Grafalon is used together with other immunosuppressive medicines to suppress immune cells responsible for acute transplant rejection and graft-versus-host disease (GVHD). It is typically used for the following purposes:

Prevention of acute transplant rejection: Grafalon is indicated in patients undergoing allogeneic solid organ transplantation. It is used alongside other immunosuppressive agents (such as glucocorticosteroids, purine antagonists, calcineurin inhibitors, or mTOR inhibitors) to strengthen immunosuppression after transplantation.

Treatment of corticosteroid-resistant rejection: Grafalon is used to treat acute rejection episodes in patients who do not respond adequately to corticosteroid therapy (e.g., methylprednisolone) following allogeneic solid organ transplantation.

Prevention of graft-versus-host disease (GVHD): Grafalon is indicated in adults with hematological malignancies undergoing allogeneic stem cell transplantation (SCT) from matched unrelated donors. It is used in combination with standard prophylaxis (Cyclosporin A and methotrexate) to prevent GVHD.

Grafalon is a polyclonal anti-T-lymphocyte immunoglobulin produced from rabbits immunized with Jurkat cells (a lymphoblastoid cell line). The T-cell marker expression on Jurkat cells corresponds with Grafalon’s effects on lymphocytes. Grafalon contains antibodies against multiple surface antigens of Jurkat cells. Studies in patients have shown that it reduces lymphocyte subsets carrying these surface proteins. It is cytotoxic to human lymphocytes, with activated lymphocytes being more sensitive. Grafalon does not directly activate T-cells (via CD3), but it inhibits T-cell activation triggered by anti-CD3 antibodies. It also reduces migration of human melanoma cells by binding to adhesion molecules. Its anti-adhesion properties (targeting LFA-1 and ICAM-1) may explain reduced vascular resistance in kidney vessels and decreased lymphocyte retention in experimental models. In animal studies: It prolonged skin graft survival in rhesus monkeys, Caused immunosuppression with leukopenia and lymphopenia, Reduced ischemia/reperfusion injury in cynomolgus monkeys by inhibiting adhesion of lymphocytes and neutrophils.

The dose of Grafalon is dependent on the indication. Dose recommendations are based on body weight.

Prevention of acute transplant rejection in patients receiving allogeneic solid organ transplants: The recommended dose range is 2 to 5 mg/kg/d of Grafalon. The most common doses are in the range of 3 to 4 mg/kg/d. Therapy should commence on the day of transplantation pre-, intra-, or immediately post-operatively. Depending on the patient's condition, selected daily dose and the concomitant immunosuppressive regimen, the recommended duration of therapy is in the range of 5 to 14 days.

Therapy of acute corticosteroid-resistant rejection after allogeneic solid organ transplantation: The recommended dose range is 3 to 5 mg/kg/d of Grafalon. The most common dosages are in the range of 3 to 4 mg/kg/d. Duration of therapy will vary according to the condition of the grafted organ and clinical response, usually between 5 to 14 days.

Prevention of graft-versus-host disease (GVHD) in adults after allogeneic stem cell transplantation (SCT): As part of myeloablative conditioning regimens for stem cell transplantation, the recommended dose is 20 mg/kg/d of Grafalon, usually starting from day -3 to day -1 prior to SCT.

Immunosuppressive medicinal products: Grafalon is commonly used together with other immunosuppressive drugs. No direct interaction has been clearly identified between Grafalon and corticosteroids, purine antagonists, calcineurin inhibitors, or mTOR inhibitors. However, using these medicines together may increase the risk of infections, thrombocytopenia, and anemia. Therefore, patients receiving combined immunosuppressive therapy should be closely monitored, and treatment adjustments may be necessary.

Vaccination: Live-attenuated vaccines should not be given to immunosuppressed patients. Additionally, the immune response to other vaccines may be reduced.

Very common (affects more than 1 in 10 patients): Fever, chills, headache, tremor, nausea, vomiting, diarrhea, abdominal pain, breathing difficulty, flushing, increased infections (e.g., CMV, urinary tract infection), and anemia.

Common (affects less than 1 in 10 patients): Thrombocytopenia, leukopenia, pancytopenia, mucosal inflammation, swelling, fatigue, chest pain, joint and muscle pain, back pain, muscle stiffness, abnormal blood pressure, tingling or numbness, rapid heartbeat, light sensitivity, abnormal lab values, increased bilirubin, blood in urine, cough, nosebleeds, skin redness, itching, rash, allergic reactions (including anaphylaxis), kidney dysfunction, lymphoproliferative disorders, liver vein blockage, sepsis, pneumonia, kidney infection, herpes, influenza, candidiasis, bronchitis, rhinitis, sinusitis, nasopharyngitis, skin infections.

The risk to the fetus is not clearly known. Grafalon should be used cautiously during pregnancy. Human immunoglobulins may cross the placenta or pass into breast milk. Therefore, the decision to use this medicine in pregnant or breastfeeding women should be made by a physician after careful risk-benefit assessment.

Patients treated with Grafalon should be managed in healthcare facilities that are properly equipped with laboratory support and emergency care services. The medicine must be given and closely observed under the supervision of qualified medical professionals.

Hypersensitivity reactions: Allergic reactions have been reported with Grafalon use. Before initiating therapy, it is advisable to evaluate whether the patient has any history of allergies, especially to rabbit proteins. Re-treatment with Grafalon or other rabbit-derived immunoglobulins may increase the risk of severe allergic reactions (such as anaphylaxis), due to prior sensitization.

Severe thrombocytopenia: Grafalon therapy should be reduced, interrupted, or discontinued in transplant patients who develop severe thrombocytopenia (platelet count below 50,000/μl), as this condition increases the risk of bleeding. Appropriate emergency measures should be readily available.

Hepatic disorders: Grafalon should be used cautiously in patients with liver disease. Existing coagulation disorders may worsen, therefore regular monitoring of platelet count and coagulation parameters is recommended.

Cardiovascular disorders: Special care is required when administering Grafalon to patients with known or suspected cardiovascular conditions. If symptoms such as low blood pressure or cardiac instability (e.g., unconsciousness, weakness, nausea, vomiting) occur, slowing down or stopping the infusion should be considered.

Vaccines, Anti-sera & Immunoglobulin

Store Grafalon in a refrigerator at 2°C to 8°C. Keep the vial in its original outer carton to protect it from light.