Drug Guide
Denileukin Diftitox
Classification
Therapeutic: Antineoplastic, Immunotoxin
Pharmacological: Cytotoxic agent
FDA Approved Indications
- Treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL) in patients with CD25-positive disease
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
- Hypersensitivity to Denileukin Diftitox or diphtheria toxin.
- Active infection.
Precautions
- Monitor for infusion-related reactions, hypersensitivity, cardiac events, and capillary leak syndrome. Use cautiously in patients with impaired cardiac or vascular function.
Adverse Reactions - Common
- Fatigue (Common)
- Nausea (Common)
- Vomiting (Common)
- Fever (Common)
Adverse Reactions - Serious
- Capillary leak syndrome (Rare but serious)
- Cardiac arrhythmias (Rare)
- Severe hypersensitivity reactions including anaphylaxis (Rare)
Drug-Drug Interactions
- Other immunosuppressants, live vaccines, other cytotoxic agents
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing 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
- Report signs of allergic reactions immediately.
- Inform about possible infusion reactions and symptoms of capillary leak syndrome.
- Advise against live vaccines during treatment.
- Follow instructions on infusion schedule and medication handling.
Special Considerations
Black Box Warnings:
- Capillary leak syndrome may be life-threatening and requires immediate management.
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.