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

Grafalon is indicated for specific immunosuppressive purposes in transplant medicine.

• Prophylaxis of acute graft‑versus‑host disease (GVHD) following hematopoietic stem cell transplantation.
• Treatment of acute rejection episodes in solid organ transplantation, such as kidney, liver, or heart.
• Component of conditioning regimens for certain allogeneic stem cell transplant protocols.
• Adjunctive therapy to reduce T‑cell mediated immune responses in selected clinical studies.

The safety profile of Grafalon reflects its immunosuppressive activity, with adverse events ranging from mild to severe.

Common

• Fever, chills, or rigors occurring during or shortly after infusion.
• Nausea, vomiting, or abdominal discomfort.
• Transient hypertension or hypotension during the infusion period.
• Mild headache or fatigue that resolves within hours.

Serious

• Severe infections resulting from profound T‑cell depletion.
• Cytokine release syndrome presenting with respiratory distress.
• Serum‑sickness–like reactions, including rash, arthralgia, and fever.
• Hemolytic anemia or thrombocytopenia.
• Acute renal impairment associated with immune complex deposition.

Because Grafalon depletes T‑lymphocytes, careful patient assessment and monitoring are required before and during therapy.

• Verify the absence of active infections prior to initiation.
• Assess baseline complete blood count and renal function.
• Monitor for signs of cytokine release syndrome throughout the infusion.
• Use pre‑medication such as antihistamines or corticosteroids as recommended to mitigate infusion reactions.
• Avoid use in patients with known hypersensitivity to rabbit proteins.
• Consider potential pregnancy risks; use only if the expected benefit outweighs possible fetal harm.

Grafalon may interact with other agents that affect immune function or hemodynamics, requiring dose adjustments or enhanced monitoring.

Avoid

• Concurrent administration of live vaccines, which may cause uncontrolled infection.
• Combination with other potent immunosuppressants (e.g., alemtuzumab) without close supervision.
• Co‑administration with drugs that significantly lower blood pressure during infusion.

Use with caution

• Concomitant corticosteroids, which may increase infection risk.
• Antimicrobial prophylaxis agents, requiring monitoring for additive toxicity.
• Anticoagulants, as infusion‑related hypotension can enhance bleeding risk.