages 6 months to 5 years weighing 5 to less than 15 kg: 200 mg subcut every 4 weeks.

Released: August 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

 


ipilimumab

Yervoy

Pharmaceutical company: Bristol-Myers Squibb

NEW INDICATION & DOSAGE

Unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with nivolumab

Adults: 1 mg/kg IV infusion every 6 weeks with nivolumab, 3 mg/kg IV infusion every 2 weeks, or 360-mg IV infusion every 3 weeks until disease progression or unacceptable toxicity occurs, or up to 2 years.

Released: August 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

 


ivosidenib

Tibsovo

Pharmaceutical company: Servier Pharmaceuticals

NEW INDICATION & DOSAGE

Newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test in patients age 75 and older, or who have comorbidities that preclude use of intensive induction chemotherapy, in combination with azacitidine

Adults age 75 and older: 500 mg PO daily with azacitidine 75 mg/m2 subcut or IV once daily on days 1 to 7 (or days 1 to 5 and 8 to 9) of each 28-day cycle until disease progression or unacceptable toxicity occurs. Treat for a minimum of 6 months to allow time for clinical response. Refer to the azacitidine manufacturer's instructions for additional dosing information.

Released: August 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

 


nivolumab

Opdivo

Pharmaceutical company: Bristol-Myers Squibb

NEW INDICATION & DOSAGE

Unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy

Adults: 240-mg IV infusion every 2 weeks or 480-mg IV infusion every 4 weeks in combination with chemotherapy. Continue nivolumab until disease progression or unacceptable toxicity occurs, or up to 2 years.

Unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab

Adults: 3 mg/kg IV infusion every 2 weeks or 360-mg IV infusion every 3 weeks with ipilimumab 1 mg/kg IV infusion every 6 weeks until disease progression or unacceptable toxicity occurs, or up to 2 years.

Released: August 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

 


risankizumab-rzaa

Skyrizi

Pharmaceutical company: AbbVie

NEW FORM

Injection (IV): 600 mg/10 mL single-dose vial

INDICATION & DOSAGE

Moderate to severe Crohn disease

Adults: 600-mg IV infusion over at least 1 hour at weeks 0, 4, and 8, then 360 mg subcut at week 12 and every 8 weeks thereafter.

Released: August 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

 


tisagenlecleucel

Kymriah

Pharmaceutical company: Novartis

INDICATION & DOSAGE

Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

Adults: 0.6 to 6.0 x 108 CAR-positive viable T cells IV infusion 2 to 6 days after completion of lymphodepleting chemotherapy.

Adjust-a-dose: May omit lymphodepleting chemotherapy if patient's WBC count is less than 1 x 109/L within 1 week before tisagenlecleucel infusion.

Released: August 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer

 


trametinib

Mekinist

Pharmaceutical company: Novartis

INDICATION & DOSAGE

Unresectable or metastatic solid tumors with BRAF V600E mutation as detected by an FDA-approved test in patients who have progressed after prior therapy and have no satisfactory alternative treatment options, in combination with dabrafenib

Adults and children ages 6 to 17 weighing 51 kg or more: 2 mg PO once daily until disease progression or unacceptable toxicity occurs.

Children ages 6 to 17 weighing 38 to 50 kg: 1.5 mg PO once daily until disease progression or unacceptable toxicity occurs.

Children ages 6 to 17 weighing 26 to 37 kg: 1 mg PO once daily until disease progression or unacceptable toxicity occurs.

Adjust-a-dose: Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.

Released: August 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer