Grafalon (Anti-T Lymphocyte Immunoglobulin For Human Use, Rabbit)

Grafalon is used primarily in the setting of organ transplantation to prevent early immune‑mediated graft injury and to facilitate successful engraftment.

• Prevention of acute cellular rejection in kidney, liver, heart, or lung transplants.
• Induction therapy in combination with other immunosuppressive agents.
• Treatment of steroid‑resistant rejection episodes.
• Part of desensitization protocols for highly sensitized recipients.
• Use in clinical trials evaluating novel transplant immunosuppression strategies.
• Supportive therapy during peri‑operative period to reduce inflammatory activation.

The immunologic activity of Grafalon can produce a range of adverse reactions, most of which are related to its T‑cell depleting properties and infusion process.

Common

• Fever, chills, or rigors during or shortly after infusion.
• Nausea, vomiting, or mild gastrointestinal discomfort.
• Transient leukopenia or lymphopenia with mild infection risk.
• Headache or mild dizziness.

Serious

• Severe infusion‑related reactions such as anaphylaxis or bronchospasm.
• Cytokine release syndrome presenting with hypotension and organ dysfunction.
• Opportunistic infections including viral, fungal, or bacterial pathogens due to profound immunosuppression.
• Development of post‑transplant lymphoproliferative disorder (PTLD).

Because Grafalon produces profound and prolonged immunosuppression, careful patient assessment and monitoring are required before, during, and after therapy.

• Verify negative screening for active infections such as hepatitis B, C, HIV, and tuberculosis.
• Assess baseline complete blood count and renal function prior to initiation.
• Monitor vital signs and laboratory parameters closely during infusion.
• Avoid use in patients with known hypersensitivity to rabbit proteins or murine antibodies.
• Consider prophylactic antimicrobial agents to reduce risk of opportunistic infections.

Grafalon may interact with other medications that affect immune function or increase the risk of infusion‑related complications.

Avoid

• Concurrent use of other T‑cell depleting agents (e.g., antithymocyte globulin) without dose adjustment.
• Live vaccines administered during or shortly after treatment.

Use with caution

• Calcineurin inhibitors (cyclosporine, tacrolimus) as combined immunosuppression may heighten infection risk.
• Antimicrobial prophylaxis agents (e.g., trimethoprim‑sulfamethoxazole) requiring dose monitoring for additive toxicity.
• Corticosteroids, which can amplify immunosuppressive effects and mask infection signs.
• Anticoagulants, because infusion reactions may increase bleeding tendency.