Grafalon

Grafalon is a rabbit-derived anti‑thymocyte globulin supplied as an intravenous solution for use. The product contains anti‑T lymphocyte immunoglobulin, an immunosuppressant classified under ATC code L04AA02. It is marketed in the European Union and is available by prescription. It is administered intravenously under medical supervision and is part of conditioning regimens for organ and hematopoietic stem cell transplantation.

Grafalon is indicated for use in transplantation and hematopoietic stem cell procedures where T‑cell mediated rejection is a concern.

- Prevention of acute graft rejection in solid‑organ transplantation (e.g., kidney, liver, heart). - Part of the conditioning regimen prior to allogeneic hematopoietic stem cell transplantation. - Induction therapy to reduce the incidence of early cellular rejection in high‑risk transplant recipients. - Adjunct to other immunosuppressive agents when a rapid and profound T‑cell depletion is required.

The safety profile of Grafalon reflects its mechanism of T‑cell depletion and includes both expected and less frequent reactions.

Common: - Fever, chills, or rigors during infusion. - Nausea, vomiting, or abdominal discomfort. - Transient hypertension or hypotension. - Mild headache or fatigue.

Serious: - Cytokine release syndrome with severe hypotension. - Acute respiratory distress or pulmonary edema. - Severe infections due to profound immunosuppression. - Serum‑sickness–like reactions with rash and arthralgia.

Because Grafalon produces extensive immune modulation, careful patient assessment and monitoring are required before and during therapy.

- Verify negative serology for active infections (e.g., CMV, EBV, hepatitis B/C) prior to initiation. - Assess baseline complete blood count and renal function; dose adjustments may be needed in renal impairment. - Monitor vital signs and temperature closely during infusion for signs of cytokine release. - Avoid use in patients with known hypersensitivity to rabbit proteins or previous anti‑thymocyte globulin reactions. - Counsel women of childbearing potential about unknown pregnancy risks and recommend effective contraception. - Consider prophylactic antimicrobial therapy to reduce opportunistic infection risk.

Grafalon may interact with other agents that affect immune function or cardiovascular stability.

Avoid: - Concurrent use of other T‑cell depleting antibodies or high‑dose steroids without medical justification. - Live vaccines administered during or shortly after treatment.

Use with caution: - Calcineurin inhibitors (e.g., cyclosporine, tacrolimus) due to additive nephrotoxicity. - Anticoagulants or antiplatelet drugs because infusion‑related hypotension can increase bleeding risk. - Agents that prolong QT interval, as electrolyte shifts may occur during therapy.