No

Biological Response Modulator; Human Growth Factor

Prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia.

C

Hypersensitivity to oprelvekin, or any component

Oprelvekin should be used cautiously in patients with conditions where expansion of plasma volume should be avoided (eg, left ventricular dysfunction, congestive heart failure, hypertension); cardiac arrhythmias or conduction defects, respiratory disease; history of thromboembolic problems; hepatic or renal dysfunction; not indicated following myeloablative chemotherapy

>10%:

Cardiovascular: Tachycardia (19% to 30%), palpitations (14% to 24%), atrial arrhythmias (12%), peripheral edema (60% to 75%)

Central nervous system: Headache (41%), dizziness (38%), insomnia (33%), fatigue (30%), fever (36%)

Dermatologic: Rash (25%)

Endocrine & metabolic: Fluid retention

Gastrointestinal: Nausea (50% to 77%), vomiting, anorexia

Hematologic: Anemia (100%), probably a dilutional phenomena; appears within 3 days of initiation of therapy, resolves in about 2 weeks after cessation of oprelvekin

Neuromuscular & skeletal: Arthralgia, myalgias

Respiratory: Dyspnea (48%), pleural effusions (10%)

1% to 10%:

Cardiovascular: Syncope (6% to 13%)

Gastrointestinal: Weight gain (5%)

Doses of oprelvekin >50 mcg/kg may be associated with an increased incidence of cardiovascular events. If an overdose is administered, discontinue oprelvekin and closely observe patient for signs of toxicity. Base reinstitution of therapy on individual patient factors (evidence of toxicity and continued need for therapy).

Store vials of lyophilized oprelvekin and diluent under refrigeration (2°C to 8°C/36°F to 46°F); do not freeze.

Oprelvekin stimulates multiple stages of megakaryocytopoiesis and thrombopoiesis, resulting in proliferation of megakaryocyte progenitors and megakaryocyte maturation

Metabolism: Uncertain

Half-life: Terminal: 5-8 hours

Time to peak serum concentration: 1-6 hours

Elimination: Renal, primarily as metabolites

S.C.:

Adults: 50 mcg/kg once daily for 10-21 days (until postnadir platelet count greater than or equal to 50,000 cells/mL)

Subcutaneously

Monitor fluid balance during therapy, appropriate medical management is advised. If a diuretic is used, carefully monitor fluid and electrolyte balance. Obtain a CBC prior to chemotherapy and at regular intervals during therapy. Monitor platelet counts during the time of the expected nadir and until adequate recovery has occurred (postnadir counts greater than or equal to 50,000 cells/mL).

Decrease in hemoglobin concentration, serum concentration of albumin and other proteins (result of expansion of plasma volume)

Dizziness, insomnia, and fatigue are common

Anemia is common; use caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

Report any swelling in the arms or legs (peripheral edema), shortness of breath (congestive failure, anemia), irregular heartbeat, headaches

Powder for injection, lyophilized: 5 mg

Du X and Williams DA, "Interleukin-11: Review of Molecular, Cell Biology, and Clinical Use," Blood, 1997, 89(11):3897-908.

Gordon MS, "Thrombopoietic Activity of Recombinant Human Interleukin 11 in Cancer Patients Receiving Chemotherapy," Cancer Chemother Pharmacol, 1996, 38 Suppl:S96-8.

Tepler I, Elias L, Smith JW 2d, et al, "A Randomized Placebo-Controlled Trial of Recombinant Human Interleukin-11 in Cancer Patients With Severe Thrombocytopenia Due to Chemotherapy," Blood, 1996, 87(9):3607-14.

Teramura M, Kobayashi S, Yoshinaga K, et al, "Effect of Interleukin 11 on Normal and Pathological Thrombopoiesis," Cancer Chemother Pharmacol, 1996, 38 Suppl:S99-102.