![HYPERHEP B HEPATITIS B IMMUNE GLOBULIN (HUMAN) 220 [iU]/mL Injection, 1 syringe — NDC 13533-0636-03 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cda35690-672f-46cd-8520-e37f4d66a8d7&name=0.5mL+carton.jpg)
HYPERHEP B HEPATITIS B IMMUNE GLOBULIN (HUMAN) 220 [iU]/mL Injection, 1 syringe
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
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🧪 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.
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UNII TE7660XO1C
Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
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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.
2 inactive ingredients listed in the exact product block matched to this NDC.
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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
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💲 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 system | Per each | Per 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. | |
| Medicare Part B allowsASP · 90371 | $136.952 / 90371 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hyperhep B 220 [iU]/mLthis 13533-0636-03 | GRIFOLS | 1 syringe | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 13533-0636-01 | 1 VIAL, GLASS in 1 CARTON (13533-636-01) / 1 mL in 1 VIAL, GLASS (13533-636-10) | 1996-10-09 | Active |
| 13533-0636-02 | 1 SYRINGE, GLASS in 1 CARTON (13533-636-02) / 1 mL in 1 SYRINGE, GLASS (13533-636-20) | 1996-10-09 | Active |
| 13533-0636-03 You're viewing this | 1 SYRINGE, GLASS in 1 CARTON (13533-636-03) / .5 mL in 1 SYRINGE, GLASS (13533-636-30) | 1996-10-09 | Active |
| 13533-0636-05 | 1 VIAL, GLASS in 1 CARTON (13533-636-05) / 5 mL in 1 VIAL, GLASS (13533-636-50) | 1996-10-09 | Active |
Pack size FAQ
What quantity is in NDC 13533-0636-03?
What is the difference between NDC 13533-0636-03 and NDC 13533-0636-01?
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🧭 About this NDC listing & data coverage
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 | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full FDA label FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining Hepatitis B Immune Globulin (Human) with hepatitis B vaccine will provide both short- and long-term protection, will be less costly than the two-dose Hepatitis B Immune Globulin (Human) treatment alone, and is the treatment of choice. (8) Hyper HEP B S/D is indicated for post-exposure prophylaxis in the following situations: Acute Exposure to Blood Containing HBsAg After either parenteral exposure, e.g., by accidental “needlestick” or direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident) involving HBsAg-positive materials such as blood, plasma or serum.
For inadvertent percutaneous exposure, a regimen of two doses of Hepatitis B Immune Globulin (Human), one given after exposure and one a month later, is about 75% effective in preventing hepatitis B in this setting. Perinatal Exposure of Infants Born to HBsAg-positive Mothers Infants born to HBsAg-positive mothers are at risk of being infected with hepatitis B virus and becoming chronic carriers. (5,8-10) This risk is especially great if the mother is HBeAg-positive.
(11-13) For an infant with perinatal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of Hepatitis B Immune Globulin (Human) at birth with the hepatitis B vaccine series started soon after birth is 85%–95% effective in preventing development of the HBV carrier state. (8,14) Regimens involving either multiple doses of Hepatitis B Immune Globulin (Human) alone or the vaccine series alone have 70%–90% efficacy, while a single dose of Hepatitis B Immune Globulin (Human) alone has only 50% efficacy.
(8,15) Sexual Exposure to an HBsAg-positive Person Sex partners of HBsAg-positive persons are at increased risk of acquiring HBV infection. For sexual exposure to a person with acute hepatitis B, a single dose of Hepatitis B Immune Globulin (Human) is 75% effective if administered within 2 weeks of last sexual exposure. (8) Household Exposure to Persons with Acute HBV Infection Since infants have close contact with primary care-givers and they have a higher risk of becoming HBV carriers after acute HBV infection, prophylaxis of an infant less than 12 months of age with Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary care-giver has acute HBV infection.
(8) Administration of Hepatitis B Immune Globulin (Human) either preceding or concomitant with the commencement of active immunization with Hepatitis B Vaccine provides for more rapid achievement of protective levels of hepatitis B antibody, than when the vaccine alone is administered. (16) Rapid achievement of protective levels of antibody to hepatitis B virus may be desirable in certain clinical situations, as in cases of accidental inoculations with contaminated medical instruments. (16) Administration of Hepatitis B Immune Globulin (Human) either 1 month preceding or at the time of commencement of a program of active vaccination with Hepatitis B Vaccine has been shown not to interfere with the active immune response to the vaccine.
(16)
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Acute Exposure to Blood Containing HBsAg(15) Table 1 summarizes prophylaxis for percutaneous (needlestick or bite), ocular, or mucous-membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure (its value beyond 7 days of exposure is unclear). If Hepatitis B Immune Globulin (Human) is indicated (see Table 1 ), an injection of 0.06 mL/kg of body weight should be administered intramuscularly (see PRECAUTIONS ) as soon as possible after exposure and within 24 hours, if possible.
Consult Hepatitis B Vaccine package insert for dosage information regarding that product. Table 1. (adapted from (20) ) Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure Exposed Person Source Unvaccinated Vaccinated HBsAg-Positive 1.
Hepatitis B Immune Globulin (Human) x1 immediately Hepatitis B Immune Globulin (Human), dose 0.06 mL / kg IM. 1. Test exposed person for anti-HBs.
2. Initiate HB Vaccine Series HB Vaccine dose 20 μg IM for adults; 10 μg IM for infants or children under 10 years of age. First dose within 1 week; second and third doses, 1 and 6 months later.
2. If inadequate antibody, Less than 10 sample ratio units (SRU) by radioimmunoassay (RIA), negative by enzyme immunoassay (EIA). Hepatitis B Immune Globulin (Human) (x1) immediately plus HB Vaccine booster dose, or 2 doses of HBIG, one as soon as possible after exposure and the second 1 month later.
Known Source (High Risk) 1. Initiate HB Vaccine Series 1. Test Source for HBsAg only if exposed is vaccine nonresponder; if source is HBsAg-positive, give Hepatitis B Immune Globulin (Human) x1 immediately plus HB Vaccine booster dose, or 2 doses of HBIG, one as soon as possible after exposure and the second 1 month later.
2. Test source for HBsAg. If positive, Hepatitis B Immune Globulin x 1 Low Risk HBsAg-Positive Initiate HB Vaccine series Nothing required.
Unknown Source Initiate HB Vaccine series within 7 days of exposure Nothing required. For persons who refuse Hepititis B Vaccine, a second dose of Hepatitis B Immune Globulin (Human) should be given 1 month after the first dose. Prophylaxis of Infants Born to HBsAg and HBeAg Positive Mothers Efficacy of prophylactic Hepatitis B Immune Globulin (Human) in infants at risk depends on administering Hepatitis B Immune Globulin (Human) on the day of birth.
It is therefore vital that HBsAg-positive mothers be identified before delivery. Hepatitis B Immune Globulin (Human) (0.5 mL) should be administered intramuscularly (IM) to the newborn infant after physiologic stabilization of the infant and preferably within 12 hours of birth. Hepatitis B Immune Globulin (Human) efficacy decreases markedly if treatment is delayed beyond 48 hours.
Hepatitis B Vaccine should be administered IM in three doses of 0.5 mL of vaccine (10 μg) each. The first dose should be given within 7 days of birth and may be given concurrently with Hepatitis B Immune Globulin (Human) but at a separate site. The second and third doses of vaccine should be given 1 month and 6 months, respectively, after the first.
If administration of the first dose of Hepatitis B Vaccine is delayed for as long as 3 months, then a 0.5 mL dose of Hepatitis B Immune Globulin (Human) should be repeated at 3 months. If Hepatitis B Vaccine is refused, the 0.5 mL dose of Hepatitis B Immune Globulin (Human) should be repeated at 3 and 6 months. Hepatitis B Immune Globulin (Human) administered at birth should not interfere with oral polio and diphtheria-tetanus-pertussis vaccines administered at 2 months of age.
(15) Sexual Exposure to an HBsAg-positive Person All susceptible persons whose sex partners have acute hepatitis B infection should receive a single dose of HBIG (0.06 mL/kg) and should begin the hepatitis B vaccine series if prophylaxis can be st…
⛔ Contraindications ▾
CONTRAINDICATIONS None known.
⚠️ Warnings ▾
WARNINGS HyperHEP B S/D is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses.
Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C.
ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Talecris Biotherapeutics, Inc. [1-800-520-2807]. The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient. Hyper HEP B S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immune globulin preparations.
Epinephrine should be available. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Hepatitis B Immune Globulin (Human) should be given only if the expected benefits outweigh the risks.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Local pain and tenderness at the injection site, urticaria and angioedema may occur; anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations. (19)
🔄 Drug Interactions ▾
Drug Interactions Although administration of Hepatitis B Immune Globulin (Human) did not interfere with measles vaccination, (18) it is not known whether Hepatitis B Immune Globulin (Human) may interfere with other live virus vaccines. Therefore, use of such vaccines should be deferred until approximately 3 months after Hepatitis B Immune Globulin (Human) administration. Hepatitis B Vaccine may be administered at the same time, but at a different injection site, without interfering with the immune response.
(16) No interactions with other products are known.
🤰 Pregnancy ▾
Pregnancy Category C Animal reproduction studies have not been conducted with Hyper HEP B S/D. It is also not known whether Hyper HEP B S/D can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyper HEP B S/D should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in the pediatric population have not been established.
🆘 Overdosage ▾
OVERDOSAGE Although no data are available, clinical experience with other immunoglobulin preparations suggests that the only manifestations would be pain and tenderness at the injection site.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Hepatitis B Immune Globulin (Human) provides passive immunization for individuals exposed to the hepatitis B virus (HBV) as evidenced by a reduction in the attack rate of hepatitis B following its use. (1-6) The administration of the usual recommended dose of this immune globulin generally results in a detectable level of circulating anti-HBs which persists for approximately 2 months or longer. The highest antibody (IgG) serum levels were seen in the following distribution of subjects studied: (7) DAY % OF SUBJECTS 3 38.9% 7 41.7% 14 11.1% 21 8.3% Mean values for half-life were between 17.5 and 25 days, with the shortest being 5.9 days and the longest 35 days.
(7) Cases of type B hepatitis are rarely seen following exposure to HBV in persons with preexisting anti-HBs. No confirmed instance of transmission of hepatitis B has been associated with this product. In a clinical study in eight healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, Rabies Immune Globulin (Human), Hyper RAB m S/D, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period.
These results suggest that passive immunization with immune globulin products is not affected by the solvent/detergent treatment.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hyper HEP B S/D is supplied in a 0.5 mL neonatal single dose syringe with attached needle, a 1 mL single dose syringe with attached needle and a 1 mL and a 5 mL single dose vial. Hyper HEP B S/D is preservative-free and latex-free. NDC Number Size 13533-636-03 0.5 mL syringe 13533-636-02 1 mL syringe 13533-636-01 1 mL vial 13533-636-05 5 mL vial
📦 Storage and Handling ▾
STORAGE Store at 2–8°C (36–46°F). Do not freeze. Do not use after expiration date.
📋 Description ▾
DESCRIPTION Hepatitis B Immune Globulin (Human) — Hyper HEP B TM S/D treated with solvent/detergent is a sterile solution of hepatitis B hyperimmune immune globulin for intramuscular administration; it is preservative-free and latex-free. Hyper HEP B S/D is prepared by cold ethanol fractionation from the plasma of donors with high titers of antibody to the hepatitis B surface antigen (anti-HBs). The immune globulin is isolated from solubilized Cohn Fraction II.
The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration.
Hyper HEP B S/D is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. Hyper HEP B S/D is then incubated in the final container for 21–28 days at 20–27°C. Each vial or syringe contains anti-HBs antibody equivalent to or exceeding the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics Evaluation and Research, FDA).
The U.S. reference has been tested against the World Health Organization standard Hepatitis B Immune Globulin and found to be equal to 220 international units (IU) per mL. The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for Hyper HEP B S/D has been validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Human Herpes viruses and other large enveloped DNA viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation.
Significant removal of model enveloped and non-enveloped viruses is achieved at two steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: the precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III. Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.
(22–25) Studies of the Hyper HEP B S/D manufacturing process demonstrate that TSE clearance is achieved during the Pooled Plasma to Effluent III Fractionation Process (6.7 log 10 ). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.