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Hyperhep B: Uses, Side Effects and Dosage

Updated:
Strength:
220 UNIT

Patient Medication Information: uses, side effects, how to take - Hyperhep B

What is HyperHEP B® used for?

HyperHEP B® may be used to prevent you from getting sick if you have been exposed to blood from a hepatitis B-positive person, or if you have had sexual contact with a hepatitis B-positive person. It may also be used to prevent your newborn baby from getting sick if born to a hepatitis B-positive mother.

How does HyperHEP B® work?

Vaccines work by stimulating your immune system to produce antibodies against a particular disease. Because vaccines require this immune response, they take time to work and are not immediately effective. HyperHEP B® is made from the blood of people who have already been vaccinated against hepatitis B and therefore already contains hepatitis B antibodies. It starts working immediately after being injected and helps to protect you from getting hepatitis B until your body starts producing its own antibodies in response to the vaccine.

What are the ingredients in HyperHEP B®?

Medicinal ingredient: Human Hepatitis B Immunoglobulin

Non-medicinal ingredient: Glycine

HyperHEP B® comes in the following dosage forms:

Serious Warnings and Precautions

  • Your doctor should discuss the risks and benefits of this product with you before prescribing or administering it to you.
  • HyperHEP B® must be injected into muscles only. It should not be injected directly into blood vessels.
  • HyperHEP B® like other products made from human plasma, part of our blood, may contain viruses or other agents that can cause infection and illness. However, the processes used to make HyperHEP B® are specifically designed with the ability to destroy or remove these agents if they are present.

Single use syringes and vials at a concentration of ≥ 220 IU/mL

  • 0.5 mL (neonatal) pre-filled syringe
  • 1 mL pre-filled syringe
  • 1 mL vial
  • 5 mL vial

Do not use HyperHEP B® if:

  • you are allergic to this drug or to any ingredient in the formulation or component of the container.
  • you have any bleeding disorder that would make it unsafe for you to be given an injection into the muscles.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take HyperHEP B®. Talk about any health conditions or problems you may have, including if you:

  • are pregnant or breastfeeding

  • have been diagnosed with thrombocytopenia or any other bleeding disorder
  • have previously had an allergic reaction to immunoglobulin or any of the other ingredients in the medicine

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with HyperHEP B®:

Certain types of vaccines.

However, measles and hepatitis B vaccinations do not interact with HyperHEP B®. Talk with your healthcare professional if you will receive any type of vaccine within 3 months of HyperHEP B® treatment.

How to take HyperHEP B®:

An intramuscular or IM injection is a shot given into a muscle, usually in the thigh or shoulder. A doctor, nurse or other caregiver trained to give injections will give your treatment.

Usual dose:

Your doctor will determine the amount of HyperHEP B® that is right for you and when your shots should be given.

Overdose:

Although there is no information on the effects of HyperHEP B® overdose, experience with similar medicines suggests that the only effect would be pain and tenderness at the needle injection site.

Missed Dose:

It is important that you receive HyperHEP B® as instructed by your healthcare professional. If your doctor tells you that more than one treatment is required, you should consult him/her if a treatment appointment is missed.

What are possible side effects from using HyperHEP B®?

These are not all the possible side effects you may have when taking HyperHEP B®. If you experience any side effects not listed here, tell your healthcare professional.

Pain may occur where the injection is given. Talk with your doctor if the pain is severe.

You should talk with your healthcare professional if you experience rash or hives (swelling, redness, intense itching, and burning), or if you develop swelling of the lips, other parts of the parts of the mouth and throat, eyelids, genitals, hands or feet.

Allergic reactions, although rare, have been reported following the injection of human immunoglobulin preparations. Talk with your doctor immediately if you experience any of these side effects, which may be symptoms of an allergic reaction: wheezing or trouble breathing, chest tightness, severe abdominal cramps, severe vomiting, or severe diarrhea.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

  • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

HyperHEP B® should be stored at 2-8°C. It should not be frozen or used past the expiration date.

Keep out of reach and sight of children.

If you want more information about HyperHEP B®:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; or by calling 1-866-482-5226.

Last Revised: September 8, 2021

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02520001

Revision date stated in the text: September 8, 2021

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Hyperhep B

DIN 02520001, 02520133
Schedule(s) SCHEDULE D
Active ingredient(s) Hepatitis B immunoglobulin (human) 220 UNIT
Dosage form(s) Solution
Route(s) of administration Intramuscular
Drug class (WHO ATC)
  1. J Antiinfectives for systemic use
    1. J06 Immune sera and immunoglobulins
      1. J06B Immunoglobulins
        1. J06BB Specific immunoglobulins
          1. J06BB04 Hepatitis B immunoglobulin
Company GRIFOLS THERAPEUTICS LLC
Strengths and forms
DIN Strength Dosage form(s) Current status
02520001 220 UNIT Solution Marketed February 21, 2023
02520133 220 UNIT Solution Approved September 10, 2021

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.