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

Grafalon is indicated for the prevention of acute rejection in organ transplantation and may be employed as part of an immunosuppressive regimen. It is administered intravenously in a controlled clinical environment.

• Prevention of acute cellular rejection following kidney, liver, or heart transplantation.
• Induction therapy to reduce early immune activation after organ grafting.
• Adjunct to maintenance immunosuppression in high‑risk transplant recipients.
• Used in clinical protocols where T‑cell depletion is desired.
• May be considered in experimental protocols for immune modulation.

Side effects of Grafalon vary in frequency and severity. Patients should be monitored for both common and serious reactions.

Common

• Fever or chills during infusion.
• Headache or malaise.
• Nausea or vomiting.
• Transient leukopenia.
• Mild hypertension.
• Rash or mild urticaria.

Serious

• Severe infections due to immunosuppression.
• Cytokine release syndrome.
• Serum sickness or hypersensitivity reactions.
• Thromboembolic events.
• Acute renal impairment.
• Hemolytic anemia.

Grafalon requires careful assessment before and during therapy. Clinicians should consider the following precautions:

• Evaluate baseline infection status and screen for latent viruses (e.g., CMV, EBV, hepatitis B/C).
• Monitor complete blood counts and renal function regularly.
• Use with caution in patients with a history of hypersensitivity to rabbit proteins.
• Adjust dosing in patients with pre‑existing cardiovascular disease.
• Avoid in pregnant or breastfeeding women unless benefits outweigh risks.
• Ensure appropriate prophylactic antimicrobial coverage when indicated.
• Maintain aseptic technique to prevent infusion‑related complications.

Grafalon may interact with other medications, influencing efficacy or safety. Consider the following interaction guidance:

Avoid

• Concurrent use of other potent immunosuppressants without dose adjustment (e.g., high‑dose steroids, calcineurin inhibitors).
• Live vaccines during treatment and for several weeks after therapy.
• Agents that significantly increase serum potassium when combined with calcineurin inhibitors.

Use with caution

• Antimicrobial prophylaxis agents (e.g., trimethoprim‑sulfamethoxazole) due to additive bone‑marrow suppression.
• Antifungal azoles that affect cytochrome P450 metabolism of co‑administered drugs.
• Diuretics that may exacerbate renal function changes.
• NSAIDs that could increase risk of nephrotoxicity.
• Other biologic agents that modulate immune response.