| DENILEUKIN DIFTITOX
Classifications: antineoplastic; cytotoxic fusion protein; interleukin-2 (il-2) receptor inhibitor; Therapeutic: antineoplastic; immunomodulator; il-2 receptor inhibitor
Pregnancy Category: C
150 mcg/mL vial
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.
Effectiveness is indicated by reduced tumor burden. Interacts with high affinity to IL-2 receptors on the cell surface in
particular leukemias and lymphomas.
Persistent or recurrent T-cell lymphoma.
Hypersensitivity to denileukin, diphtheria toxin, or interleukin-2; serum albumin levels below 3 g/dL; pregnancy (category
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
Adult: IV 9 or 18 mcg/kg/d for 5 d every 21 d
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,
. 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.
No clinically significant interactions established.
Primarily distributed to liver and kidneys. Metabolism:
By proteolytic degradation. Half-Life:
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
- 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).