Rabies immune globulin (intramuscular route)


    Brand Name

    US Brand Name

    Bayrab

    HyperRAB S/D

    Imogam Rabies-HT

    Kedrab


    Description

    Rabies immune globulin is used together with rabies vaccine to prevent infection caused by the rabies virus. It works by giving your body the antibodies it needs to protect it against the rabies virus. This is called passive protection. This passive protection lasts long enough to protect your body until it can produce its own antibodies against the rabies virus.

    Rabies immune globulin is given to persons who have been exposed (eg, by a bite, scratch, or lick) to an animal that is known or thought to have rabies. This is called post-exposure prophylaxis. Rabies immune globulin is used only in persons who have never before received the rabies vaccine.

    Rabies infection is serious and often fatal. In the U.S., rabies in wild animals, especially raccoons, skunks, and bats, accounts for the 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 have also been known to become infected with rabies. In much of the rest of the world, including Latin America, Africa, and Asia, dogs account for the 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 medicine is to be given only by or under the supervision of your doctor or other health care professional.

    This product is available in the following dosage forms:

    • Solution

    Before Using

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

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of rabies immune globulin in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    No information is available on the relationship of age to the effects of HyperRAB® in geriatric patients.

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of KedRAB® in the elderly.

    Breastfeeding

    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.

    Drug Interactions

    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 medicine, 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.

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Adenovirus Vaccine Type 4, Live
    • Adenovirus Vaccine Type 7, Live
    • 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

    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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Bleeding disorders or
    • Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.
    • 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 (increase in the consistency of the blood) or
    • Patients requiring inactivity for a long time or—Use with caution. May increase the risk for developing thrombosis (blood clots).
    • Immunoglobulin A (IgA) deficiencies—Rabies immune globulin may cause an allergic reaction to occur.

    Proper Use

    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.


    Precautions

    It is very important that your doctor check you closely to make sure that 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. Human donors and donated blood are both tested for viruses to 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 have any immunizations (vaccinations) without your doctor's approval. You should not receive measles vaccine within 4 months after receiving rabies immune globulin. You should not also receive other live virus vaccines (eg, 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.


    Side Effects

    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

    • 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. 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

    • 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.






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