Denileukin Diftitox 300 mcg Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 300 mcg

Reference Brands: Lymphir (USA)

Category: Oncology Cancer Care

Denileukin diftitox is a recombinant fusion protein combining human interleukin‑2 with fragments of diphtheria toxin. It selectively binds to IL‑2 receptors on malignant T-cells and delivers the toxin to kill these cells. It is used to treat adults with relapsed or refractory Cutaneous T‑cell Lymphoma (CTCL) and requires careful monitoring due to potential serious side effects such as infusion reactions, capillary leak syndrome, and liver toxicity.

Product Description:

Denileukin diftitox is a fusion protein rather than a conventional drug: human interleukin-2 spliced to the enzymatically active and membrane-translocating fragments of diphtheria toxin. The IL-2 portion acts as a homing device, binding the high-affinity IL-2 receptor expressed on malignant T cells; the toxin fragment is then internalised and shuts down protein synthesis inside the cell, killing it. Normal resting lymphocytes express the receptor at far lower density and are largely spared.

It is used for relapsed or refractory cutaneous T-cell lymphoma in adults, given as a short intravenous infusion on consecutive days in cycles. The toxicity requires an experienced unit. Capillary leak syndrome, with hypotension, oedema and hypoalbuminaemia, is the most serious risk and demands pre-treatment assessment of albumin and careful fluid management. Infusion reactions, transaminase elevation, rash and visual disturbance including loss of visual acuity are reported.

Sourcing notes. Originator biologic, recently re-approved under a new manufacturing process after the earlier version was withdrawn from the market in 2014 — these are not interchangeable products and only the current one should be quoted. Frozen storage and cold chain integrity are critical. Rare indication, very small volumes, specialist centres only.