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

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.