Denileukin Diftitox

What is Denileukin Diftitox?

• Denileukin diftitox (Ontak) is a CD25-directed cytotoxin that is used as an antineoplastic agent to treat cutaneous T cell lymphomas that express IL-2 receptors.

What are the uses of this medicine?

Denileukin diftitox (Ontak) is used to treat:

• Cutaneous T-cell lymphoma (a certain type). It is used in adults whose disease has not gotten better with other treatment or has recurred (come back).

How does this medicine work?

• Denileukin (den" i loo' kin) diftitox (dif' ti tox) is a fusion protein that combines human interleukin-2 (IL-2) with diphtheria toxin fragments A and B.
• After binding to the IL-2 receptor on the cell surface, denileukin diftitox is internalized by receptor-mediated endocytosis.
• The fusion protein is subsequently cleaved, releasing diphtheria toxin enzymatic and translocation domains from the IL-2 fragment, resulting in the inhibition of protein synthesis and ultimately, cell death.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug-drug interaction studies have been conducted with Ontak.

Is this medicine FDA approved?

• Denileukin diftitox was approved for use in the United States in 1999 and the indications remain limited to therapy of refractory cutaneous T cell lymphomas that express the CD25 component of the IL-2 receptor on the surface of the malignant cells.
• Once taken up by the cells expressing the IL-2 receptor, the diphtheria toxin is released into the cytoplasm causing cell death.

How should this medicine be used?

• Premedicate with an antihistamine and acetaminophen prior to each Ontak infusion.

Recommended dosage:

• Administer at 9 or 18 mcg/kg/day by intravenous infusion over 30 to 60 minutes for 5 consecutive days every 21 days for 8 cycles.

Administration:

• Denileukin diftitox comes as a solution (liquid) to be injected over 30 to 60 minutes intravenously (into a vein).
• Denileukin diftitox is administered by a doctor or nurse in a medical office or infusion center.
• It is usually given once a day for 5 days in a row.
• This cycle may be repeated every 21 days for up to eight cycles.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Single-use vial containing 150 mcg/mL (300 mcg in 2 mL).

This medicine is available in fallowing brand namesː

• Ontak

What side effects can this medication cause?

The most common side effects of this medicine include:

• pyrexia
• nausea
• fatigue
• rigors
• vomiting
• diarrhea
• headache
• peripheral edema
• cough
• dyspnea
• pruritus

• Less common but potentially severe adverse reactions include anaphylaxis, severe infections, thrombotic events and pancreatitis.

What special precautions should I follow?

• Infusion reactions, defined as symptoms occurring within 24 hours of infusion and resolving within 48 hours of the last infusion in that course, were reported Immediately stop and permanently discontinue Ontak for serious infusion reactions. Monitor patients following infusion.
• Capillary leak syndrome was defined as the occurrence of at least 2 of the following 3 symptoms (hypotension, edema, serum albumin <3.0 g/dL) at any time during Ontak therapy. Monitor weight, edema, blood pressure and serum albumin levels.
• Loss of visual acuity, usually with loss of color vision, with or without retinal pigment mottling has been reported following administration of Ontak. Monitor visual acuity and color vision.
• Monitor serum albumin levels prior to the initiation of each treatment course. Delay administration of Ontak until serum albumin levels are at least 3.0 g/dL.
• High doses of denileukin diftitox can cause mild-to-moderate elevations in serum enzymes and bilirubin, but rarely result in clinically significant acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea
• vomiting
• fever
• chills
• persistent asthenia

Management of overdosage:

• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• It is not known whether Ontak can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
• Ontak should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient: Denileukin diftitox

Inactive ingredients:

Who manufactures and distributes this medicine?

Manufactured by:

• Eisai Medical Research Inc.
• Ridgefield Park, NJ

Manufactured at: Hollister-Stier Labs LLC Spokane, WA

Distributed by:

• Eisai Inc.
• Woodcliff Lake, NJ

What should I know about storage and disposal of this medication?

• Store frozen at or below -10°C (14°F).

Alphabetic list of antineoplastic agents - 0-9 - A1 - A2 - A3 - A4 - A5 -A6 - B - C - D - E - F - G - H - I - JK - L - M - NO - PQ - R - S - T - UVW - XYZ

 

• Dailymed label info on Denileukin Diftitox
• FDA Denileukin Diftitox

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