Grafalon

Indications

Anti-human T-lymphocyte immunoglobulin (from rabbits) is a strong immune-suppressing medicine used in transplant medicine. It is used to help prevent rejection of a transplanted organ such as a kidney, liver or heart, and to help prevent graft-versus-host disease (when donor immune cells attack the patient) in people receiving a stem cell (bone marrow) transplant from a donor.

How It Works

It is made from antibodies produced in rabbits against human T-lymphocytes, the immune cells that drive organ rejection. The antibodies attach to these cells and remove or inactivate them, sharply lowering the number of active T-cells for a period of time. This gives the new organ or stem cells a better chance to settle without being attacked.

Dosage and Administration

It is given only in a transplant centre by doctors and nurses, as a slow infusion into a large vein over several hours. The dose and number of days are calculated from body weight and the type of transplant, and given as prescribed. Medicines such as a corticosteroid, an antihistamine and paracetamol are usually given beforehand to reduce reactions, and the patient is closely monitored during and after each infusion.

Interactions

• Other immunosuppressants (such as Ciclosporin, Tacrolimus, Mycophenolate, corticosteroids) add to the risk of infection and certain cancers; doses are planned by the transplant team
• Live vaccines must not be given during or soon after treatment, and other vaccines may work less well

Contraindications

• Allergy to rabbit proteins or to any ingredient
• Active, uncontrolled bacterial, viral, fungal or parasitic infections
• Severe low platelet count in solid organ transplant patients, as judged by the doctor

Side Effects

Infusion reactions are common: fever, chills, shaking, rash, itching, headache, nausea, vomiting, fast heartbeat, changes in blood pressure and shortness of breath (cytokine release). Low white blood cells and low platelets are common. Serum sickness (fever, rash, joint pain, swollen glands) may occur 1 to 2 weeks later. There is a raised risk of infections, including viral reactivation such as cytomegalovirus, and in the long term of some lymphomas and other cancers.

Get urgent medical help, or tell the nurse at once, for difficulty breathing, wheezing, swelling of the face or throat, chest pain, fainting, high fever, unusual bleeding or bruising, or any sign of infection after discharge.

Pregnancy and Lactation

There is little information on use in pregnancy, so it is given only if clearly needed; effective contraception is advised during treatment and for some months afterwards, as advised by the doctor. It is not known whether it passes into breast milk; breastfeeding should be stopped during treatment.

Precautions and Warnings

Blood counts, kidney and liver function and vital signs are monitored closely. Patients receive medicines to prevent certain infections. Tell the team about any previous treatment with rabbit or horse antibody products. Avoid people with infections and follow hygiene advice after discharge.

Overdose

Overdose may cause severe drops in white cells and platelets and a higher risk of infection. Treatment is supportive and given in hospital.

Therapeutic Class

Immunosuppressant; polyclonal anti-T-lymphocyte immunoglobulin (rabbit).

Storage

Store in a refrigerator at 2 to 8°C, do not freeze, and keep in the outer carton to protect from light. Hospital storage as directed on the pack.