Pronunciation:

hep-a-TYE-tis B VAX-een ree-KOM-bi-nant, AD-joo-van-ted

Brand Names:

• Heplisav-B
• Prehevbrio

Dosage Forms:

• Solution
• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Hepatitis B vaccine is used to prevent infection caused by all known subtypes of the hepatitis B virus.

This vaccine is to be given by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of hepatitis B vaccine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hepatitis B vaccine in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to yeast—Heplisav-B® should not be used in patients with this condition.

• Hepatitis B infection, active or unrecognized or
• Weak immune system—May decrease the effect of the vaccine and the body's response to it.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot into one of your muscles, usually in the deltoid (upper arm).

Prehevbrio™ is given in 3 doses. The first 2 doses are given at least 1 month apart. The third dose is given at least 6 months after the first dose. Heplisav-B® is given in 2 doses, at least 1 month apart. To get the best possible protection against infection with the HBV virus, you should complete your vaccine dosing schedule.

Precautions While Using This Medicine:

It is important that your doctor check your progress to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results..

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

Chest pain or discomfort

inability to move the arms and legs

nausea

pain or discomfort in the arms, jaw, back, or neck

sudden numbness and weakness in the arms and legs

sweating

vomiting

Incidence not known

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest tightness

cough

difficulty swallowing

dizziness

fast heartbeat

hives, itching, skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

stomach pain

trouble breathing

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty in moving

general feeling of discomfort or illness

headache

joint pain

muscle aches, cramps, pains, or stiffness

pain or tenderness at the injection site

swollen joints

Less common

Fever

redness or swelling at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.