Thymoglobulin (Intravenous)

Anti-thymocyte globulin (rabbit) injection is used along with other medicines to prevent and treat kidney transplant rejection.

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

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

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

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 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 a 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, which increases 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.

In deciding to use a medicine, it is important to consider the risks of taking the medicine against the benefits it may provide. This decision will be made between you and your doctor. For this medicine, the following points should be taken into account:

Allergies

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

Pediatric

Studies conducted so far have not shown any specific problems in children that would limit the usefulness of anti-thymocyte globulin (rabbit) injection. However, safety and effectiveness have not been confirmed.

Geriatric

There is no information available about how age affects the effects of anti-thymocyte globulin (rabbit) injection in older patients.

Breast Feeding

There are no adequate studies on women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. When receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and may not be a complete list.

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

• Adenovirus Vaccine
• 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 Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the same time as eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works. Be sure to tell your doctor about any other medical problems, especially:

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

• Infection—May reduce your body's ability to fight infections.

• Liver disease—Use with caution. May worsen this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, 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. Your health care professional may also 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.

In the U.S.

• Thymoglobulin

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Immune Suppressant

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.