Pronunciation:

hep-a-TYE-tis A VAX-een, in-AK-ti-vay-ted, hep-a-TYE-tis B VAX-een re-KOM-bin-ant

Brand Names:

• Twinrix
• Twinrix Adult
• Twinrix Junior

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Hepatitis A and hepatitis B combination vaccine is used to prevent infection caused by all known subtypes of the hepatitis A and hepatitis B virus. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Hepatitis A is a serious disease of the liver that can cause death. It is caused by the hepatitis A virus (HAV), and is spread most often through infected food or water. Hepatitis A may also be spread by close person-to-person contact with infected persons (such as between persons living in the same household). Although some infected persons do not appear to be sick, they are still able to spread the virus to others.

Hepatitis A is less common in the U.S. and other areas of the world that have a higher level of sanitation and good water and sewage (waste) systems. However, it is a significant health problem in parts of the world that do not have such systems. If you are traveling to certain countries or remote (out-of-the-way) areas, hepatitis A vaccine will help protect you from hepatitis A disease.

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

Hepatitis A and hepatitis B combination vaccine is recommended for all persons 18 years of age or older who are at risk from infection from their jobs or some behaviors, or from traveling to the following parts of the world:

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

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

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of hepatitis A and hepatitis B combination vaccine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of hepatitis A and hepatitis B combination vaccine have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell 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 decrease the useful effects of the vaccine.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is important that your doctor check your progress to make sure this vaccine is working properly. Blood tests may be needed to check for unwanted effects.

Fainting may occur after you receive this vaccine. Your doctor may want you to be observed after you get the injection to prevent and manage fainting.

This vaccine may not protect everyone who receives 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 reduce the risk of hepatitis A or hepatitis B infection.

Side Effects of This Medicine:

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

reddening of the 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 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

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.