Grafalon

Grafalon is an injectable solution containing anti‑T‑lymphocyte immunoglobulin (rabbit) for human use, supplied in a standard strength as a prescription‑only product in the European Union. It belongs to the immunosuppressant drug class and is administered intravenously to modulate the immune response in specific transplant settings.

Grafalon is indicated for use in transplant medicine where T‑cell mediated immunity must be controlled. It is employed in both solid‑organ and hematopoietic stem cell transplantation protocols.

- Prevention of acute rejection following kidney, liver, heart, or lung transplantation. - Induction therapy to facilitate engraftment in hematopoietic stem cell transplantation. - Part of conditioning regimens prior to allogeneic stem cell transplant. - Adjunct to other immunosuppressive agents in multi‑drug transplant protocols. - Situations requiring rapid T‑cell depletion to reduce immune activation.

Grafalon may cause a range of adverse reactions, some of which are expected and others that require immediate medical attention.

Common: - Fever and chills during or shortly after infusion. - Nausea, vomiting, or abdominal discomfort. - Headache or mild dizziness. - Transient hypertension or blood pressure fluctuations. - Mild leukopenia or lymphopenia. - Injection‑site reactions such as erythema or swelling.

Serious: - Severe infections due to profound immunosuppression. - Cytokine release syndrome presenting with hypotension and respiratory distress. - Serum sickness or type III hypersensitivity reactions. - Anaphylaxis or severe allergic response. - Pulmonary edema or acute respiratory distress syndrome. - Renal impairment or acute kidney injury.

When prescribing Grafalon, clinicians should evaluate patient‑specific risk factors and monitor closely for complications.

- Screen for active infections (viral, bacterial, fungal) before initiation. - Monitor complete blood counts, renal function, and liver enzymes regularly. - Avoid use in patients with known hypersensitivity to rabbit proteins. - Use with caution in pregnant or breastfeeding individuals; discuss potential risks. - Ensure appropriate vaccination status; avoid live vaccines during treatment. - Adjust dosing in patients with pre‑existing renal insufficiency. - Provide prophylactic antimicrobial therapy as recommended by transplant protocols.

Grafalon can interact with other agents that affect immune function or hemostasis.

Avoid: - Live attenuated vaccines during and for several weeks after therapy. - Concurrent use of other T‑cell depleting antibodies without specialist guidance.

Use with caution: - Calcineurin inhibitors (e.g., tacrolimus, cyclosporine) due to additive nephrotoxicity. - Antimetabolites such as mycophenolate mofetil or azathioprine. - Antiviral prophylaxis agents (e.g., ganciclovir) requiring dose adjustments. - Anticoagulants or antiplatelet drugs because of potential bleeding risk. - Corticosteroids, which may amplify immunosuppressive effects.