Denileukin Diftitox Injection
Denileukin diftitox (LYMPHIR) is a targeted cancer therapy used to treat a type of skin lymphoma that has returned or stopped responding to prior treatment.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
LYMPHIR carries a boxed warning — the FDA's most serious safety alert — for capillary leak syndrome (CLS). CLS is a condition where fluid escapes from your blood vessels into body tissues. It can cause severe swelling, a dangerous drop in blood pressure, and very low levels of albumin (a key blood protein). In some cases, CLS has been life-threatening or fatal. This can happen at any point during treatment. Your medical team will watch for signs like sudden swelling, lightheadedness, or low blood pressure, and will hold or stop treatment depending on how serious it is. Report any of these symptoms to your care team immediately.
📖 Denileukin Diftitox Injection: Patient Information Guide
A plain-language walkthrough of Denileukin Diftitox Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Denileukin Diftitox Injection is used for
▾
LYMPHIR treats a type of blood cancer that primarily affects the skin. It is approved for adults with:
- Relapsed or refractory cutaneous T-cell lymphoma (CTCL) — specifically Stage I, II, or III disease
- Patients who have already received at least one prior systemic (whole-body) therapy
How Denileukin Diftitox Injection works
▾
LYMPHIR is engineered as a fusion protein — two functional parts joined together. The first part targets the IL-2 receptor, a protein found on the surface of the abnormal T-cells responsible for CTCL. The second part is a modified diphtheria toxin. When LYMPHIR binds to an IL-2 receptor-bearing cell and gets pulled inside, the toxin is released, blocks the cell's ability to make proteins, and kills it. It also works to deplete regulatory T cells (Tregs) — immune cells that can shield tumors from the body's natural defenses.
How Denileukin Diftitox Injection is taken (dosage)
▾
LYMPHIR is given as an IV infusion in a clinical or hospital setting — not taken at home. It is infused once daily over 60 minutes on Days 1 through 5 of a 21-day cycle, then you have about 16 days off before the next cycle begins. Treatment continues until the disease progresses or side effects become unacceptable.
- Pre-medications (to reduce infusion reactions) are given at least 30 minutes before each infusion, especially in the first three cycles
- Your albumin level and liver and kidney function will be checked before each cycle starts
- If your albumin is too low, your care team will delay the next cycle until it recovers
Denileukin Diftitox Injection side effects in detail
▾
The most common side effects reported in clinical trials include:
- Elevated liver enzymes (a sign the liver is under stress)
- Low albumin levels in the blood
- Nausea
- Swelling (edema)
- Low hemoglobin (anemia — low red blood cell count)
- Fatigue
- Muscle and bone pain
- Rash, chills, fever, and constipation
More serious reactions — including capillary leak syndrome, liver toxicity, vision changes, and infusion reactions — require prompt medical attention. Contact your care team right away if any of these develop.
Denileukin Diftitox Injection warnings and precautions
▾
- Capillary leak syndrome (CLS): The most serious risk. Fluid leaks from blood vessels, causing swelling, low blood pressure, and low albumin. Can be life-threatening. Treatment may be paused or permanently stopped based on severity.
- Vision changes: Some patients experience visual impairment during treatment. Your care team will monitor your eyesight and may hold or discontinue treatment if problems arise.
- Infusion-related reactions: Reactions during the IV infusion can occur. Pre-medications are given to reduce this risk, and the infusion may be slowed or stopped if a reaction happens.
- Liver toxicity (hepatotoxicity): Liver enzymes and bilirubin (a liver marker) are checked at baseline and throughout treatment. Higher drug exposure increases this risk.
- Fetal harm: LYMPHIR can harm a developing baby. Women of childbearing potential must use effective contraception during treatment and for 7 days after the last dose.
Denileukin Diftitox Injection interactions: what it interacts with
▾
The FDA label for LYMPHIR does not identify specific drug, food, or supplement interactions at this time. Always tell your entire care team — including your pharmacist — about every medication, supplement, and herbal product you take.
- No specific interactions are listed in the current prescribing information
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Denileukin Diftitox Injection
▾
- Pregnancy: This drug can harm a fetus. A pregnancy test is required before starting, and effective contraception must be used during treatment and for 7 days after the last dose.
- Breastfeeding: Do not breastfeed during treatment or for 7 days after the last dose — the drug's effects on a nursing infant are unknown.
- Male fertility: Animal studies suggest LYMPHIR may affect male fertility; whether this is reversible is unknown. Discuss this with your doctor before starting.
- Children: Safety and effectiveness in patients under 18 have not been established.
- Older adults: About half of patients in the main clinical trial were 65 or older; no clear difference in response was identified, but clinical data were limited.
- Liver or kidney impairment: Mild impairment does not significantly change how the drug behaves, but moderate-to-severe hepatic impairment or severe renal impairment have not been fully studied.
- Low albumin: Treatment will be delayed if your blood albumin is below 3 g/dL at the start of a cycle.
Pharmacodynamics: what Denileukin Diftitox Injection does in the body
▾
Higher levels of LYMPHIR in the blood are linked to a greater chance of serious side effects — including capillary leak syndrome, liver toxicity, severe adverse reactions, and treatment discontinuation. In other words, more drug exposure means more risk, which is why dosing and monitoring are carefully managed. The exact time course of how and when the drug produces its effects in the body is not fully known.
Pharmacokinetics: how your body processes Denileukin Diftitox Injection
▾
LYMPHIR is given as a one-hour IV infusion and reaches peak blood levels relatively quickly. Its half-life — the time it takes for half the drug to clear from your body — is about 112 minutes (roughly under 2 hours). It does not build up in the body with repeated daily dosing over the 5-day cycle. The drug is broken down (metabolized) into small peptides through normal body processes and is cleared from the body at a predictable rate. Age, weight, sex, race, and mild-to-moderate kidney or liver problems do not appear to meaningfully change how the body handles it.
How to store Denileukin Diftitox Injection
▾
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.
📄 Written from Denileukin Diftitox Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Denileukin Diftitox Injection
17 supplements and herbal products have documented interactions with Denileukin Diftitox Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Denileukin Diftitox Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Denileukin Diftitox Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this drug treating, and why was I given it instead of something else?
▾
How is this given — do I take it at home?
▾
What side effects should I just expect versus which ones mean I need to call someone right away?
▾
I've heard there's a really serious warning with this drug — what should I know?
▾
Can I get pregnant or breastfeed while on this treatment?
▾
Will my liver and kidneys be checked while I'm on this?
▾
Is Denileukin Diftitox Injection available over the counter?
▾
When was Denileukin Diftitox Injection first available?
▾
💬 Answers drafted from Denileukin Diftitox Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Denileukin Diftitox Injection on HelloPharmacist
💊 Denileukin Diftitox Injection forms and strengths (how it comes)
Denileukin Diftitox Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
📊 Denileukin Diftitox Injection on the U.S. market: products, makers and brands
How Denileukin Diftitox Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
🔍 Compare Denileukin Diftitox Injection products
A representative set of FDA-listed product records for Denileukin Diftitox Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|
| 💊Injection | |||
| 150 mcg/mL | FUJIFILM Diosynth Biotechnologies UK Ltd. | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Denileukin Diftitox Injection NDCs →
📈 Denileukin Diftitox Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Denileukin Diftitox Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Denileukin Diftitox Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Denileukin Diftitox Injection FDA approval history
How Denileukin Diftitox Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Denileukin Diftitox Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 214470 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 1807475In current FDA listingsClinical drug / strength (SCD) cxdl 0.3 MGRxCUI 2700750
Look up RxCUI 214470 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Denileukin Diftitox Injection supply and shortage status
Whether Denileukin Diftitox Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Denileukin Diftitox Injection brand names
🏭 Who makes Denileukin Diftitox Injection: manufacturers and labelers
Denileukin Diftitox Injection drug class (RxNorm)
Denileukin Diftitox Injection belongs to the CD25-directed Cytotoxin class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Denileukin Diftitox Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Citius Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.