Pronunciation:

RAY-beez vak-seen

Brand Names:

• Imovax Rabies
• Rabavert

Dosage Forms:

• Powder for Solution
• Injectable
• Powder for Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Rabies vaccine is an active immunizing agent used to prevent infection caused by the rabies virus. The vaccine works by causing your body to produce its own protection (antibodies) against the rabies virus.

Rabies vaccine is used in two ways. Rabies vaccine is given to persons who have been exposed (for example, by a bite, scratch, or lick) to an animal that is known, or thought, to have rabies. This is called post-exposure prophylaxis. Rabies vaccine may also be given ahead of time to persons who have a high risk of getting infected with rabies virus. These persons include veterinarians, animal handlers, travelers who will spend more than 1 month in countries having a high rate of rabies infection, and persons who live, work, or take vacations in wild areas of the country where they are likely to come into contact with wild animals. This is called pre-exposure prophylaxis.

Rabies infection is a serious, and often fatal, infection. In the U.S., rabies in wild animals, especially raccoons, skunks, and bats, accounts for most cases of rabies passed on to humans, pets, and other domestic animals. In Canada, the animals most often infected with rabies are foxes, skunks, bats, dogs, and cats. Horses, swine, and cattle also have been known to become infected with rabies. In much of the rest of the world, including Latin America, Africa, and Asia, dogs account for most cases of rabies passed on to humans.

If you are being (or will be) treated for a possible rabies infection while traveling outside of the U.S. or Canada, contact your doctor as soon as you return to the U.S. or Canada, since it may be necessary for you to have additional treatment.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

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—

This vaccine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—

Many vaccines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of rabies vaccine in the elderly with use in other age groups.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

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.

• Chloroquine

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:

• Illness, severe, with fever—The symptoms of the condition may be confused with the possible side effects of the vaccine.

• Immune deficiency condition (or family history of)—May decrease the useful effects of the vaccine

Proper Use of This Medicine:

In order for rabies vaccine to work properly, it is very important that you do not miss any doses. Keep your appointments with your doctor.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For post-exposure prophylaxis if you have never received rabies vaccine before:
    • Adults and children—One dose on the first day, then one dose three, seven, fourteen, and twenty-eight days later for a total of five doses. The vaccine is injected into the muscle (deltoid) in the upper arm. Very young or small children may have the vaccine injected into the upper leg (thigh) muscle. On the first day, you will also receive an injection of another medicine (rabies immune globulin).
  • For post-exposure prophylaxis if you have received rabies vaccine before:
    • Adults and children—One dose on the first day, then one dose three days later for a total of two doses. The vaccine is injected into the muscle (deltoid) in the upper arm. Very young or small children may have the vaccine injected into the upper leg (thigh) muscle.
  • For pre-exposure prophylaxis if you have never received rabies vaccine before:
    • Adults and children—One dose on the first day, then one dose seven and twenty-one or twenty-eight days later for a total of three doses. The vaccine is injected into the muscle (deltoid) in the upper arm. Very young or small children may have the vaccine injected into the upper leg (thigh) muscle.
  • For pre-exposure prophylaxis if you have received rabies vaccine before (also known as a booster dose):
    • Adults and children—One dose injected into the muscle (deltoid) in the upper arm. Very young or small children may have the vaccine injected into the upper leg (thigh) muscle.

• For injection dosage form:
  • For post-exposure prophylaxis if you have never received rabies vaccine before:
    • Adults and children—One dose on the first day, then one dose three, seven, fourteen, and twenty-eight days later for a total of five doses. The vaccine is injected into the muscle (deltoid) in the upper arm. Very young or small children may have the vaccine injected into the upper leg (thigh) muscle. On the first day, you will also receive an injection of another medicine (rabies immune globulin).
  • For post-exposure prophylaxis if you have received rabies vaccine before:
    • Adults and children—One dose on the first day, then one dose three days later for a total of two doses. The vaccine is injected into the muscle (deltoid) in the upper arm. Very young or small children may have the vaccine injected into the upper leg (thigh) muscle.
  • For pre-exposure prophylaxis if you have never received rabies vaccine before:
    • Adults and children—One dose on the first day, then one dose seven and twenty-one or twenty-eight days later for a total of three doses. The vaccine is injected into, or under the skin of, the muscle (deltoid) in the upper arm. Very young or small children may have the vaccine injected into the upper leg (thigh) muscle.
  • For pre-exposure prophylaxis if you have received rabies vaccine before (also known as a booster dose):
    • Adults and children—One dose injected into, or under the skin of, the muscle (deltoid) in the upper arm. Very young or small children may have the vaccine injected into the upper leg (thigh) muscle.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

This vaccine may cause some people to become dizzy. Make sure you know how you react to this vaccine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.

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 as soon as possible if any of the following side effects occur:

Rare

Hives or skin rash

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

Chills

dizziness

fever

general feeling of discomfort or illness

headache

itching, pain, redness, or swelling at the place of injection

muscle or joint aches

nausea

stomach or abdomen pain

tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.