Grafalon

Grafalon is a rabbit anti‑thymocyte globulin (ATG) immunoglobulin for human use supplied as a lyophilised powder for reconstitution, provided as a sterile solution for intravenous injection. It belongs to the immunosuppressant drug class and is marketed in the European Union for clinical use under prescription.

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.