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

Grafalon is employed in clinical settings where modulation of the immune response is required.

• Prevention of acute rejection in organ transplantation, including kidney, liver, and heart grafts.
• Treatment of severe aplastic anemia when conventional therapies have failed.
• Management of graft‑versus‑host disease (GVHD) after hematopoietic stem cell transplantation.
• Induction of immunosuppression in selected autoimmune disorders that are refractory to standard treatment.

The immunologic activity of Grafalon can be associated with a range of adverse effects, varying in frequency and severity.

Common

• Fever, chills, or rigors during or shortly after infusion.
• Infusion‑related reactions such as flushing, rash, or mild hypotension.
• Transient leukopenia or lymphopenia.
• Mild hypertension or tachycardia.
• Nausea or mild gastrointestinal discomfort.

Serious

• Severe infections, including opportunistic bacterial, viral, or fungal pathogens.
• Cytokine release syndrome presenting with high fever, hypotension, and respiratory distress.
• Serum sickness‑like reactions with fever, arthralgia, and rash.
• Acute renal impairment or hemolytic anemia.
• Thromboembolic events such as deep‑vein thrombosis or pulmonary embolism.

Clinicians should consider several safety aspects before initiating Grafalon therapy.

• Assess baseline complete blood count and renal function; monitor these parameters regularly during treatment.
• Screen for active infections, including hepatitis B, C, HIV, and tuberculosis, and treat appropriately before use.
• Use caution in patients with a history of hypersensitivity to rabbit proteins or other immunoglobulin products.
• Evaluate cardiovascular status, as infusion may provoke hemodynamic changes.
• Counsel patients about the increased risk of malignancies associated with long‑term immunosuppression.
• Avoid use during pregnancy or lactation unless the potential benefit justifies the potential risk.

Grafalon may interact with other agents that influence immune function or hemodynamics.

Avoid

• Concurrent use of other potent immunosuppressants (e.g., anti‑thymocyte globulin, alemtuzumab) without careful monitoring.
• Live vaccines during and for several weeks after therapy due to impaired immune response.
• High‑dose corticosteroids combined without dose adjustment, which may exacerbate infection risk.

Use with caution

• Antimicrobial prophylaxis agents (e.g., trimethoprim‑sulfamethoxazole) to prevent opportunistic infections.
• Anticoagulants, as Grafalon‑related thrombocytopenia may increase bleeding risk.
• Drugs that affect renal clearance (e.g., aminoglycosides) in patients with pre‑existing kidney dysfunction.