Antithymocyte Globulin (Rabbit)

Absorption

Onset

T-cell depletion usually observed within 1 day after initiating therapy.b g

Plasma Concentrations

Average 21.5 and 87 mcg/mL 4–8 hours post-infusion after first and last IV doses, respectively, when given for 7–11 days.b

Duration

Lymphopenia may persist ≥1–2 years after ATG (rabbit) administration.5 g r

Distribution

Extent

Not known whether ATG (rabbit) distributes into human milk; however, other immunoglobulins are distributed into human milk.a b

Elimination

Half-life

2–3 days after first dose;b may increase after multiple-dose administration.2 y

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach or throwing up.
• Belly pain.
• Loose stools (diarrhea).
• Feeling tired or weak.
• Muscle or joint pain.
• Not able to sleep.
• Sweating a lot.
• Pimples (acne).
• Hard stools (constipation).
• Back pain.
• Not hungry.
• Redness or swelling where the shot is given.
• Pain where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If you need to store antithymocyte globulin at home, talk with your doctor, nurse, or pharmacist about how to store it.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take antithymocyte globulin (rabbit) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to antithymocyte globulin. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Chronic graft-versus-host disease (prevention)

Data from a randomized, controlled, multicenter phase III study supports the use of antithymocyte globulin (rabbit; thymoglobulin) for the prevention of chronic graft-versus-host disease (as part of the myeloablative or nonmyeloablative conditioning regimen) in patients receiving a stem cell transplant from unrelated donors [Walker 2016]. Data from another randomized, controlled, multicenter phase III study supports the use of antithymocyte globulin (rabbit; ATG-Fresenius [ATG-F]) for the prevention of chronic graft-versus-host disease (as part of the myeloablative conditioning regimen) in patients receiving an allogeneic peripheral stem cell transplant from an HLA-identical sibling [Kröger 2016].

Based on the Prophylaxis and Treatment of GVHD: EBMT-ELN Working Group Recommendations for a Standardized Practice, antithymocyte globulin (rabbit) may be used to prevent chronic graft-versus-host disease (GVHD) in patients who have received both myeloablative and reduced intensity conditioning regimens [Ruutu 2013].

Heart transplant (induction therapy)

Based on recommendations from a working group of international experts, antithymocyte globulin (rabbit) is recommended as an induction agent in heart transplantation to prevent rejection in certain groups of high risk patients [Zuckermann 2015].

Heart transplant (acute cellular rejection) (treatment)

Based on the International Society of Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients, antithymocyte globulin (rabbit), in combination with intravenous corticosteroids, is effective and recommended in symptomatic acute cellular rejection (ACR) of the cardiac allograft if hemodynamic compromise is present and/or if no clinical improvement has occurred within 12 to 24 hours of intravenous corticosteroid administration. There are currently no large randomized trials evaluating treatments for ACR in cardiac transplantation; recommendations are based on consensus.

Intestinal and multivisceral transplantation (induction therapy)

Data from a retrospective study and clinical experience suggests that antithymocyte globulin (rabbit) (in combination with rituximab, followed by maintenance tacrolimus) may have utility as induction immunosuppression in intestinal and multivisceral transplantation [Trevizol 2012], [Vianna 2008]. Additional data may be necessary to further define the role of antithymocyte globulin (rabbit) in this condition.

Lung transplant (induction therapy)

Data from two single center, randomized, prospective studies in adult lung transplant recipients support the use of antithymocyte globulin (rabbit) for prevention of acute rejection after lung transplant. The incidence of acute rejection was decreased in patients receiving antithymocyte globulin (rabbit), however there was no difference in overall survival [Hartwig 2008], [Palmer 1999]. Additional trails may be necessary to further define the role of antithymocyte globulin (rabbit) for prevention of rejection after lung transplant.

Lung transplant (persistent acute cellular rejection) (treatment)

Clinical experience suggests that antithymocyte globulin (rabbit) is an option for treatment of persistent acute rejection after lung transplantation [Martinu 2000]. Additional data may be necessary to further define the role of antithymocyte globulin (rabbit) in treatment of acute cellular rejection after lung transplantation.

There are no dosage adjustments provided in the manufacturer's labeling.

There are no dosage adjustments provided in the manufacturer's labeling.

Potential interference with rabbit antibody-based immunoassays and with cross-match or panel-reactive antibody cytotoxicity assays. Has not been shown to interfere with routine clinical laboratory tests which do not use immunoglobulins.

Animal reproduction studies have not been conducted. Females of reproductive potential should use effective contraception during and for at least 3 months following treatment.

The National Transplantation Pregnancy Registry (NTPR) is a registry which follows pregnancies which occur in maternal transplant recipients or those fathered by male transplant recipients. The NTPR encourages reporting of pregnancies following solid organ transplant by contacting them at 877-955-6877 or NTPR@giftoflifeinstitute.org.