Drug Guide

Generic Name

Denileukin Diftitox

Brand Names Ontak

Classification

Therapeutic: Antineoplastic, Immunotoxin

Pharmacological: Cytotoxic agent

FDA Approved Indications

Mechanism of Action

Denileukin Diftitox is a recombinant fusion protein that combines interleukin-2 (IL-2) with diphtheria toxin. It binds to IL-2 receptors (particularly CD25) on target cells, is internalized, and delivers the diphtheria toxin intracellularly, inhibiting protein synthesis and leading to cell death.

Dosage and Administration

Adult: 7.5 μg/kg via intravenous infusion over 15 minutes daily for 5 consecutive days, repeated every 3 weeks as needed.

Pediatric: Not typically recommended; consult specific pediatric protocols.

Geriatric: No specific dosage adjustment, but caution with renal and hepatic function.

Renal Impairment: No specific adjustment; monitor renal function.

Hepatic Impairment: No specific adjustment reported.

Pharmacokinetics

Absorption: Not applicable; administered intravenously.

Distribution: Widely distributed in body tissues.

Metabolism: Enzymatic degradation in tissues and plasma.

Excretion: Primarily via proteolytic degradation; not explicitly excreted unchanged.

Half Life: Approximately 24 hours.

Contraindications

Precautions

Adverse Reactions - Common

Adverse Reactions - Serious

Drug-Drug Interactions

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for signs of infusion reactions, hypersensitivity, and capillary leak syndrome. Assess cardiac status and fluid balance.

Diagnoses:

  • Risk for fluid volume overload
  • Risk for hypersensitivity reactions

Implementation: Administer via slow IV infusion under close monitoring. Ensure emergency management measures are available.

Evaluation: Monitor for reduction in CTCL symptoms, adverse effects, and infusion site reactions.

Patient/Family Teaching

Special Considerations

Black Box Warnings:

Genetic Factors: No specific genetic markers identified for response.

Lab Test Interference: May alter immune cell counts; monitor labs accordingly.

Overdose Management

Signs/Symptoms: Severe hypotension, shock, edema, or signs of capillary leak syndrome.

Treatment: Supportive care, manage fluid status, and provide intensive care support as needed.

Storage and Handling

Storage: Store vials refrigerated at 2-8°C. Protect from light.

Stability: Stable until the expiration date when stored properly.

This guide is for educational purposes only and is not intended for clinical use.