Pronunciation: limf-fur
Generic name: denileukin diftitox
Dosage form: injection for intravenous infusion
Drug class: Miscellaneous antineoplastics

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 22, 2024.

What is Lymphir?

Lymphir (denileukin diftitox-cxdl) is a recombinant fusion protein that may be used to treat cutaneous T-cell lymphoma (CTCL) in adults that has returned or persisted despite treatment.

Lymphir consist of 2 parts, interleukin-2 (IL-2) and diptheria toxin. IL-2 helps the medication attach to specific cells called T-cells which then uptake the diphtheria toxin which is poisonous to the cells and kills them. Lymphir also targets other immune system cells called immunosuppressive regulatory T-cells (Tregs) that can shield cancer cells from the body's immune response. This dual mechanism of action helps Lymphir fight cancer more effectively.

Lymphir gained FDA approval on August 7, 2024, and is an updated version of an older cancer treatment called Ontak that was taken off the market in 2014.

Lymphir side effects

The most common side effects of Lymphir are:

• laboratory test changes, including changes in liver enzymes, red blood cells, and albumin
• nausea,
• fluid in the feet and legs (edema)
• fatigue
• muscle pain
• rash
• chills,
• constipation
• fever
• capillary leak syndrome (when fluid and proteins leak out of capillary walls into the surrounding tissue – can lead to a rapid drop in blood pressure).

Serious side effects and warnings

Lymphir carries a Boxed Warning for capillary leak syndrome.

Lymphir carries a serious risk of capillary leak syndrome (CLS). This condition can be life-threatening and causes fluid to leak from blood vessels into surrounding tissues. Symptoms include low blood pressure, swelling, and low protein levels. One in four patients experienced CLS during clinical trials, with some cases being severe or even fatal. Seek urgent medical attention if you experience any signs of CLS, including weight gain, swelling, shortness of breath, or low blood pressure.

Serious vision problems, including changes in how well you can see and changes in your color vision have been reported with Lymphir. About 9% of patients experienced vision issues, including blurry vision, during treatment. While most of these problems went away on their own, some people needed to stop taking Lymphir. Tell your healthcare provider right away if you experience changes in your eyesight, color vision, or blurred vision.

Severe reactions when infused. Infusion-related reactions were reported in 69% of people allocated Lymphir in clinical trials with most experiencing the reaction in Cycles 1 and 2. The most common symptoms included nausea, fatigue, chills, and muscle aches. To manage these side effects, healthcare providers will give pre-medications for the first 3 cycles at least 30 minutes before the infusion and monitor patients closely. If severe reactions occur, the medication may need to be stopped or the dose reduced.

Liver damage. Many patients who took Lymphir experienced elevated liver enzymes, with a smaller number experiencing severe liver damage. Your healthcare provider will monitor your liver function closely during treatment and may adjust or stop Lymphir if liver problems occur.

Lymphir can harm an unborn baby. Women who can become pregnant should use effective birth control while on this medication and for 1 week after treatment ends.

It is not known if Lymphir is safe and effective in children.

To report suspected adverse reactions, contact Citius Pharmaceuticals, Inc. at 1-844-459-6744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Related/similar drugs

Before taking

Before taking Lymphir, tell your healthcare provider about all your medical conditions, including if you:

• Have or have had liver disease
• Have low blood pressure
• Have vision problems
• Are taking other medications
• Have anemia or other blood disorder
• Are constipated
• Have experienced an infusion-related reaction to Lymphir before
• Are pregnant or intend to become pregnant
• Are breastfeeding.

Pregnancy

Lymphir can harm an unborn baby. Females should not be pregnant when starting Lymphir and females of childbearing age should use effective birth control during treatment and for a week after the last dose.

Animal studies suggest male fertility may be affected by Lymphir treatment.

Breastfeeding

Women should not breastfeed while taking Lymphir and for 7 days after the last dose. Talk to your doctor about the best way to feed your baby during this time.

How is Lymphir administered?

Lymphir is administered by a healthcare provider in a hospital or a clinic.

• Before starting each treatment cycle your healthcare provider will assess your liver and kidney function. Lymphir may be delayed depending on the result.
• Premedications, consisting of an anti-fever medicine (eg, acetaminophen), an antihistamine (eg, diphenhydramine), and an anti-nausea pill are administered at least 30 minutes before the infusion for at least the first 3 cycles.
• 250 mL to 500 mL of 0.9% sodium chloride is also given intravenously.

Lymphir is administered via a vein in your arm (intravenous infusion) over 60 minutes.

Lymphir dosage

The recommended dosage of Lymphir is based on your actual body weight.

• The usual adult dosage of Lymphir for CTCL is 9 mcg/kg/day
• Administered as an intravenous infusion on Days 1 through 5 of a 21-day cycle.
• Administer Lymphir until disease progression or unacceptable toxicity occurs.

Lymphir storage

Your healthcare provider will store Lymphir in the refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light. Do not freeze

Lymphir ingredients

Active ingredients: denileukin diftitox-cxdl 300 mcg

Inactive ingredients: citric acid monohydrate (4.2 mg), edetate disodium (0.04 mg), methionine (3 mg), polysorbate 20 (1.2 mg), and trehalose (100.4 mg). Sodium hydroxide is used to adjust the pH of the formulation buffer

Available as a single dose vial.

Who makes Lymphir?

Citius Pharmaceuticals, Inc. manufactures Lymphir.

Lymphir Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Lymphir.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer