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

Grafalon is used as an immunosuppressive therapy in specific transplant and hematopoietic settings.

• Prevention of acute rejection in kidney, liver, heart, and lung transplantation.
• Prophylaxis of graft‑versus‑host disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplantation.
• Treatment of established acute GVHD when corticosteroids are insufficient.
• Part of conditioning regimens prior to organ transplantation to reduce T‑cell mediated immune response.
• Adjunctive therapy in selected autoimmune conditions under specialist guidance.

The safety profile of Grafalon reflects its immunomodulatory activity and includes a range of observed adverse events.

Common

• Fever, chills, or rigors during infusion
• Nausea, vomiting, or abdominal discomfort
• Mild rash or pruritus at infusion site

Serious

• Severe infection due to profound T‑cell depletion
• Cytokine release syndrome with hypotension and respiratory distress
• Hemolytic anemia, thrombocytopenia, or acute renal impairment

Clinicians should consider several precautions when prescribing Grafalon to minimize risks and ensure appropriate patient monitoring.

• Baseline screening for active infections, including viral, bacterial, and fungal pathogens.
• Monitoring of complete blood count, liver and renal function before and during therapy.
• Avoid use in patients with known hypersensitivity to rabbit proteins or previous anti‑thymocyte globulin reactions.
• Caution in pregnant or breastfeeding women; benefits must outweigh potential risks.
• Prophylactic antimicrobial therapy may be required to prevent opportunistic infections.
• Assess cardiovascular status, as infusion may cause hemodynamic changes.
• Ensure adequate hydration to reduce risk of renal complications.

Grafalon may interact with other medications, influencing immunosuppression or increasing adverse event risk.

Avoid

• Concurrent use of other potent immunosuppressants (e.g., high‑dose steroids, calcineurin inhibitors) without dose adjustment.
• Live vaccines during treatment and for several weeks after the last dose.
• Agents that significantly lower platelet count or cause hemolysis.

Use with caution

• Antimicrobial prophylaxis agents (e.g., trimethoprim‑sulfamethoxazole) due to additive bone‑marrow suppression.
• Drugs affecting renal function (e.g., aminoglycosides, NSAIDs) as Grafalon can impact kidney perfusion.
• Vaccinations with inactivated vaccines may have reduced efficacy; timing should be planned.