Product image of Grafalon (Anti-T Lymphocyte Immunoglobulin For Human Use, Rabbit) supplied by GNH India

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 anti‑T lymphocyte immunoglobulin (rabbit) for human use. It is supplied as a sterile intravenous preparation and classified as a prescription immunosuppressant. The product is marketed in the European Union and is intended for use under medical supervision to modulate cellular immune responses.

Manufacturer / TM Owner

Neovii Biotech Gmbh

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Indications & Clinical Uses

Grafalon is employed as an immunosuppressive agent in clinical settings where T‑cell depletion is desired. It is commonly used in the following contexts:

  • Induction of immunosuppression prior to solid organ transplantation.
  • Treatment of acute cellular rejection episodes after transplantation.
  • Management of severe aplastic anemia resistant to conventional therapy.
  • Adjunct therapy in certain autoimmune disorders requiring profound T‑cell suppression.
  • Conditioning regimen for hematopoietic stem cell transplantation.

Side Effects

Side effects of Grafalon vary in frequency and severity. Common reactions are typically mild to moderate, while serious events are less frequent but require prompt medical attention.

Common

  • Fever, chills, or rigors during infusion.
  • Nausea, vomiting, or abdominal discomfort.
  • Headache or dizziness.
  • Transient hypotension or hypertension.
  • Rash, pruritus, or mild urticaria.
  • Elevated liver enzymes.

Serious

  • Serum sickness–like reactions.
  • Severe infection due to immunosuppression.
  • Cytokine release syndrome.
  • Anaphylaxis or severe hypersensitivity.
  • Acute renal impairment.
  • Thromboembolic events.

Precautions & Warnings

Grafalon should be administered with careful consideration of patient‑specific factors and monitoring requirements. Important precautions include:

  • Screening for active infections (e.g., hepatitis, HIV, tuberculosis) before initiation.
  • Baseline and periodic assessment of complete blood count, renal and hepatic function.
  • Avoid use in patients with known hypersensitivity to rabbit proteins.
  • Pregnancy and lactation status should be evaluated; safety data are limited.
  • Monitor for signs of cytokine release or serum sickness during and after infusion.
  • Ensure appropriate vaccination status; avoid live vaccines while immunosuppressed.

Avoid Interactions

Grafalon may interact with other agents that affect immune function or hemostasis. Consider the following when co‑administering:

Avoid

  • Concurrent use of other potent immunosuppressants without dose adjustment (e.g., high‑dose steroids, calcineurin inhibitors).
  • Live attenuated vaccines during treatment.

Use with caution

  • Nephrotoxic drugs (e.g., aminoglycosides, amphotericin B).
  • Anticoagulants or antiplatelet agents, due to potential bleeding risk.
  • Other biologic agents targeting lymphocytes.
  • Medications that may exacerbate hypertension or hypotension.

Frequently Asked Questions

Grafalon contains anti‑T lymphocyte immunoglobulin derived from rabbit serum, which targets human T‑cells.

Grafalon is supplied as an injectable solution and is given intravenously under the supervision of a healthcare professional.

Grafalon is commonly prescribed for induction of immunosuppression before organ transplantation, treatment of acute cellular rejection, and as part of conditioning regimens for stem cell transplantation.

Common side effects include fever, chills, nausea, headache, transient blood pressure changes, and mild skin rash.

Serious reactions may include serum‑sickness–like symptoms, severe infections, cytokine release syndrome, anaphylaxis, renal impairment, and thromboembolic events.

Grafalon should not be used in patients with known hypersensitivity to rabbit proteins or in those with active uncontrolled infections.

Baseline complete blood count, liver and kidney function tests, and screening for viral infections such as hepatitis B, hepatitis C, HIV, and tuberculosis are recommended.

Safety data for Grafalon during pregnancy and lactation are limited; the medication should be used only if the potential benefit justifies the potential risk.

Grafalon may increase the overall level of immunosuppression when combined with other agents, so dose adjustments and close monitoring are often required.

Live vaccines are generally avoided during treatment with Grafalon because of the heightened risk of infection.

Patients should be monitored for vital signs, infusion reactions, and laboratory parameters such as blood counts and organ function throughout the infusion and afterward.

Infusion should be stopped immediately, and appropriate emergency measures, including administration of antihistamines, corticosteroids, and epinephrine, should be initiated.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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