Recombivax

DRUG DESCRIPTION

RECOMBIVAX HB* Hepatitis B Vaccine (Recombinant) is a non-infectious subunit viral vaccine derived from hepatitis B surface antigen (HBsAg) produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories.

The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. The vaccine contains no detectable yeast DNA but may contain not more than 1% yeast protein. The vaccine produced by the Merck method has been shown to be comparable to the plasma-derived vaccine in terms of animal potency (mouse, monkey, and chimpanzee) and protective efficacy (chimpanzee and human).

The vaccine against hepatitis B, prepared from recombinant yeast cultures, is free of association with human blood or blood products.

Each lot of hepatitis B vaccine is tested for sterility.

RECOMBIVAX (hepatitis b vaccine recombinant) HB is a sterile suspension for intramuscular injection. However, for persons at risk of hemorrhage following intramuscular injection, the vaccine may be administered subcutaneously. (See DOSAGE AND ADMINISTRATION).

RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is supplied in three formulations. (See HOW SUPPLIED.)

Pediatric/Adolescent Formulation (Without Preservative), 10 mcg/mL: each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen.

Adult Formulation (Without Preservative), 10 mcg/mL: each 1 mL dose contains 10 mcg of hepatitis B surface antigen.

Dialysis Formulation (Without Preservative), 40 mcg/mL: each 1 mL dose contains 40 mcg of hepatitis B surface antigen.

All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine. In each formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine. The vaccine is of the adw subtype. RECOMBIVAX (hepatitis b vaccine recombinant) HB is indicated for vaccination of persons at risk of infection from hepatitis B virus including all known subtypes. RECOMBIVAX (hepatitis b vaccine recombinant) HB Dialysis Formulation is indicated for vaccination of adult predialysis and dialysis patients against infection caused by all known subtypes of hepatitis B virus.

What are the possible side effects of this vaccine (Engerix-B, Engerix-B Pediatric, Recombivax HB Adult, Recombivax HB Dialysis Formulation, Recombivax HB Pediatric/Adolescent)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis B is much more dangerous to your health than receiving the vaccine to protect against it....

Read All Potential Side Effects and See Pictures of Recombivax

What are the precautions when taking hepatitis b vaccine (recombinant) (Recombivax)?

Before getting hepatitis B vaccine, tell your doctor or pharmacist if you are allergic to it; or to yeast; or other vaccines; or if you have any other allergies. Some vials and prefilled syringes may use latex rubber stoppers or plungers. Tell your doctor if you are allergic to latex. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (such as hemophilia, low platelets, anticoagulant treatment), current illness with fever.

If you are a hemodialysis patient, you may not respond as well to the vaccine and will need to have hepatitis B antibody levels checked yearly. If...

Read All Potential Precautions of Recombivax

What are the possible side effects of this vaccine (Engerix-B, Engerix-B Pediatric, Recombivax HB Adult, Recombivax HB Dialysis Formulation, Recombivax HB Pediatric/Adolescent)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis B is much more dangerous to your health than receiving the vaccine to protect against it....

Read All Potential Side Effects and See Pictures of Recombivax

What are the precautions when taking hepatitis b vaccine (recombinant) (Recombivax)?

Before getting hepatitis B vaccine, tell your doctor or pharmacist if you are allergic to it; or to yeast; or other vaccines; or if you have any other allergies. Some vials and prefilled syringes may use latex rubber stoppers or plungers. Tell your doctor if you are allergic to latex. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (such as hemophilia, low platelets, anticoagulant treatment), current illness with fever.

If you are a hemodialysis patient, you may not respond as well to the vaccine and will need to have hepatitis B antibody levels checked yearly. If...

Read All Potential Precautions of Recombivax


Recombivax Consumer (continued)

SIDE EFFECTS: Pain/soreness/redness/swelling at the injection site, fever, headache, tiredness, sore throat, nausea, diarrhea, loss of appetite, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Fainting right after the injection may occur. Your healthcare provider will usually watch you for 15 minutes after the injection to monitor you for this reaction.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before getting hepatitis B vaccine, tell your doctor or pharmacist if you are allergic to it; or to yeast; or other vaccines; or if you have any other allergies. Some vials and prefilled syringes may use latex rubber stoppers or plungers. Tell your doctor if you are allergic to latex. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (such as hemophilia, low platelets, anticoagulant treatment), current illness with fever.

If you are a hemodialysis patient, you may not respond as well to the vaccine and will need to have hepatitis B antibody levels checked yearly. If antibodies drop too low over time, you may be given another dose of vaccine (often called a booster shot).

If you have decreased immune function from other medications (see also Drug Interactions) or other illness (such as HIV, leukemia, lymphoma, other cancer), your body may not make enough antibodies to protect you from hepatitis B infection. Antibody levels may be checked after the vaccine series.

The elderly may not make as many antibodies to the vaccine. Talk to your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Recombivax Patient Information Including Side Effects

Brand Names: Engerix-B, Engerix-B Pediatric, Recombivax HB Adult, Recombivax HB Dialysis Formulation, Recombivax HB Pediatric/Adolescent

Generic Name: hepatitis B vaccine (Pronunciation: HEP a TYE tis)

  • What is hepatitis B vaccine (Recombivax)?
  • What are the possible side effects of this vaccine (Recombivax)?
  • What is the most important information I should know about this vaccine (Recombivax)?
  • What should I discuss with my healthcare provider before receiving this vaccine (Recombivax)?
  • How is this vaccine given (Recombivax)?
  • What happens if I miss a dose (Recombivax)?
  • What happens if I overdose (Recombivax)?
  • What should I avoid before or after receiving this vaccine (Recombivax)?
  • What other drugs will affect hepatitis B vaccine (Recombivax)?
  • Where can I get more information?

What is hepatitis B vaccine (Recombivax)?

Hepatitis B is a disease of the liver that is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when a baby is born to a mother who is infected. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

The hepatitis B vaccine is used to help prevent this disease.

This vaccine works by exposing you to a small amount of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Vaccination with hepatitis B vaccine is recommended for all adults and children who are at risk of getting hepatitis B. Risk factors include: having more than one sex partner in 6 months; being a homosexual male; having sexual contact with infected people; having cirrhosis or chronic hepatitis C; using intravenous (IV) drugs; being on dialysis or receiving blood transfusions; working in healthcare or public safety and being exposed to infected blood or body fluids; being in the military or traveling to high-risk areas; and living with a person who has chronic hepatitis B infection.

Like any vaccine, the hepatitis B vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (Recombivax)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis B is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • fussiness, irritability, crying for an hour or longer;
  • fast or pounding heartbeats; or
  • easy bruising or bleeding.

Less serious side effects include:

  • redness, pain, swelling, or a lump where the shot was given;
  • headache, dizziness;
  • low fever;
  • joint pain, body aches;
  • tired feeling; or
  • nausea, vomiting, stomach pain, constipation, diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about this vaccine (Recombivax)?

Hepatitis B vaccine will not protect you against infection with hepatitis A, C, and E, or other viruses that affect the liver. It will also not protect you from hepatitis B if you are already infected with the virus, even if you do not yet show symptoms.

Vaccination with hepatitis B vaccine is recommended for all adults and children who are at risk of getting hepatitis B. Risk factors include: having more than one sex partner in 6 months; being a homosexual male; having sexual contact with infected people; having cirrhosis or chronic hepatitis C; using intravenous (IV) drugs; being on dialysis or receiving blood transfusions; working in healthcare or public safety and being exposed to infected blood or body fluids; being in the military or traveling to high-risk areas; and living with a person who has chronic hepatitis B infection.

The hepatitis B vaccine is given in a series of shots. The booster shots are sometimes given 1 month and 6 months after the first shot. If you have a high risk of hepatitis B infection, you may be given an additional booster 2 months after the first shot.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis B is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Related Drug Centers
  • Recombivax
  • Engerix B


Related Drugs Index: