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

Grafalon is employed as an immunosuppressive agent in clinical settings where T‑cell mediated immune responses need to be controlled.

• Prevention of acute rejection in organ transplantation (e.g., kidney, liver, heart) when used as induction therapy.
• Treatment of severe aplastic anemia resistant to standard therapy.
• Management of graft‑versus‑host disease (GVHD) following hematopoietic stem cell transplantation.
• Adjunctive therapy in certain autoimmune disorders requiring profound T‑cell depletion, as determined by a specialist.

The safety profile of Grafalon reflects its mechanism of T‑cell depletion; side effects range from mild infusion‑related reactions to rare but serious complications.

Common

• Fever or chills during or shortly after infusion.
• Nausea, vomiting, or abdominal discomfort.
• Transient hypertension or hypotension.
• Mild rash or urticaria at the infusion site.
• Elevated liver enzymes or mild hepatic dysfunction.

Serious

• Severe allergic or anaphylactic reactions.
• Cytokine release syndrome with high fever and hypotension.
• Opportunistic infections such as cytomegalovirus or fungal infections.
• Hemolytic anemia or thrombocytopenia.
• Acute renal impairment or failure.

Because Grafalon profoundly suppresses the immune system, careful assessment and monitoring are required before, during, and after treatment.

• Verify patient’s infection status; active infections should be treated before administration.
• Assess baseline liver and kidney function; dose adjustments may be needed for organ impairment.
• Monitor complete blood counts regularly to detect cytopenias.
• Evaluate for prior sensitization to rabbit proteins or known hypersensitivity.
• Use caution in pregnant or breastfeeding individuals; benefits must outweigh potential risks.
• Ensure appropriate vaccination status, avoiding live vaccines during therapy.

Grafalon may interact with other agents that affect immune function or hemodynamics; awareness of these interactions helps minimize adverse outcomes.

Avoid

• Concomitant use of other potent immunosuppressants (e.g., high‑dose steroids, calcineurin inhibitors) without close monitoring.
• Live attenuated vaccines during and for several weeks after therapy.
• Agents known to cause severe hypersensitivity reactions in rabbit‑derived products.

Use with caution

• Antimicrobial prophylaxis (antivirals, antifungals) to prevent opportunistic infections.
• Drugs that influence renal clearance (e.g., aminoglycosides, NSAIDs) due to potential nephrotoxicity.
• Medications that may exacerbate hypertension or hypotension during infusion (e.g., vasopressors).
• Cytokine‑modulating agents that could amplify cytokine release syndrome.