Antithymocyte globulin rabbit Intravenous

In the U.S.

• Thymoglobulin

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Immune Suppressant

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

antithymocyte globulin rabbit 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 antithymocyte globulin rabbit as well as the risks of using it.

antithymocyte globulin rabbit is to be given only by or under the direct supervision of your doctor.

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 antithymocyte globulin rabbit, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to antithymocyte globulin rabbit 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 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.

Geriatric

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

Pregnancy

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.

Interactions with 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 antithymocyte globulin rabbit, 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 antithymocyte globulin rabbit 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
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera 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
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

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 antithymocyte globulin rabbit. 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.

A doctor will give you antithymocyte globulin rabbit in a hospital. antithymocyte globulin rabbit 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.

antithymocyte globulin rabbit 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

antithymocyte globulin rabbit 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.

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:

• 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

• 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

• 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:

• 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.