New Drug Indications - March 2022


brexpiprazole

Rexulti

Pharmaceutical company: Otsuka America Pharmaceuticals

NEW INDICATION & DOSAGE

Schizophrenia

Children age 13 and older: Initially, 0.5 mg PO once daily on days 1 through 4; then titrate to 1 mg PO once daily on days 5 through 7; then increase to 2 mg PO once daily on day 8 based on patient's response and tolerability. Increase by 1 mg weekly, if indicated. Recommended target dose, 2 to 4 mg daily. Maximum daily dose, 4 mg.

Boxed Warning: Safety and effectiveness in children with major depressive disorder haven't been established.

Boxed Warning: Closely monitor all antidepressant-treated patients for worsening and emergence of suicidal thoughts and behaviors, especially during initial months of therapy and after dosage change.

Released: March 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


emtricitabine and tenofovir alafenamide

Descovy

Pharmaceutical company: Gilead Sciences

NEW AVAILABLE FORM

Tablets: 120 mg emtricitabine and 15 mg tenofovir alafenamide

NEW INDICATION & DOSAGE

HIV-1 infection in combination with other antiretrovirals other than protease inhibitors that require a CYP3A inhibitor

Children weighing at least 14 to less than 25 kg with creatinine clearance of 30 mL/minute or more: One 120 mg/15 mg tablet PO once daily.

Released: March 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


glycopyrrolate

Dartisla ODT

Pharmaceutical company: Edenbridge Pharma

NEW AVAILABLE FORM

Tablets (ODT [orally disintegrating tablets]): 1.7 mg

NEW INDICATION & DOSAGE

Adjunct to treatment to reduce symptoms in patients with peptic ulcer 

Adults: 1.7 mg b.i.d. or t.i.d. Maximum daily dosage, 6.8 mg.

Adjust-a-dose: Patients receiving 2-mg dose of another oral tablet form of glycopyrrolate may be switched to ODT. Use lowest effective dose to control symptoms; switch to another oral tablet form of glycopyrrolate in patients who can be titrated to lower dose.

Released: March 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


lumateperone

Caplyta

Pharmaceutical company: Intra-Cellular Therapies

NEW INDICATION & DOSAGE

Depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy or as adjunctive therapy with lithium or valproate

Adults: 42 mg PO once daily.

Released: March 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


ribociclib

Kisqali

Pharmaceutical company: Novartis

NEW INDICATION & DOSAGE

Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in men

Men: 600 mg (three 200-mg tablets) PO once daily for 21 consecutive days followed by 7 days off therapy. When combined with fulvestrant, give 500 mg fulvestrant PO on days 1, 15, and 29, and once monthly thereafter. Refer to full prescribing information of fulvestrant. Men should also be treated with a luteinizing hormone-releasing hormone agonist, according to current clinical practice standards.

Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustment. For patients with moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment, reduce starting dose to 400 mg once daily. For patients with severe renal impairment, reduce starting dose to 200 mg PO once daily. If use with a strong CYP3A inhibitor can't be avoided, reduce ribociclib dose to 400 mg daily; allow five half-lives of the inhibitor after discontinuation of the inhibitor before returning to the initial ribociclib dose.

Released: March 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


rivaroxaban

Xarelto

Pharmaceutical company: Janssen Pharmaceuticals

NEW FORMULATION

Granules for oral suspension: 1 mg/mL after reconstitution

INDICATIONS & DOSAGE

Venous thromboembolism and reduction of risk of recurrent venous thromboembolism after at least 5 days of initial parenteral anticoagulant therapy

Children from birth to less than age 18, weighing 50 kg or more: 20 mg oral suspension or tablets PO daily.

Children from birth to less than age 18, weighing 30 to 49.9 kg: 15 mg oral suspension or tablets PO daily.

Children from birth to less than age 18, weighing 12 to 29.9 kg: 5 mg oral suspension PO b.i.d.

Children from birth to less than age 18, weighing 10 to 11.9 kg: 3 mg oral suspension PO t.i.d.

Children from birth to less than age 18, weighing 9 to 9.9 kg: 2.8 mg oral suspension PO t.i.d.

Children from birth to less than age 18, weighing 8 to 8.9 kg: 2.4 mg oral suspension PO t.i.d.

Children from birth to less than age 18, weighing 7 to 7.9 kg: 1.8 mg oral suspension PO t.i.d.

Children from birth to less than age 18, weighing 5 to 6.9 kg: 1.6 mg oral suspension PO t.i.d.

Children from birth to less than age 18, weighing 4 to 4.9 kg: 1.4 mg oral suspension PO t.i.d.

Children from birth to less than age 18, weighing 3 to 3.9 kg: 0.9 mg oral suspension PO t.i.d.

Children from birth to less than age 18, weighing 2.6 to 2.9 kg: 0.8 mg oral suspension PO t.i.d.

Adjust-a-dose: Children less than 6 months should have been at least 37 weeks of gestation at birth, have had at least 10 days of oral feeding, and weigh 2.6 kg or more at the time of dosing. Continue therapy for at least 3 months and up to 12 months, when necessary. In children less than age 2 with catheter-related thrombosis, continue therapy for at least 1 month and up to 3 months, when necessary. Avoid use in children age 1 and older with moderate or severe renal impairment (eGFR less than 50 mL/min/1.73 m2). Refer to the manufacturer's instructions for renal impairment in children less than age 1 and for recommendations for switching to and from other anticoagulants.

Thromboprophylaxis in patients with congenital heart disease after the Fontan procedure

Children age 2 and older, weighing 50 kg or more: 10 mg oral suspension or tablets PO daily.

Children age 2 and older, weighing 30 to 49.9 kg: 7.5 mg oral suspension PO daily.

Children age 2 and older, weighing 20 to 29.9 kg: 2.5 mg oral suspension PO b.i.d.

Children age 2 and older, weighing 12 to 19.9 kg: 2 mg oral suspension PO b.i.d.

Children age 2 and older weighing 10 to 11.9 kg: 1.7 mg oral suspension PO b.i.d.

Children age 2 and older, weighing 8 to 9.9 kg: 1.6 mg oral suspension PO b.i.d.

Children age 2 and older weighing 7 to 7.9 kg: 1.1 mg oral suspension PO b.i.d.

Adjust-a-dose: Avoid use in children age 1 and older with moderate or severe renal impairment (eGFR less than 50 mL/min/1.73 m2). Refer to the manufacturer's instructions for renal impairment in children less than age 1 and for recommendations for switching to and from other anticoagulants.

Released: March 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


secukinumab

Cosentyx

Pharmaceutical company: Novartis

NEW INDICATION & DOSAGE

Active psoriatic arthritis

Children age 2 and older, weighing more than 50 kg: 150 mg subcut at weeks 0, 1, 2, 3, and 4; then 150 mg every 4 weeks thereafter.

Children age 2 and older, weighing 15 to less than 50 kg: 75 mg subcut at weeks 0, 1, 2, 3, and 4; then 75 mg every 4 weeks thereafter.

Active enthesitis-related arthritis

Children age 4 and older, weighing more than 50 kg: 150 mg subcut at weeks 0, 1, 2, 3, and 4; then 150 mg every 4 weeks thereafter.

Children age 4 and older, weighing 15 to less than 50 kg: 75 mg subcut at weeks 0, 1, 2, 3, and 4; then 75 mg every 4 weeks thereafter.

Released: March 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


upadacitinib

Rinvoq

Pharmaceutical company: AbbVie Inc.

NEW INDICATION & DOSAGE

Psoriatic arthritis in patients with inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers

Adults: 15 mg PO once daily.

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

Refractory, moderate to severe atopic dermatitis not adequately controlled with other systemic drugs, including biologics, or when use of those therapies is inadvisable

Adults and children age 12 and older weighing at least 40 kg: Initially, 15 mg PO once daily. May increase to 30 mg once daily. If adequate response isn't achieved with 30-mg dose, stop therapy. Use lowest effective dose needed to maintain response.

Adjust-a-dose: In older adults or patients with severe renal impairment (creatinine clearance less than 30 mL/minute), give 15 mg once daily. If used concomitantly with strong CYP3A4 inhibitors, give 15 mg once daily. Not recommended for patients with severe hepatic impairment.

Released: March 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer


voxelotor

Oxbryta

Pharmaceutical company: Global Blood Therapeutics

NEW AVAILABLE FORM

Tablet for suspension: 300 mg

INDICATION & DOSAGE

Sickle cell disease

Children age 4 to less than 12, weighing 40 kg or more: 1,500 mg PO once daily, with or without hydroxyurea.

Children age 4 to less than 12, weighing 20 to less than 40 kg: 900 mg PO once daily, with or without hydroxyurea.

Children age 4 to less than 12, weighing 10 to less than 20 kg: 600 mg PO once daily, with or without hydroxyurea.

Adjust-a-dose: For children age 4 to less than 12 with severe hepatic impairment (Child-Pugh class C) reduce dose based on body weight. If 40 kg or more, give 1,000 mg (two 500-mg tablets) or 900 mg (three 300-mg tablets for oral suspension) daily; if 20 to less than 40 kg, give 600 mg daily; if 10 to less than 20 kg, give 300 mg daily. For children age 4 to less than 12 who are currently receiving a strong or moderate CYP3A4 inducer, see the manufacturer's instructions for dosage adjustment based on weight.

Released: March 2022

Nursing Drug Handbook

© 2022 Wolters Kluwer