New Drug Indications - June 2021


alirocumab

Praluent

Pharmaceutical company: Regeneron

NEW INDICATION & DOSAGE

Adjunct to other LDL cholesterol (LDL-C)-lowering therapies in patients with homozygous familial hypercholesterolemia to reduce LDL-C

Adults: 150 mg subcut every 2 weeks.

Released: June 2021

© 2021 Wolters Kluwer

cetuximab

Erbitux

Pharmaceutical company: Lilly

NEW INDICATION & DOSAGE

Squamous cell carcinoma of the head and neck, as a single agent or in combination with platinum-based therapy and fluorouracil

Adults: 500 mg/m2-IV infusion over 2 hours every 2 weeks. Complete infusion 1 hour before platinum-based therapy with fluorouracil. Continue therapy until disease progression or unacceptable toxicity occurs.

KRAS mutation-negative (wild type), epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer as determined by FDA-approved tests given in combination with FOLFIRI (irinotecan, 5-FU, leucovorin) chemotherapy regimen for first-line treatment or in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, or given as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan

Adults: 500 mg/m2-IV infusion over 2 hours every 2 weeks. Complete infusion 1 hour before irinotecan or FOLFIRI. Continue therapy until disease progression or unacceptable toxicity occurs.

Adjust-a-dose (for all indications): Refer to the manufacturer’s instructions for dosage adjustments for adverse reactions and treatment-related toxicities.

Released: June 2021

© 2021 Wolters Kluwer

daunorubicin and cytarabine liposome

Vyxeos

Pharmaceutical company: Jazz Pharmaceuticals

NEW INDICATION & DOSAGE

Newly diagnosed, therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changes

Children age 1 and older: A full course of therapy consists of one or two induction cycles followed by up to two consolidation cycles. For initial induction cycle, 44 mg/mdaunorubicin/100 mg/m2 cytarabine IV infusion on days 1, 3, and 5. For patients who fail to achieve a response from first induction cycle, give a second induction cycle of 44 mg/m2 daunorubicin/100 mg/m2 cytarabine IV infusion on days 1 and 3. May give second induction cycle 2 to 5 weeks after first induction cycle if no unacceptable toxicity occurs with previous cycle.

Give first consolidation cycle 5 to 8 weeks after start of the last induction. Recommended dose for each consolidation cycle is 29 mg/m2 daunorubicin/65 mg/m2 cytarabine IV infusion on days 1 and 3. Give second consolidation cycle 5 to 8 weeks after start of first consolidation cycle if no disease progression or unacceptable toxicity occurs.

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

Released: June 2021

© 2021 Wolters Kluwer

diazepam

Diastat

Pharmaceutical company: Bausch Health

NEW INDICATION & DOSAGE

Acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) that are distinct from patient's usual seizure pattern

Adults and children age 12 and older: 0.2 mg/kg PR, rounding up to the nearest available dose form. A second dose may be given 4 to 12 hours later.

Children ages 6 to 11: 0.3 mg/kg PR, rounding up to the nearest available dose form. A second dose may be given 4 to 12 hours later.

Children ages 2 to 5: 0.5 mg/kg PR, rounding up to the nearest available dose form. A second dose may be given 4 to 12 hours later.

Released: June 2021

© 2021 Wolters Kluwer

nivolumab

Opdivo

Pharmaceutical company: Bristol-Myers Squibb

NEW INDICATION & DOSAGE

Advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy

Adults: 360-mg IV infusion every 3 weeks along with fluoropyrimidine- and platinum-containing chemotherapy every 3 weeks; or 240-mg IV infusion every 2 weeks along with fluoropyrimidine- and platinum-containing chemotherapy every 2 weeks until disease progression or unacceptable toxicity occurs, or up to 2 years in patients without disease progression.

Adjust-a-dose: Refer to the manufacturer’s instructions for dosage adjustments for adverse reactions and treatment-related toxicities.

Released: June 2021

© 2021 Wolters Kluwer

treprostinil

Tyvaso

Pharmaceutical company: United Therapeutics Corp.

NEW INDICATION & DOSAGE

Pulmonary arterial hypertension associated with interstitial lung disease in patients (WHO group 3) to improve exercise ability

Adults: Initially, 3 breaths (18 mcg) per treatment session q.i.d., approximately 4 hours apart. Increase dose by 3 breaths in 1- to 2-week intervals, as tolerated, to target maintenance dose of 9 breaths (54 mcg) q.i.d. If 3 breaths are not tolerated initially, decrease to 1 or 2 breaths and increase as tolerated.

Released: June 2021

© 2021 Wolters Kluwer

valsartan

Diovan

Pharmaceutical company: Novartis

NEW INDICATION & DOSAGE

Hypertension

Children ages 1 to 16: Initially, 1 mg/kg PO daily (up to 40 mg total). Adjust according to patient response and tolerability, up to 4 mg/kg or 160 mg daily.

Adjust-a-dose: Consider starting dose of 2 mg/kg in select cases when greater reduction of blood pressure is needed.

Released: June 2021

© 2021 Wolters Kluwer