Prehevbrio: Uses, Side Effects and Dosage

What is PREHEVBRIO used for?

• PREHEVBRIO is a vaccine which prevents infection caused by the hepatitis B virus. It is used in adults to protect from all known types of hepatitis B virus.
• PREHEVBRIO may also protect against hepatitis D which can only occur in people who have hepatitis B infection.

How does PREHEVBRIO work?

When a person is given the PREHEVBRIO vaccine, it helps the body’s natural defence system (immune system) produce specific protection (antibodies) against the hepatitis B virus.

• PREHEVBRIO contains a substance (called an ‘adjuvant’) which improves the body’s production of antibodies and makes the protection last for longer.
• A course of three injections of PREHEVBRIO is required to provide full protection against hepatitis B.
• PREHEVBRIO is not used to treat a person who is already infected with the hepatitis B virus including anyone who has previously been infected and who is now a carrier of the virus.

What are the ingredients in PREHEVBRIO?

Medicinal ingredients: Hepatitis B surface antigens (S, pre-S1 and pre-S2).

Non-medicinal ingredients: aluminium hydroxide, disodium phosphate dodecahydrate, hydrochloric acid, potassium chloride, potassium dihydrogen phosphate, sodium chloride, sodium hydroxide, water for injection

PREHEVBRIO contains sodium and potassium. This medicinal product contains less than 1 mmol of sodium (23 mg) per dose, i.e. is essentially 'sodium-free’, and less than 1 mmol of potassium (39 mg) per dose, i.e. is essentially ‘potassium-free’.

PREHEVBRIO comes in the following dosage forms:

Sterile suspension for intramuscular injection supplied as a single-dose vial. A single dose vial of PREHEVBRIO contains 10 micrograms of non-infectious, recombinant Hepatitis B surface antigens (pre-S1, pre-S2 and S) in 1.0 mL of suspension.

You should not receive PREHEVBRIO if:

• if you are allergic to the active medicinal ingredient or any of the other non-medicinal ingredients of vaccine. Signs of an allergic reaction may include breathing difficulty, swelling, light-headedness, fast heartbeat, sweating, and loss of consciousness.
• if you have ever previously had a sudden, life-threatening allergic reaction to any vaccine against hepatitis B.

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

• are pregnant, think you may be pregnant or plan to become pregnant. Your healthcare professional will tell you if you should receive PREHEVBRIO.

• are breast-feeding. It is unknown whether PREHEVBRIO is excreted in human milk. Your healthcare professional will tell you if you should receive PREHEVBRIO.
• are ill with a high fever. Your healthcare professional will tell you if you should receive PREHEVBRIO.
• have low blood platelets or any blood-clotting disorders, then bleeding or bruising may occur after you are given the injection.

Other warnings you should know about:

• If you are on dialysis for a kidney problem or if you have a weakened immune system your doctor may need to do a blood test to check if the vaccination has worked well enough to protect you against hepatitis B.
• Fainting can occur following, or even before, any needle injection, therefore tell your healthcare professional if you fainted with a previous injection
• PREHEVBRIO may not prevent hepatitis B infection if you already have an unrecognised hepatitis B infection at the time of vaccine administration.
• As with any vaccine, PREHEVBRIO may not protect all people who are vaccinated.
• PREHEVBRIO does not protect you against other liver infections such as hepatitis A, C, and E.
• PREHEVBRIO should not be given to individuals under 18 years of age.
• In addition to PREHEVBRIO, you may be given an injection of hepatitis B 'immuno-globulins'. This will give you immediate short-term protection against hepatitis B infection. If this happens, your healthcare professional will make sure that the two injections are given in different parts of the body.

• PREHEVBRIO is unlikely to have any effect on the ability to drive and use machines. If you feel tired, or have a headache or feel dizzy after having the vaccine, do not drive or use any machines until you feel well again.

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 PREHEVBRIO:

There is no information on the use of PREHEVBRIO with other vaccines or medications.

Tell your healthcare professional if you are taking, have recently taken, or might take any other medications, including any other vaccine.

How to take PREHEVBRIO:

PREHEVBRIO will be given to you by a healthcare professional in a healthcare setting.

Usual dose:

• PREHEVBRIO will be injected into a muscle in your upper arm.

You will be given a total of three injections. Each injection will be given on separate visits:

• 1st injection: on a date agreed with your healthcare professional;
• 2nd injection: 1 month after the 1st injection;
• 3rd injection: 6 months after the 1st injection.
• The recommended dose for each injection is 10 micrograms (1.0 mL of injection suspension).
• It is very important that you return for all injections, or the vaccine may not work as well.
• If you have any further questions on the use of PREHEVBRIO, ask your healthcare professional.

If you forget to go back to your healthcare professional at the scheduled time for your next dose, ask your healthcare professional for advice.

Overdose:

Missed Dose:

If you forget to go back to your healthcare professional at the scheduled time for your next dose, ask your healthcare professional for advice.

What are possible side effects from using PREHEVBRIO?

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

Very common (may affect more than 1 in 10 people):

• feeling very tired;
• pain or tenderness at the injection site;
• rash and itching at the injection site;
• muscle pain;
• headache.

Common (may affect up to 1 in 10 people):

• diarrhea;
• feeling sick (nausea/vomiting);
• redness, bruising or swelling at the injection site;
• fever.

Uncommon (may affect up to 1 in 100 people):

• swollen lymph nodes;
• hives or itchy skin;
• dizziness;
• stomach pain;
• flushing or hot flushes;
• rash.

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

Storage:

PREHEVBRIO should be stored, supplied, and administered by a healthcare professional.

Store in a refrigerator at 2°C to 8°C. Protect from light.

Do not freeze; discard if the vaccine has been frozen.

Do not use the vaccine after the expiration date shown on the vial label after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any foreign particulate matter and/or discoloration.

Keep out of reach and sight of children.

If you want more information about PREHEVBRIO:

• 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 1-888-421-8808.

Last Revised March 17, 2023