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Details for: HEPAGAM B

Company: SAOL THERAPEUTICS RESEARCH LIMITED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02290979HEPAGAM BHEPATITIS B IMMUNOGLOBULIN (HUMAN)312 UNIT / MLSOLUTIONINTRAMUSCULAR
02290979HEPAGAM BHEPATITIS B IMMUNOGLOBULIN (HUMAN)312 UNIT / MLSOLUTIONINTRAVENOUS
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

  • Prevention of hepatitis B infection following exposure to the hepatitis B virus (post-exposure prophylaxis)
  • Prevention of hepatitis B recurrence following liver transplantation in patients with hepatitis B.
What it does

HepaGam B binds to the hepatitis B virus and helps to remove the virus from circulation.

HepaGam B also prevents development of a hepatitis B infection after exposure to the hepatitis B virus. HepaGam B should be administered within 12 hours of birth or 48 hours of exposure to the hepatitis B virus.

HepaGam B protects the newly transplanted liver from reinfection with the hepatitis B virus. For HepaGam B to be effective in preventing hepatitis B recurrence, treatment should be started during liver transplantation and continued regularly after transplant. Laboratory tests will determine if HepaGam B is working by measuring levels of HepaGam B in serum (the liquid portion of blood) and by looking for signs of hepatitis B infection.

When it should not be used
  • in patients with a history of allergic reactions to blood products
  • in patients deficient in IgA, a specific type of blood protein
What the medicinal ingredient is

Hepatitis B Immune Globulin (Human)

What the non-medicinal ingredients are

Human plasma protein
Maltose
Polysorbate 80

HepaGam B may contain trace amounts of tri-n-butyl phosphate and Triton X-100®.

For a full listing of non-medicinal ingredients see Part 1 of the product monograph.

What dosage form it comes in

HepaGam B is a sterile liquid supplied in 1 mL and 5 mL vials containing >312 IU/mL.

Warnings and precautions

Serious Warnings and Precautions

  • HepaGam B is made from human plasma which may contain the causative agents of viral diseases. The risk of getting a disease from this product has been reduced by screening plasma donors, testing for the presence of certain viruses and by inactivating and removing certain viruses during manufacturing. However, there is still a possibility that plasma products could transmit disease.

  • Allergic or anaphylactic reactions are rare. These reactions can occur in patients with a history of allergy to blood products or in patients lacking the IgA blood protein.

  • Before using HepaGam B, discuss the risk and benefits with your doctor.

BEFORE you use HepaGam B talk to your doctor or pharmacist if:

  • You have experienced allergic reactions to blood products in the past
  • You have a known IgA deficiency
  • You are pregnant or nursing
  • If you use any device to measure blood or urine glucose

While being treated with HepaGam B, regular blood tests will be conducted to check for adequate drug levels.

Interactions with this medication

Drugs that may interact with HepaGam B have not been established.

Immune globulins like HepaGam B may impair the effectiveness of certain live virus vaccines such as measles, rubella (German measles), mumps and varicella (chicken pox). Talk to your doctor if you have been recently vaccinated.

Proper use of this medication

Usual dose (post-exposure prophylaxis)

Each neonatal dose of HepaGam B is 0.5 mL, administered once intramuscularly. An adult dose of HepaGam B is 0.06 mL/kg, administered once intramuscularly.

Usual dose (following liver transplant)

Each dose of 35 mL (10,920 international units) HepaGam B will be given by an intravenous injection taking approximately 20 minutes.

The typical dose schedule is as follows:

  • first dose during liver transplantation operation
  • daily doses for the first week post-operative
  • once every two weeks for the first three months postoperative
  • once a month thereafter

Overdose

The consequences of an overdose are not known. In case of an overdose, consult your doctor.

Missed Dose

If a scheduled dose is missed, it should be given as soon as possible after the missed dose. Your doctor will adjust your dosing schedule if required.

Side effects and what to do about them

The most common side effects are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia (pain in joints) and moderate low back pain. These side effects are usually mild, but if they require treatment ask your health care professional.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk to your doctor or pharmacist Only if severe Talk to your doctor or pharmacist In all cases Stop taking drug and call your doctor or pharmacist
Common
Not applicable*      
Uncommon
Allergic Reaction  

* Serious side effects are not common.
This is not a complete list of side effects. For any unexpected effects while taking HepaGam B, contact your doctor or pharmacist.
How to store

Store HepaGam B under refrigeration. Do not freeze. Do not use after expiration date.

Keep out of reach of children.

Reporting side effects

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

Toll-free telephone: 866-234-2345
Toll-free fax: 866-678-6789
By email: cadrmp@hc-sc.gc.ca

By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

More information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Saol Therapeutics Research Limited at 1-877-443-0224.

This leaflet was prepared by Saol Therapeutics Research Limited.
HepaGam B® is a registered trademark of Saol.
PLANOVA® is a registered trademark of Asahi Kasei Medical Co., Ltd. TRITON® is a registered trademark of Union Carbide Corporation.

Last revised: November 14, 2017

Date modified: