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New Drug Indications - February 2024

isavuconazonium

Cresemba

Pharmaceutical company: Astellas Pharma

NEW FORMULATION
Capsules: 74.5 mg
 

NEW INDICATION & DOSAGE
Invasive aspergillosis; invasive mucormycosis

Children 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

pirtobrutinib

Jaypirca

Pharmaceutical company: Eli Lilly and Company
 

NEW INDICATION & DOSAGE

Chronic 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 inhibitor

Adults: 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

New Drug Indications Archive

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
New Drug Indications - January 2022
bictegravir–emtricitabine–tenofovir alafenamideBiktarvyPharmaceutical company: Gilead SciencesNEW AVAILABLE FORMTablets: 30 mg bictegravir; 120 mg emtricitabine; 15 mg tenofovir alafenamideNEW INDICATION & DOSAGEHIV-1 infection in children weighing 14 to less than 25 kg who have no antiretroviral treatment history, or to replace current antiretroviral regimen in children who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to individual componentsChildren weighing 14 to less than 25 kg: 1 tablet of 30 mg bictegravir; 120 mg emtricitabine; 15 mg tenofovir alafenamide PO daily.Released: January 2022Nursing Drug Handbook© 2022 Wolters KluwerdupilumabDupixentPharmaceutical company: Sanofi and Regeneron PharmaceuticalsNEW INDICATION & DOSAGEAdd-on maintenance treatment of moderate to severe eosinophilic or oral corticosteroid-dependent asthmaChildren ages 6 to 11 weighing 30 kg or more: 200 mg subcut every other week.Children ages 6 to 11 weighing 15 to less than 30 mg: 100 mg subcut every other week or 300 mg every 4 weeks.Released: January 2022Nursing Drug Handbook© 2022 Wolters Kluwerferric carboxymaltoseInjectaferPharmaceutical company: Daiichi SankyoNEW INDICATION & DOSAGEIron deficiency anemia in patients intolerant to or who have had unsatisfactory response to oral ironChildren age 1 and older weighing 50 kg or more: 750 mg IV on day 1; repeat dose after at least 7 days. May repeat course of therapy if anemia recurs. Maximum cumulative dose is 1,500 mg per course.Children age 1 and older weighing less than 50 kg: 15 mg/kg IV on day 1; repeat dose after at least 7 days. May repeat course of therapy if anemia recurs.Released: January 2022Nursing Drug Handbook© 2022 Wolters KluwerlacosamideVimpatPharmaceutical company: UCB, Inc.NEW INDICATION & DOSAGEMonotherapy for partial-onset seizuresChildren age 1 month and older weighing 6 to less than 11 kg: Initially, 1 mg/kg PO or IV b.i.d. Then increase by 1 mg/kg b.i.d. at weekly intervals to recommended dose of 3 to 6 mg/kg b.i.d.Children age 1 month and older weighing less than 6 kg: Initially, 0.66 mg/kg IV t.i.d. Then increase by 0.66 mg/kg IV t.i.d. at weekly intervals to recommended IV dose of 2.5 to 5 mg/kg t.i.d. Or initially, 1 mg/kg PO b.i.d. Then increase by 1 mg/kg b.i.d. at weekly intervals to recommended PO dose of 3.75 to 7.5 mg/kg b.i.d.Released: January 2022Nursing Drug Handbook© 2022 Wolters Kluwerpilocarpine hydrochloride (ophthalmic)VuityPharmaceutical company: AllerganNEW AVAILABLE FORMOphthalmic solution: 1.25%INDICATION & DOSAGEPresbyopia (Vuity)Adults: Instill 1 drop of 1.25% solution in each eye once daily.Released: January 2022Nursing Drug Handbook© 2022 Wolters Kluwer
New Drug Indications - December 2021
abemaciclibVerzenioPharmaceutical company: Eli Lilly and CompanyNEW INDICATION & DOSAGEAdjuvant treatment for hormone receptor-positive, HER2-negative, node-positive, early breast cancer, in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), in patients at high risk of recurrence and with a Ki-67 score of 20% or more as determined by an FDA-approved testAdults: 150 mg PO b.i.d. until completion of 2 years of treatment or until disease recurrence or unacceptable toxicity occurs.Released: December 2021Nursing Drug Handbook© 2021 Wolters KluweratezolizumabTecentriqPharmaceutical company: GenentechNEW INDICATION & DOSAGEAdjuvant treatment after resection and platinum-based chemotherapy for patients with stage II to IIIA non–small-cell lung cancer whose tumors express PD-L1, as determined by an FDA-approved testAdults: 840-mg IV infusion every 2 weeks; or 1,200 mg every 3 weeks; or 1,680 mg every 4 weeks until disease recurrence or unacceptable toxicity occurs, or up to 1 year.Released: December 2021Nursing Drug Handbook© 2021 Wolters KluwercetuximabErbituxPharmaceutical company: Eli Lilly and CompanyNEW INDICATION & DOSAGEMetastatic colorectal cancer with BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy, in combination with encorafenibAdults: Initially, 400 mg/m2 IV infusion over 120 minutes, then 250 mg/m2 IV infusion over 60 minutes weekly with encorafenib 300 mg PO daily until disease progression or unacceptable toxicity occurs. Refer to encorafenib prescribing information.Released: December 2021Nursing Drug Handbook© 2021 Wolters Kluwerdexamethasone ophthalmic insertDextenzaPharmaceutical company: Ocular TherapeutixNEW FORMULATIONOphthalmic insert:0.4 mgINDICATION & DOSAGEOcular itching associated with allergic conjunctivitisAdults: Place a single 0.4-mg insert into lower lacrimal canaliculus.Released: December 2021Nursing Drug Handbook© 2021 Wolters KluwerevolocumabRepathaPharmaceutical company: AmgenINDICATION & DOSAGEAdjunct to diet and other LDL-lowering therapies to reduce LDL cholesterol in children with heterozygous familial hypercholesterolemiaChildren age 10 and older: 140 mg subcut every 2 weeks or 420 mg subcut once monthly. When switching dosage regimens, give first dose of new regimen on next scheduled date of prior regimen.Adjunct to other LDL-lowering therapies for homozygous familial hypercholesterolemia in those who require additional lowering of LDL cholesterolAdults and children age 10 and older: 420 mg subcut once monthly. May increase dose to 420 mg every 2 weeks if clinically meaningful response isn't achieved in 12 weeks. Patients on lipid apheresis may initiate treatment with 420 mg every 2 weeks given after apheresis session is complete.Released: December 2021Nursing Drug Handbook© 2021 Wolters KluwerpembrolizumabKeytrudaPharmaceutical company: Merck Sharp & DohmeINDICATION & DOSAGEPersistent, recurrent, or metastatic cervical cancer in patients whose tumors express PD-L1, as determined by an FDA-approved test, in combination with chemotherapy, with or without bevacizumabAdults: 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 chemotherapy with or without bevacizumab when given the same day.Released: December 2021Nursing Drug Handbook© 2021 Wolters Kluwer
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