belumosudil
Rezurock
Pharmaceutical company: Kadmon Pharmaceuticals
Pharmacologic classification:Kinase inhibitor
Therapeutic classification:Immunomodulator
AVAILABLE FORMS
Tablets: 200 mg
INDICATIONS AND DOSAGES
Chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy
Adults and children age 12 and older: 200 mg PO daily with food until progression of chronic GVHD requires new systemic therapy.
Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments. When coadministered with strong CYP3A inducers or proton pump inhibitors, increase dosage of belumosudil to 200 mg b.i.d.
CONTRAINDICATIONS AND CAUTIONS
- Use in patients with preexisting severe renal or hepatic impairment hasn’t been studied.
- The safety and effectiveness in children younger than age 12 haven’t been established.
- Dialyzable drug: Unknown.
PREGNANCY-LACTATION-REPRODUCTION
- This drug may cause fetal harm. Advise pregnant females of fetal risk.
- No data are available on the presence of this drug in human milk or its effects on breastfed children or milk production. Because of the potential for serious adverse reactions, breastfeeding during treatment and for at least one week after the last dose isn’t recommended.
- Females of reproductive potential and males with female partners of reproductive potential should use effective contraception during treatment and for at least one week after the last dose.
- This drug may cause reversible impairment of fertility in females and males.
INTERACTIONS
Drug-drug. Proton pump inhibitors (rabeprazole, omeprazole): May decrease belumosudil level and reduce its efficacy. Increase belumosudil dose to 200 mg b.i.d.
Strong CYP3A inducers (rifampin):May decrease belumosudil level and reduce its efficacy. Increase belumosudil dose to 200 mg b.i.d.
ADVERSE REACTIONS
CNS: asthenia, fever, headache.
CV: edema, hypertension, hypotension, hemorrhage.
EENT: nasal congestion.
GI: nausea, diarrhea, abdominal pain, dysphagia, decreased appetite.
GU: elevated creatinine, renal failure.
Hematologic: lymphocytopenia, anemia, thrombocytopenia, neutropenia.
Hepatic: increased GGT, increased alkaline phosphatase, increased ALT.
Metabolic: hypophosphatemia, hypocalcemia, hyperkalemia.
Musculoskeletal: musculoskeletal pain, muscle spasm, arthralgia.
Respiratory: dyspnea, cough.
Skin: rash, pruritus.
Other: infection (including bacterial and viral).
Reactions in bold italics are life-threatening.
Released: November 2021
Nursing Drug Handbook
© 2021 Wolters Kluwer
finerenone
Kerendia
Pharmaceutical company: Bayer Pharmaceuticals
Pharmacologic classification:Mineralocorticoid receptor antagonist
Therapeutic classification:Miscellaneous renal drug
AVAILABLE FORMS
Tablets: 10 mg, 20 mg
INDICATIONS AND DOSAGES
To reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, nonfatal MI, and hospitalization for heart failure in patients with chronic kidney disease associated with type 2 diabetes
Adults: Initially,10 mg or 20 mg PO once daily based on eGFR and serum potassium thresholds. Don’t initiate treatment if serum potassium is more than 5.0 mEq/L. If eGFR is 60 mL/min/1.73 m2 or more, start at 20 mg once daily; if eGFR is 25 to less than 60 mL/min/1.73 m2, start at 10 mg once daily. If starting with 10 mg, increase dosage after 4 weeks to the target dose of 20 mg once daily, based on eGFR and serum potassium thresholds.
Adjust-a-dose: Adjust dosage as needed based on every 4-week potassium and eGFR level results. If current serum potassium is 4.8 mEq/L or less and patient is on 10 mg daily, increase to 20 mg daily, except if eGFR has decreased by more than 30% compared to previous measurement; if so, maintain 10 mg dose. If on 20 mg dose already, stay at 20 mg daily.
If current serum potassium is more than 4.8 to 5.5 mEq/L and patient is on 10 mg daily, stay at 10 mg daily; if on 20 mg dose already, stay at 20 mg daily.
If current serum potassium is more than 5.5 mEq/L and patient is on 10 mg daily, hold and consider restarting at 10 mg once daily when serum potassium is 5.0 mEq/L or less; if on 20-mg dose already, hold and restart at 10 mg once daily when serum potassium is 5.0 mEq/L or less.
CONTRAINDICATIONS AND CAUTIONS
- Contraindicated in patients with adrenal insufficiency.
- This drug is not recommended if eGFR is less than 25 mL/min/1.73 m2.
- This drug increases the risk of hyperkalemia, especially in patients with decreased kidney function and those with higher baseline potassium and risk factors for hyperkalemia (concomitant drugs that increase serum potassium or impair its excretion). If serum potassium levels are more than 4.8 to 5.0 mEq/L, initiation may be considered with additional serum potassium monitoring within the first 4 weeks based on clinical judgement and serum potassium levels.
- Avoid use in patients with severe hepatic impairment (Child Pugh C), and consider additional potassium monitoring in patients with moderate hepatic impairment (Child Pugh B).
- This drug is not approved for use in pediatric patients.
- Use cautiously in older adults.
- Dialyzable drug: Unlikely.
PREGNANCY-LACTATION-REPRODUCTION
- This drug has not been studied in patients who are pregnant.
- Breastfeeding is not recommended during treatment and for at least 1 day after the last dose of the drug.
INTERACTIONS
Drug-drug. Drugs that may increase potassium (ACE inhibitors, angiotensin-receptor blockers, potassium sparing diuretics): May increase retention of potassium; monitor potassium levels frequently.
Moderate (erythromycin) and weak (amiodarone) CYP3A inhibitors: May increase finerenone level and risk of adverse reactions; use cautiously together and monitor potassium.
Strong (rifampicin) or moderate (efavirenz) CYP3A inducers: May decrease finerenone level; avoid concurrent use.
Strong CYP3A inhibitors (itraconazole): May significantly increase finerenone level; use together is contraindicated.
Drug-herb. St. John’s wort:May decrease finerenone level; use together cautiously.
Drug-food. Grapefruit or grapefruit juice: May increase finerenone level; discourage use together.
ADVERSE REACTIONS
CV: hypotension.
Metabolic: hyperkalemia, hyponatremia.
Reactions in bold italics are life-threatening.
Released: November 2021
Nursing Drug Handbook
© 2021 Wolters Kluwer
odevixibat
Bylvay
Pharmaceutical company: Albireo Pharma
Pharmacologic classification:Bile acid transporter inhibitor
Therapeutic classification:Miscellaneous GI drug
AVAILABLE FORMS
Capsules: 400 mcg, 1,200 mcg
Oral pellets: 200 mcg, 600 mcg
INDICATIONS AND DOSAGES
Pruritus in patients with progressive familial intrahepatic cholestasis
Adults and children age 3 months and older:40 mcg/kg PO daily with morning meal. If there is no improvement in pruritus after 3 months, increase dose in 40 mcg/kg increments up to 120 mcg/kg PO daily. Maximum total daily dose is 6 mg.
Adjust-a-dose: Interrupt the drug if new onset liver function test (LFT) abnormalities or symptoms of clinical hepatitis are observed. Once LFTs return to baseline or stabilize at a new baseline, restart at 40 mcg/kg/day and increase dose as tolerated and appropriate. Consider permanent discontinuation if LFT abnormalities recur. Interrupt drug if persistent diarrhea occurs. Restart at 40 mcg/kg/day when diarrhea resolves and increase dose as tolerated and appropriate. If diarrhea persists and no alternate etiology is identified, discontinue treatment.
CONTRAINDICATIONS AND CAUTIONS
- Patients who are exclusively on liquid food should not use odevixibat, including children who only take liquids (human milk, formula).
- This drug may not be effective in PFIC type 2 patients with ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump protein (BSEP-3).
- Efficacy and safety in patients with clinically significant portal hypertension and in patients with decompensated cirrhosis haven’t been established.
- Fat-soluble vitamin deficiency may develop or worsen. Monitor vitamin levels (A, D, E) and INR (for vitamin K activity) and supplement as indicated.
- The safety and effectiveness of this drug in patients less than 3 months or greater than 65 years of age have not been established.
- Dialyzable drug: Unlikely.
PREGNANCY-LACTATION-REPRODUCTION
- There are no human data on use in pregnant women. Based on data from animal reproduction studies, in utero exposure may cause fetal harm, including cardiac malformations. Use only if clearly needed.
- There are no data on the presence of this drug in human milk or its effects on breastfed infants or on milk production. This drug has low absorption following oral administration, and breastfeeding is not expected to result in exposure of the infant at recommended doses.
- Monitor fat-soluble vitamin levels and increase fat-soluble vitamin intake if deficiency is observed during lactation.
INTERACTIONS
Drug-drug. Bile acid binding resins (cholestyramine, colesevelam, colestipol): May bind odevixibat in the gut and reduce efficacy. Administer binding resin at least 4 hours before or 4 hours after odevixibat.
ADVERSE REACTIONS
GI: diarrhea, vomiting, abdominal pain.
Hepatic: increased transaminases, hyperbilirubinemia, cholelithiasis.
Metabolic: fat-soluble vitamin deficiency, dehydration.
Musculoskeletal: fracture.
Other: splenomegaly.
Reactions in bold italics are life-threatening.
Released: November 2021
Nursing Drug Handbook
© 2021 Wolters Kluwer