Dosing & Administration

Dosing Overview

8.5 mg once-daily subcutaneous injection¹
No dose adjustment required for patients with:

Mild hepatic impairment (Child-Pugh Class A)^1,a
Mild, moderate, or severe renal impairment with creatinine clearance (CrCl) greater than or equal to 15 mL per minute^1,b

Treatment Duration

Treatment should be continued as long as it is associated with a response to treatment^1,c
Hepatic function should be monitored closely with both clinical and laboratory follow-up, including HBV DNA and HDV RNA viral load, for at least 6 months in patients who discontinue HEPCLUDEX¹
If a dose is missed, that dose should be taken as soon as possible. However, if it is almost time for the next dose, the patient should skip the missed dose and resume the original schedule

^aThe safety and efficacy of HEPCLUDEX in patients with Child-Pugh B or C hepatic impairment or patients with decompensated liver disease have not been evaluated.

^bHEPCLUDEX has not been studied in patients with end-stage renal disease (CrCl less than 15 mL per minute).¹

^cOptimal treatment duration is unknown.

The HEPCLUDEX Patient Materials Help Patients Approach Treatment With Confidence

Patient education and training resources are available
to help patients start HEPCLUDEX treatment with confidence
and support at-home administration.

Featured Resources

Patient Injection Training Video

The Patient Injection Training Video is designed to reinforce injection training with a step-by-step demonstration patients can review at home.

VIEW VIDEO

Patient Injection Guide

Step-by-step instructions that reinforce proper injection preparation and administration.

DOWNLOAD

Patient FAQ Booklet

Answers to common questions about preparing for and administering HEPCLUDEX.

DOWNLOAD

The Hepatitis Delta Nurse Educator Program^a

The Hepatitis Delta Nurse Educator Program provides injection
training and education to help patients prepare for at-home
administration of HEPCLUDEX.

In-person or virtual injection training provided
by a Nurse Educator
Medically trained interpreters
available in 300+ languages

Patients can enroll by calling
1-855-769-7284 (option 5)

^aNurse Educators cannot provide medical advice or in-office medication administration training. Your patient should speak to their healthcare provider if they have any questions about their Gilead medication.

Expand Collapse

INDICATION¹

HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis.

This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Please see full Prescribing Information for HEPCLUDEX, including BOXED WARNING and Instructions for Use.

IMPORTANT SAFETY INFORMATION

BOXED 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.

Warnings and Precautions

Hypersensitivity Reactions Including Anaphylaxis: Hypersensitivity reactions, including anaphylaxis, have been reported with HEPCLUDEX. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue HEPCLUDEX and initiate appropriate treatment.

Adverse Reactions

Most common adverse reactions (incidence ≥10%; all grades) in HEPCLUDEX clinical trials were injection site reactions, headache, abdominal pain, fatigue and pruritus.

Dosage and Administration

Dosage in adults: 8.5 mg once daily administered by subcutaneous injection.
HEPCLUDEX should be continued as long as it is associated with a response to treatment. The optimal treatment duration is unknown.
In all patients, manage the underlying hepatitis B virus (HBV) infection as clinically appropriate.

Pregnancy and Lactation

Pregnancy: There are insufficient data from human pregnancies exposed to HEPCLUDEX to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Lactation: There are no data on the presence of HEPCLUDEX in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HEPCLUDEX and any potential adverse effects on the breastfed child from HEPCLUDEX or from the underlying maternal condition.