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

Grafalon is indicated for specific immunological challenges associated with organ transplantation and related complications.

• Prevention of acute cellular rejection in kidney, liver, heart, or lung transplants.
• Treatment of graft‑versus‑host disease (GVHD) following hematopoietic stem cell transplantation.
• Induction therapy to reduce early immune activation in high‑risk transplant recipients.
• Adjunctive immunosuppression when conventional agents are contraindicated or insufficient.
• Use in clinical protocols requiring profound T‑cell depletion prior to transplantation.

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

Common

• Fever, chills, or rigors during or shortly after infusion.
• Transient hypotension or mild hypertension.
• Nausea, vomiting, or mild gastrointestinal discomfort.
• Headache or fatigue.

Serious

• Severe infusion‑related reactions such as anaphylaxis or bronchospasm.
• Cytokine release syndrome presenting with high fever and organ dysfunction.
• Profound and prolonged lymphopenia increasing infection risk.
• Hemolytic anemia or thrombocytopenia.

Because Grafalon profoundly suppresses cellular immunity, several precautions should be observed before and during therapy.

• Verify patient’s infection status; active bacterial, viral, or fungal infections should be treated prior to administration.
• Assess baseline complete blood count and liver function; monitor for cytopenias and hepatic toxicity.
• Screen for prior sensitization to rabbit proteins to reduce risk of severe allergic reactions.
• Use pre‑medication (e.g., antihistamines, corticosteroids) to mitigate infusion‑related symptoms.
• Maintain strict aseptic technique during intravenous infusion to prevent catheter‑related infections.
• Counsel patients on signs of infection and advise prompt medical evaluation.

Grafalon may interact with other agents that affect immune function or hemodynamics, requiring careful management.

Avoid

• Concurrent use with live vaccines, as immunosuppression can diminish vaccine efficacy and increase risk.
• Co‑administration with other T‑cell depleting antibodies or potent immunosuppressants without dose adjustment.

Use with caution

• Antifungal or antiviral prophylaxis agents, which may require dose modification due to overlapping toxicity.
• Drugs that prolong QT interval, as Grafalon‑related electrolyte shifts can increase arrhythmia risk.
• Diuretics or antihypertensives, because Grafalon‑induced fluid shifts may affect blood pressure control.