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

Grafalon is indicated for specific immunological conditions where suppression of T‑cell activity is required.

• Prevention of acute rejection in solid‑organ transplantation (e.g., kidney, liver, heart).
• Treatment and prophylaxis of graft‑versus‑host disease (GVHD) following hematopoietic stem cell transplantation.
• Induction therapy in high‑risk transplant recipients to reduce early immune activation.
• Adjunctive immunosuppression in combined‑organ transplant protocols.
• Use in desensitization protocols for sensitized patients awaiting transplantation.
• Support in experimental protocols for autoimmune disease modulation under clinical investigation.

The immunological activity of Grafalon can be associated with a range of adverse events, which are generally categorized by frequency and severity.

Common

• Fever, chills, or rigors during or shortly after infusion.
• Transient hypertension or hypotension.
• Nausea, vomiting, or mild gastrointestinal discomfort.
• Headache or dizziness.
• Mild rash or urticaria.
• Elevated liver enzymes.

Serious

• Severe infusion‑related reactions such as anaphylaxis or bronchospasm.
• Cytokine release syndrome presenting with high fever and organ dysfunction.
• Opportunistic infections due to profound T‑cell depletion (e.g., CMV, fungal infections).

Because Grafalon produces marked immunosuppression, careful patient assessment and monitoring are required before and during therapy.

• Verify negative screening for active infections (e.g., hepatitis B/C, HIV, tuberculosis) prior to initiation.
• Assess baseline cardiac function; monitor blood pressure and heart rate during infusion.
• Perform complete blood count and differential to detect early leukopenia or thrombocytopenia.
• Evaluate renal and hepatic function; dose adjustments may be needed in impairment.
• Counsel patients on infection‑prevention measures and the need to report fever or respiratory symptoms promptly.
• Consider pregnancy risk; avoid use in pregnant women unless benefits outweigh unknown risks.

Grafalon may interact with other agents that affect immune function or complement activity, requiring dose adjustments or heightened monitoring.

Avoid

• Concurrent use of other potent immunosuppressants (e.g., high‑dose corticosteroids, calcineurin inhibitors) without close therapeutic drug monitoring.
• Live vaccines administered during or shortly after treatment, due to risk of uncontrolled infection.
• Complement‑inhibiting drugs that could alter Grafalon’s mechanism of action.

Use with caution

• Antithymocyte globulin preparations from other species, as additive immunosuppression may increase infection risk.
• Cytotoxic chemotherapy agents, which may exacerbate bone‑marrow suppression.
• Antiviral prophylaxis agents (e.g., ganciclovir) that require renal dosing adjustments when combined with Grafalon.