Imogam Rabies-HT (Intramuscular)

Rabies immune globulin is used along with the rabies vaccine to prevent infection from the rabies virus. It helps your body by providing the antibodies needed to protect against the rabies virus. This is known as passive protection. This protection lasts long enough for your body to make its own antibodies against the rabies virus.

Rabies immune globulin is given to people who have been exposed (for example, by a bite, scratch, or lick) to an animal that is known or suspected to have rabies. This is referred to as post-exposure prophylaxis. Rabies immune globulin is only used in individuals who have never received the rabies vaccine before.

Rabies infection is very serious and often fatal. In the U.S., rabies cases in wild animals, particularly raccoons, skunks, and bats, are the main sources of rabies transmission to humans, pets, and other domestic animals. In Canada, the animals most frequently infected with rabies include foxes, skunks, bats, dogs, and cats. Horses, pigs, and cattle can also get rabies. In many other parts of the world, such as Latin America, Africa, and Asia, dogs are the primary source of rabies transmission 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 get back to the U.S. or Canada, as you may need additional treatment.

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

It is very important that your doctor checks you closely to make sure this medicine is working properly. Blood tests are needed to check for unwanted effects.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Both human donors and donated blood are tested for viruses to help keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

While you are being treated with rabies immune globulin, do not get any immunizations (vaccinations) without your doctor's approval. You should not receive the measles vaccine within 4 months after receiving rabies immune globulin. You should also not receive other live virus vaccines (e.g., mumps, polio, rubella) within 3 months after receiving this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may increase your risk of developing blood problems, including blood clots or hemolysis (breakdown of red blood cells). Check with your doctor right away if you have swelling and pain in your arms, legs, or stomach, chest pain, shortness of breath, loss of sensation, confusion, problems with muscle control or speech, stomach or back pain, dark urine, decreased urination, fever, tiredness, or yellow eyes or skin.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. Here are some important points to consider for this medicine:

Allergies

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

Pediatric

There have not been enough studies to determine how rabies immune globulin affects children. Safety and effectiveness have not been established in this age group.

Geriatric

There is no information available on how HyperRAB® affects older patients.

Studies have not found specific problems in older adults that would limit the usefulness of KedRAB®.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if an interaction might happen. In these cases, your doctor may need to adjust the dose or take other precautions. When you receive this medicine, it's important for your healthcare professional to know if you are taking any of the following medicines. The following interactions have been chosen based on their potential significance and may not include all possibilities.

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both may be necessary for your treatment. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Adenovirus Vaccine
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around mealtime or with certain foods due to possible interactions. Drinking alcohol or using tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to tell your doctor about any other medical problems you have, particularly:

• Bleeding disorders or
• Thrombocytopenia (low number of platelets)—Use with caution. This may worsen these conditions.

• Blood clotting problems, or history of, or
• Heart and blood vessel problems, or history of, or
• High cholesterol or fats in the blood, or
• Hyperviscosity syndrome (increased thickness of the blood), or
• Patients who need to remain inactive for an extended period—Use with caution. This may increase the risk of developing thrombosis (blood clots).

• Immunoglobulin A (IgA) deficiencies—Rabies immune globulin may cause an allergic reaction.

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

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Body aches or pain
• Chills
• Cough
• Difficulty in breathing
• Ear congestion
• Fever
• Headache
• Loss of voice
• Nasal congestion
• Runny nose
• Sneezing
• Sore throat
• Unusual tiredness or weakness

Rare

• Cloudy or bloody urine
• High blood pressure
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Swelling of the face, feet, or lower legs

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. Your health care professional may also 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, are bothersome, or if you have any questions about them:

More common

• Dizziness
• Joint pain
• Muscle pain
• Pain, soreness, tenderness, or stiffness at the injection site

Less common

• Fever

Rare

• Skin rash

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.

• Bayrab
• HyperRAB S/D
• Imogam Rabies-HT
• Kedrab

Available Dosage Forms:

• Solution

Therapeutic Class: Immune Serum

A doctor, nurse, or other trained health professional will give you this medicine in a hospital or clinic. It is given as a shot in the upper arm (deltoid) or thigh muscle. It may also be injected directly into the body part that was bitten or scratched which caused your exposure to rabies.

This medicine is given together with your first rabies vaccine dose as soon as possible after exposure. It may also be given within 7 days after the first dose of the rabies vaccine.

All bite wounds and scratches should be cleaned well right away with soap and water. Other medicines (including povidone-iodine solution, anti-tetanus vaccine, or medicine to treat infection) should be given as directed by your doctor.