Molecule
Denileukin diftitox is a CD25-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. MedsAcross supplies Denileukin diftitox for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
LYMPHIR is indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
Source: US FDA prescribing information
Denileukin diftitox-cxdl is a fusion protein designed to direct the cytocidal action of diphtheria toxin (DT) to cells which express the IL-2 receptor. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.
Source: US FDA prescribing information
Delay start of treatment cycle if serum albumin level is below 3 g/dL. The recommended dosage of LYMPHIR is 9 mcg/kg/day actual body weight administered as an intravenous infusion on Days 1 through 5 of a 21-day cycle. Administer premedication as recommended. See full prescribing information for preparation and administration instructions.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (capillary leak syndrome): Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity. Visual Impairment: Monitor and evaluate for visual impairment throughout treatment. Withhold LYMPHIR until visual impairment resolves or permanently discontinue based on severity. Infusion-Related Reactions: Monitor patients closely during infusions. Interrupt or discontinue for infusion-related reactions based on severity. Hepatotoxicity: Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the label: Capillary Leak Syndrome Visual Impairment Infusion-Related Reactions Hepatotoxicity The most common adverse reactions (≥20%), including laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome.
Source: US FDA prescribing information
Store LYMPHIR in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Denileukin diftitox, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Lymphir 300 mcg/2 mL powder for injectionIntravenous Cold chain | Citius Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 5 February 1999 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Denileukin diftitox and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Denileukin diftitox, including Lymphir.
Yes. The US FDA first approved Denileukin diftitox on 5 February 1999, according to Drugs@FDA.
At least one listed presentation of Denileukin diftitox must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Denileukin diftitox is classified under ATC code L01XX29 (Denileukin diftitox).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.