Twinrix

DRUG DESCRIPTION

TWINRIX® [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine] is a sterile bivalent vaccine containing the antigenic components used in producing HAVRIX® (Hepatitis A Vaccine, Inactivated) and ENGERIX-B® [Hepatitis B Vaccine (Recombinant)]. TWINRIX (hepatitis a inactivated & hepatitis b recombinant vaccine) is a sterile suspension of inactivated hepatitis A virus (strain HM175) propagated in MRC-5 cells, and combined with purified surface antigen of the hepatitis B virus. The purified hepatitis B surface antigen (HBsAg) is obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus, in synthetic media containing inorganic salts, amino acids, dextrose, and vitamins. Bulk preparations of each antigen are adsorbed separately onto aluminum salts and then pooled during formulation.

A 1.0-mL dose of vaccine contains 720 ELISA Units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum in the form of aluminum phosphate and aluminum hydroxide as adjuvants, amino acids, 5.0 mg 2-phenoxyethanol as a preservative, sodium chloride, phosphate buffer, polysorbate 20, Water for Injection, traces of formalin (not more than 0.1 mg), a trace amount of thimerosal (<1 mcg mercury) from the manufacturing process, and residual MRC-5 cellular proteins (not more than 2.5 mcg). Neomycin sulfate, an aminoglycoside antibiotic, is included in the cell growth media; only trace amounts (not more than 20 ng) remain following purification. The manufacturing procedures used to manufacture TWINRIX (hepatitis a inactivated & hepatitis b recombinant vaccine) result in a product that contains no more than 5% yeast protein.

TWINRIX (hepatitis a inactivated & hepatitis b recombinant vaccine) is supplied as a sterile suspension for intramuscular administration. The vaccine is ready for use without reconstitution; it must be well shaken before administration to obtain a homogeneous, turbid, white suspension.

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

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 A or B is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is...

Read All Potential Side Effects and See Pictures of Twinrix »

What are the precautions when taking hepatitis a inactivated & hepatitis b (recombinant) vaccine (Twinrix)?

Before getting hepatitis A/hepatitis B vaccine, tell your doctor or pharmacist if you are allergic to it; or to other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex rubber, yeast, neomycin, formalin), 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 A or B antibody levels checked yearly. If antibodies drop too low over time, you may be given another dose of...

Read All Potential Precautions of Twinrix »


Twinrix Consumer (continued)

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

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. Report all side effects to your doctor before you receive the next injection.

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 A/hepatitis B vaccine, tell your doctor or pharmacist if you are allergic to it; or to other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex rubber, yeast, neomycin, formalin), 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 A or 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 A or 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.


Twinrix Patient Information Including Side Effects

Brand Names: Twinrix

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

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

What is hepatitis A and hepatitis B vaccine (Twinrix)?

Hepatitis A and B are serious diseases caused by virus.

Hepatitis A is spread through contact with the stool (bowel movements) of a person infected with the hepatitis A virus. This usually occurs by eating food or drinking water that has become contaminated as a result of handling by an infected person.

Hepatitis B 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 A and hepatitis B vaccine is used to help prevent these diseases. The vaccine works by exposing you to a small dose 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 A and hepatitis B is recommended for all adults who are at risk of getting hepatitis A or 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 either hepatitis A or B infection.

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

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

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 A or B is much more dangerous to your health than receiving the vaccine to protect against these diseases. 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;
  • fast or pounding heartbeats; or
  • easy bruising or bleeding.

Less serious side effects include:

  • redness, pain, tenderness, swelling, or a hard lump where the shot was given;
  • headache, tired feeling;
  • mild fever;
  • runny or stuffy nose, sore throat, other cold symptoms; or
  • nausea, vomiting, loss of appetite, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

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

You should not receive this vaccine if you are allergic to yeast or neomycin (Mycafradin, Neo-Fradin, Neo-Tab), or if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A or hepatitis B.

Before receiving this vaccine, tell the doctor if you have multiple sclerosis, a bleeding or blood clotting disorder, seizures, a weak immune system, if you are taking a blood thinner, or if you are allergic to rubber.

Vaccination with hepatitis A and hepatitis B is recommended for all adults who are at risk of getting hepatitis A or 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 either hepatitis A or B infection.

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

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

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 A or B is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Related Drug Centers
  • Twinrix


Related Drugs Index: