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

Grafalon is indicated for several immunological indications where T‑cell suppression is required.

• Prevention of acute rejection in solid organ transplantation, including kidney, liver, and heart grafts.
• Treatment of graft‑versus‑host disease (GVHD) following allogeneic hematopoietic stem cell transplantation.
• Induction therapy for severe aplastic anemia as part of a conditioning regimen.
• Use in combination with other immunosuppressants for desensitization protocols prior to transplantation.
• Management of certain autoimmune conditions under specialist guidance (off‑label in some jurisdictions).

The safety profile of Grafalon reflects its immunosuppressive activity and includes both frequent and less common adverse events.

Common

• Fever, chills, or rigors during or shortly after infusion.
• Nausea, vomiting, or abdominal discomfort.
• Transient lymphopenia with reduced white‑blood‑cell counts.
• Mild hypotension or flushing at the infusion site.
• Headache or dizziness during infusion.

Serious

• Severe infections, including opportunistic bacterial, viral, or fungal pathogens.
• Cytokine release syndrome presenting with high fever, hypotension, and respiratory distress.
• Serum sickness–like reactions with rash, arthralgia, and fever.
• Acute renal impairment or hemolytic anemia.
• Thromboembolic events such as deep vein thrombosis.
• Life‑threatening anaphylaxis or severe hypersensitivity reactions.

Because Grafalon produces profound T‑cell depletion, careful patient assessment and monitoring are required before, during, and after therapy.

• Verify negative screening for active infections, including tuberculosis, hepatitis B/C, and HIV.
• Assess baseline complete blood count and renal and hepatic function prior to initiation.
• Monitor for signs of cytokine release syndrome during the first infusion and adjust infusion rate as needed.
• Avoid use in patients with known hypersensitivity to rabbit proteins or previous severe reactions to anti‑thymocyte globulin.
• Provide prophylactic antimicrobial coverage to reduce risk of opportunistic infections.
• Counsel women of childbearing potential about unknown pregnancy risks and advise effective contraception.
• Consider dose adjustment in patients with impaired renal clearance.

Grafalon may interact with other agents that affect immune function or hemodynamics, requiring attention to dosing and timing.

Avoid

• Concurrent use of other depleting antibodies (e.g., alemtuzumab) that could cause excessive immunosuppression.
• Live vaccines administered during or shortly after treatment, due to impaired immune response.
• High‑dose corticosteroids without appropriate monitoring, which may increase infection risk.

Use with caution

• Calcineurin inhibitors (cyclosporine, tacrolimus) – monitor drug levels and renal function.
• Mycophenolate mofetil or azathioprine – adjust doses based on blood counts.
• Antifungal or antiviral prophylaxis agents – watch for additive nephrotoxicity.