Pronunciation:

an-tye-THYE-moe-site GLOB-ue-lin RAB-it

Brand Names:

• Thymoglobulin

Dosage Forms:

• Powder for Solution

Warnings:

Antithymocyte globulin rabbit should only be used by physicians experienced in immunosuppressive therapy in transplantation .

Classifications:

Therapeutic—

Immune Suppressant

Uses of This Medicine:

Anti-thymocyte globulin (rabbit) injection is used together with other medicines to prevent and treat the body from rejecting a transplanted kidney.

This medicine is an immunosuppressant. When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Anti-thymocyte globulin (rabbit) works by preventing the white blood cells from doing this.

The effect of anti-thymocyte globulin (rabbit) on the white blood cells may also reduce the body's ability to fight infections. Before you begin treatment, you and your doctor should talk about the benefits of this medicine as well as the risks of using it.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of anti-thymocyte globulin (rabbit) injection in children. However, safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of anti-thymocyte globulin (rabbit) injection in geriatric patients.

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 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 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.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Belatacept
• Cholera Vaccine, 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 Monkeypox Vaccine
• Typhoid Vaccine, Live
• 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:

• Allergic to rabbit protein, history of—Should not be used in patients with this condition.

• Infection—May decrease your body's ability to fight infection.

• Liver disease—Use with caution. May make this condition worse.

Proper Use of This Medicine:

A doctor will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so the needle will need to stay in place for 4 to 6 hours.

This medicine is usually given for 4 to 7 days to prevent rejection of the kidney transplant. It is given for 7 to 14 days to treat rejection of the kidney transplant.

You may be given other medicines (eg, acetaminophen, steroids, allergy medicines) at least 1 hour before you receive anti-thymocyte globulin (rabbit) injection to help prevent infusion reactions.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious types of allergic reactions, including infusion reaction and anaphylaxis. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have cough, trouble breathing, hives, itching, or skin rash, lightheadedness, dizziness, or fainting, tightness in the chest, or swelling of the face or lips.

Anti-thymocyte globulin (rabbit) can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may increase your risk of getting cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

While you are being treated with anti-thymocyte globulin (rabbit), and after you stop treatment with it, it is important to see your doctor about the immunizations (vaccinations) you should receive. Do not get any immunizations (vaccines) without your doctor's approval. Anti-thymocyte globulin (rabbit) may lower your body's resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

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

Black, tarry stools

bladder pain

bleeding gums

blurred vision

chest pain

chills

cloudy or bloody urine

cold

confusion

cough or hoarseness

diarrhea

dizziness

fast heartbeat

fever

frequent urge to urinate

general feeling of discomfort or illness

headache

irregular or slow heartbeat

joint pain

loss of appetite

lower back or side pain

muscle aches and pains

nausea

nervousness

numbness or tingling around the lips, hands, or feet

painful or difficult urination

pounding in the ears

runny nose

shivering

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

troubled breathing

unexplained anxiety

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weakness or heaviness of the legs

Less common

Burning feeling in chest or stomach tenderness

burning or stinging of the skin

indigestion

inflammation of joints

painful cold sores or blisters on the lips, nose, eyes, or genitals

stomach upset

Rare

Difficulty swallowing

hives, itching, rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

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

Abdominal or stomach pain

anxiety

loss of strength or energy

nausea

pain

swelling of the ankles, feet, and fingers

tightness in the chest

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.