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Denileukin Diftitox

Pronouncation: (duh-nih-LOO-kin DIFF-tih-tox)
Class: Biologic response modifier

Trade Names:
Ontak
- Frozen, solution for injection 150ߙmcg/mL

Pharmacology

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Denileukin, a recombinant DNA-derived cytotoxic protein fused to diphtheria toxin fragments A and B, is designed to direct the cytocidal action of diphtheria toxin to cells that express the IL-2 receptor.

Pharmacokinetics

Distribution

Distribution t _½ approximately 2ߙto 5ߙmin. Vd is 0.06 to 0.08 L/kg.

Metabolism

Metabolized by proteolytic degradation.

Elimination

Terminal t _½ approximately 70 to 80 min. Cl approximately 1.5 to 2 mL/min/kg. Excreted material is less than 25% of the dose and consisted of metabolites.

Indications and Usage

Cutaneous T-cell lymphoma.

Contraindications

Standard considerations.

Dosage and Administration

Cutaneous T-Cell Lymphoma
Adults

IV 1 treatment cycle is 9 or 18ߙmcg/kg/day administered for 5 consecutive days every 21 days. Infuse over at least 15ߙmin.

Pretreatment Regimen Adults

Give acetaminophen 650 mg PO or rectal and diphenhydramine 25 to 50 mg PO or IV 30 to 60 min before administering denileukin diftitox.

Dosage Adjustments Adults

Delay therapy in patients with serum albumin below 3 g/dL.

General Advice

Administer by IV infusion only. Do not administer as a bolus injection. Do not physically mix with other drugs. Do not administer through an in-line filter.
Dilute the desired dose with sodium chloride 0.9% for a final concentration of at least 15ߙmcg/mL. The denileukin diftitox concentration should not be less than 15ߙmcg/mL at any time during product preparation. Swirl vial gently to mix the solution. Do not shake vial.
Administer prepared solutions within 6 h, using a syringe pump or IV infusion bag.
Discard unused portions immediately.
Do not use glass IV containers.

Storage/Stability

Store frozen at no more than −10°C (14°F). Must be brought to room temperature, at no more than 25°C (77°F), before preparing the dose. The vials may be thawed in the refrigerator at 2° to 8°C (36° to 46°F) for no more than 24 h or at room temperature for 1 to 2 h. Do not heat denileukin. Do not refreeze.

Drug Interactions

Beta blockers, other antihypertensives

May exacerbate denileukin diftitox-induced hypotension.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Capillary leak syndrome; hypotension; edema; chest pain; tachycardia; thrombotic events; MI.

CNS

Asthenia; headache; dizziness; paresthesia; nervousness; confusion; insomnia.

Dermatologic

Rash; pruritus; injection site irritation.

Endocrine

Hypoalbuminemia; infection; impaired immune function; hypocalcemia; albuminuria.

GI

Nausea; vomiting; elevated LFTs; anorexia; diarrhea; constipation; weight loss; dysphagia.

Genitourinary

Hematuria; pyuria.

Hematologic

Anemia; thrombocytopenia; leukopenia.

Hypersensitivity

Hypotension; dyspnea; vasodilation; rash; pruritus; anaphylaxis.

Metabolic

Dehydration.

Musculoskeletal

Myalgia; arthralgia; pain.

Renal

Hematuria; pyuria; increased serum creatinine.

Respiratory

Dyspnea; cough increase; pharyngitis; rhinitis.

Miscellaneous

Chills; fever.

Precautions

Monitor

Prior to administration of this product, test the patient's malignant cells for CD25 expression. Perform a CBC and a blood chemistry panel, including liver and renal function and serum albumin levels, prior to initiation of treatment and weekly during therapy.

Pregnancy

Category C .

Lactation

Undetermined. Patients receiving denileukin should discontinue breast-feeding.

Children

Safety and efficacy not established.

Elderly

Anorexia, hypotension, anemia, confusion, rash, nausea, or vomiting tended to be more frequent or severe in patients at least 65ߙyr of age.

Hypersensitivity

Acute hypersensitivity reactions were reported in 69% of patients during or within 24 h of infusion; about 50% of the events occurred on the first day of dosing regardless of the treatment cycle.

Vascular leak syndrome

Occurs within 2 wk after starting therapy. Take special caution in patients with preexisting CV disease.

Patient Information

Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a health care setting.
Review dosing schedule with patient, family, or caregiver.
Advise patient, family, or caregiver that home blood pressure measurements and weighing may be necessary. Instruct patient, family, or caregiver in proper technique if necessary.
Advise patient, family, or caregiver to immediately report any of the following to health care provider: rash; hives; flushing; difficulty breathing; chest pain or tightness; back pain; difficulty swallowing; fainting; swelling; fever, chills, or other signs of infection; sores in mouth; unusual bleeding or bruising.
Advise patient, family, or caregiver to report any of the following to health care provider: persistent nausea, vomiting, diarrhea or appetite loss; persistent or worsening general body weakness; pain, redness, or swelling at injection site.