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denileukin diftitox[den″ĭ-loo´kin dif´tĭ-toks]
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.
Recombinant DNA-derived cytotoxic protein. Interacts with interleukin-2 (IL-2) receptors on cell surface and inhibits cellular protein synthesis, causing cell death.
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
• Hypersensitivity to drug, its components, diphtheria toxin, or IL-2
Use cautiously in:
• cardiovascular disease
• elderly patients
• pregnant or breastfeeding patients
• children (safety and efficacy not established).
• 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.
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
Drug-drug. Live-virus vaccines: decreased antibody reaction
Drug-diagnostic tests. Albumin, calcium, potassium: decreased levels
Urine creatinine: increased level
• 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.
☞ 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.