Home › NDC Lookup › Ingredients › Bulevirtide › 61958-3104-01
Hepcludex Bulevirtide 8.5 mg Injection, Powder, Lyophilized, For Solution, 30 vials — NDC 61958-3104-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hepcludex Bulevirtide 8.5 mg Injection, Powder, Lyophilized, For Solution, 30 vials — NDC 61958-3104-1 (Billing 61958-3104-01)

by Gilead Sciences, Inc. · 30 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

This is a package of 30 vials of Hepcludex Bulevirtide 8.5 mg Injection, Powder, Lyophilized, For Solution from Gilead Sciences, Inc., marketed since May 2026 and currently FDA-listed. It is this product's only package size.

NDC 61958-3104-01
🏷️ FDA NDC (as labeled) 61958-3104-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 61958-3104-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
61958 labeler · 3104 product · 1 package
Package marketed since
May 22, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 6195831041 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61958-3104-1
Product NDC 61958-3104
11-digit billing NDC 61958310401
NCPDP billing unit EA — each (per item)
RxCUI 2743611, 2743617
UNII LLM855Y3S3
Application # BLA761468
SPL Set ID 12391cc2-38c2-4cf5-86d3-2be9370127fc
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-22
Route SUBCUTANEOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance BULEVIRTIDE ACETATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 12354020012130
GCN Seq No 088987
GCN 59201
HICL code 048141
Ingredient (HICL) Bulevirtide Acetate-Gmod
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W51
Therapeutic class — specific (HIC3) Hepatitis D Treatment Agents
AHFS code 08:18.42.04
AHFS class Entry Inhibitors
FDB label name HEPCLUDEX 8.5 MG VIAL
FDB brand name Hepcludex
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 088987
  • GCN: 59201
  • GPI-14 (Medi-Span): 12354020012130
  • HICL (First Databank): 048141
  • AHFS class code: 08:18.42.04
  • RxCUI (RxNorm): 2743611
Why two NDCs? The FDA registers this code as 61958-3104-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 61958-3104-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other antivirals class.

Drug family (ATC) Other antivirals
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name HEPCLUDEX 8.5 MG VIAL Ingredient Bulevirtide Acetate-Gmod
📖 What it is MedlinePlus · NLM

Bulevirtide-gmod injection is used to treat certain cases of chronic (long-lasting) hepatitis delta virus (HDV; a viral infection of the liver) infection. Bulevirtide-gmod is in a class of medications called antivirals. It works by decreasing the amount of HDV in the body.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
61958-3104-01 You're viewing this Main listing 30 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2026-05-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hepcludex 8.5 mgthis 61958-3104-01 Gilead 30 vials — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII N762921K75
    A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGilead Sciences, Inc.
FDA applicationBLA761468 (BLA)
Labeler code61958
First marketedMay 2026
Product typeHuman Prescription Drug
Portfolio42 products on file

More NDCs from Gilead Sciences, Inc. labeler code 61958

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 191 words ▾

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 )

🎯 Indications and Usage 152 words ▾

1 INDICATIONS AND USAGE 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 [see Clinical Studies (14) ] . 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). HEPCLUDEX is a sodium taurocholate co-transporting polypeptide (NTCP)-directed HDV attachment inhibitor indicated for the treatment of chronic HDV infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on participants who achieved a decrease in HDV RNA and alanine aminotransferase (ALT) normalization.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 , 14 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage in adults: HEPCLUDEX 8.5 mg once daily by subcutaneous injection. ( 2.1 ) Instructions for Use should be followed for preparation and administration of HEPCLUDEX. ( 2.2 )

2.1Recommended Dosage in Adults The recommended dosage in adults is HEPCLUDEX 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. If a dose is missed, that dose should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and resume the original schedule.

2.2Dose 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.

💊 Dosage Forms and Strengths 41 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 8.5 mg as a white to off-white lyophilized powder or cake in a single-dose vial for reconstitution. For injection: 8.5 mg as a lyophilized powder or cake, in a single-dose vial. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 159 words ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Including Anaphylaxis: Hypersensitivity reactions 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. ( 5.2 )

5.1Exacerbation of Hepatitis D and B After Discontinuation of Treatment Severe acute exacerbations of HDV and HBV infection 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 monitoring HBV DNA and HDV RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted.

5.2Hypersensitivity 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 [see Adverse Reactions (6.2) ] .

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Exacerbation of Hepatitis D and B After Discontinuation of Treatment [see Warnings and Precautions (5.1) ]. The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with HEPCLUDEX are injection site reactions, headache, abdominal pain, fatigue, and pruritus . ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The overall safety profile of HEPCLUDEX is based on Phase 2 and Phase 3 data from 165 adults with chronic HDV infection without cirrhosis or with compensated cirrhosis who received at least 48 weeks of HEPCLUDEX 8.5 mg subcutaneous injection once daily.

Trial MYR301 was a Phase 3 randomized, multi-center, open-label, parallel-arm trial in 101 adults. In this trial, 50 adults received 8.5 mg HEPCLUDEX daily for 144 weeks and 51 adults who were in the Delayed Treatment group received no HDV treatment for the first 48 weeks; 50 adults in the Delayed Treatment group then received HEPCLUDEX 8.5 mg once daily for 96 weeks [see Clinical Studies (14) ]. Table 1 displays the frequency of the adverse reactions (all grades) ≥ 10% in the HEPCLUDEX group at Week 48.

No participant discontinued treatment with HEPCLUDEX due to an adverse reaction through Week 48. Table 1 Adverse Reactions Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug. (All Grades) Reported in ≥ 10% of Participants with Chronic HDV Infection Without Cirrhosis or With Compensated Cirrhosis Receiving HEPCLUDEX in Trial MYR301 (Week 48 Analysis) Adverse Reaction HEPCLUDEX (N=50) Delayed Treatment Participants who received no HDV treatment in Trial MYR301 for the first 48 weeks.

(N=51) Injection site reactions Grouped term includes injection site abscess, injection site erythema, injection site reaction, injection site pruritus, injection site swelling, injection site hematoma, injection site rash, injection site dermatitis, and injection site pain. 30% 0 Headache 20% 0 Abdominal pain Grouped term includes abdominal pain, abdominal pain lower, and abdominal pain upper. 18% 2% Fatigue 14% 2% Pruritus 14% 0 A similar safety profile was observed through Week 144 in Trial MYR301 and for participants in the Delayed Treatment group who switched to treatment with HEPCLUDEX at Week 48 through to Week 144.

Additionally, a similar safety profile was observed through Week 96 in Phase 2b Trial MYR204. Laboratory Abnormalities Eosinophil Count Increased: In MYR301, increases in eosinophil counts were reported in 33% of participants (all Grade 1) receiving HEPCLUDEX; there were no associated clinical sequelae, hepatic adverse reactions, or significant liver-related laboratory abnormalities. Total Bile Salts Increased: HEPCLUDEX inhibits sodium taurocholate co-transporting polypeptide (NTCP)-mediated bile acid transport.

Consistent with this, elevations in total serum bile salt levels were observed in clinical trials of HEPCLUDEX. In MYR301, all participants who received HEPCLUDEX had elevated serum bile salts. Bile salt levels showed visit-to-visit variability and peaked by Week 8 of treatment in both participants without cirrhosis and those with compensated cirrhosis, although median levels trended higher in the latter group.

Bile salt elevations resolved upon discontinuation of HEPCLUDEX. In MYR301, 14% of HEPCLUDEX recipients experienced Grade 1 or 2 pruritus that was self-limited. The magnitude of total serum bile salt elevations did not correlate with the severity of pru… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 66 words ▾

7 DRUG INTERACTIONS

7.1Effects 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) ].

7.2Effects 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) ].

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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.

8.2Lactation Risk Summary 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 HEPCLUDEX and any potential adverse effects on the breastfed child from HEPCLUDEX or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of HEPCLUDEX in pediatric patients less than 18 years of age have not been established.

8.5Geriatric Use Clinical trials of HEPCLUDEX did not include participants aged 65 and over to determine whether they respond differently from younger participants [see Clinical Pharmacology (12.3) ].

8.6Renal 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 (12.3) ]. HEPCLUDEX has not been studied in patients with end-stage renal disease (CrCl less than 15 mL per minute).

8.7Hepatic Impairment No dosage adjustment of HEPCLUDEX is recommended in patients with mild hepatic impairment (Child-Pugh Class A) [see Clinical Pharmacology (12.3) ]. 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.

🤰 Pregnancy 216 words ▾

8.1Pregnancy 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.

🧒 Pediatric Use 22 words ▾

8.4Pediatric Use The safety and effectiveness of HEPCLUDEX in pediatric patients less than 18 years of age have not been established.

🧓 Geriatric Use 29 words ▾

8.5Geriatric Use Clinical trials of HEPCLUDEX did not include participants aged 65 and over to determine whether they respond differently from younger participants [see Clinical Pharmacology (12.3) ].

🆘 Overdosage 64 words ▾

10 OVERDOSAGE No data are available on overdose of HEPCLUDEX in patients. Treatment of overdose with HEPCLUDEX should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with HEPCLUDEX. Hemodialysis is unlikely to result in significant removal of bulevirtide since bulevirtide is highly bound to plasma protein.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action HEPCLUDEX is an antiviral drug [see Microbiology (12.4) ].

12.2Pharmacodynamics HEPCLUDEX 8.5 mg once daily was associated with a higher percentage of trial participants with undetectable HDV RNA at Week 144 compared to a lower once daily dose.

12.3Pharmacokinetics The pharmacokinetic properties of bulevirtide were characterized after intravenous administration in healthy participants, and after subcutaneous administration in healthy participants and participants with chronic HDV infection. The systemic exposure of bulevirtide increased in a more than proportional manner with increasing doses. At steady state, AUC and C max increased by approximately 2-fold compared to the AUC and C max after the first dose.

The pharmacokinetic parameters of bulevirtide are provided in Table 2 . The steady-state PK parameters of bulevirtide (based on population PK analysis of participants with chronic HDV infection) are provided in Table 3 . Table 2 Pharmacokinetic Parameters of Bulevirtide Absorption % absolute bioavailability 57 T max (h) (range) 3.00 (1.00 - 4.00) Distribution % bound to human plasma proteins > 99 Elimination t 1/2 (h) t 1/2 values refer to mean terminal plasma half-life.

(range) 3 (2 - 6) Metabolism Metabolic pathway Bulevirtide, a linear peptide consisting of L-amino acids, is expected to be degraded to smaller peptides and individual amino acids. No active metabolites are expected. Catabolized by peptidases to amino acids Excretion Major route of elimination Excreted as smaller peptides and amino acids Table 3 Steady-State Pharmacokinetic Parameters of Bulevirtide Following Subcutaneous Administration of HEPCLUDEX in Adults with HDV Infection Empirical Bayesian post hoc exposure estimates from Population pharmacokinetic analysis in MYR301 trial, N=100.

Parameter Geometric Mean (90% CI) CI=Confidence Interval C max (ng/mL) 184 (160 - 211) AUC 0-24h (ng•h/mL) 1935 (1680 - 2230) Specific Populations Age (18 to 65 years), sex, race (87.5% White, 1.9% Black, 10.3% Asian, 0.2% Other), or body weight (39.7 to 110 kg) did not have a clinically relevant impact on the systemic exposure of bulevirtide. Geriatric Patients The pharmacokinetics of bulevirtide have not been evaluated in elderly participants with HDV infection (65 years of age and older) [see Use in Specific Populations (8.5) ].

Patients with Renal Impairment In a Phase 1, open-label study in participants without HDV infection, the steady state pharmacokinetics of bulevirtide were similar among participants with normal renal function and participants with severe renal impairment (CrCl 15 to less than 30 mL per minute), and no clinically relevant differences in total bile acid elevations were observed between the two groups. The pharmacokinetics of bulevirtide have not been evaluated in participants with end-stage renal disease (CrCl less than 15 mL per minute), including those on dialysis.

As bulevirtide is greater than 99% protein bound, dialysis is not expected to alter exposures of bulevirtide [see Use in Specific Populations (8.6) ]. Patients with Hepatic Impairment In a Phase 1, open-label study in participants without HDV infection, the steady-state pharmacokinetics of bulevirtide were approximately 27% lower in participants with moderate hepatic impairment (Child-Pugh Class B) than participants with normal hepatic function. The steady state pharmacokinetics of bulevirtide were similar among participants with severe hepatic impairment (Child-Pugh Class C) and participants with normal hepatic function [see Use in Specific Populations (8.7) ].

Drug Interaction Studies Effect of Bulevirtide on Other Drugs Cytochrome P450 (CYP) Enzymes: In vitro studies have shown, bulevirtide is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. Bulevirtide is not an inducer of CYP1A2, CYP2B6, or CYP3A4. Consistent with in vitro results, bulevirtide at steady state did not impact the pharmacokinetics of… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 77 words ▾

12.1Mechanism of Action HEPCLUDEX is an antiviral drug [see Microbiology (12.4) ].

Mechanism of Action Bulevirtide is a synthetic 47-amino acid lipopeptide with a myristoylated N-terminus and an amidated C-terminus derived from amino acids 13-59 of the L-HBsAg preS1 domain from an HBV genotype (GT)-C consensus sequence (corresponding to GT-D preS1 amino acids 2-48). Bulevirtide inhibits HDV infection by binding to the HDV receptor NTCP on the plasma membrane of hepatocytes, blocking HDV attachment to NTCP.

📦 How Supplied / Storage and Handling 100 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING HEPCLUDEX (bulevirtide-gmod) for injection 8.5 mg is supplied in a carton (NDC 61958-3104-1) of 30 single-dose vials. Each single-dose vial contains a sterile, preservative-free, white to off-white lyophilized powder or cake. It requires reconstitution prior to administration by subcutaneous injection [see Dosage and Administration (2.2) ] .

The container closure is not made with natural rubber latex. Store HEPCLUDEX vials at room temperature between 68 °F to 77 °F (20 °C to 25 °C), excursions permitted from 59 °F to 86 °F (15 °C to 30 °C). After reconstitution, use vials immediately.

Discard unused portion.

📋 Description 173 words ▾

11 DESCRIPTION Bulevirtide-gmod is an NTCP-directed HDV attachment inhibitor. Bulevirtide as an acetate salt, is a 47-amino acid protein with a fatty acid myristoyl residue at the N-terminus and an amidated C-terminus. All chiral amino acids are in the L-configuration.

The counter ion acetate is bound in ionic form to basic groups of the peptide molecule in a nonstoichiometric ratio. Bulevirtide acetate has a molecular formula of C 248 H 355 N 65 O 72 (net) and a molecular weight of 5398.9 Da (average mass, net), and has the following structural formula: HEPCLUDEX (bulevirtide-gmod) for injection is a sterile, preservative-free, white to off-white lyophilized powder or cake for subcutaneous injection after reconstitution. Each single-dose vial delivers 8.5 mg of bulevirtide-gmod (equivalent to approximately 8.6 mg of bulevirtide acetate).

The inactive ingredients are histidine (3.3 mg), mannitol (51 mg), and sucrose (8.5 mg), and may include hydrochloric acid and/or sodium hydroxide to adjust the pH to 8.5. HEPCLUDEX requires reconstitution prior to administration by subcutaneous injection [see Dosage and Administration (2.2) ]. Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ) for proper preparation and administration instructions. Important Preparation and Administration Considerations Healthcare professionals should train patients or caregivers in the proper technique for reconstituting HEPCLUDEX with Sterile Water for Injection and administering subcutaneous injections using a syringe and consider preparation and administration of the first dose under the supervision of a healthcare provider.

Inform patients that the Sterile Water for Injection, syringes, and needles needed for preparation and injection of HEPCLUDEX are obtained separately from the pharmacy. Exacerbation of Hepatitis D and B after Discontinuation of Treatment Inform patients that discontinuation of HEPCLUDEX may result in severe acute exacerbations of hepatitis D and B. Advise the patient to inform their healthcare provider before they discontinue HEPCLUDEX [see Warnings and Precautions (5.1) ].

Hypersensitivity Reactions Including Anaphylaxis Advise patients that hypersensitivity reactions, including anaphylaxis, have been reported with HEPCLUDEX. Advise patients to immediately discontinue HEPCLUDEX and alert their healthcare provider if signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur [see Warnings and Precautions (5.2) ] . Missed Dosage Inform patients that it is important to take HEPCLUDEX on a regular dosing schedule and to avoid missing doses.

If a dose is missed, that dose should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and resume the original schedule [see Dosage and Administration (2.1) ]. Treatment Duration Advise patients that in the treatment of chronic hepatitis D, the optimal duration of treatment is unknown [see Dosage and Administration (2.1) ].

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetic properties of bulevirtide were characterized after intravenous administration in healthy participants, and after subcutaneous administration in healthy participants and participants with chronic HDV infection. The systemic exposure of bulevirtide increased in a more than proportional manner with increasing doses. At steady state, AUC and C max increased by approximately 2-fold compared to the AUC and C max after the first dose.

The pharmacokinetic parameters of bulevirtide are provided in Table 2 . The steady-state PK parameters of bulevirtide (based on population PK analysis of participants with chronic HDV infection) are provided in Table 3 . Table 2 Pharmacokinetic Parameters of Bulevirtide Absorption % absolute bioavailability 57 T max (h) (range) 3.00 (1.00 - 4.00) Distribution % bound to human plasma proteins > 99 Elimination t 1/2 (h) t 1/2 values refer to mean terminal plasma half-life.

(range) 3 (2 - 6) Metabolism Metabolic pathway Bulevirtide, a linear peptide consisting of L-amino acids, is expected to be degraded to smaller peptides and individual amino acids. No active metabolites are expected. Catabolized by peptidases to amino acids Excretion Major route of elimination Excreted as smaller peptides and amino acids Table 3 Steady-State Pharmacokinetic Parameters of Bulevirtide Following Subcutaneous Administration of HEPCLUDEX in Adults with HDV Infection Empirical Bayesian post hoc exposure estimates from Population pharmacokinetic analysis in MYR301 trial, N=100.

Parameter Geometric Mean (90% CI) CI=Confidence Interval C max (ng/mL) 184 (160 - 211) AUC 0-24h (ng•h/mL) 1935 (1680 - 2230) Specific Populations Age (18 to 65 years), sex, race (87.5% White, 1.9% Black, 10.3% Asian, 0.2% Other), or body weight (39.7 to 110 kg) did not have a clinically relevant impact on the systemic exposure of bulevirtide. Geriatric Patients The pharmacokinetics of bulevirtide have not been evaluated in elderly participants with HDV infection (65 years of age and older) [see Use in Specific Populations (8.5) ].

Patients with Renal Impairment In a Phase 1, open-label study in participants without HDV infection, the steady state pharmacokinetics of bulevirtide were similar among participants with normal renal function and participants with severe renal impairment (CrCl 15 to less than 30 mL per minute), and no clinically relevant differences in total bile acid elevations were observed between the two groups. The pharmacokinetics of bulevirtide have not been evaluated in participants with end-stage renal disease (CrCl less than 15 mL per minute), including those on dialysis.

As bulevirtide is greater than 99% protein bound, dialysis is not expected to alter exposures of bulevirtide [see Use in Specific Populations (8.6) ]. Patients with Hepatic Impairment In a Phase 1, open-label study in participants without HDV infection, the steady-state pharmacokinetics of bulevirtide were approximately 27% lower in participants with moderate hepatic impairment (Child-Pugh Class B) than participants with normal hepatic function. The steady state pharmacokinetics of bulevirtide were similar among participants with severe hepatic impairment (Child-Pugh Class C) and participants with normal hepatic function [see Use in Specific Populations (8.7) ].

Drug Interaction Studies Effect of Bulevirtide on Other Drugs Cytochrome P450 (CYP) Enzymes: In vitro studies have shown, bulevirtide is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. Bulevirtide is not an inducer of CYP1A2, CYP2B6, or CYP3A4. Consistent with in vitro results, bulevirtide at steady state did not impact the pharmacokinetics of the CYP3A4 probe substrate midazolam, administered as an oral 30 μg microdose, in clinical drug-interaction studies.

Transporter Systems: In vitro studies have shown that no clinically relevant interactions are expected for efflux transporters including MDR1, BCRP, BSEP, MATE1, and MATE2K and u… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 30 words ▾

12.2Pharmacodynamics HEPCLUDEX 8.5 mg once daily was associated with a higher percentage of trial participants with undetectable HDV RNA at Week 144 compared to a lower once daily dose.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Clinical Trials in Adults with Chronic HDV Infection Without Cirrhosis or With Compensated Cirrhosis Trial MYR301 The efficacy of HEPCLUDEX once daily in the treatment of adults with chronic HDV infection without cirrhosis or with compensated cirrhosis is based on data through Week 144 from a multi-center, randomized, open-label, parallel-arm Phase 3 trial, Trial MYR301(NCT03852719), in which 100 participants received HEPCLUDEX 8.5 mg once daily. The MYR301 protocol specified the HEPCLUDEX dose as 10 mg; however, a dose recovery study later showed that the delivered dose was 8.5 mg.

In Trial MYR301, participants with chronic HDV infection without cirrhosis or with compensated cirrhosis were randomized to immediate treatment with HEPCLUDEX 8.5 mg once daily by subcutaneous injection for 144 weeks or to delayed treatment with an observational period of 48 weeks followed by HEPCLUDEX 8.5 mg once daily by subcutaneous injection for 96 weeks. Randomization was stratified by the presence or absence of compensated cirrhosis. The groups were followed for 96 weeks after treatment ended.

Demographic and clinical characteristics at baseline were balanced between treatment groups. The mean age was 41 years; 55% were male, 82% were White, 17% were Asian, and 1% were Black or African American. Forty-eight percent had compensated liver cirrhosis, 98% had HDV genotype 1, and 87% had HBV genotype D.

Fifty-seven percent of participants had received previous interferon therapy and 59% were receiving nucleos(t)ide analog reverse transcriptase inhibitors for chronic hepatitis B. The primary efficacy endpoint was combined response, defined as undetectable HDV RNA or ≥ 2 log 10 IU/mL decline from baseline and ALT normalization, at Week 48. Table 4 presents efficacy outcomes at Week 48 from Trial MYR301.

Table 4 Trial MYR301: Efficacy Outcomes of HEPCLUDEX versus Delayed Treatment at Week 48 HEPCLUDEX (Immediate Treatment) (N=50) Delayed Treatment (N=51) Rate Difference 96% CI (%) CI=Confidence Interval, NA=Not applicable Combined Response Defined as virologic response (HDV RNA undetectable or ≥ 2 log 10 IU/mL decline) and ALT normalization. 48% 2% 46% p < 0.0001 (by Fisher’s exact test) for HEPCLUDEX vs. Delayed Treatment.

The 96% confidence interval was calculated using score statistics with unconditional confidence limits method. A two-sided significance level of 0.04 was used to control the overall Type I error rate of 0.05 following a prespecified interim analysis conducted at the 0.01 level. (96% CI: 31% to 61%) Virologic Response Defined as HDV RNA below lower limit of quantification (LLOQ) (50 IU/mL) with target not detected or ≥ 2 log 10 IU/mL decline from baseline.

76% 4% NA ALT Normalization Defined as an ALT value within the normal range: Russian sites, ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites, ≤ 34 U/L for females and ≤ 49 U/L for males. 56% 12% NA At Week 48, the rate of undetectable HDV RNA (defined as less than the lower limit of quantification [LLOQ] [50 IU/mL] with target not detected) was 20% in the HEPCLUDEX group compared with 0% in the Delayed Treatment group. At Weeks 96 and 144, these rates increased to 36% and 50%, respectively, in the HEPCLUDEX group.

At Week 96, the HEPCLUDEX group demonstrated a 56% combined response rate, 82% virologic response rate (defined as undetectable HDV RNA or ≥ 2 log 10 IU/mL decline from baseline), and 64% ALT normalization rate. At Week 144, these rates were 54%, 76%, and 60%, respectively. Participants in the Delayed Treatment group switched to HEPCLUDEX 8.5 mg once daily at Week 48.

At Week 144 (after 96 weeks of treatment), the combined response rate in the Delayed Treatment group was 56%, the rate of undetectable HDV RNA was 52%, virologic response rate was 92%, and ALT normalization rate was 58%. At posttreatment Week 24, 32% and 20% of participants in the HEPCLUDEX group and the Delayed Treatment group, respectively, had combined response, and… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 43 words ▾

13 NONCLINICAL TOXICOLOGY Carcinogenicity and genotoxicity studies have not been conducted with bulevirtide. Bulevirtide did not affect fertility or mating performance or early embryonic development in rats at approximately 3 times higher exposures (AUC) than in humans given the recommended dose of HEPCLUDEX.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 05/2026 PATIENT INFORMATION HEPCLUDEX ® (hep-CLUE-decks) (bulevirtide-gmod) for injection, for subcutaneous use What is the most important information I should know about HEPCLUDEX?

HEPCLUDEX can cause serious side effects, including: Worsening of hepatitis delta virus (HDV) and hepatitis B virus (HBV) infection. Your HDV or HBV infection may get worse (flare-up) if you stop taking HEPCLUDEX, especially if you have cirrhosis. A "flare-up" is when your HDV or HBV infection suddenly returns in a worse way than before.

Do not run out of HEPCLUDEX. Refill your prescription or talk to your healthcare provider before your HEPCLUDEX is all gone. Do not stop taking HEPCLUDEX without first talking to your healthcare provider.

If you stop taking HEPCLUDEX, your healthcare provider will need to check your health often and do blood tests regularly for at least 6 months to check your liver, and may give you medicine to treat your virus infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking HEPCLUDEX. For more information about side effects, see " What are the possible side effects of HEPCLUDEX? " What is HEPCLUDEX?

HEPCLUDEX is a prescription medicine used to treat chronic (long-lasting) hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. It is not known if HEPCLUDEX is safe and effective in children less than 18 years of age. Before taking HEPCLUDEX, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant.

It is not known if HEPCLUDEX can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if HEPCLUDEX can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with HEPCLUDEX.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I take HEPCLUDEX? See the Instructions for Use for instructions on how to prepare and inject your prescribed dose of HEPCLUDEX .

Take HEPCLUDEX exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to. HEPCLUDEX is given as an injection under your skin (subcutaneous) by you or a caregiver.

Your healthcare provider should show you or your caregiver how to prepare and inject HEPCLUDEX before you use it for the first time. Take HEPCLUDEX 1 time each day. Do not change your dose or stop taking HEPCLUDEX without first talking with your healthcare provider.

Stay under a healthcare provider's care when taking HEPCLUDEX. Do not miss a dose of HEPCLUDEX. If you miss a dose, take that dose as soon as possible on that day.

However, if it is almost time for your next dose, skip the missed dose and go back to the regular dosing schedule. If you take too much HEPCLUDEX, call your healthcare provider or go to the nearest hospital emergency room right away. When your HEPCLUDEX supply starts to run low, get more from your healthcare provider or pharmacy.

This is very important because your HDV and HBV infection may get worse (flare-up) if you stop taking HEPCLUDEX. What are the possible side effects of HEPCLUDEX? HEPCLUDEX can cause serious side effects, including: See “ What is the most important information I should know about HEPCLUDEX? ” Allergic reactions, including severe allergic reactions (anaphylaxis).

Stop taking HEPCLUDEX and tell your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of a severe allergic reaction, including: trouble swallowing or breathing throat tightness severe rash, hives, or itching swelling of the mouth, lips, tongue, or face dizziness or fainting stomach area pain, nausea, diarrhea, or vomiting The most common side effects of HEPC… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE HEPCLUDEX ® [hep-CLUE-decks] (bulevirtide-gmod) for injection, for subcutaneous use single-dose vial This Instructions for Use contains information on how to prepare and inject HEPCLUDEX. Read this Instructions for Use before you start using HEPCLUDEX and each time you get a refill. There may be new information.

Do not use HEPCLUDEX unless you have been trained by your healthcare provider. Your healthcare provider should show you or your caregiver how to prepare and inject HEPCLUDEX before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider.

Read the Patient Information that comes with HEPCLUDEX for more information. If you have any problems using HEPCLUDEX, including if you do not give a full dose of medicine, contact your healthcare provider. Important Information You Need to Know Before Injecting HEPCLUDEX: Your carton of HEPCLUDEX contains 30 vials.

This is a 30-day supply of medicine. HEPCLUDEX comes as a powder or cake in a vial. HEPCLUDEX must be mixed and dissolved with Sterile Water for Injection before use.

Mixed HEPCLUDEX must be used right away. Do not reuse or save mixed HEPCLUDEX for later use. Your pharmacy will provide you with the following supplies for mixing and injecting HEPCLUDEX: Transfer Needles Empty Syringes Sterile Water for Injection Vials Injection Needles Note: The supplies not included in the HEPCLUDEX carton may slightly differ in size, shape and color from the figures in this Instructions for Use.

These instructions provide the steps to mix and inject HEPCLUDEX using an example set of supplies. If you have any questions, contact your healthcare provider or pharmacist. Only use the Sterile Water for Injection Vial provided by your pharmacy to mix HEPCLUDEX.

Sterile Water for Injection is different from bottled water or water from a faucet. Sterile Water for Injection Vials are for one-time use only and must be thrown away (disposed of) after that use, even if there is water remaining in the vial. Reusing Sterile Water for Injection Vials may lead to infection.

Do not touch the needle or syringe tip or allow the needle or syringe tip to touch any other surface. If you touch the needle or syringe tip or allow the needle or syringe tip to touch any other surface, throw them away in a sharps disposal container (see “ Disposing of Used Needles ” ) and use a new needle or syringe. Touching the needle or syringe tip would make it non-sterile and could lead to an infection.

Do not reuse any of the supplies. Throw away any used Transfer Needles and Injection Needles in a sharps disposal container. See “ Disposing of Used Needles ” .

How should I store HEPCLUDEX? Store HEPCLUDEX Vials at room temperature between 68 °F to 77 °F (20 °C to 25 °C). After mixing, use the HEPCLUDEX Vial right away.

Throw away (discard) unused portion. Store all other supplies according to the manufacturer instructions. Keep HEPCLUDEX Vials, all supplies, and all medicines out of the reach of children.

Guide to Parts HEPCLUDEX Vial Supplies Needed to Mix HEPCLUDEX (not included in the HEPCLUDEX carton; supplies from the pharmacy may look different than supplies pictured here) Sterile Water for Injection Vial (used to mix HEPCLUDEX) Sterile Transfer Needles (used to transfer Sterile Water for Injection to HEPCLUDEX Vial and to withdraw mixed HEPCLUDEX) Supplies Needed to Inject HEPCLUDEX After Mixing (not included in the HEPCLUDEX carton; supplies from the pharmacy may look different than supplies pictured here) Sterile Injection Needle with Safety Shield (used to inject after HEPCLUDEX has been mixed) Do not insert the Injection Needle into the vials Note: When the needle safety shield is closed over the Injection Needle, the needle is locked and cannot be used.

Additional Supplies Needed (may be provided by pharmacy) Gather HEPCLUDEX Vial and Supplies Step 1. Take 1 vial from the HEPCLUDEX Vial carton. Gather the supplies for mixing and… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 65 words ▾

PRINCIPAL DISPLAY PANEL - 8.5 mg Vial Label NDC 61958- 3104 -2 (bulevirtide-gmod) HEPCLUDEX ® for injection 8.5 mg per vial For Subcutaneous Use. GILEAD Label

PRINCIPAL DISPLAY PANEL - 8.5 mg Vial Carton NDC 61958- 3104 -1 (bulevirtide-gmod) HEPCLUDEX ® for injection 8.5 mg per vial For Subcutaneous Use Reconstitute Hepcludex prior to use. Rx Only 30 single-dose vials. Discard unused portion. GILEAD Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Gilead Sciences, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Gilead Sciences, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 61958-3005-01 · Gilead 61958-3301-01 · Gilead →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.