Antithymocyte Globulin Rabbit

Antithymocyte Globulin Rabbit is a purified, pasteurized, gamma immune globulin, indicated for the treatment of renal transplant acute rejection in conjunction with concomitant immunosuppression.

• Antithymocyte Globulin Rabbit is available under the following different brand names: Thymoglobulin, ATG rabbit

Adult dosage

Powder for injection

• 25mg/vial

Acute Renal Graft Rejection

Adult dosage

• Treatment: 1.5 mg/kg IV infusion every day for 7-14 days  
• Prophylaxis: 1.5 mg/kg IV every day with the first dose initiated before reperfusion of the donor's kidney; usual duration is 4-7 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Antithymocyte Globulin Rabbit include:

• chills
• low levels of white blood cells (leukopenia)
• headache
• abdominal pain
• high blood pressure (hypertension)
• nausea
• shortness of breath
• high levels of potassium in the blood (hyperkalemia)
• muscle pain
• insomnia
• low blood pressure (hypotension)
• rash
• sweating
• a general feeling of being unwell (malaise), and
• acne.

Serious side effects of Antithymocyte Globulin Rabbit include:

• fever, chills, body aches, flu symptoms,
• mouth and throat ulcers,
• rapid heart rate, rapid and shallow breathing,
• weakness, tired feeling,
• a light-headed feeling,
• white patches inside the mouth or on the lips,
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under the skin,
• swollen glands, rash or itching, joint pain,
• pain or burning while urinating,
• dry cough, wheezing, feeling short of breath, and
• 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).

Rare side effects of Antithymocyte Globulin Rabbit include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Antithymocyte Globulin Rabbit has severe interactions with no other drugs.
• Antithymocyte Globulin Rabbit has serious interactions with at least 69 other drugs.
• Antithymocyte Globulin Rabbit has moderate interactions with at least 25 other drugs.
• Antithymocyte Globulin Rabbit has minor interactions with the following drug:
  • protein a column

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• History of allergy or anaphylaxis to rabbit proteins
• Active acute or chronic infections that contraindicate any additional immunosuppression

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Antithymocyte Globulin Rabbit?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Antithymocyte Globulin Rabbit?”

Cautions

• To prevent overimmunosuppression, physicians may decrease the dose of the maintenance immunosuppression regimen during the period of antithymocyte Globulin Rabbit use
• Serious immune-mediated reactions, including anaphylaxis (including fatal anaphylaxis) or severe cytokine release syndrome (CRS), are reported; if an anaphylactic reaction occurs, terminate the infusion immediately and implement emergency treatment (e.g., 0.3-0.5 mL epinephrine (1 mg/mL) SC and other resuscitative measures including oxygen, IV fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated
• CRS is reported with rapid infusion rates; CRS is attributed to the release of cytokines by activated monocytes and lymphocytes; severe acute CRS can cause serious cardiorespiratory events and/or death; close compliance with the recommended dosage and infusion time may reduce the incidence and severity of infusion-associated reactions; slowing the infusion rate may minimize many of this risk (see Administration)
• Low counts of platelets and WBCs (including low counts of lymphocytes and neutrophils) have been identified and are reversible following dose adjustments (see Dosage Modifications)
• Routinely used in combination with other immunosuppressive agents; infections (bacterial, fungal, viral, and protozoal), reactivation of infection (particularly CMV), and sepsis are reported; these infections can be fatal; monitor carefully and administer appropriate anti-infective treatment when indicated
• Immunosuppressives may increase the incidence of malignancies, including lymphoma or lymphoproliferative disorders
• Safety of immunization with attenuated live vaccines following antithymocyte Globulin Rabbit therapy has not been studied, and therefore, is not recommended following recent therapy
• May interfere with rabbit antibody-based immunoassays and with crossmatch or panel-reactive antibody cytotoxicity assays

Pregnancy and Lactation

• Unknown whether antithymocyte Globulin Rabbit therapy can cause fetal harm; use only if the benefit outweighs the risk
• Animal reproduction studies have not been conducted
• Lactation
  • Has not been studied in breastfeeding women; unknown if excreted in human milk
  • Because other immunoglobulins are excreted in human milk, breastfeeding should be discontinued during antithymocyte Globulin Rabbit therapy