Imovax Rabies (Intramuscular)

Rabies vaccine is a type of medicine that helps your body fight off the rabies virus. It works by making your body produce its own protection (antibodies) against the virus.

Rabies vaccine is used in two main ways. It is given to people who have been exposed (for example, through a bite, scratch, or lick) to an animal that is known or suspected to have rabies. This is known as post-exposure prophylaxis. The vaccine can also be given ahead of time to people who are at high risk of getting infected with the rabies virus. This includes veterinarians, animal handlers, travelers who will be in countries with a high rabies infection rate for more than 1 month, and people who live, work, or vacation in areas where they may come into contact with wild animals. This is called pre-exposure prophylaxis.

Rabies infection is a serious and often deadly illness. In the U.S., most rabies cases in humans, pets, and other domestic animals come from wild animals like raccoons, skunks, foxes, and bats. In Canada, the animals most commonly infected with rabies are foxes, skunks, bats, dogs, and cats. Horses, pigs, and cattle can also get rabies. In many other parts of the world, including Latin America, Africa, and Asia, dogs are the main source of rabies cases in 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, as you may need additional treatment.

This vaccine should only be given by or under the supervision of your doctor or another health care professional.

It is very important that your doctor checks you or your child's progress at regular visits to ensure that this vaccine is working properly. Blood tests may be needed to check for side effects.

This medicine is made from donated human blood. There is a very small risk of transmitting viral diseases. Human donors and donated blood are both tested for viruses to keep this risk low. Talk with your doctor about this risk if you are worried.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a vaccine, you and your doctor must weigh the risks of taking the vaccine against its benefits. For this vaccine, consider the following:

Allergies

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

Pediatric

Studies done so far have not shown any specific problems in children that would limit the use of the rabies vaccine.

Geriatric

There is no information available about how age affects the use of the rabies vaccine in older patients.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together, even if an interaction could happen. In these situations, your doctor may adjust the dose, or other precautions may be needed. 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 considered significant but may not include all possible interactions.

Using this vaccine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Chloroquine
• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used 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. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Severe illness with fever—Symptoms of this illness may be confused with possible side effects of the vaccine.

• Immune system problems—These may reduce the effectiveness of the vaccine.

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

Contact your doctor or nurse right away if any of the following side effects occur:

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• confusion
• cough
• difficulty with moving
• difficulty with swallowing
• fast heartbeat
• feeling of discomfort
• irritability
• lack or loss of strength
• muscle pain, stiffness, or weakness
• paralysis or severe weakness of the legs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• seizures
• skin rash, hives, or redness
• stiffness of arms, legs, or neck
• swelling of the joints
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tightness in the chest
• unusual tiredness
• vomiting

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. Additionally, your health care professional may be able to explain ways to prevent or lessen some of these side effects. Contact your health care professional if any of the following side effects continue, 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 injection site
• muscle or joint aches
• nausea
• stomach pain

Incidence not known

• Bruising at the injection site
• diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, consult 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.

• Imovax Rabies
• Rabavert

Available Dosage Forms:

• Powder for Suspension

Therapeutic Class: Vaccine

You will receive this vaccine while you are in a hospital or clinic. A nurse or other trained health professional will give you this vaccine. The vaccine is injected into the upper arm muscle (deltoid). Very young or small children may have the vaccine injected into the upper leg (thigh) muscle.

If you are a veterinarian, work with animals, or will be going to a country where rabies is common, you are at risk for exposure to the rabies virus. If you are getting the vaccine because you are at risk of being exposed to rabies, you will receive 3 doses on 3 different days within a 1-month period.

If you have already received the vaccine in the past and have been exposed to the rabies virus, you will need to get 2 doses on 2 different days within a 1-month period.

If you have not yet received the vaccine and were exposed to the rabies virus, you will need a total of 5 doses on 5 different days within a 1-month period. You will also receive a shot of rabies immune globulin.

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

Missed Dose

Call your doctor or pharmacist for instructions.