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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 - April 2024
irinotecan liposome Onivyde Pharmaceutical company: Ipsen Biopharmaceuticals  NEW INDICATION & DOSAGEMetastatic pancreatic adenocarcinoma, as first-line treatment in combination with oxaliplatin, fluorouracil (5-FU), and leucovorinAdults: 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 2024Nursing Drug Handbook© 2024 Wolters Kluwerceftazidime—avibactam sodiumAvycazPharmaceutical company: AbbVie  NEW INDICATION & DOSAGEComplicated intra-abdominal infections caused by susceptible microorganisms, used in combination with metronidazoleInfants 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 microorganismsInfants 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 microorganismsInfants 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 2024Nursing Drug Handbook© 2024 Wolters Kluweromalizumab Xolair Pharmaceutical company: Genentech and Novartis  NEW INDICATION & DOSAGEReduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in patients with IgE-mediated food allergyAdults 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 2024Nursing Drug Handbook© 2024 Wolters Kluwerosimertinib Tagrisso Pharmaceutical company: AstraZeneca  NEW INDICATION & DOSAGEFirst-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 mutationsAdults: 80 mg PO once daily until disease progression or unacceptable toxicity occurs due to osimertinib.  Released: April 2024Nursing Drug Handbook© 2024 Wolters Kluwer
New Drug Indications - March 2024
pembrolizumab Keytruda Pharmaceutical company: Merck  NEW INDICATION & DOSAGEInternational Federation of Gynecology and Obstetrics 2014 stage III to IVA cervical cancer in combination with chemoradiotherapyAdults: 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 in patients without disease progression. Give before chemoradiotherapy when given on the same day.Released: March 2024Nursing Drug Handbook© 2024 Wolters KluwerdupilumabDupixentPharmaceutical company: Sanofi and Regeneron Pharmaceuticals  NEW INDICATION & DOSAGEEosinophilic esophagitisChildren age 1 and older weighing at least 40 kg: 300 mg subcut once a week.Children age 1 and older weighing 30 to less than 40 kg: 300 mg subcut every other week.Children age 1 and older weighing 15 to less than 30 kg: 200 mg subcut every other week.Released: March 2024Nursing Drug Handbook© 2024 Wolters Kluwer
New Drug Indications - February 2024
isavuconazonium Cresemba Pharmaceutical company: Astellas PharmaNEW FORMULATIONCapsules: 74.5 mg  NEW INDICATION & DOSAGEInvasive aspergillosis; invasive mucormycosisChildren age 6 to younger than 18 weighing 32 kg or more: Loading doses, 372 mg NG or PO (five 74.5-mg capsules) every 8 hours for six doses (48 hours); followed by 372 mg NG or PO once daily, beginning 12 to 24 hours after last loading dose.Children age 6 to younger than 18 weighing 25 to less than 32 kg: Loading doses, 298 mg NG or PO (four 74.5-mg capsules) every 8 hours for six doses (48 hours); followed by 298 mg NG or PO once daily, beginning 12 to 24 hours after last loading dose.Children age 6 to younger than 18 weighing 18 to less than 25 kg: Loading doses, 223.5 mg NG or PO (three 74.5-mg capsules) every 8 hours for six doses (48 hours); followed by 223.5 mg NG or PO once daily, beginning 12 to 24 hours after last loading dose.Children age 6 to younger than 18 weighing 16 to less than 18 kg: Loading doses, 149 mg NG or PO (two 74.5-mg capsules) every 8 hours for six doses (48 hours); followed by 149 mg NG or PO once daily, beginning 12 to 24 hours after last loading dose.Children age 3 to younger than 18 weighing 37 kg or more: Loading doses, 372 mg IV every 8 hours for six doses (48 hours); followed by 372 mg IV once daily, beginning 12 to 24 hours after last loading dose.Children age 3 to younger than 18 weighing less than 37 kg: Loading doses, 10 mg/kg IV every 8 hours for six doses (48 hours); followed by 10 mg/kg IV once daily, beginning 12 to 24 hours after last loading dose.Children age 1 to younger than 3 weighing less than 18 kg: Loading doses, 15 mg/kg IV every 8 hours for six doses (48 hours); followed by 15 mg/kg IV once daily, beginning 12 to 24 hours after last loading dose.Released: February 2024Nursing Drug Handbook© 2024 Wolters KluwerpirtobrutinibJaypircaPharmaceutical company: Eli Lilly and Company  NEW INDICATION & DOSAGEChronic lymphocytic leukemia or small lymphocytic lymphoma in patients who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitorAdults: 200 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. If eGFR range is 15 to 29 mL/minute and the current dose is 200 mg once daily, reduce the dose to 100 mg once daily; otherwise reduce the dose by 50 mg. If the current dose is 50 mg once daily, discontinue the drug. If concomitant use of a strong CYP3A inhibitor can't be avoided, reduce the pirtobrutinib dose by 50 mg. If the current dose is 50 mg once daily, interrupt pirtobrutinib therapy for the duration of the strong CYP3A inhibitor use. After discontinuation of the strong CYP3A inhibitor for five half-lives, the patient may resume the pirtobrutinib dose taken before initiating the inhibitor. If concomitant use with a moderate CYP3A inducer can't be avoided and the current dose of pirtobrutinib is 200 mg once daily, increase the dose to 300 mg. If the current pirtobrutinib dose is 50 mg or 100 mg once daily, increase the dose by 50 mg.Released: February 2024Nursing Drug Handbook© 2024 Wolters Kluwer
New Drug Indications - January 2024
abataceptOrenciaPharmaceutical company: Bristol-Myers Squibb  NEW INDICATION & DOSAGEActive psoriatic arthritisChildren age 2 and older weighing 50 kg or more: 125 mg subcut once weekly without an IV loading dose.Children age 2 and older weighing 25 to less than 50 kg: 87.5 mg subcut once weekly without an IV loading dose.Children age 2 and older weighing 10 to less than 25 kg: 50 mg subcut once weekly without an IV loading dose.Released: January 2024Nursing Drug Handbook© 2024 Wolters KluwerenzalutamideXtandiPharmaceutical company: Astellas Pharma  NEW INDICATION & DOSAGENonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasisAdults: 160 mg PO once daily until disease progression or unacceptable toxicity occurs, with or without a gonadotropin-releasing hormone analog.Adjust-a-dose: Suspend treatment after 36 weeks of therapy if prostate-specific antigen (PSA) is undetectable (less than 2 ng/mL). Restart treatment when PSA has increased to 2 ng/ML or more for patients who had prior radical prostatectomy, or 5 ng/mL or more for patients who had prior primary radiation therapy.Released: January 2024Nursing Drug Handbook© 2024 Wolters Kluwerinfliximab-dyybZymfentraPharmaceutical company: Celltrion, Inc.NEW FORMULATIONSubcut injection: 120 mg/mL prefilled syringe or pen.NEW INDICATION & DOSAGEMaintenance of moderately to severely active ulcerative colitis after initial treatment with IV infliximab productAdults: Patients responding to maintenance therapy with IV infliximab product, give first subcut dose in place of the next scheduled IV infusion. Week 10 and thereafter, give 120 mg subcut once every two weeks.Maintenance of moderately to severely active Crohn disease after initial treatment with IV infliximab productAdults: Patients responding to maintenance therapy with IV infliximab product, give first subcut dose in place of the next scheduled IV infusion. Week 10 and thereafter, give 120 mg subcut once every two weeks.Released: January 2024Nursing Drug Handbook© 2024 Wolters KluwerivosidenibTibsovoPharmaceutical company: Servier PharmaceuticalsNEW INDICATION & DOSAGERelapsed or refractory myelodysplastic syndromesAdults: 500 mg PO once daily. Treat for a minimum of 6 months to allow time for clinical response or until disease progression or unacceptable toxicity occurs.Released: January 2024Nursing Drug Handbook© 2024 Wolters Kluwer  pembrolizumabKeytrudaPharmaceutical company: MerckNEW INDICATION & DOSAGEAdvanced or metastatic biliary tract cancer in combination with gemcitabine and cisplatinAdults 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks until disease progression, unacceptable toxicity occurs, or up to 24 months. Give before chemotherapy when given the same day.First-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemotherapyAdults: 200-mg IV infusion every 3 weeks or 400-mg IV infusion every 6 weeks until disease progression, unacceptable toxicity occurs, or up to 24 months. Give before chemotherapy when given on the same day.Released: January 2024Nursing Drug Handbook© 2024 Wolters KluwersecukinumabCosentyxPharmaceutical company: NovartisNEW INDICATION & DOSAGEModerate to severe hidradenitis suppurativaAdults: 300 mg subcut at weeks 0,1,2,3, and 4; then every 4 weeks thereafter. If inadequate response, may increase to 300 mg every 2 weeks.Released: January 2024Nursing Drug Handbook© 2024 Wolters KluwertirzepatideZepboundPharmaceutical company: Eli Lilly and CompanyNEW INDICATION & DOSAGEAdjunct to a reduced-calorie diet and increased physical activity for chronic weight management in patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (for example, hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease) (Zepbound only)Adults: Initially, 2.5 mg subcut once weekly for 4 weeks, then increase to 5 mg. May increase in 2.5-mg increments after at least 4 weeks at the current dose. The recommended maintenance dosage is 5 mg, 10 mg, or 15 mg once weekly based on response and tolerability.Released: January 2024Nursing Drug Handbook© 2024 Wolters Kluwer
New Drug Indications - December 2023
bosutinibBosulifPharmaceutical company: PfizerNEW FORMULATIONCapsules: 50 mg, 100 mgNEW INDICATION & DOSAGEChronic-phase Philadelphia chromosome–positive (Ph+) chronic myelogenous leukemia (CML) in patients with resistance or intolerance to prior therapyChildren age 1 and older: 100 mg/m2 PO once daily, until disease progression or unacceptable intolerance occurs. If there is insufficient response after 3 months, consider increasing the dose by 50-mg increments up to a maximum of 100 mg above staring dose in children with BSA less than 1.1 m2. Follow adult recommendations to increase the dose in children with BSA of 1.1 m2 or more to a maximum of 600 mg daily.Newly diagnosed chronic-phase Ph+ CMLChildren age 1 and older: 300 mg/m2 PO once daily, until disease progression or unacceptable intolerance occurs. If there is insufficient response after 3 months, consider increasing the dose by 50-mg increments up to a maximum of 100 mg above staring dose in children with BSA less than 1.1 m2. Follow adult recommendations to increase the dose in children with BSA of 1.1 m2 or more to a maximum of 600 mg daily.Released: December 2023Nursing Drug Handbook© 2023 Wolters Kluwerelexacaftor–tezacaftor–ivacaftor and ivacaftorTrikaftaPharmaceutical company: Vertex PharmaceuticalsNEW FORMULATIONOral granules: 80 mg elexacaftor, 40 mg tezacaftor, 60 mg ivacaftor (fixed-dose combination) copackaged with 59.5 mg ivacaftor; 100 mg elexacaftor, 50 mg tezacaftor, 75 mg ivacaftor (fixed-dose combination), copackaged with 75 mg ivacaftorNEW INDICATION & DOSAGECystic fibrosis in patients who have at least one F508del mutation in the CFTR gene or a CFTR gene mutation responsive to elexacaftor–tezacaftor–ivacaftor and ivacaftor based on in vitro dataChildren ages 2 to younger than 6 years weighing 14 kg or more: One packet of oral granules (each containing 100 mg elexacaftor, 50 mg tezacaftor, and 75 mg ivacaftor) PO in the morning, followed by one 75-mg ivacaftor packet of oral granules about 12 hours later.Children ages 2 to younger than 6 years weighing 14 kg or less: One packet of oral granules (each containing 80 mg elexacaftor, 40 mg tezacaftor, and 60 mg ivacaftor) PO in the morning, followed by one 59.5-mg ivacaftor packet of oral granules about 12 hours later.Adjust-a-dose: For patients with Child-Pugh class B liver impairment and those receiving moderate and strong CYP3A inhibitors, refer to the manufacturer's instructions for dosage adjustments.Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwerempagliflozinJardiancePharmaceutical company: Boehringer Ingelheim PharmaceuticalsNEW INDICATION & DOSAGETo reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), kidney failure, CV death, and hospitalization in patients with chronic kidney disease at risk of progressionAdults: 10 mg PO daily in the morning.Adjust-a-dose: Discontinue the drug if eGFR is less than 30 mL/minute/1.73 m2 in patients with diabetes mellitus or an eGFR of less than 20 mL/minute/1.73 m2 in those with heart failure.Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwerentrectinibRozlytrekPharmaceutical company: GenentechNEW FORMULATIONOral pellets: 50 mg/packetNEW INDICATION & DOSAGESolid tumors that have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation, that are metastatic or when surgical resection is likely to result in severe morbidity, and that have progressed after treatment or have no satisfactory alternativeChildren older than 6 months with BSA of at least 1.51 m2: 600 mg PO once daily until disease progression or unacceptable toxicity occurs.Children older than 6 months with BSA of 1.11 to 1.50 m2: 400 mg PO once daily until disease progression or unacceptable toxicity occurs.Children older than 6 months with BSA of 0.81 to 1.10 m2: 300 mg PO once daily until disease progression or unacceptable toxicity occurs.Children older than 6 months with BSA of 0.51 to 0.80 m2: 200 mg PO once daily until disease progression or unacceptable toxicity occurs.Children older than 6 months with BSA of 0.50 m2 or less: 300 mg/m2 PO once daily until disease progression or unacceptable toxicity occurs.Children older than 1 month to 6 months: 250 mg/m2 PO once daily until disease progression or unacceptable toxicity occurs.Adjust-a-dose: For patients age 2 and older, refer to the manufacturer's instructions for dosage when used with moderate or strong CYP3A4 inhibitors. After discontinuation of the CYP3A inhibitor for three to five elimination half-lives, resume entrectinib dose given before initiating the CYP3A inhibitor.Released: December 2023Nursing Drug Handbook© 2023 Wolters Kluwer  nivolumabOpdivoPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEAdjuvant treatment of patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanomaAdults and children age 12 and older weighing 40 kg or more: 240-mg IV infusion every 2 weeks or 480 mg every 4 weeks.Children age 12 and older weighing less than 40 kg: 3 mg/kg-IV infusion every 2 weeks or 6 mg/kg every 4 weeks.Adjust-a-dose: Continue until disease recurrence or unacceptable toxicity for up to 1 year.Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwerpatiromerVeltassaPharmaceutical company: Vifor PharmaNEW FORMULATIONOral powder: 1-g packetNEW INDICATION & DOSAGENonemergency treatment of hyperkalemiaChildren ages 12 to 17: Initially, 4 g PO once daily. Monitor serum potassium level and adjust dose by 4 g daily, as needed, at intervals of 1 week or longer to reach desired potassium concentration. Maximum dosage is 25.2 g once daily.Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: Merck & Co.NEW INDICATION & DOSAGEResectable (tumors of at least 4 cm or node positive) non–small-cell lung cancer in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgeryAdults: 200-mg IV infusion every 3 weeks or 400 mg every 6 weeks. Continue adjuvant treatment until disease recurrence, unacceptable toxicity occurs, or up to 12 months in patients without disease recurrence.Released: December 2023Nursing Drug Handbook© 2023 Wolters Kluwerpilocarpine ophthalmicQlosiPharmaceutical company: Orasis Pharmaceuticals, Inc.NEW FORMULATIONOphthalmic solution: 0.4%NEW INDICATION & DOSAGEPresbyopia (Qlosi)Adults: Instill one drop of 0.4% solution in each eye daily. May repeat after 2 to 3 hours for an effect up to 8 hours.Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwertemozolomideTemodarPharmaceutical company: Merck Sharp & DohmeNEW INDICATION & DOSAGEAdjuvant treatment of patients with newly diagnosed anaplastic astrocytomaAdults: Initiate the drug four weeks after the end of radiotherapy. Cycle 1, give 150 mg/m2 PO daily on days 1 to 5 of a 28-day cycle. Then, cycles 2 to 12, give 200 mg/m2 daily on days 1 to 5 of each 28-day cycle. If the dose wasn't increased at the start of cycle 2 due to toxicity, don't increase during cycles 3 to 6.Adjust-a-dose: Refer to the manufacturer's instructions for toxicity-related dosage adjustments.Released: December 2023Nursing Drug Handbook© 2023 Wolters KluwervosoritideVoxzogoPharmaceutical company: BioMarin Pharmaceutical, Inc.NEW INDICATION & DOSAGEIncrease of linear growth in patients with achondroplasia with open epiphysesChildren weighing 3 kg or more: 0.096 mg to 0.8 mg subcut once daily, based on actual body weight. Refer to the prescribing information for dosing table.Adjust-a-dose: Adjust the dose every 3 to 6 months, according to actual body weight. Permanently discontinue the drug upon confirmation of closed epiphyses.Released: December 2023Nursing Drug Handbook© 2023 Wolters Kluwer
New Drug Indications - November 2023
canakinumabIlarisPharmaceutical company: Novartis Pharmaceuticals CorporationNEW INDICATION & DOSAGEGout flares when NSAIDs and colchicine are contraindicated, are not tolerated, or don't provide an adequate response, and when repeated courses of corticosteroids are not appropriateAdults: 150 mg subcut as a single dose. May re-treat after at least 12 weeks.Released: November 2023Nursing Drug Handbook© 2023 Wolters Kluwerdabrafenib mesylateTafinlarPharmaceutical company: Novartis Pharmaceuticals CorporationNEW INDICATION & DOSAGEUnresectable or metastatic solid tumors with BRAF V600E mutation in patients who have progressed after prior therapy and have no satisfactory alternative treatment options, in combination with trametinibChildren ages 1 to 17 weighing 51 kg or more: 150 mg (as capsules or oral suspension) PO b.i.d.Children ages 1 to 17 weighing 38 to 50 kg: 100 mg (as capsules) PO b.i.d.Children ages 1 to 17 weighing at least 26 to 37 kg: 75 mg (as capsules) PO b.i.d.Children ages 1 to 17 weighing 8 to 50 kg: 20 to 130 mg (as oral suspension) PO b.i.d. based on body weight. See the manufacturer's instructions for recommended dosage table.  Adjust-a-dose: Refer to the trametinib prescribing information for recommended trametinib dosing information. Refer to the manufacturer's instructions for toxicity-related dose adjustments. Continue treatment until disease progression or unacceptable toxicity occurs.Released: November 2023Nursing Drug Handbook© 2023 Wolters Kluwerluspatercept-aamtReblozylPharmaceutical company: Bristol-Myers SquibbNEW INDICATION & DOSAGEAnemia in patients with very-low-risk to intermediate-risk myelodysplastic syndromes who may require RBC transfusions and who are erythropoiesis-stimulating-agent naïveAdults: 1 mg/kg subcut once every 3 weeks. Maximum dose, 1.75 mg/kg.Released: November 2023Nursing Drug Handbook© 2023 Wolters Kluwertrametinib dimethyl sulfoxideMekinistPharmaceutical company: Novartis Pharmaceuticals CorporationNEW INDICATION & DOSAGEUnresectable or metastatic solid tumors with BRAF V600E mutation in patients who have progressed after prior therapy and have no satisfactory alternative treatment options, in combination with dabrafenibChildren ages 1 to 17 weighing 51 kg or more: 2 mg (as tablets or oral solution) PO daily.Children ages 1 to 17 weighing 38 to 50 kg: 1.5 mg (as tablets) PO once daily.Children ages 1 to 17 weighing at least 26 to 37 kg: 1 mg (as tablets) PO once daily.Children ages 1 to 17 weighing 8 to 50 kg: 0.3 to 1.6 mg (as oral solution) PO daily based on body weight. See the manufacturer's instructions for recommended dosage table.  Adjust-a-dose: Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information. Refer to the manufacturer's instructions for toxicity-related dose adjustments. Continue treatment until disease progression or unacceptable toxicity occurs.Released: November 2023Nursing Drug Handbook© 2023 Wolters Kluwer
New Drug Indications - October 2023
trifluridine–tipiracilLonsurfPharmaceutical company: Taiho OncologyNEW INDICATION & DOSAGEMetastatic colorectal cancer in patients previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy and, if RAS wild-type, an anti-EGFR therapy in combination with bevacizumabAdults: 35 mg/m2 PO b.i.d. up to a maximum of 80 mg/dose (based on trifluridine component) on days 1 through 5 and days 8 through 12 of a 28-day cycle. Round doses to nearest 5-mg increment. Continue until disease progression or unacceptable toxicity occurs. Refer to bevacizumab prescribing information for additional information.Adjust-a-dose (for all indications): Refer to the manufacturer's instructions for dosage adjustments for kidney failure and hematologic and nonhematologic toxicities.Released: October 2023Nursing Drug Handbook© 2023 Wolters KluwervalbenazineIngrezzaPharmaceutical company: Neurocrine BiosciencesNEW INDICATION & DOSAGEChorea associated with Huntington diseaseAdults: Initially, 40 mg PO once daily. Increase dose in 20-mg increments every 2 weeks to the recommended dosage of 80 mg once daily. Some patients, 40 to 60 mg once daily may be appropriate based on response and tolerability.Adjust-a-dose: For patients with Child-Pugh class B or C liver impairment, for those who are known poor metabolizers of CYP2D6, or if the drug is administered with a strong CYP2D6 or CYP3A4 inhibitor, give 40 mg once daily.Boxed Warning: This drug increases the risk of depression and suicidality in patients with Huntington disease. Risks should be balanced with the clinical need for treatment when considering use. Use cautiously in patients with a history of depression or prior suicide attempts or suicidality. Monitor patients with Huntington disease for emergence or worsening of depression, suicidality, or unusual changes in behavior.Released: October 2023Nursing Drug Handbook© 2023 Wolters Kluwer
New Drug Indications - September 2023
tapentadol hydrochlorideNucyntaPharmaceutical company: Collegium Pharmaceutical, Inc.NEW INDICATION & DOSAGEAcute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate (immediate-release)Children age 6 and older weighing 80 kg or more: 50 mg PO every 4 hours. May increase dosage to 75 mg every 4 hours, then 100 mg every 4 hours to maintain adequate analgesia, as tolerated. Maximum single dose, 100 mg.Children age 6 and older weighing 60 to 79 kg: 50 mg PO every 4 hours. May increase dosage to 75 mg every 4 hours to maintain adequate analgesia, as tolerated. Maximum single dose, 75 mg.Children age 6 and older weighing 40 to 59 kg: 50 mg PO every 4 hours. Maximum single dose, 50 mg.Adjust-a-dose: Maximum daily dose is 7.5 mg/kg/day (six 1.25-mg/kg doses over 24 hours). In children with a high BMI, maximum daily dose must not exceed the maximum dose for a body weight at the 97th percentile for a given age. Reduce dosage over time as acute pain decreases. Duration of treatment for children shouldn't exceed 3 days. Use in children with liver or kidney impairment isn't recommended.Released: September 2023Nursing Drug Handbook© 2023 Wolters Kluwer
New Drug Indications - August 2023
bezlotoxumabZinplavaPharmaceutical company: Merck Sharp & DohmeNEW INDICATION & DOSAGETo reduce recurrence of Clostridioides difficile infection (CDI) in patients receiving antibacterial treatment for CDI and who are at high risk for CDI recurrenceChildren age 1 and older: 10 mg/kg by IV infusion over 60 minutes as a one-time dose during antibacterial treatment for CDI.Released: August 2023Nursing Drug Handbook© 2023 Wolters KluwercolchicineLodocoPharmaceutical company: Agepha PharmaNEW FORMTablets: 0.5 mgNEW INDICATION & DOSAGETo reduce the risk of MI, stroke, coronary revascularization, and CV death in patients with established atherosclerotic disease or multiple risk factors for CV disease (Lodoco only)Adults: 0.5 mg PO once daily.Adjust-a-dose: Use is contraindicated in patients with creatinine clearance less than 15 mL/minute, Child-Pugh class C liver impairment, preexisting blood dyscrasias, or concurrent use of strong CYP3A4 or P-glycoprotein inhibitors.Released: August 2023Nursing Drug Handbook© 2023 Wolters Kluwerferric carboxymaltoseInjectaferPharmaceutical company: Daiichi-SankyoNEW INDICATION & DOSAGEIron deficiency in patients with New York Heart Association class II/III heart failure to improve exercise capacityAdults weighing at least 70 kg:  If hemoglobin (Hb) is 14 g/dL or less, give 1,000 mg IV on day 1. If Hb is more than 14 g/dL to less than 15 g/dL, give 500 mg IV on day 1. At week 6, give 1,000 mg if Hb is less than 10 g/dL or 500 mg if Hb is 10 to 14 g/dL. No additional dose is needed if Hb is greater than 14 g/dL at week 6.Adults weighing less than 70 kg:  If Hb is 14 g/dL or less, give 1,000 mg IV on day 1. If Hb is more than 14 g/dL to less than 15 g/dL, give 500 mg IV on day 1. At week 6, give 500 mg if Hb is less than 10 g/dL. No additional dose is needed if Hb is greater than 14 g/dL at week 6.Adjust-a-dose: Give addition maintenance dose of 500 mg IV at weeks 12, 24, and 36 if ferritin level is less than 100 ng/mL or ferritin is 100 to 300 ng/mL with transferrin saturation of less than 20%. May repeat treatment if iron deficiency recurs.Released: August 2023Nursing Drug Handbook© 2023 Wolters KluwerletermovirPrevymisPharmaceutical company: Merck Sharp & DohmeNEW INDICATION & DOSAGEProphylaxis of CMV disease in kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative)Adults: 480 mg administered once daily PO or IV infusion over 1 hour beginning day 0 to 7 posttransplant through 200 days posttransplant.Adjust-a-dose:  If the drug is administered with cyclosporine, decrease the dose to 240 mg PO or IV once daily. If cyclosporine is initiated after the start of letermovir, decrease the next dose of letermovir to 240 mg once daily. If cyclosporine is discontinued after the start of letermovir, increase the next dose of letermovir 480 mg once daily. If cyclosporine dosing is interrupted due to high cyclosporine level, no letermovir dosage adjustment is needed.Released: August 2023Nursing Drug Handbook© 2023 Wolters Kluwer  linaclotideLinzessPharmaceutical company: AbbVieNEW INDICATION & DOSAGEFunctional constipationChildren ages 6 to 17: 72 mcg PO once daily.Released: August 2023Nursing Drug Handbook© 2023 Wolters KluwerodevixibatBylvayPharmaceutical company: Albireo PharmaNEW INDICATION & DOSAGECholestatic pruritus in patients with Alagille syndromeAdults and children age 12 months and older: 120 mcg/kg PO once daily in the morning with a meal.Adjust-a-dose:  May decrease to 40 mcg/kg/day if intolerance occurs without other cause. Once tolerability stabilizes, increase to 120 mcg/kg/day. Interrupt therapy if new-onset liver function test abnormalities or signs and symptoms of hepatitis occur. Once liver function test values return to baseline or stabilize at new baseline, restart drug at 40 mcg/kg/day and increase dose as tolerated. Consider permanently stopping the drug if liver function test abnormalities recur. Discontinue the drug if hepatic decompensation (ascites, variceal hemorrhage, hepatic encephalopathy) occurs. Interrupt therapy if persistent diarrhea occurs. Restart drug at 40 mcg/kg/day when diarrhea resolves and increase dose as tolerated. Stop the drug if diarrhea persists and no alternative etiology is identified.Released: August 2023Nursing Drug Handbook© 2023 Wolters KluwerolaparibLynparzaPharmaceutical company: AstraZenecaNEW INDICATION & DOSAGEDeleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisoloneAdults: 300 mg PO b.i.d., until disease progression or unacceptable toxicity occurs. Give in combination with a GnRH analogue or after bilateral orchiectomy. Recommended abiraterone dosage, 1,000 mg PO once daily in combination with prednisone or prednisolone 5 mg PO b.i.d. Refer to the abiraterone prescribing information for additional information.Released: August 2023Nursing Drug Handbook© 2023 Wolters Kluwer 
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