Prehevbrio (Intramuscular)

Hepatitis B vaccine is used to prevent infection from all known types of the hepatitis B virus.

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

It is important for your doctor to monitor your progress to ensure this medicine is effective. Blood tests may be required to check for side effects.

This vaccine can cause serious allergic reactions, including anaphylaxis, which can be life-threatening and need immediate medical help. Contact your doctor right away if you experience a rash, itching, a rapid heartbeat, difficulty breathing, trouble swallowing, or any swelling of your hands, face, or mouth after getting the vaccine.

Inform any doctor or dentist treating you that you are using this medicine. This medicine may impact the results of certain medical tests.

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

In deciding to use a vaccine, you and your doctor need to weigh the risks against the benefits. For this vaccine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care provider know about any other allergies, including food, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the effects of the hepatitis B vaccine in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of the hepatitis B vaccine.

Breast Feeding

There are no adequate studies in breastfeeding women to determine the risk to infants when using this medication. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare provider if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this vaccine. Be sure to 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, whether active or unrecognized, or
• Weak immune system—This may reduce the vaccine's effectiveness and the body's response to it.

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

In the U.S.

• Heplisav-B
• Prehevbrio

Available Dosage Forms:

• Solution
• Suspension

Therapeutic Class: Vaccine

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.