Details for: HEPAGAM B
Company: SAOL THERAPEUTICS RESEARCH LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02290979 | HEPAGAM B | HEPATITIS B IMMUNOGLOBULIN (HUMAN) | 312 UNIT / ML | SOLUTION | INTRAMUSCULAR |
| 02290979 | HEPAGAM B | HEPATITIS B IMMUNOGLOBULIN (HUMAN) | 312 UNIT / ML | SOLUTION | INTRAVENOUS |
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.
| 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