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New Drug Indications - April 2024

irinotecan liposome

Onivyde

Pharmaceutical company: Ipsen Biopharmaceuticals
 

NEW INDICATION & DOSAGE
Metastatic pancreatic adenocarcinoma, as first-line treatment in combination with oxaliplatin, fluorouracil (5-FU), and leucovorin

Adults: 50 mg/m2 IV infusion every 2 weeks. Premedicate with a corticosteroid and an antiemetic 30 minutes before infusion. Administer the drug before oxaliplatin, leucovorin, and 5-FU.

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

Released: April 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

ceftazidime—avibactam sodium

Avycaz

Pharmaceutical company: AbbVie
 

NEW INDICATION & DOSAGE

Complicated intra-abdominal infections caused by susceptible microorganisms, used in combination with metronidazole
Infants age 29 days to younger than 3 months: 37.5 mg/kg IV every 8 hours for 5 to 14 days.
Infants age 28 days or younger (gestational age 31 weeks and older): 25 mg/kg IV every 8 hours for 5 to 14 days.

Complicated UTI, including pyelonephritis, caused by susceptible microorganisms
Infants age 29 days to younger than 3 months: 37.5 mg/kg IV every 8 hours for 7 to 14 days.
Infants age 28 days or younger (gestational age 31 weeks and older): 25 mg/kg IV every 8 hours for 7 to 14 days.

Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible microorganisms
Infants age 29 days to younger than 3 months: 37.5 mg/kg IV every 8 hours for 7 to 14 days.
Infants age 28 days or younger (gestational age 31 weeks and older): 25 mg/kg IV every 8 hours for 7 to 14 days.

Released: April 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

omalizumab

Xolair

Pharmaceutical company: Genentech and Novartis
 

NEW INDICATION & DOSAGE
Reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in patients with IgE-mediated food allergy

Adults and children age 1 year and older: 75 to 600 mg subcut every 2 or 4 weeks. Dose and frequency vary with pretreatment IgE level (international units/mL) and patient weight. (Refer to the manufacturer's instructions). To be used in conjunction with food allergen avoidance.

Alert:  Not indicated for emergency treatment of allergic reactions.

Released: April 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

osimertinib

Tagrisso

Pharmaceutical company: AstraZeneca
 

NEW INDICATION & DOSAGE
First-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer (in combination with pemetrexed and platinum-based chemotherapy) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations

Adults: 80 mg PO once daily until disease progression or unacceptable toxicity occurs due to osimertinib.
 

Released: April 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

New Drug Indications Archive

New Drug Indications - October 2022
baloxavir marboxilXofluzaPharmaceutical company: GenentechNEW INDICATION & DOSAGETreatment of acute, uncomplicated influenza in patients who have been symptomatic for no more than 48 hours, who are otherwise healthyChildren age 5 and older weighing 80 kg or more: 80 mg PO as a single dose.Children age 5 and older weighing 20 to less than 80 kg: 40 mg PO as a single dose.Postexposure influenza prophylaxisChildren age 5 and older weighing 80 kg or more: 80 mg PO as a single dose.Children age 5 and older weighing 20 to less than 80 kg: 40 mg PO as a single dose.Children age 5 and older weighing less than 20 kg: 2 mg/kg PO as a single dose.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer  belimumabBenlystaPharmaceutical company: GlaxoSmithKlineNEW INDICATION & DOSAGEActive lupus nephritis in patients who are receiving standard therapyChildren age 5 and older: 10 mg/kg IV infusion every 2 weeks for first three doses, then every 4 weeks thereafter.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer  ibrutinibImbruvicaPharmaceutical company: Pharmacyclics and Janssen BiotechNEW INDICATION & DOSAGEChronic graft-versus-host disease (GVHD) after failure of one or more lines of systemic therapyChildren age 12 and older: 420 mg PO once daily until GVHD progresses, underlying malignancy recurs, unacceptable toxicity occurs, or patient no longer requires treatment.Children age 1 to less than 12 years: 240 mg/m2 PO once daily (maximum dose 420 mg) until GVHD progresses, underlying malignancy recurs, unacceptable toxicity occurs, or patient no longer requires treatment.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer  relugolix–estradiol–norethindrone acetateMyfembreePharmaceutical company: Myovant Sciences NEW INDICATION & DOSAGEManagement of moderate to severe pain associated with endometriosisAdults: 1 tablet PO daily for up to 24 months.Adjust-a-dose: If use with oral P-glycoprotein inhibitors can’t be avoided, give relugolix–estradiol–norethindrone acetate first, and separate dosing by at least 6 hours.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer  ustekinumabStelaraPharmaceutical company: Janssen BiotechNEW INDICATION & DOSAGEAcute psoriatic arthritisChildren ages 6 to 17 weighing more than 100 kg with coexistent moderate-to-severe plaque psoriasis: Initially, 90 mg subcut; repeat dose in 4 weeks, followed by maintenance dose of 90 mg subcut every 12 weeks.Children ages 6 to 17 weighing 60 kg or more: Initially, 45 mg subcut; repeat dose in 4 weeks, followed by maintenance dose of 45 mg subcut every 12 weeks.Children ages 6 to 17 weighing less than 60 kg: Initially, 0.75 mg/kg subcut; repeat dose in 4 weeks, followed by maintenance dose of 0.75 mg/kg subcut every 12 weeks.Released: October 2022Nursing Drug Handbook© 2022 Wolters Kluwer 
New Drug Indications - September 2022
crizotinibXalkoriPharmaceutical company: PfizerNEW INDICATION & DOSAGEUnresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumorAdults: 250 mg PO b.i.d.Adjust-a-dose: For creatinine clearance less than 30 mL/minute (not requiring dialysis), give 250 mg once daily. For preexisting moderate hepatic impairment, give 200 mg b.i.d. For preexisting severe hepatic impairment, give 250 mg once daily. For unavoidable concomitant use with strong CYP3A inhibitors, decrease crizotinib to 250 mg once daily. Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Children age 1 and older: 280 mg/m2 PO b.i.d.Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments, dosage adjustments for renal or hepatic impairment, and for concomitant use of strong CYP3A inhibitors.Released: September 2022Nursing Drug Handbook© 2022 Wolters Kluwer phentermine and topiramateQsymiaPharmaceutical company: Vivus LLCNEW INDICATION & DOSAGEChronic weight management, as an adjunct to diet and increased physical activity in children with BMI in the 95th percentile or more standardized for age and sexChildren age 12 and older: Initially, 3.75 mg phentermine/23 mg topiramate PO every morning for 14 days; then increase to 7.5 mg phentermine/46 mg topiramate every morning. Evaluate weight loss after 12 weeks of therapy. If the child hasn't lost at least 3% of baseline BMI, escalate dose to 11.25 mg phentermine/69 mg topiramate every morning for 14 days, followed by 15 mg phentermine/92 mg topiramate every morning. Evaluate BMI 12 weeks after dose escalation. If the patient hasn't lost at least 5% of baseline BMI, discontinue the drug by decreasing the dose to every other day for at least 1 week before stopping therapy altogether.Adjust-a-dose: If the child's weight loss exceeds 0.9 kg/week, consider dose reduction. For patients with moderate renal impairment (creatinine clearance of 30 to less than 50 mL/minute), severe renal impairment (creatinine clearance less than 30 mL/minute), or moderate hepatic impairment (Child-Pugh class B), don't exceed 7.5 mg phentermine/46 mg topiramate once daily.Released: September 2022Nursing Drug Handbook© 2022 Wolters Kluwer stiripentolDiacomitPharmaceutical company: BiocodexNEW INDICATION & DOSAGESeizures associated with Dravet syndrome in patients taking clobazamChildren age 1 and older weighing 10 kg or more: 25 mg/kg PO b.i.d. or 16.67 mg/kg PO t.i.d.Children age 1 and older weighing 7 to less than 10 kg: 25 mg/kg PO b.i.d.Children age 6 months to younger than age 1 weighing 7 kg or more: 25 mg/kg PO b.i.d.Adjust-a-dose: If exact dosage can't be achieved with the available strengths, round to the nearest dosage, which is usually within 50 to 150 mg of the recommended 50 mg/kg/day. Maximum dose, 3,000 mg/day. If somnolence occurs, consider reducing clobazam dosage by 25%. If somnolence persists, consider decreasing clobazam dosage by an additional 25%. Consider adjusting the dosage of other concomitant anticonvulsants with sedating properties.Released: September 2022Nursing Drug Handbook© 2022 Wolters Kluwer 
New Drug Indications - August 2022
brexanoloneZulressoPharmaceutical company: Sage TherapeuticsNEW INDICATION & DOSAGEPostpartum depressionWomen 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 2022Nursing Drug Handbook© 2022 Wolters Kluwer brolucizumab-dbllBeovuPharmaceutical company: NovartisNEW INDICATION & DOSAGEDiabetic macular edemaAdults: 6-mg intravitreal injection every 6 weeks (every 39 to 45 days) for five doses, then every 8 to 12 weeks thereafter.Released: August 2022Nursing Drug Handbook© 2022 Wolters Kluwer dabrafenib mesylateTafinlarPharmaceutical company: NovartisNEW INDICATION & DOSAGEUnresectable 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 trametinibAdults 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 2022Nursing Drug Handbook© 2022 Wolters Kluwer dupilumabDupixentPharmaceutical company: RegeneronNEW INDICATION & DOSAGEModerate-to-severe atopic dermatitis not adequately controlled with topical therapy or when those therapies aren't advisableChildren 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 2022Nursing Drug Handbook© 2022 Wolters Kluwer ipilimumabYervoyPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEUnresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with nivolumabAdults: 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 2022Nursing Drug Handbook© 2022 Wolters Kluwer ivosidenibTibsovoPharmaceutical company: Servier PharmaceuticalsNEW INDICATION & DOSAGENewly 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 azacitidineAdults 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 2022Nursing Drug Handbook© 2022 Wolters Kluwer nivolumabOpdivoPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEUnresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapyAdults: 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 ipilimumabAdults: 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 2022Nursing Drug Handbook© 2022 Wolters Kluwer risankizumab-rzaaSkyriziPharmaceutical company: AbbVieNEW FORMInjection (IV): 600 mg/10 mL single-dose vialINDICATION & DOSAGEModerate to severe Crohn diseaseAdults: 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 2022Nursing Drug Handbook© 2022 Wolters Kluwer tisagenlecleucelKymriahPharmaceutical company: NovartisINDICATION & DOSAGERelapsed or refractory follicular lymphoma after two or more lines of systemic therapyAdults: 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 2022Nursing Drug Handbook© 2022 Wolters Kluwer trametinibMekinistPharmaceutical company: NovartisINDICATION & DOSAGEUnresectable 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 dabrafenibAdults 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 2022Nursing Drug Handbook© 2022 Wolters Kluwer 
New Drug Indications - July 2022
azacitidineVidazaPharmaceutical company: Bristol Myers SquibbNEW INDICATION & DOSAGENewly 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 2022Nursing Drug Handbook© 2022 Wolters KluwerdupilumabDupixentPharmaceutical company: Regeneron PharmaceuticalsNEW INDICATION & DOSAGEEosinophilic esophagitisAdults and children age 12 and older weighing at least 40 kg: 300 mg subcut once a week.Released: July 2022Nursing Drug Handbook© 2022 Wolters KluweredaravoneRadicava ORSPharmaceutical company: Mitsubishi Tanabe Pharma AmericaNEW FORMOral suspension: 105 mg/5 mL.NEW INDICATION & DOSAGEAmyotrophic lateral sclerosisAdults: 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 2022Nursing Drug Handbook© 2022 Wolters Kluwerravulizumab-cwvzUltomirisPharmaceutical company: Alexion PharmaceuticalsINDICATION & DOSAGEGeneralized myasthenia gravis in patients who are anti-acetylcholine receptor antibody-positiveAdults 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 2022Nursing Drug Handbook© 2022 Wolters KluwerremdesivirVekluryPharmaceutical company: Gilead Sciences, Inc.INDICATION & DOSAGETreatment of nonhospitalized patients with mild-to-moderate coronavirus disease 2019 (COVID-19) at high risk for progression to severe COVID-19, including hospitalization or deathChildren 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 hospitalizationChildren 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.ADMINISTRATIONAlert: Only remdesivir lyophilized powder form is approved for use in children weighing less than 40 kg.Released: July 2022Nursing Drug Handbook© 2022 Wolters KluwerupadacitinibRinvoqPharmaceutical company: AbbVieINDICATION & DOSAGEAnkylosing spondylitis in patients who have had an inadequate response or intolerance to one of more tumor necrosis factor blockersAdults: 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 2022Nursing Drug Handbook© 2022 Wolters KluwerviloxazineQelbreePharmaceutical company: Supernus PharmaceuticalsINDICATION & DOSAGEAttention deficit hyperactivity disorderAdults: 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 2022Nursing Drug Handbook© 2022 Wolters Kluwer
New Drug Indications - June 2022
alpelisibVijoicePharmaceutical company: NovartisNEW INDICATION & DOSAGESevere manifestations of PIK3CA-related overgrowth spectrum requiring systemic therapy Adults: 250 mg PO once daily until disease progression or unacceptable toxicity occurs.Children ages 6 to less than 18: Initially, 50 mg PO once daily. May increase after 24 weeks to 125 mg for response optimization. Continue until disease progression or unacceptable toxicity occurs.Children ages 2 to less than 6: 50 mg PO once daily until disease progression or unacceptable toxicity occurs.Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: June 2022Nursing Drug Handbook© 2022 Wolters Kluweraxicabtagene ciloleucelYescartaPharmaceutical company: Kite Pharma, Inc.NEW INDICATION & DOSAGELarge B-cell lymphoma that is refractory to or relapses within 12 months of first-line chemoimmunotherapyAdults: 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).Released: June 2022Nursing Drug Handbook© 2022 Wolters Kluwerceftolozane and tazobactamZerbaxaPharmaceutical company: Merck & Co.NEW INDICATION & DOSAGEComplicated intra-abdominal infections caused by Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, K. pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, S. constellatus, or S. salivarius treated concurrently with metronidazoleBirth to less than age 18: 30 mg/kg (up to maximum 1.5 g) IV every 8 hours for 5 to 14 days.Adjust-a-dose: Use isn't recommended in children with eGFR 50 mL/min/1.73 m2 or less.Complicated UTIs, including pyelonephritis, caused by Escherichia coli, K. pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosaBirth to less than age 18: 30 mg/kg (up to maximum 1.5 g) IV every 8 hours for 7 to 14 days.Adjust-a-dose: Use isn't recommended in children with eGFR 50 mL/min/1.73 m2 or less.Released: June 2022Nursing Drug Handbook© 2022 Wolters Kluwerdexmedetomidine hydrochlorideIgalmiPharmaceutical company: Bioxcel TherapeuticsNEW FORMSublingual film: 120 mcg, 180 mcgINDICATION & DOSAGEAcute treatment of agitation associated with schizophrenia or bipolar I or II disorderAdults: 120 mcg sublingually or buccally for mild or moderate, agitation; if agitation persists, may give up to two additional 60-mcg doses at least 2 hours apart. Or 180 mcg sublingually or buccally for severe agitation; if agitation persists, may give up to two additional 90-mcg doses at least 2 hours apart.Adults age 65 or older: 120 mcg sublingually or buccally for mild, moderate, or severe agitation; if agitation persists, may give up to two additional 60-mcg doses at least 2 hours apart.Adjust-a-dose: If mild or moderate hepatic impairment, give 90 mcg for mild or moderate agitation or 120 mcg for severe agitation. If severe hepatic impairment, give 60 mcg for mild or moderate agitation, or 90 mcg for severe agitation. If agitation persists in patients with hepatic impairment, may give up to two additional 60-mcg doses at least 2 hours apart. If systolic blood pressure (SBP) is less than 90 mm Hg, diastolic blood pressure (DBP) is less than 60 mm Hg, heart rate is less than 60 beats per minute or postural decrease in SBP is more than 20 mm Hg or DBP is more than 10 mm Hg after prior dose, don't repeat dose.Released: June 2022Nursing Drug Handbook© 2022 Wolters Kluwerfluticasone propionateArmonAir DigihalerPharmaceutical company: Teva RespiratoryNEW FORMOral inhalation powder: 30 mcg, 55 mcg, 113 mcg, 232 mcgINDICATION & DOSAGEAs preventive maintenance of chronic asthma in patients requiring oral corticosteroids (ArmonAir Digihaler)Adults and children age 12 and older not on an inhaled corticosteroid: 55 mcg by oral inhalation b.i.d. Patients with greater asthma severity may use 113 mcg or 232 mcg by oral inhalation b.i.d. Maximum dose is 232 mcg b.i.d.Adults and children age 12 and older previously taking inhaled corticosteroids: 55 mcg, 113 mcg, or 232 mcg by oral inhalation b.i.d. based on asthma severity and strength of prior therapy. Maximum dose is 232 mcg b.i.d.Children ages 4 to 11 not on an inhaled corticosteroid: 30 mcg by oral inhalation b.i.d. After 2 weeks, may increase dose to 55 mcg b.i.d.Children ages 4 to 11 previously taking inhaled corticosteroids: 30 mcg or 55 mcg by oral inhalation b.i.d. based on asthma severity and strength of prior therapy. Doses above 55 mcg b.i.d. haven't been established in children ages 4 to 11.Adjust-a-dose: For patients who don't respond adequately to starting dose after 2 weeks of therapy, an increased dose may improve control.Released: June 2022Nursing Drug Handbook© 2022 Wolters KluwerrilpivirineEdurantPharmaceutical company: Janssen ProductsINDICATION & DOSAGEIn combination with cabotegravir for short-term treatment of HIV-1 infection in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen as an oral lead-in to assess tolerability of rilpivirine before use of cabotegravir and rilpivirine (Cabenuva) extended-release injectable suspensionsAdolescents age 12 and older weighing 35 kg or more: 25 mg PO once daily in combination with cabotegravir 30 mg PO once daily. Use oral lead-in dose for at least 28 days.In combination with cabotegravir for short-term treatment of HIV-1 infection in patients with HIV-1 RNA less than 50 copies/mL who are on a stable oral therapy regimen but who will miss scheduled injections with cabotegravir and rilpivirine (Cabenuva) extended-release injectable suspensions by more than 7 days to up to 2 consecutive monthsAdolescents age 12 and older and weighing 35 kg or more: 25 mg PO once daily in combination with cabotegravir 30 mg PO once daily starting about 1 month after the last injection and continuing until the day injection dosing is restarted. Refer to the Cabenuva prescribing information for dosing instructions.Adjust-a-dose: For oral therapy with rilpivirine and cabotegravir of durations greater than 2 months, an alternative oral regimen is recommended, which may include rilpivirine.Released: June 2022Nursing Drug Handbook© 2022 Wolters Kluwer
New Drug Indications - May 2022
nivolumabOpdivoPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGENeoadjuvant treatment of resectable non–small-cell lung cancer (tumors of at least 4 cm or node-positive) in combination with platinum-doublet chemotherapyAdults: 360-mg IV infusion followed by platinum-doublet chemotherapy on the same day every 3 weeks for 3 cycles.Released: May 2022Nursing Drug Handbook© 2022 Wolters KluwersirolimusHyftorPharmaceutical company: Nobelpharma AmericaNEW FORMTopical gel:2 mg/gINDICATION & DOSAGEFacial angiofibroma associated with tuberous sclerosisAdults and children age 12 and older: Apply to facial skin b.i.d. Maximum dose, 800 mg (2.5 cm).Children ages 6 to 11: Apply to facial skin b.i.d. Maximum dose, 600 mg (2 cm).Adjust-a-dose: Reevaluate need for the drug if symptoms don’t improve within 12 weeks of treatment.Released: May 2022Nursing Drug Handbook© 2022 Wolters KluwerupadacitinibRinvoqPharmaceutical company: AbbVieNEW INDICATION & DOSAGEModerate to severe active ulcerative colitis after inadequate response or intolerance to one or more TNF blockersAdults: 45 mg PO once daily for 8 weeks, followed by a maintenance dose of 15 mg once daily. May increase maintenance dose to 30 mg once daily for patients with refractory, severe, or extensive disease. If patient response to 30-mg dose is inadequate, discontinue the drug. Use the lowest effective dose needed to maintain response.Adjust-a-dose: If the patient has severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2), mild to moderate hepatic impairment (Child-Pugh class A or B), or is taking a strong CYP3A4 inhibitor, give induction dose, 30 mg once daily for 8 weeks; then maintenance dose, 15 mg once daily.Released: May 2022Nursing Drug Handbook© 2022 Wolters Kluwer 
New Drug Indications - April 2022
remdesivirVekluryPharmaceutical company: Gilead Sciences, Inc.NEW INDICATION & DOSAGETreatment of non-hospitalized patients with mild-to-moderate coronavirus disease 2019 (COVID-19) at high risk for progression to severe COVID-19, including hospitalization or deathAdults and children age 12 and older, weighing 40 kg or more: Initiate therapy as soon as possible after diagnosis and within 7 days of symptom onset with 200-mg IV infusion on day 1, followed by 100-mg IV infusion once daily on days 2 and 3.Adjust-a-dose:Consider discontinuing the drug if ALT level increases to greater than 10 × the upper limit of normal. Discontinue if ALT elevation is accompanied by signs or symptoms of liver inflammation.Released: April 2022Nursing Drug Handbook© 2022 Wolters Kluwer  risankizumab-rzaaSkyriziPharmaceutical company: AbbVie Inc.NEW INDICATION & DOSAGEActive psoriatic arthritisAdults: 150 mg (two 75-mg injections) subcut at week 0, week 4, and every 12 weeks thereafter, alone or in combination with nonbiologic disease-modifying antirheumatic drugs.Released: April 2022Nursing Drug Handbook© 2022 Wolters Kluwer  secnidazoleSolosecPharmaceutical company: Lupin Pharmaceuticals, Inc.NEW INDICATION & DOSAGEBacterial vaginosisFemales age 12 and older: One single dose of 2 g PO.TrichomoniasisChildren age 12 and older: One single dose of 2 g PO. Treat sexual partners with same dose at same time.Released: April 2022Nursing Drug Handbook© 2022 Wolters Kluwer
New Drug Indications - March 2022
brexpiprazoleRexultiPharmaceutical company: Otsuka America PharmaceuticalsNEW INDICATION & DOSAGESchizophreniaChildren 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 2022Nursing Drug Handbook© 2022 Wolters Kluweremtricitabine and tenofovir alafenamideDescovyPharmaceutical company: Gilead SciencesNEW AVAILABLE FORMTablets: 120 mg emtricitabine and 15 mg tenofovir alafenamideNEW INDICATION & DOSAGEHIV-1 infection in combination with other antiretrovirals other than protease inhibitors that require a CYP3A inhibitorChildren 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 2022Nursing Drug Handbook© 2022 Wolters KluwerglycopyrrolateDartisla ODTPharmaceutical company: Edenbridge PharmaNEW AVAILABLE FORMTablets (ODT [orally disintegrating tablets]): 1.7 mgNEW INDICATION & DOSAGEAdjunct 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 2022Nursing Drug Handbook© 2022 Wolters KluwerlumateperoneCaplytaPharmaceutical company: Intra-Cellular TherapiesNEW INDICATION & DOSAGEDepressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy or as adjunctive therapy with lithium or valproateAdults: 42 mg PO once daily.Released: March 2022Nursing Drug Handbook© 2022 Wolters KluwerribociclibKisqaliPharmaceutical company: NovartisNEW INDICATION & DOSAGEHormone 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 menMen: 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 2022Nursing Drug Handbook© 2022 Wolters KluwerrivaroxabanXareltoPharmaceutical company: Janssen PharmaceuticalsNEW FORMULATIONGranules for oral suspension: 1 mg/mL after reconstitutionINDICATIONS & DOSAGEVenous thromboembolism and reduction of risk of recurrent venous thromboembolism after at least 5 days of initial parenteral anticoagulant therapyChildren 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 procedureChildren 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 2022Nursing Drug Handbook© 2022 Wolters KluwersecukinumabCosentyxPharmaceutical company: NovartisNEW INDICATION & DOSAGEActive psoriatic arthritisChildren 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 arthritisChildren 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 2022Nursing Drug Handbook© 2022 Wolters KluwerupadacitinibRinvoqPharmaceutical company: AbbVie Inc.NEW INDICATION & DOSAGEPsoriatic arthritis in patients with inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockersAdults: 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 inadvisableAdults 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 2022Nursing Drug Handbook© 2022 Wolters KluwervoxelotorOxbrytaPharmaceutical company: Global Blood TherapeuticsNEW AVAILABLE FORMTablet for suspension: 300 mgINDICATION & DOSAGESickle cell diseaseChildren 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 2022Nursing Drug Handbook© 2022 Wolters Kluwer
New Drug Indications - February 2022
abataceptOrenciaPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEProphylaxis of acute graft-versus-host disease, in combination with a calcineurin inhibitor and methotrexate, in patients undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donorAdults and children age 6 and older: 10 mg/kg dose (maximum dose 1,000 mg) IV infusion over 60 minutes on the day before transplantation, followed by a dose on days 5, 14, and 28 after transplant.Children ages 2 to less than 6: 15 mg/kg dose IV infusion over 60 minutes on the day before transplantation, followed by 12 mg/kg on days 5, 14, and 28 after transplant.Released: February 2022Nursing Drug Handbook© 2022 Wolters KluwerbudesonideTarpeyoPharmaceutical company: Calliditas TherapeuticsNEW AVAILABLE FORMDelayed-release capsules: 4 mgINDICATION & DOSAGEProteinuria in patients with primary immunoglobulin A nephropathy at risk for rapid disease progressionAdults: 16 mg PO daily in the morning at least 1 hour before a meal.Adjust-a-dose: Reduce dose to 8 mg daily for 2 weeks before discontinuing the drug.Released: February 2022Nursing Drug Handbook© 2022 Wolters KluwercarfilzomibKyprolisPharmaceutical company: Amgen, Inc.NEW INDICATION & DOSAGERelapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj and dexamethasone after one to three prior lines of therapyAdults: For twice-weekly 20/56 mg/m2 regimen, give as a 30-minute IV infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle in combination with subcut daratumumab and hyaluronidase-fihj, and dexamethasone until disease progression or unacceptable toxicity occurs. Initially, give 20 mg/m2 on cycle 1, days 1 and 2. If tolerated, escalate to 56 mg/m2 on cycle 1, day 8 and thereafter. Give dexamethasone 30 minutes to 4 hours before carfilzomib and 1 to 3 hours before IV daratumumab and hyaluronidase-fihj.For once-weekly 20/70 mg/m2 regimen, give as a 30-minute IV infusion on days 1, 8, and 15 of each 28-day cycle in combination with subcut daratumumab and hyaluronidase-fihj, and dexamethasone until disease progression or unacceptable toxicity occurs. Initially, give 20 mg/m2 on cycle 1, day 1. If tolerated, escalate to 70 mg/m2 on cycle 1, day 8 and thereafter. Give dexamethasone 30 minutes to 4 hours before carfilzomib and 1 to 3 hours before IV daratumumab and hyaluronidase-fihj.Adjust-a-dose: Refer to the manufacturer's instructions for daratumumab and hyaluronidase-fihj for dosage information.Released: February 2022Nursing Drug Handbook© 2022 Wolters Kluwerclindamycin phosphateXaciatoPharmaceutical company: Daré BiosciencesNEW FORMULATIONGel: 2%INDICATION & DOSAGEBacterial vaginosisAdults and children age 12 and older: 1 applicatorful vaginally as a single dose.Released: February 2022Nursing Drug Handbook© 2022 Wolters Kluwerelbasvir–grazoprevirZepatierPharmaceutical company: Merck Sharp & Dohme CorpNEW INDICATION & DOSAGEChronic hepatitis C virus (HCV) genotypes 1 or 4 infection, with or without ribavirinChildren age 12 and older or weighing at least 30 kg: 1 tablet PO once daily. See manufacturer's instructions for recommended dosing regimens and durations for treatment of HCV genotype 1 or 4 in patients with or without cirrhosis.Adjust-a-dose: If ALT level is greater than 10 times the upper limit of normal, consider discontinuing the drug. If ALT level is elevated and accompanied by signs or symptoms of liver inflammation, increased conjugated bilirubin or alkaline phophatase level, or increased INR, discontinue the drug. If creatinine clearance is 50 mL/minute or less and ribavirin is used, refer to ribavirin prescribing information for ribavirin dose adjustment.Released: February 2022Nursing Drug Handbook© 2022 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: Merck & Co.NEW INDICATION & DOSAGEAdjuvant treatment of melanoma with lymph node involvement after complete resectionChildren age 12 and older: 2 mg/kg IV over 30 minutes every 3 weeks up to maximum dose of 200 mg. Continue until disease recurrence or unacceptable toxicity occurs, or up to 12 months in patients without disease recurrence.Released: February 2022Nursing Drug Handbook© 2022 Wolters KluwerrituximabRituxanPharmaceutical company: GenentechNEW INDICATION & DOSAGEPreviously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia in combination with chemotherapyChildren age 6 months and older: 375 mg/m2 IV infusion in combination with systemic Lymphome Malin B chemotherapy. Give the drug on day 2 and day 1 (48 hours apart) of each of the induction courses, and on day 1 of each of the two consolidation courses. Give prednisone component of regimen before rituximab. Refer to the manufacturer's instructions for additional dosing information.Released: February 2022Nursing Drug Handbook© 2022 Wolters KluwertofacitinibXeljanz and Xeljanz XRPharmaceutical company: PfizerNEW INDICATION & DOSAGEAnkylosing spondylitis after inadequate response or intolerance to one or more tumor necrosis factor blockersAdults: 5 mg (immediate-release) PO twice daily. Or, 11 mg (extended-release) PO once daily.Adjust-a-dose: Reduce dosage to 5 mg (immediate-release) PO daily in patients with moderate to severe renal impairment or moderate hepatic impairment in those receiving concurrent potent CYP3A4 inhibitors, and in those receiving a moderate CYP3A4 inhibitor with a strong CYP2C19 inhibitor.Released: February 2022Nursing Drug Handbook© 2022 Wolters Kluwer
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