denileukin diftitox

denileukin diftitox

 [den″ĭ-loo´kin dif´tĭ-toks]

a genetically engineered construct containing amino acid sequences for specific diphtheria toxin fragments linked to sequences for interleukin-2 (IL-2), so that the cytotoxic action of the diphtheria toxin is targeted to cells expressing a specific form of the IL-2 receptor, as in certain leukemias and lymphomas. It is used as an antineoplastic in the treatment of cutaneous T-cell lymphomas, administered intravenously.

Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition. © 2003 by Saunders, an imprint of Elsevier, Inc. All rights reserved.

denileukin diftitox

Ontak

Pharmacologic class: Biological response modifier

Therapeutic class: Antineoplastic

Pregnancy risk category C

FDA Box Warning

• Give only under supervision of physician experienced in cancer chemotherapy, in facility equipped and staffed for cardiopulmonary resuscitation where patient can be monitored closely.

Action

Recombinant DNA-derived cytotoxic protein. Interacts with interleukin-2 (IL-2) receptors on cell surface and inhibits cellular protein synthesis, causing cell death.

Availability

Frozen solution for injection: 150 mcg/ml

Indications and dosages

➣ Persistent or recurrent cutaneous T-cell lymphoma that expresses CD25 component of IL-2 receptor

Adults: 9 or 18 mcg/kg/day I.V. infused over 15 minutes for 5 consecutive days q 21 days

Contraindications

• Hypersensitivity to drug, its components, diphtheria toxin, or IL-2

Precautions

Use cautiously in:

• cardiovascular disease

• elderly patients

• pregnant or breastfeeding patients

• children (safety and efficacy not established).

Administration

• Follow facility procedures for safe handling, administration, and disposal of chemotherapeutic agents.

☞ Administer by I.V. infusion only. Don't give by I.V. bolus.

• Dilute I.V. dose further with normal saline to concentration of at least 15 mcg/ml. Infuse over at least 15 minutes.

• Premedicate with acetaminophen, nonsteroidal anti-inflammatory drugs, and antihistamines, as ordered, to minimize infusion-related events.

• Gently swirl vial to mix, but avoid vigorous agitation.

• Don't mix with other drugs.

• Don't deliver through in-line filter.

• Infuse over at least 15 minutes.

☞ During infusion, observe closely for signs and symptoms of hypersensitivity reaction.

Adverse reactions

CNS: dizziness, paresthesia, nervousness, confusion, insomnia, syncope, headache

CV: hypotension, hypertension, vasodilation, tachycardia, chest pain, capillary leak syndrome (with extravasation), thrombosis, arrhythmias

EENT: rhinitis, pharyngitis, laryngospasm

GI: nausea, vomiting, diarrhea, constipation, flatulence, dyspepsia, difficulty swallowing, anorexia

GU: hematuria, albuminuria, pyuria

Hematologic: anemia, thrombocytopenia, leukopenia

Musculoskeletal: myalgia, back or joint pain

Metabolic: hypoalbuminemia, hypocalcemia, hypokalemia, dehydration

Respiratory: dyspnea, cough, lung disorder

Skin: rash, pruritus, sweating

Other: weight loss, edema, flulike symptoms, injection site reaction, hypersensitivity reactions including anaphylaxis

Interactions

Drug-drug. Live-virus vaccines: decreased antibody reaction

Drug-diagnostic tests. Albumin, calcium, potassium: decreased levels

Urine creatinine: increased level

Patient monitoring

• Monitor patient closely during first infusion and for 24 hours afterward.

• Evaluate patient for vascular leak syndrome (marked by at least two of the following: edema, hypotension, hypoalbuminemia).

• Monitor CBC, blood chemistry panel, renal and hepatic function, and albumin level. Repeat all tests weekly during therapy.

Patient teaching

☞ Instruct patient to immediately report chest pain, difficulty breathing, chills, burning at infusion site, or throat tightness, redness, swelling, or pain.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• Inform patient that drug makes him more susceptible to infection. Advise him to avoid crowds and exposure to illness.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

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