DENILEUKIN DIFTITOX
| DENILEUKIN DIFTITOX (den-i-leu'kin dif'ti-tox) Ontak Classifications: antineoplastic; cytotoxic fusion protein; interleukin-2 (il-2) receptor inhibitor; Therapeutic: antineoplastic; immunomodulator; il-2 receptor inhibitor Pregnancy Category: C |
Availability
150 mcg/mL vial
Action
A recombinant DNA cytotoxic protein that is an interleukin-2 (IL-2) receptor-specific protein that acts as an antineoplastic agent. It acts against malignant cells that express particular high-affinity IL-2 receptors on the cell surface, thus inhibiting cellular protein synthesis and causing cell death in malignant cells.
Therapeutic Effect
Effectiveness is indicated by reduced tumor burden. Interacts with high affinity to IL-2 receptors on the cell surface in particular leukemias and lymphomas.
Uses
Persistent or recurrent T-cell lymphoma.
Contraindications
Hypersensitivity to denileukin, diphtheria toxin, or interleukin-2; serum albumin levels below 3 g/dL; pregnancy (category C), lactation.
Cautious Use
Cardiovascular disease; peripheral vascular disease, coronary artery disease; hepatic and renal impairment, elderly; preexisting lowering of serum albumin levels. Safety and efficacy in children <18 y are unknown.
Route & Dosage
| T-Cell Lymphoma Adult: IV 9 or 18 mcg/kg/d for 5 d every 21 d |
Administration
| Intravenous PREPARE: IV Infusion: Bring vials to room temperature (solution will be clear when room temperature is reached). Swirl to mix, but do not shake. Use only plastic syringe and plastic IV bag. Withdraw the calculated dose and inject it into an empty IV bag. Add NO MORE THAN 9 mL sterile saline without preservative to IV bag for each 1 mL of drug. Use within 6 h of preparation. ADMINISTER: IV Infusion: Infuse over at least 15 min without an in-line filter. Stop infusion and notify physician if S&S of hypersensitivity occur. INCOMPATIBILITIES Solution/additive: Do not physically mix with any other drug. |
Adverse Effects (≥1%)
Body as a Whole: Chills, fever, asthenia, infection, pain, headache, chest pain, flu-like syndrome; injection site reaction; acute hypersensitivity reaction (hypotension, back pain, dyspnea, vasodilation, rash, chest pain or tightness, tachycardia, dysphagia, syncope, anaphylaxis), myalgia, arthralgia. CNS: Dizziness, paresthesia, nervousness, confusion, insomnia. CV: Vascular leak syndrome (hypotension, edema, hypoalbuminemia); hypotension, vasodilation, tachycardia, thrombotic events, hypertension, arrhythmia. GI: Nausea, vomiting, anorexia, diarrhea, constipation, dyspepsia, dysphagia. Hematologic: Anemia, thrombocytopenia, leukopenia. Metabolic: Hypoalbuminemia; transaminase increase; edema; hypocalcemia; weight loss; dehydration; hypokalemia. Respiratory: Dyspnea, cough, pharyngitis, rhinitis, lung disorder. Skin: Rash, pruritus, sweating. Urogenital: Hematuria, albuminuria, pyuria, increased creatinine. Special Senses: Loss of visual acuity.Interactions
No clinically significant interactions established.Pharmacokinetics
Distribution: Primarily distributed to liver and kidneys. Metabolism: By proteolytic degradation. Half-Life: 70–80 min.Nursing Implications
Assessment & Drug Effects
- Monitor and notify physician immediately for S&S of hypersensitivity or anaphylaxis that occur during/within 24 h of infusion.
- Monitor and notify physician immediately for S&S of flu-like syndrome that occur within several hours to days following infusion.
- Monitor outpatients for weight gain, developing edema, or declining blood pressure. Notify physician immediately for S&S of vascular leak syndrome (e.g., edema PLUS hypotension or hypoalbuminemia) that may occur within 2 wk of infusion.
- Lab tests: Baseline and weekly CBC with differential, platelet count, blood chemistry panel (including serum electrolytes, serum albumin, renal and liver functions).
Patient & Family Education
- Report S&S of infection promptly to physician.
- Check weight daily and report rapid weight gain or swelling of extremities promptly.
- Report bothersome adverse effects or S&S of infection or flu-like symptoms (e.g., fever, nausea, vomiting, diarrhea, rash).
Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; 
Canadian drug name; 
Prototype drug