Oprelvekin

A to Z Drug Facts

Actions Interleukin 11 (IL-11) is a thrombopoietic growth factor that directly stimulates the proliferation of hematopoietic stem cells and megakaryocyte progenitor cells and induces megakaryocyte maturation, resulting in increased platelet production. In a study a single 50 mcg/kg SC dose was administered producing a peak serum concentration (C_max) of 17.4 ng/mL reached in 3.2 hr (T_max). Terminal half-life was 6.9 hr. In a second study 75 mcg/kg SC and IV doses showed an absolute bioavailability more than 80% of oprelvekin. In rats, oprelvekin was rapidly cleared from the serum and distributed to highly perfused organs. The kidney was the primary route of elimination.

 Indications Prevent severe thrombocytopenia and reduce the need for platelet transfusions following myelosuppressive chemotherapy in patients with nonmyeloid malignancies.

 Contraindications Standard considerations.

 Route/Dosage

Prevent Severe Thrombocytopenia and Reduce the Need for Platelet Transfusions Following Myelosuppressive Chemotherapy in Patients with Nonmyeloid Malignancies

ADULTS: SC 50 mcg/kg once daily, starting 6 to 24 hr after completing chemotherapy. Continue therapy until the postnadir platelet count is at least 50,000/mm³ or for a maximum of 21 days. Discontinue oprelvekin at least 2 days before starting the next chemotherapy cycle.

Interactions None well documented.

Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Plasma volume expansion; symptomatic atrial arrhythmias, syncope, tachycardia, peripheral edema. CNS: Headache, fatigue, dizziness. DERMATOLOGIC: Transient rash at injection site. EENT: Transient visual blurring, papilledema. GI: Nausea; vomiting; mucositis; diarrhea; oral moniliasis. HEMATOLOGIC: Dilutional anemia. METABOLIC: Weight gain. RESPIRATORY: Dyspnea, rhinitis; increased cough; pharyngitis; pleural effusion. OTHER: Edema; neutropenic fever; fever.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. Fluid retention: Oprelvekin is known to cause fluid retention; use with caution in patients with clinically evident CHF, patients who may be susceptible to developing CHF, and patients with a history of heart failure. Patients have commonly experienced mild to moderate fluid retention as indicated by peripheral edema or dyspnea on exertion. Monitor preexisting fluid collections, including pericardial effusions or ascites. Sudden deaths have occurred in oprelvekin-treated patients receiving chronic diuretic therapy and ifosfamide who developed severe hypokalemia. Cardiovascular events: Use with caution in patients with a history of atrial arrhythmia. Transient atrial arrhythmias (atrial fibrillation or flutter) have occurred in approximately 10% of patients following treatment with oprelvekin. Ophthalmologic events: Transient, mild visual blurring has occasionally been reported. Antibody formation/allergic reactions: A small proportion (1%) of patients developed antibodies to oprelvekin and transient rashes were occasionally observed at the injection site. Chronic administration: Oprelvekin has been administered safely using the recommended dosing schedule for no more than 6 cycles following chemotherapy. Continuous dosing (2 to 13 wk) in primates produced joint capsule, tendon fibrosis, and periosteal hyperostosis. Chemotherapy: The safety and efficacy of administering oprelvekin before or concurrently with chemotherapy has not been evaluated.

 Administration/Storage

• Refrigerate sterile powder; do not freeze. Unreconstituted vials are stable at room temperature for no more than 3 days.
• Reconstitute vial with 1 mL of sterile water for injection, for a final concentration of 5 mg/mL. Direct sterile water at side of vial and swirl contents gently. Do not shake vial or excessive foaming will occur.
• The diluent vial supplied contains mL of sterile water for injection. Use only 1 mL of sterile water to reconstitute oprelvekin powder.
• After reconstitution, oprelvekin is stable for no more than 3 hr refrigerated or at room temperature.
• Administer by SC injection.

 Assessment/Interventions

• During dosing with oprelvekin, monitor fluid balance. If a diuretic is used, carefully monitor fluid and electrolyte balance.
• Obtain a complete blood count prior to chemotherapy and at regular intervals during oprelvekin therapy. Monitor platelet counts during the time of the expected nadir and until adequate recovery has occurred (post-nadir counts at least 50,000).
• Begin dosing with oprelvekin 6 to 24 hr following the completion of chemotherapy dosing.
• Oprelvekin has not been evaluated in patients receiving chemotherapy regimens of more than 5 days duration or regimens associated with delayed myelosuppression (eg, nitrosoureas, mitomycin-C).

 Patient/Family Education

• Instruct people who will be administering oprelvekin as to the proper dose and the method for reconstituting and administering oprelvekin. Instruct patients in the importance of proper disposal and caution against the reuse of needles, syringes, drug product, and diluent.
• Inform patients of the most common adverse reactions associated with oprelvekin administration, including those symptoms related to fluid retention. Mild to moderate peripheral edema and shortness of breath on exertion can occur within the first week of treatment and may continue for the duration of administration. Advise patients who have preexisting pleural or other effusions or a history of CHF to contact their health care provider if dyspnea worsens.
• Most patients who receive oprelvekin develop some anemia.
• Contact health care provider if symptoms attributable to atrial arrhythmia develop and are not transient.
• Advise women of childbearing potential of the possible risks of oprelvekin to the fetus.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts