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

Grafalon is indicated for use in transplant and hematology settings where profound T‑cell depletion is required.

• Prophylaxis of acute graft rejection in solid organ transplantation (e.g., kidney, liver, heart).
• Conditioning regimen for hematopoietic stem cell transplantation.
• Adjunct therapy in severe aplastic anemia undergoing immunosuppressive treatment.
• Treatment of steroid‑refractory acute graft‑versus‑host disease.
• Part of desensitization protocols for highly sensitized transplant candidates.

Grafalon may cause a range of adverse reactions that vary in frequency and severity.

Common

• Fever, chills, and rigors during infusion.
• Nausea, vomiting, or abdominal discomfort.
• Transient hypertension or hypotension.
• Headache or dizziness.
• Mild leukopenia or thrombocytopenia.
• Rash or mild urticaria.

Serious

• Severe infections due to profound immunosuppression.
• Cytokine release syndrome with hypotension and respiratory distress.
• Serum sickness–like reactions.
• Acute renal impairment.
• Pulmonary edema or interstitial pneumonitis.
• Hemolytic anemia or thrombocytopenic purpura.

When prescribing Grafalon, clinicians should assess patient risk factors and monitor closely.

• Screen for active infections, including viral, bacterial, and fungal pathogens before initiation.
• Evaluate baseline renal and hepatic function; adjust dosing in organ impairment.
• Monitor complete blood counts and immune cell subsets regularly.
• Use pre‑medication (e.g., antihistamines, corticosteroids) to reduce infusion reactions.
• Avoid use in patients with known hypersensitivity to rabbit proteins.
• Counsel women of child‑bearing potential about unknown pregnancy risks and advise effective contraception.

Grafalon can interact with several drug classes, influencing safety and efficacy.

Avoid

• Live vaccines during and for several months after therapy due to impaired immunity.
• Concurrent use of other potent immunosuppressants without dose adjustment (e.g., high‑dose steroids, calcineurin inhibitors).

Use with caution

• Antimicrobial agents (e.g., antivirals, antifungals) that may increase nephrotoxicity.
• Hematopoietic growth factors that could mask bone‑marrow suppression.
• Drugs affecting coagulation, as thrombocytopenia may exacerbate bleeding risk.
• Agents that prolong QT interval, given potential electrolyte disturbances.