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

Grafalon is indicated for specific clinical situations where strong immunosuppression is required.

• Prevention of acute rejection in solid organ transplantation (e.g., kidney, liver, heart).
• Induction therapy in bone marrow or stem cell transplantation to reduce graft‑versus‑host disease.
• Treatment of severe aplastic anemia when other therapies are insufficient.
• Use as part of conditioning regimens prior to hematopoietic stem cell transplantation.

The immunologic activity of Grafalon can produce a range of adverse effects, which are generally categorized by frequency and severity.

Common

• Fever and chills
• Rash or urticaria
• Nausea or vomiting
• Hypotension during infusion
• Headache
• Arthralgia or muscle aches

Serious

• Serum sickness-like reactions
• Severe infections (bacterial, viral, fungal)
• Pulmonary edema or respiratory distress
• Renal dysfunction or failure
• Cytokine release syndrome
• Hemolytic anemia or thrombocytopenia

Because Grafalon causes profound depletion of T‑cells, careful patient assessment and monitoring are essential before and during therapy.

• Assess for active infections and treat before initiation.
• Evaluate baseline liver and kidney function.
• Monitor complete blood count and immunoglobulin levels regularly.
• Use prophylactic antimicrobials to reduce opportunistic infection risk.
• Avoid use in patients with known hypersensitivity to rabbit proteins.
• Consider pregnancy and breastfeeding status; limited data are available.

Grafalon may interact with other agents that affect immune function or increase the risk of adverse reactions.

Avoid

• Concomitant use of other potent immunosuppressants without dose adjustment.
• Live vaccines during treatment and for several weeks after.
• High‑dose corticosteroids that may exacerbate infection risk.

Use with caution

• Antimicrobial agents (e.g., antifungals, antivirals) that may require dose modification.
• Cytokine‑targeted therapies such as IL‑2 or interferon.
• Drugs that prolong QT interval, as electrolyte disturbances can occur.