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

Grafalon is indicated for several immunologic conditions where T‑cell suppression is required.

• Prevention of acute rejection in solid‑organ transplantation (kidney, liver, heart, lung).
• Treatment of graft‑versus‑host disease following hematopoietic stem‑cell transplantation.
• Management of severe aplastic anemia when other immunosuppressive therapies are insufficient.
• Use as part of conditioning regimens for bone‑marrow transplantation to facilitate engraftment.
• Adjunct therapy in certain autoimmune disorders under specialist supervision.

The safety profile of Grafalon includes a range of adverse events that vary in frequency and severity.

Common

• Fever, chills, or rigors occurring during or shortly after the intravenous infusion.
• Nausea, vomiting, or abdominal discomfort that may be mild to moderate in intensity.
• Transient changes in blood pressure, including episodes of hypertension or hypotension.
• Headache, fatigue, or general malaise that usually resolves after treatment.

Serious

• Cytokine release syndrome, which can present with severe hypotension, respiratory distress, or organ dysfunction.
• Serum‑sickness–like reactions, characterized by rash, arthralgia, fever, and lymphadenopathy.
• Opportunistic or severe infections resulting from profound T‑cell depletion.

Clinicians should consider several precautions and warnings when prescribing Grafalon to minimize risks and ensure appropriate patient monitoring.

• Baseline assessment of infection status; avoid use in active uncontrolled infections.
• Monitoring of complete blood count and lymphocyte levels before, during, and after therapy.
• Pre‑medication with antipyretics, antihistamines, or corticosteroids to reduce infusion‑related reactions.
• Caution in patients with cardiovascular disease due to possible hemodynamic changes.
• Evaluate renal and hepatic function, as dose adjustments may be required.
• Pregnancy and breastfeeding status should be assessed; safety data are limited.
• Long‑term immunosuppression may increase risk of malignancies; regular surveillance is advised.

Grafalon may interact with other medications, influencing its efficacy or safety profile; awareness of these interactions guides clinical decisions.

Avoid

• Live attenuated vaccines, because immunosuppression can lead to uncontrolled infection.
• Concurrent use of other potent T‑cell depleting agents (e.g., alemtuzumab) without specialist guidance.
• High‑dose corticosteroids that may exacerbate infection risk when combined.

Use with caution

• Antimicrobial prophylaxis (e.g., antivirals, antifungals) should be tailored to infection risk.
• Calcineurin inhibitors (cyclosporine, tacrolimus) may require dose adjustments due to additive nephrotoxicity.
• Hematopoietic growth factors (G‑CSF) may be needed to support neutrophil recovery.
• Diuretics or antihypertensives, as blood pressure fluctuations can occur during infusion.