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

Grafalon Sct is employed in transplant and hematopoietic settings to modulate cellular immunity.

• Prevention of acute organ‑allograft rejection in kidney, liver, heart or lung transplantation.
• Treatment of graft‑versus‑host disease (GVHD) following allogeneic stem cell transplantation.
• Induction therapy to reduce the risk of early immune activation after transplantation.
• Adjunctive immunosuppression in patients who are at high immunologic risk.

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

Common

• Fever, chills or rigors during infusion.
• Nausea, vomiting or mild abdominal discomfort.
• Transient leukopenia or lymphopenia.
• Mild hypotension or flushing.

Serious

• Severe infusion‑related reactions such as anaphylaxis.
• Cytokine release syndrome with high fever and hypotension.
• Opportunistic infections including viral, bacterial or fungal pathogens.
• Hemolytic anemia or thrombocytopenia.
• Serum sickness–like reactions.

Clinicians should evaluate several safety considerations before initiating Grafalon Sct therapy.

• Baseline complete blood count and differential to assess lymphocyte levels.
• Screening for active infections, especially viral hepatitis, CMV, or HIV.
• Monitoring of renal and hepatic function during treatment.
• Caution in patients with a history of hypersensitivity to rabbit proteins.
• Avoid use in pregnant or breastfeeding individuals unless benefits clearly outweigh risks.
• Consider prophylactic antimicrobial therapy to reduce infection risk.
• Observe for signs of cytokine release during the first infusion.

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

Avoid

• Concurrent use of other T‑cell depleting antibodies or potent immunosuppressants without dose adjustment.
• Live vaccines administered during or shortly after therapy.
• High‑dose corticosteroids given simultaneously without monitoring.

Use with caution

• Calcineurin inhibitors (e.g., cyclosporine, tacrolimus) due to additive nephrotoxicity.
• Antiviral agents that require dose modification in immunocompromised patients.
• Hematopoietic growth factors such as G‑CSF, which may alter leukocyte recovery.
• Diuretics that can exacerbate infusion‑related hypotension.