Hepcludex (bulevirtide acetate-gmod)

It isessentialthat the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

*Recommended dosage in adults: 8.5 mg once daily administered by subcutaneous injection. Continue therapy as long as there is a response to treatment. The optimal treatment duration is unknown.

*Reconstitute the drug with sterile water for injection before use.

*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).

*See manufacturer's Instructions for Use for additional instructions on preparation and administration of bulevirtide-gmod.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with bulevirtide-gmod are injection site reactions, headache, abdominal pain, fatigue, and pruritus.

Less Frequent

• Hypersensitivity drug reaction

Less Frequent

• Arthralgia
• Dizziness
• Eosinophilia
• Fatigue
• Flu-like symptoms
• Headache disorder
• Injection site sequelae
• Nausea
• Pruritus of skin

No enhanced messaging available.

The safety and effectiveness of bulevirtide-gmod in pediatric patients less than 18 years of age have not been established.

There are insufficient human data on the use of bulevirtide-gmod 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).

It is not known whether bulevirtide is present in human breast milk, affects human milk production, or has effects on the breastfed infant. In nonclinical pre- and postnatal developmental rat studies, bulevirtide was not measured in the plasma of pups or in the milk of nursing animals. However, due to its high protein binding, liver tropism, and high specificity for NTCP, bulevirtide is not likely to be secreted in milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for bulevirtide and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Clinical trials of bulevirtide-gmod did not include participants 65 years of age and over to determine whether they respond differently from younger participants