Denileukin

Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: N-l-Methionyl-387-l-histidine-388-l-alanine-1-388 toxin (Corynebacterium diphtheriae strain C7) (377→2′) protein with 2-133-interleukin 2 (human clone pTIL2-21a).
Molecular Formula: C₂₅₆₀H₄₀₃₈N₆₇₈O₇₉₉S₁₇
CAS Number: 173146-27-5
Brands: Ontak

Medically reviewed by Drugs.com on Jun 21, 2021. Written by ASHP.

Introduction

Antineoplastic agent; recombinant DNA-derived cytotoxic protein.

Uses for Denileukin

Cutaneous T-cell Lymphoma

Treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL) in patients whose malignant cells express the CD25 component of the IL-2 receptor (designated an orphan drug by FDA for this use).

Safety and efficacy in patients with CTCL whose malignant cells do not express the CD25 component of the IL-2 receptor not established but currently being studied.

Denileukin Dosage and Administration

General

• Consult specialized references for procedures for proper handling and disposal of antineoplastics.

• Prior to initiation of denileukin therapy, test patient’s malignant cells for CD25 expression.

Premedication

• Limited data suggest that administering oral corticosteroids (e.g., oral prednisone 20 mg) prior to each IV denileukin infusion or administering IV corticosteroids (e.g., IV dexamethasone 8 mg) on day 1 and prior to each subsequent IV denileukin infusion may minimize risk of potentially fatal acute hypersensitivity reactions.

• Not known if prophylactic administration of antipyretics, antiemetics, or antidiarrhea agents will ameliorate or decrease the incidence of flu-like syndrome.

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion; not for rapid (i.e., bolus) IV injection.

Do not use in-line filter.

Prior to administration, thaw denileukin diftitox concentrate at room temperature for 1–2 hours or under refrigeration (2–8°C) for up to 24 hours; do not heat solution.

Must then be diluted with preservative-free 0.9% sodium chloride injection prior to administration.

Do not admix with any other drug.

Dilution

Use strict aseptic technique and only plastic syringes and plastic IV bags to prepare and/or administer the drug; do not use glass containers. (See Compatibility under Stability.)

Add appropriate volume of denileukin diftitox concentrate to an empty IV infusion bag and dilute each mL of the concentrate with no more than 9 mL of the 0.9% sodium chloride injection to provide a solution containing at least 15 mcg/mL, a concentration that must be maintained during all steps of solution preparation.