Heplisav-B

What is Heplisav-B used for?

Heplisav-B is a vaccine that is used to prevent hepatitis B infection.

Description

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] is a sterile solution for intramuscular injection.

The HBsAg is expressed in a recombinant strain of Hansenula polymorpha yeast. The fermentation process involves growth of the recombinant H. polymorpha on chemically-defined fermentation media containing vitamins and mineral salts.

The HBsAg is expressed intra-cellularly in the yeast cells. It is released from the yeast cells by cell disruption and purified by a series of physicochemical steps. Each dose may contain residual amounts of yeast protein (≤5.0% of total protein), yeast DNA (<20 picogram), and deoxycholate (<0.9 ppm) from the HBsAg manufacturing process.

HEPLISAV-B is prepared by combining the purified HBsAg together with the CpG 1018 adjuvant, a 22-mer phosphorothioate linked oligodeoxynucleotide in a phosphate buffered saline (sodium chloride, 9.0 mg/mL; sodium phosphate, dibasic dodecahydrate, 1.75 mg/mL; sodium phosphate, monobasic dihydrate, 0.48 mg/mL; and polysorbate 80, 0.1 mg/mL).

Each 0.5-mL dose is formulated to contain 20 mcg of HBsAg and 3000 mcg of CpG 1018 adjuvant.

HEPLISAV-B is available in prefilled syringes. The tip caps and stoppers of the prefilled syringes are not made with natural rubber latex.

HEPLISAV-B is formulated without preservatives.

Mechanism of Action

Infection with hepatitis B virus can have serious consequences including acute massive hepatic necrosis and chronic active hepatitis. Chronically infected persons are at increased risk for cirrhosis and hepatocellular carcinoma.

Antibody concentrations ≥10 mIU/mL against HBsAg are recognized as conferring protection against hepatitis B virus infection.

Before taking Heplisav-B, tell your doctor:

• If you are allergic to Heplisav-B; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Heplisav-B with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Heplisav-B?

• Tell all of your health care providers that you take Heplisav-B. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may not protect all people who use it. Talk with the doctor.
• This medicine is a vaccine with a virus that is not active. It cannot cause the disease.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Heplisav-B.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Heplisav-B while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Heplisav-B best taken?

Use Heplisav-B as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Heplisav-B that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Heplisav-B?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain where the shot was given.
• Feeling tired or weak.
• Headache.
• Muscle pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Heplisav-B?

• If you need to store Heplisav-B at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

Principal Panel – Carton – Prefilled Syringes

• NDC 43528-003-05           Rx only
• Hepatitis B Vaccine
  (Recombinant),
  Adjuvanted
• HEPLISAV-B®
• 5 x 0.5 mL single-dose syringes
• For intramuscular
  administration only
• For Adult Use Only
• NEEDLES NOT INCLUDED
• DYNAVAX

 

Principal Panel – Label – Prefilled Syringes

• HEPLISAV-B®
• 1 dose (0.5 mL)
• Hepatitis B Vaccine
  (Recombinant), Adjuvanted
• NDC 43528-003-01     Rx only
  For IM use only DO NOT FREEZE
  Store at 2-8°C (36-46°F)
  Mfd. by Dynavax Tech. Corp.

SRC: NLM .