Denileukin diftitox-cxdl

What Denileukin diftitox-cxdl is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

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.

— FDA label: Lymphir, Citius Pharmaceuticals, Inc., effective January 23, 2025. Read the full label on DailyMed →

Label quoted: the one for the most common form (injection, powder, lyophilized, for solution, intravenous), Lymphir, Citius Pharmaceuticals, Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: CAPILLARY LEAK SYNDROME. Read it on the full label →

Denileukin diftitox-cxdl boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

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 [see Dosage and Administration (2.1, 2.4) and Warnings and Precautions (5.1)]. WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning.

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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. (2.1, 2.4, 5.1)

— FDA label: Lymphir, Citius Pharmaceuticals, Inc., effective January 23, 2025. Read the full label on DailyMed →

Denileukin diftitox-cxdl side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The following adverse reactions are discussed in greater detail in other sections of the label: Capillary Leak Syndrome [see Warnings and Precautions (5.1)] Visual Impairment [see Warnings and Precautions (5.2)] Infusion-Related Reactions [see Warnings and Precautions (5.3)] Hepatotoxicity [see Warnings and Precautions (5.4)] 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.

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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Citius Oncology, Inc. at 1-844-459-6744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to LYMPHIR as a single agent in 119 patients with CTCL across 3 clinical trials. Patients received treatment with LYMPHIR as an intravenous infusion at 9 mcg/kg daily from Day 1 through Day 5 of each 21-day cycle until disease progression or unacceptable toxicity. Among 119 patients who received LYMPHIR the median number of cycles received was 5 (range: 1 to 42), with 13% exposed for 6 months or longer. In this pooled safety population, the most common (≥ 20%) adverse reactions, including laboratory abnormalities, were increased transaminases (70%), albumin decreased (53%), nausea (40%), edema (35%), hemoglobin decreased (34%), fatigue (30%), musculoskeletal pain (26%), rash (23%), chills (22%), constipation (22%), pyrexia (21%), and capillary leak syndrome (20%). Relapsed or Refractory Stage I-III CTCL Study 302 The safety of LYMPHIR was evaluated in Study 302, an open-label, single-arm, multicenter trial that included 69 patients with relapsed or refractory Stage I-III CTCL [see Clinical Studies (14)]. Patients received treatment with LYMPHIR 9 mcg/kg daily from Day 1 through Day 5 of each 21-day cycle. Treatment was administered until disease progression or unacceptable toxicity. The median number of LYMPHIR cycles was 6 (range: 1 to 42). The median age of patients was 64 years (range: 28 to 87 years), 49% were 65 years of age or older, 65% were men, 72% were White, 19% were Black or African American, 1.4% were Asian, and 14% were Hispanic or Latino. Serious adverse reactions occurred in 38% of patients who received LYMPHIR. Serious adverse reactions in > 2% of patients included capillary leak syndrome (10%), infusion-related reaction (9%), sepsis (7%), skin infection (2.9%), pyrexia (2.9%), and rash (2.9%). Permanent discontinuation of LYMPHIR due to an adverse reaction occurred in 12% of patients. Adverse reactions resulting in permanent discontinuation of LYMPHIR included capillary leak syndrome, infusion-related reaction, renal insufficiency, respiratory failure, and sepsis. Dosage interruptions of LYMPHIR due to an adverse reaction occurred in 38% of patients. Adverse reactions requiring dosage interruption of LYMPHIR included capillary leak syndrome, infusion-related reaction, weight increase, nausea, and tachycardia.

— FDA label: Lymphir, Citius Pharmaceuticals, Inc., effective January 23, 2025. This is part of the section. Read the full label on DailyMed →

Denileukin diftitox-cxdl dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Delay start of treatment cycle if serum albumin level is below 3 g/dL. (2.1) 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. (2.2) Administer premedication as recommended. (2.3) See full prescribing information for preparation and administration instructions. (2.5) 2.1 Important Dosing Instructions Prior to starting each treatment cycle, assess hepatic and renal function.

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If serum albumin is less than 3 g/dL, delay administration of LYMPHIR until serum albumin is greater than or equal to 3 g/dL [see Warnings and Precautions (5.1)]. 2.2 Recommended Dosage The recommended dosage of LYMPHIR is 9 mcg/kg/day actual body weight administered as an intravenous infusion over 60 minutes on Days 1 through 5 of a 21-day treatment cycle. Administer LYMPHIR until disease progression or unacceptable toxicity. 2.3 Recommended Premedications Administer premedications prior to starting a LYMPHIR infusion in Cycles 1 through 3, as outlined in Table 1, to reduce the risk of infusion-related reactions [see Warnings and Precautions (5.3)]. Table 1. Premedication to be Administered to Patients Prior to LYMPHIR Infusion Treatment Cycle Premedication Dosage Administration Cycles 1-3 (optional thereafter) Antipyretic Oral acetaminophen 650 mg or per local institutional guidelines At least 30 minutes prior to infusion Antihistamine Diphenhydramine 25 mg intravenously or other antihistamine per local institutional guidelines At least 30 minutes prior to infusion Antiemetic Per institutional guidelines At least 30 minutes prior to infusion Hydration 250 to 500 mL 0.9% Sodium Chloride Injection intravenously (or other amount of fluid considered to be most appropriate for the subject’s condition) At least 30 minutes prior to infusion If patients experience a Grade 2 or higher infusion reaction, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid such as dexamethasone 4 mg (or equivalent) via slow intravenous push, for at least 3 cycles. 2.4 Dosage Modifications for Adverse Reactions Dosage modifications for adverse reactions with LYMPHIR are shown in Table 2 below. Table 2: Recommended Dosage Modifications for Adverse Reactions Adverse Reaction Severity* Dosage Modification Capillary leak syndrome (CLS) [see Warnings and Precautions (5.1)] Grade 2 Withhold LYMPHIR until CLS resolves to Grade 1. Grade 3 Withhold LYMPHIR and provide supportive care until CLS resolves to Grade 1. Resume LYMPHIR at 50% dose. Consider steroid premedication for subsequent infusions. Permanently discontinue upon recurrence. Grade 4 Permanently discontinue LYMPHIR. Visual impairment [see Warnings and Precautions (5.2)] Grade 1 or 2 Consider withholding or discontinuing LYMPHIR as appropriate. Refer for ophthalmic evaluation. Grade 3 or 4 Withhold LYMPHIR until resolved to Grade 1 or baseline. Refer for ophthalmic evaluation. Permanently discontinue LYMPHIR if impairment does not resolve to Grade 1 or baseline. Infusion-related reactions [see Warnings and Precautions (5.3)] Grade 2 or 3 Interrupt infusion and manage signs and symptoms.

— FDA label: Lymphir, Citius Pharmaceuticals, Inc., effective January 23, 2025. This is part of the section. Read the full label on DailyMed →

Denileukin diftitox-cxdl in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox.

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Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

— FDA label: Lymphir, Citius Pharmaceuticals, Inc., effective January 23, 2025. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Citius Pharmaceuticals, Inc.1 product

FDA approval history

• BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.

Shortage status

The FDA drug shortage list does not show these products.

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Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Lymphir, Citius Pharmaceuticals, Inc., effective January 23, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

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