Bulevirtide
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B Severe acute exacerbations of hepatitis D and hepatitis B may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Monitor hepatic function closely with both clinical and laboratory follow-up, including hepatitis B virus (HBV) DNA and hepatitis delta virus (HDV) RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted [see Warnings and Precautions (5.1) ] .
WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B See full prescribing information for complete boxed warning . Severe acute exacerbations of hepatitis D and hepatitis B may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Monitor hepatic function closely with both clinical and laboratory follow-up, including hepatitis B virus (HBV) DNA and hepatitis delta virus (HDV) RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted. ( 5.1 )
Dosing in kidney impairment
Renal Impairment No dosage adjustment of HEPCLUDEX is recommended in patients with mild, moderate, or severe renal impairment (creatinine clearance [CrCl] greater than or equal to 15 mL per minute) [see Clinical Pharmacology ]. HEPCLUDEX has not been studied in patients with end-stage renal disease (CrCl less than 15 mL per minute).
Dosing in liver impairment
Hepatic Impairment No dosage adjustment of HEPCLUDEX is recommended in patients with mild hepatic impairment (Child-Pugh Class A) [see Clinical Pharmacology ]. The safety and efficacy of HEPCLUDEX have not been studied in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
Preparation and administration
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Dose Preparation and Administration See the HEPCLUDEX full Instructions for Use for details on the preparation and administration of HEPCLUDEX. Healthcare professionals should train patients or caregivers on the proper reconstitution and administration of HEPCLUDEX, and subcutaneous injection techniques. Consider preparation and administration of the first dose under healthcare professional supervision.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Aseptically reconstitute HEPCLUDEX lyophilized powder or cake by adding 1 mL of Sterile Water for Injection to the HEPCLUDEX vial. Administer entire contents of vial by subcutaneous injection into the upper thigh, lower abdomen, or back of the upper arm (only if administered by a caregiver).
Use reconstituted product immediately. Do not store for later use.
Drug interactions
Check bulevirtide against a medication listLabel text (3 paragraphs)
7 DRUG INTERACTIONS
7.1 Effects of HEPCLUDEX on Other Drugs No CYP enzyme or transporter mediated inhibition or induction by bulevirtide is anticipated at clinically relevant concentrations [see Clinical Pharmacology (12.3) ].
7.2 Effects of Other Drugs on HEPCLUDEX Due to peptide catabolism of bulevirtide, the drug-drug interaction potential of other drugs to impact bulevirtide pharmacokinetics, via CYP enzymes, is low [see Clinical Pharmacology (12.3) ].
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are insufficient human data on the use of HEPCLUDEX during pregnancy to inform a drug-associated risk of birth defects and miscarriage. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
In nonclinical reproductive toxicity studies, bulevirtide demonstrated no adverse effect on embryofetal development when administered to pregnant rats and rabbits at systemic exposures (AUC) 4- and 37-fold relative to exposure in humans at the recommended human dose (RHD). Data Animal Data Bulevirtide was administered via subcutaneous injection to pregnant rats and rabbits (2.5 mg/kg/day) on Gestation Days 6 through 17 and 6 through 20, respectively, and also to rats from Gestation Day 6 to Lactation/Postpartum Day 20. There were no adverse effects on embryofetal development in rats and rabbits.
During organogenesis, exposure in rats and rabbits was 4 and 37 times higher, respectively, than the exposure in humans at the RHD. In a pre/postnatal development study in rats, bulevirtide (2.5 mg/kg/day) was administered via subcutaneous injection from Gestation Day 6 to Lactation Day 21. No effects were observed in the offspring at maternal exposures 3 times the exposure at the RHD.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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