New Drug Indications - July 2021


dapagliflozin

Farxiga

Pharmaceutical company: AstraZeneca

NEW INDICATION & DOSAGE

To reduce the risk of sustained eGFR decline, end-stage renal disease (ESRD), CV death, and hospitalization for heart failure in patients with chronic kidney disease at risk for progression

Adults: 10 mg PO once daily.

Adjust-a-dose: This drug is not recommended for initiation when eGFR is less than 25 mL/min/1.73 m2; however, patient may continue 10 mg PO once daily to reduce the risk of eGFR decline, ESRD, CV death, and hospitalization for heart failure.

CONTRAINDICATIONS & CAUTIONS

This drug is not recommended for treatment of chronic kidney disease in patients with polycystic kidney disease or those with current or recent immunosuppressive therapy for kidney disease.

Released: July 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer


diclofenac potassium

Zipsor

Pharmaceutical company: Assertio Therapeutics, Inc.

NEW INDICATION & DOSAGE

Mild to moderate acute pain (Zipsor)

Adults and children age 12 and older: 25 mg PO q.i.d.

Released: July 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer


nivolumab

Opdivo

Pharmaceutical company: Bristol-Myers Squibb

NEW INDICATION & DOSAGE

Adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy

Adults: 240-mg IV infusion every 2 weeks, or 480-mg IV infusion every 4 weeks, until disease progression or unacceptable toxicity occurs, or up to 1 year of treatment.

Released: July 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer


pembrolizumab

Keytruda

Pharmaceutical company: Merck Sharp & Dohme

NEW INDICATION & DOSAGE

First-line treatment in patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy

Adults: 200-mg IV infusion over 30 minutes every 3 weeks, or 400-mg IV infusion over 30 minutes every 6 weeks prior to trastuzumab and chemotherapy when given on the same day. Continue until disease progression or unacceptable toxicity occurs, or up to 24 months in those without disease progression.

Monotherapy treatment in patients with locally recurrent advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy

Adults: 200-mg IV infusion over 30 minutes every 3 weeks, or 400-mg IV infusion over 30 minutes every 6 weeks until disease progression or unacceptable toxicity occurs, or up to 24 months in those without disease progression.

Released: July 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer


spinosad

Natroba

Pharmaceutical company: ParaPRO

NEW INDICATION & DOSAGE

Scabies infestation

Adults and children age 4 and older: Apply to skin to completely cover body from the neck to soles of feet. Patients with balding scalp should also apply to scalp, hairline, temples, and forehead. Allow skin to dry for 10 minutes before getting dressed. Leave on skin for 6 hours before showering or bathing.

Released: July 2021

Nursing Drug Handbook

© 2021 Wolters Kluwer

New Drug Indications Archive


New Drug Indications - July 2021
dapagliflozinFarxigaPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGETo reduce the risk of sustained eGFR decline, end-stage renal disease (ESRD), CV death, and hospitalization for heart failure in patients with chronic kidney disease at risk for progressionAdults: 10 mg PO once daily.Adjust-a-dose: This drug is not recommended for initiation when eGFR is less than 25 mL/min/1.73 m2; however, patient may continue 10 mg PO once daily to reduce the risk of eGFR decline, ESRD, CV death, and hospitalization for heart failure.CONTRAINDICATIONS & CAUTIONSThis drug is not recommended for treatment of chronic kidney disease in patients with polycystic kidney disease or those with current or recent immunosuppressive therapy for kidney disease.Released: July 2021Nursing Drug Handbook© 2021 Wolters Kluwerdiclofenac potassiumZipsorPharmaceutical company: Assertio Therapeutics, Inc.NEW INDICATION & DOSAGEMild to moderate acute pain (Zipsor)Adults and children age 12 and older: 25 mg PO q.i.d.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwernivolumabOpdivoPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEAdjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapyAdults: 240-mg IV infusion every 2 weeks, or 480-mg IV infusion every 4 weeks, until disease progression or unacceptable toxicity occurs, or up to 1 year of treatment.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: Merck Sharp & DohmeNEW INDICATION & DOSAGEFirst-line treatment in patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapyAdults: 200-mg IV infusion over 30 minutes every 3 weeks, or 400-mg IV infusion over 30 minutes every 6 weeks prior to trastuzumab and chemotherapy when given on the same day. Continue until disease progression or unacceptable toxicity occurs, or up to 24 months in those without disease progression.Monotherapy treatment in patients with locally recurrent advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapyAdults: 200-mg IV infusion over 30 minutes every 3 weeks, or 400-mg IV infusion over 30 minutes every 6 weeks until disease progression or unacceptable toxicity occurs, or up to 24 months in those without disease progression.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwerspinosadNatrobaPharmaceutical company: ParaPRONEW INDICATION & DOSAGEScabies infestationAdults and children age 4 and older: Apply to skin to completely cover body from the neck to soles of feet. Patients with balding scalp should also apply to scalp, hairline, temples, and forehead. Allow skin to dry for 10 minutes before getting dressed. Leave on skin for 6 hours before showering or bathing.Released: July 2021Nursing Drug Handbook© 2021 Wolters Kluwer
New Drug Indications - June 2021
alirocumabPraluentPharmaceutical company: RegeneronNEW INDICATION & DOSAGEAdjunct to other LDL cholesterol (LDL-C)-lowering therapies in patients with homozygous familial hypercholesterolemia to reduce LDL-CAdults: 150 mg subcut every 2 weeks.Released: June 2021© 2021 Wolters KluwercetuximabErbituxPharmaceutical company: LillyNEW INDICATION & DOSAGESquamous cell carcinoma of the head and neck, as a single agent or in combination with platinum-based therapy and fluorouracilAdults: 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 irinotecanAdults: 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 Kluwerdaunorubicin and cytarabine liposomeVyxeosPharmaceutical company: Jazz PharmaceuticalsNEW INDICATION & DOSAGENewly diagnosed, therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changesChildren 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/m2 daunorubicin/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 KluwerdiazepamDiastatPharmaceutical company: Bausch HealthNEW INDICATION & DOSAGEAcute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) that are distinct from patient's usual seizure patternAdults 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 KluwernivolumabOpdivoPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEAdvanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapyAdults: 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 KluwertreprostinilTyvasoPharmaceutical company: United Therapeutics Corp.NEW INDICATION & DOSAGEPulmonary arterial hypertension associated with interstitial lung disease in patients (WHO group 3) to improve exercise abilityAdults: 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 KluwervalsartanDiovanPharmaceutical company: NovartisNEW INDICATION & DOSAGEHypertensionChildren 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
New Drug Indications - May 2021
adalimumabHumiraPharmaceutical company: AbbVieNEW INDICATION & DOSAGEModerately to severely active ulcerative colitisChildren age 5 and older weighing 40 kg or more: Initially, 160 mg subcut on day 1, given in 1 day or split over 2 consecutive days; then 80 mg on days 8 and 15, followed by a maintenance dose of 80 mg every other week or 40 mg every week starting at week 4 (day 29).Children age 5 and older weighing from 20 to less than 40 kg: Initially, 80 mg subcut on day 1, followed by 40 mg on days 8 and 15, followed by a maintenance dose of 40 mg every other week or 20 mg every week starting at week 4 (day 29).Released: May 2021© 2021 Wolters KluweraxicabtageneYescartaPharmaceutical company: Kite Pharma NEW INDICATION & DOSAGERelapsed or refractory follicular lymphoma after two or more lines of systemic therapyAdults: 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).Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: May 2021© 2021 Wolters KluwermirabegronMyrbetriq; Myrbetriq GranulesPharmaceutical company: Astellas Pharma, Inc. NEW INDICATION & DOSAGENeurogenic detrusor overactivityChildren age 3 and older weighing 35 kg or more (extended-release tablets): 25 mg PO once daily. After 4 to 8 weeks, may increase to maximum dose of 50 mg once daily.Children age 3 and older weighing 35 kg or more (extended-release granules): Initially, 6 mL (48 mg) PO once daily. After 4 to 8 weeks, may increase to maximum dose, 10 mL (80 mg) once daily.Children age 3 and older weighing 22 to less than 35 kg (extended-release granules): Initially, 4 mL (32 mg) PO once daily. After 4 to 8 weeks, may increase to maximum dose, 8 mL (64 mg) once daily.Children age 3 and older weighing 11 to less than 22 kg (extended-release granules): Initially, 3 mL (24 mg) PO once daily. After 4 to 8 weeks, may increase to maximum dose, 6 mL (48 mg) once daily.Released: May 2021© 2021 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: Merck Sharp & Dohme Corp. NEW INDICATION & DOSAGELocally advanced or metastatic esophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapyAdults: 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks until disease progression or unacceptable toxicity occurs, or up to 24 months. Give pembrolizumab before chemotherapy when given on the same day.Locally advanced or metastatic esophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive chemoradiation as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 as determined by an FDA-approved testAdults: 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks until disease progression or unacceptable toxicity occurs, or up to 24 months.Released: May 2021© 2021 Wolters KluwertocilizumabActemraPharmaceutical company: Genentech NEW INDICATION & DOSAGESlowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung diseaseAdults: 162 mg subcut once every week.Released: May 2021© 2021 Wolters Kluwer