Anti-thymocyte globulin rabbit

Anti-thymocyte globulin is a sterilized solution made of the cells of rabbits that have been injected with white blood cells from humans.

Anti-thymocyte globulin lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Anti-thymocyte globulin is used together with other medicines to prevent your body from rejecting a kidney transplant.

Anti-thymocyte globulin may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with anti-thymocyte globulin. Stop using this medicine and call your doctor right away if you have signs of infection such as:

• fever, chills, body aches, flu symptoms;

• mouth and throat ulcers;

• rapid heart rate, rapid and shallow breathing;

• weakness, tired feeling; or

• feeling like you might pass out.

Call your doctor at once if you have a serious side effect such as:

• white patches inside your mouth or on your lips;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• swollen glands, rash or itching, joint pain;

• pain or burning when you urinate;

• dry cough, wheezing, feeling short of breath;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling; or

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Less serious side effects may include:

• headache, dizziness;

• nausea, vomiting, diarrhea, stomach pain;

• swelling in your hands or feet; or

• pain, swelling, or redness where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to anti-thymocyte globulin (rabbit): intravenous powder for solution

Along with its needed effects, anti-thymocyte globulin (rabbit) 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 while taking anti-thymocyte globulin (rabbit):

• 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 of anti-thymocyte globulin (rabbit) 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

Applies to anti-thymocyte globulin (rabbit): intravenous powder for injection

General

General side effects have included chills, fever, infections and pain.[Ref]

Cardiovascular

Cardiovascular side effects have included hypertension, peripheral edema, tachycardia, pulmonary edema and myocardial infarction.[Ref]

Other

Other side effects have included infections (bacterial, fungal, viral and protozoal), reactivation of infections (particularly cytomegalovirus [CMV]) and sepsis.[Ref]

Nervous system

Nervous system side effects have included headache, malaise, asthenia and dizziness.[Ref]

Hematologic

Hematologic side effects have included leukopenia and thrombocytopenia.[Ref]

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal and oral moniliasis, abdominal pain, nausea, diarrhea and vomiting.[Ref]

Genitourinary

Genitourinary side effects have included urinary tract infection and vaginitis.[Ref]

Dermatologic

Dermatologic side effects have included herpes simplex infections and rash.[Ref]

Respiratory

Respiratory side effects have included pneumonia, acute respiratory distress syndrome, pulmonary edema and dyspnea.[Ref]

Metabolic

Metabolic side effects have included hyperkalemia.[Ref]

Some side effects of anti-thymocyte globulin (rabbit) may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

1.5 mg/kg/day by IV infusion for 7 to 14 days.

Data not available

Data not available

Anti-thymocyte globulin has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Anti-thymocyte globulin is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk