difelikefalin
Korsuva
Pharmaceutical company: Vifor, Inc.
Pharmacologic classification:Kappa opioid receptor agonist
Therapeutic classification:Miscellaneous CNS agent
AVAILABLE FORMS
Injection: 65 mcg/1.3 mL (50 mcg/mL)
INDICATIONS AND DOSAGES
Moderate-to-severe pruritus associated with chronic kidney disease in those undergoing hemodialysis
Adults: 0.5 mcg/kg IV bolus injection into venous line of dialysis circuit at the end of each hemodialysis treatment.
CONTRAINDICATIONS AND CAUTIONS
- This drug isn’t recommended for use in those on peritoneal dialysis or in those with severe hepatic impairment.
- Safety and effectiveness in children haven’t been established.
- Dialyzable drug: Yes.
- Overdose S&S: Dizziness, somnolence, mental status changes, paresthesia, fatigue, hypertension, vomiting.
PREGNANCY-LACTATION-REPRODUCTION
- There are limited human data on use in women who are pregnant. Use only if clearly needed.
- There are no data on the presence of this drug in human milk, its effects on breastfed infants, or on milk production. Consider the benefits to the mother versus the risks to the infant from the drug or the underlying maternal condition.
INTERACTIONS
Drug-drug. CNS depressants, sedating antihistamines, opioids: May increase the risk of CNS adverse reactions. Use cautiously together.
ADVERSE REACTIONS
CNS: dizziness, gait disturbances, headache, somnolence, mental status change.
GI: diarrhea, nausea.
Metabolic: hyperkalemia.
Reactions in bold italics are life-threatening.
Released: December 2021
Nursing Drug Handbook
© 2021 Wolters Kluwer
maralixibat
Livmarli
Pharmaceutical company: Mirum Pharmaceuticals, Inc.
Pharmacologic classification:Ileal bile acid transporter (IBAT) inhibitor
Therapeutic classification:Miscellaneous GI drug
AVAILABLE FORMS
Oral solution: 9.5 mg/mL
INDICATIONS AND DOSAGES
Cholestatic pruritus in patients with Alagille syndrome (ALGS)
Adults and children age 1 and older: Initially 190 mcg/kg PO once daily. After one week, increase dose to 380 mcg/kg once daily, as tolerated. Maximum dose is 28.5 mg (3 mL) daily in patients weighing 70 kg or more.
Adjust-a-dose: Decrease dose or interrupt therapy for liver function study abnormalities or GI adverse reactions. Once the liver study abnormalities either return to baseline or stabilize at a new baseline value, consider restarting at 190 mcg/kg, and increase as tolerated. If liver function study abnormalities or GI reactions recur, or symptoms consistent with clinical hepatitis, portal hypertension, or hepatic decompensation (variceal hemorrhage, ascites, hepatic encephalopathy) occur, discontinue therapy.
CONTRAINDICATIONS AND CAUTIONS
- Safety and effectiveness in patients with ALGS with clinically significant portal hypertension or decompensated cirrhosis haven’t been established.
- Safety and effectiveness in patients age 65 and older and children less than age 1 haven’t been established.
- Dialyzable drug: Unknown.
PREGNANCY-LACTATION-REPRODUCTION
- Patients with ALGS can have fat-soluble vitamin (FSV) deficiency as part of their disease and maralixibat may reduce absorption of FSV. Increased maternal supplementation of FSVs during pregnancy and lactation may be needed.
- Maternal use at the recommended dose is not expected to result in measurable fetal exposure because systemic absorption is low, but it may decrease fetal absorption of FSV.
- There are no data on the presence of this drug in human milk, its effects on the breastfed infant or on milk production. Breastfeeding is not expected to result in exposure of the infant to maralixibat at the recommended dose.
INTERACTIONS
Drug-drug. Bile acid binding resins (cholestyramine, colesevelam, colestipol): May bind to maralixibat in the GI tract. Give bile acid binding resin at least 4 hours before or 4 hours after maralixibat.
OATP2B1 substrates (statins): May decrease absorption of the OATP2B1 substrate. Monitor effect of the substrate.
ADVERSE REACTIONS
GI: diarrhea, vomiting, nausea, GI bleeding, abdominal pain.
Hepatic: increased liver function studies.
Metabolic: FSV deficiency.
Musculoskeletal: bone fracture.
Reactions in bold italics are life-threatening.
Released: December 2021
Nursing Drug Handbook
© 2021 Wolters Kluwer