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New Drug Indications - July 2022


azacitidine

Vidaza

Pharmaceutical company: Bristol Myers Squibb

NEW INDICATION & DOSAGE

Newly diagnosed juvenile myelomonocytic leukemia (JMML)

Children age 1 and older weighing 10 kg or more: 75 mg/m2 IV infusion daily for 7 days in a 28-day cycle. Treat for minimum of 3 cycles and maximum of 6 cycles.

Children age 1 month to less than 1 year or weighing less than 10 kg: 2.5 mg/kg IV infusion daily for 7 days in a 28-day cycle. Treat for minimum of 3 cycles and maximum of 6 cycles.

Adjust-a-dose: Treatment delays up to 14 days can be considered for nonhematologic toxicities. Hematologic toxicity will be difficult to differentiate from natural course of JMML; dose reduction for hematologic toxicity isn't recommended during the first 3 cycles. Discontinue therapy if neutrophil count is less than 0.5 x 109/L at the end of cycle 3 or on day 1 of cycles 5 or 6. Refer to the manufacturer's instructions for toxicity-related dose adjustments.

Released: July 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


dupilumab

Dupixent

Pharmaceutical company: Regeneron Pharmaceuticals

NEW INDICATION & DOSAGE

Eosinophilic esophagitis

Adults and children age 12 and older weighing at least 40 kg: 300 mg subcut once a week.

Released: July 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


edaravone

Radicava ORS

Pharmaceutical company: Mitsubishi Tanabe Pharma America

NEW FORM

Oral suspension: 105 mg/5 mL.

NEW INDICATION & DOSAGE

Amyotrophic lateral sclerosis

Adults: For initial treatment cycle, 105 mg PO or via nasogastric tube in the morning after overnight fasting for 14 days followed by a 14-day drug-free period. For all subsequent cycles, 105 mg PO or via nasogastric tube daily for 10 out of 14 days, followed by a 14-day drug-free period.

Adjust-a-dose: Patient may be switched from 60 mg IV daily to 105 mg PO solution daily.

Released: July 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


ravulizumab-cwvz

Ultomiris

Pharmaceutical company: Alexion Pharmaceuticals

INDICATION & DOSAGE

Generalized myasthenia gravis in patients who are anti-acetylcholine receptor antibody-positive

Adults weighing 100 kg or more: 3,000-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 3,600-mg IV infusion once every 8 weeks.

Adults weighing 60 to less than 100 kg: 2,700-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 3,300-mg IV infusion once every 8 weeks.

Adults weighing 40 to less than 60 kg: 2,400-mg IV infusion loading dose, followed in 2 weeks by maintenance dose of 3,000-mg IV infusion once every 8 weeks.

Adjust-a-dose (all-indications):Supplemental dosing is required for patients weighing 40 kg or more receiving concomitant plasma exchange (PE), plasmapheresis (PP), or intravenous immunoglobulin (IVIg). Additional dose is given within 4 hours following PE, PP, or IVIg and is based on weight, current dose, and concomitant treatment. Refer to the manufacturer's instructions for ravulizumab-cwvz dosing.

Released: July 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


remdesivir

Veklury

Pharmaceutical company: Gilead Sciences, Inc.

INDICATION & DOSAGE

Treatment of nonhospitalized patients with mild-to-moderate coronavirus disease 2019 (COVID-19) at high risk for progression to severe COVID-19, including hospitalization or death

Children age 28 days and older weighing 3 kg to less than 40 kg: Initiate therapy as soon as possible after diagnosis and within 7 days of symptom onset with 5 mg/kg IV infusion on day 1, followed by 2.5 mg/kg IV infusion once daily on days 2 and 3.

Adjust-a-dose: Consider discontinuing the drug if ALT level increases to greater than 10 times the upper limit of normal (ULN). Discontinue if ALT elevation is accompanied by signs or symptoms of liver inflammation.

Treatment of COVID-19 requiring hospitalization

Children age 28 days and older weighing 3 kg to less than 40 kg: Initiate therapy as soon as possible after diagnosis with 5 mg/kg IV infusion on day 1, followed by maintenance dose of 2.5 mg/kg IV infusion once daily on day 2 for 5 days in patients not requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); if no clinical improvement, may extend therapy 5 additional days. Therapy duration for patients requiring invasive mechanical ventilation or ECMO is 10 days.

Adjust-a-dose: Consider discontinuing the drug if ALT level increases to greater than 10 × ULN. Discontinue if ALT elevation is accompanied by signs or symptoms of liver inflammation.

ADMINISTRATION

Alert: Only remdesivir lyophilized powder form is approved for use in children weighing less than 40 kg.

Released: July 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


upadacitinib

Rinvoq

Pharmaceutical company: AbbVie

INDICATION & DOSAGE

Ankylosing spondylitis in patients who have had an inadequate response or intolerance to one of more tumor necrosis factor blockers

Adults: 15 mg PO once daily.

Adjust-a-dose: If serious infection develops, interrupt the drug until the infection is controlled. Interrupt therapy if absolute neutrophil count (ANC) is less than 1,000 cells/mm3, or absolute lymphocyte count (ALC) is less than 500 cells/mm3, or hemoglobin (Hb) level is less than 8 g/dL. May restart the drug once ANC, ALC, or Hb level returns to above these values. If hepatic transaminase levels rise and drug-induced liver injury is suspected, interrupt therapy.

Released: July 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


viloxazine

Qelbree

Pharmaceutical company: Supernus Pharmaceuticals

INDICATION & DOSAGE

Attention deficit hyperactivity disorder

Adults: Initially, 200 mg PO once daily. After 1 week, may titrate by 200-mg increments to maximum dose of 600 mg daily, depending on response and tolerability.

Adjust-a-dose: For severe renal impairment (eGFR less than 30 mL/min/1.73 m2), starting dose is 100 mg once daily. May titrate weekly by 50-mg to 100-mg increments once daily to maximum dose of 200 mg once daily.

Released: July 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer