Twinrix (Intramuscular)

Hepatitis A and hepatitis B combination vaccine is used to prevent infections from all known types of the hepatitis A and hepatitis B viruses. The vaccine helps your body create its own protection (antibodies) against the diseases.

Hepatitis A is a serious liver disease that can be fatal. It is caused by the hepatitis A virus (HAV) and is most commonly spread through contaminated food or water. Hepatitis A can also spread through close contact with infected individuals (like people living in the same household). Even if some infected people do not show symptoms, they can still transmit the virus to others.

Hepatitis A is less common in the U.S. and in areas with good sanitation and effective water and sewage systems. However, it remains a major health issue in regions without these systems. If you are traveling to certain countries or remote areas, the hepatitis A vaccine can help protect you from hepatitis A disease.

Hepatitis B is caused by the hepatitis B virus (HBV) and spreads through contact with body fluids, such as blood, saliva, semen, or vaginal fluids; through needle sticks or sharing needles; or from mother to child.

Hepatitis A and hepatitis B combination vaccine is recommended for all individuals 18 years of age or older who are at risk of infection due to their jobs, behaviors, or travel to the following regions:

• Africa.
• Central and South America.
• Eastern and Southern Europe.
• South and Southeast Asia (except Japan).
• The Caribbean.
• The Middle East.
• The former Soviet Union.

Hepatitis A and Hepatitis B combination vaccine is also recommended for:

• Military personnel.
• People living in or moving to areas with a high rate of HAV infection and who are at high risk of HBV infection.
• Individuals engaging in high-risk sexual activities, such as homosexual and bisexual males.
• Individuals who use illegal injection drugs.
• People at risk through their work, such as laboratory workers handling live hepatitis A and hepatitis B viruses, police, first aid or medical responders, and those who come in contact with stool or sewage.
• People working in child daycare centers and correctional facilities, residents of drug and alcohol treatment centers, and patients and staff in hemodialysis units.
• Individuals at increased risk for HBV infection who are in close contact with patients having hepatitis A or B.
• People with hemophilia.
• People with chronic liver disease.

This vaccine should only be given by or under the supervision of a doctor.

It is important for your doctor to check how you are doing to ensure this vaccine is working correctly. Blood tests may be needed to look for any unwanted effects.

Fainting can happen after you receive this vaccine. Your doctor may want you to be watched after the injection to prevent and handle fainting.

This vaccine may not protect everyone who gets it. This vaccine will not treat symptoms of hepatitis A or hepatitis B infection if you already have the disease. It is very important to take precautions to lower the risk of hepatitis A or hepatitis B infection.

In deciding to use a vaccine, it's important to consider the risks of the vaccine against its benefits. This is a choice you and your doctor will make together. For this vaccine, please consider the following:

Allergies

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

Pediatric

Studies have not been done on how age affects the hepatitis A and hepatitis B combination vaccine in children. Its safety and effectiveness have not been established for this age group.

Geriatric

Studies on how age affects the hepatitis A and hepatitis B combination vaccine in older adults have not been performed. However, no specific problems for older adults have been identified so far.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a risk of interaction. In such cases, your doctor may adjust the dose or take other precautions. When receiving this vaccine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are highlighted for their potential importance but are not necessarily a complete list.

Receiving this vaccine with any of the following medicines is usually not recommended but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this vaccine. Be sure to inform your doctor if you have any other medical problems, especially:

• Allergy to neomycin or
• Allergy to yeast—Should not be used in patients with these conditions.

• Moderate or severe illness with fever—Your dose may need to be given at a later time.

• Weak immune system—This condition may reduce the effectiveness of the vaccine.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

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

More common

• Fever more than 99.5 degrees F
• Unusual tiredness or weakness

Rare

• Difficulty with breathing or swallowing
• Hives
• Itching, especially of the hands or feet
• Reddish skin, especially around the ears
• Swelling of the eyes, face, or inside of the nose
• Unusual tiredness or weakness (sudden and severe)

Incidence not known

• Agitation
• Back pain
• Being forgetful
• Black, tarry stools
• Bleeding gums
• Blistering, peeling, or loosening of the skin
• Blood in the urine or stools
• Bloody nose
• Blurred vision
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Chest tightness
• Chills
• Coma
• Confusion
• Cough
• Dark urine
• Diarrhea
• Difficulty controlling your bladder or bowels
• Difficulty with walking
• Dizziness
• Drowsiness
• Fast, irregular, pounding, or racing heartbeat or pulse
• Feeling of discomfort
• Feeling sad or depressed
• General feeling of illness
• General tiredness and weakness
• Hallucinations
• Headache
• Heavier menstrual periods
• Inability to move the arms and legs
• Increased sweating
• Inflammation of the joints
• Irritability
• Itching
• Joint or muscle pain
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Light-colored stools
• Muscle aches or cramps
• Nausea or vomiting
• Numbness or tingling in your arms, face, hands, or legs
• Partial or slight paralysis
• Pinpoint red spots on the skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rash
• Red, irritated eyes
• Redness, soreness, or itching skin
• Seizures
• Severe headache
• Slurred speech or problems with swallowing
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Sores, welting, or blisters
• Stiff neck or back
• Sudden numbness and weakness in the arms and legs
• Swollen lymph glands
• Trouble breathing
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Upper right abdominal or stomach pain
• Yellow eyes and skin

Some side effects may happen 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

• Body aches or pain
• Ear congestion
• Hard lump, redness, soreness, or swelling at the injection site
• Loss of voice
• Nasal congestion
• Runny nose
• Sneezing

Rare

• Bruising at the injection site
• Dry mouth
• Fainting or lightheadedness when getting up suddenly from a lying or sitting position
• Feeling of constant movement of self or surroundings
• Feeling of warmth
• Headache, severe and throbbing
• Hyperventilation
• Large, flat, blue or purplish patches in the skin at the injection site
• Loss of appetite
• Muscle pain or stiffness
• Pain, swelling, or redness in the joints
• Redness of the face, neck, arms, and occasionally, upper chest
• Restlessness
• Sensation of spinning
• Shaking
• Sleepiness or unusual drowsiness
• Sleeplessness
• Small, red or purple spots on the skin
• Stomach pain
• Sweating
• Trouble with sleeping
• Unusually fast heartbeat
• Unusually warm skin
• Weakness
• Weight loss

Incidence not known

• Acid or sour stomach
• Belching
• Continuing ringing or buzzing or other unexplained noise in the ears
• Disturbed color perception
• Double vision
• Earache
• Hair loss or thinning of the hair
• Halos around lights
• Hearing loss
• Heartburn
• Indigestion
• Night blindness
• Overbright appearance of lights
• Painful blisters on the trunk of the body
• Stomach discomfort or upset
• Tunnel vision
• Weakness of the muscles in your face

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.

• Twinrix

In Canada

• Twinrix Adult
• Twinrix Junior

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

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

This vaccine is usually given as 3 or 4 doses. The first 2 doses are given at least 1 month (for patients receiving 3 doses) or 7 days apart (for patients receiving 4 doses). The third dose is given at least 6 months (for patients receiving 3 doses) or 21 to 30 days (for patients receiving 4 doses) after the first dose. The booster dose is given at least 12 months (for patients receiving 4 doses) after the first dose. To get the best possible protection against infection with the HAV or HBV, you should complete your vaccine dosing schedule.