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Grafalon

Active Ingredient:
Anti-T Lymphocyte Immunoglobulin For Human Use, Rabbit
Origin:
EU

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

Grafalon is an injectable solution containing the active ingredient Anti‑T Lymphocyte Immunoglobulin for Human Use, Rabbit. It is supplied without a specified strength and is administered intravenously under prescription. As a rabbit-derived anti‑thymocyte globulin, Grafalon belongs to the immunosuppressant class and is used in clinical settings to modulate T‑cell activity in transplant patients. The product is marketed in the European Union and is classified under ATC code L04AA02.

Manufacturer / TM Owner

Neovii Biotech Gmbh

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Indications & Clinical Uses

Grafalon is indicated for specific immunosuppressive purposes in transplant medicine.

  • Prevention of acute graft‑versus‑host disease (GVHD) following allogeneic hematopoietic stem cell transplantation.
  • Induction of immunosuppression to reduce the risk of acute rejection in solid organ transplantation, such as kidney, liver, or heart grafts.
  • Adjunct therapy in conditioning regimens for bone marrow transplantation to facilitate engraftment.
  • Use as part of a prophylactic immunosuppressive protocol in patients receiving high‑risk transplants.

Side Effects

The safety profile of Grafalon includes a range of observed adverse reactions, which are categorized by frequency and clinical significance.

Common

  • Fever, chills, or rigors during infusion.
  • Nausea, vomiting, or mild gastrointestinal upset.
  • Transient lymphopenia with reduced T‑cell counts.

Serious

  • Severe infusion reactions including anaphylaxis or bronchospasm.
  • Cytokine release syndrome with high fever and hypotension.
  • Opportunistic infections such as viral, fungal, or bacterial due to profound immunosuppression.

Precautions & Warnings

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

  • Assess baseline complete blood count and renal function before initiation.
  • Monitor vital signs and temperature closely during and after each infusion.
  • Screen for active infections, including viral hepatitis and HIV, prior to treatment.
  • Use pre‑medication (e.g., antihistamines, corticosteroids) to reduce infusion‑related reactions.
  • Adjust dose or discontinue therapy in patients with severe hypersensitivity or uncontrolled infections.

Avoid Interactions

Grafalon may interact with other medications, influencing its efficacy or safety profile.

Avoid

  • Concurrent use with live vaccines due to heightened risk of infection.
  • Simultaneous administration of other potent T‑cell depleting agents without specialist guidance.

Use with caution

  • Combine with nephrotoxic drugs such as calcineurin inhibitors; monitor renal function.
  • Co‑administer antiviral agents that require dose adjustment in immunosuppressed patients.
  • Monitor blood glucose closely if combined with corticosteroids, as hyperglycemia risk may increase.

Frequently Asked Questions

Grafalon is a rabbit-derived anti‑thymocyte globulin. It contains polyclonal antibodies that bind to T‑lymphocyte surface antigens, leading to complement‑mediated lysis and opsonisation, which depletes circulating T cells and modulates the immune response.

Grafalon is commonly used to prevent acute graft‑versus‑host disease after allogeneic hematopoietic stem cell transplantation and to induce immunosuppression that reduces the risk of acute rejection in solid organ transplants such as kidney, liver, and heart.

Grafalon is administered intravenously as an injectable solution under the supervision of a qualified healthcare professional.

Pre‑medication with antihistamines, acetaminophen, or corticosteroids is often recommended to lessen the likelihood of infusion‑related reactions such as fever, chills, or hypotension.

Baseline complete blood count, renal function tests, and screening for active infections (including hepatitis B, hepatitis C, and HIV) are typically performed before starting Grafalon.

Patients should have vital signs and temperature monitored closely during and after each infusion, and periodic blood counts and renal function assessments are advised throughout therapy.

Live vaccines are generally avoided in patients receiving Grafalon because the drug’s immunosuppressive effect increases the risk of vaccine‑derived infection.

Common side effects include fever, chills, rigors during infusion, nausea, vomiting, mild gastrointestinal upset, and a transient decrease in circulating T‑cell numbers.

Serious reactions can include severe infusion reactions such as anaphylaxis or bronchospasm, cytokine release syndrome with high fever and hypotension, and opportunistic infections due to profound immunosuppression.

The pregnancy safety category for Grafalon is unknown; it should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

When used together, Grafalon may increase the risk of nephrotoxicity; renal function should be monitored closely and dose adjustments considered as needed.

The infusion should be stopped immediately, appropriate emergency measures (such as administration of epinephrine, antihistamines, and corticosteroids) should be taken, and the treating physician should evaluate the need for future dosing or alternative therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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