Medication Guide App

Oprelvekin Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Thrombocytopenia Drug Induced

Nonmyeloid malignancy:
50 mcg/kg subcutaneously once daily following myelosuppressive chemotherapy

Usual Pediatric Dose for Thrombocytopenia Drug Induced

Study-Phase 1, (n=43) - Nonmyeloid malignancy:
25 to 100 mcg/kg/day following myelosuppressive chemotherapy.

Renal Dose Adjustments

Oprelvekin is eliminated primarily by the kidney. There are no dosing data for patients with mild or moderate renal impairment.

Liver Dose Adjustments

Data not available

Dose Adjustments

Dosage should be continued until the post-nadir platelet count is greater than or equal to 50,000/microliter

Precautions

Oprelvekin has caused allergic or hypersensitivity reactions, including anaphylaxis. The use of oprelvekin should be attended by appropriate precautions in case allergic reactions occur. In addition, patients should be advised about the symptoms for which they should seek medical attention. Signs and symptoms reported have included edema of the face, tongue, or larynx, shortness of break, wheezing, mental status changes, rash, urticaria, flushing, and fever. Reactions have occurred after the first dose or subsequent doses of oprelvekin. Administration of oprelvekin should be permanently discontinued in any patient who develops an allergic or hypersensitivity reaction.

Oprelvekin is not indicated after myeloablative chemotherapy. In a randomized, placebo-controlled Phase 2 study, the effectiveness of oprelvekin was not evident. In this study, a statistically significant increase in the incidence in edema, conjunctival bleeding, hypotension, and tachycardia was reported in patients received oprelvekin as compared to placebo.

Treatment should begin 6 to 24 hours after the completion of chemotherapy. And, it should be stopped at least 2 days before starting the next planned cycle of chemotherapy. The safety and efficacy of oprelvekin given immediately prior to or concurrently with cytotoxic chemotherapy or initiated at the time of expected nadir have not been established. The effectiveness of oprelvekin has not been evaluated in patients receiving chemotherapy regimens of greater that five days duration or regimens associated with delayed myelosuppression (e.g., nitrosoureas, mitomycin-C). A complete blood count should be obtained prior to chemotherapy and at regular intervals during oprelvekin therapy. Platelet counts should be monitored during the time of the expected nadir and until adequate recovery has occurred (post nadir counts greater than or equal to 50,000 per microliter). The safety and efficacy of chronic administration of oprelvekin have not been established beyond the recommended dosage scheduled, for up to 6 cycles following chemotherapy. Dosing beyond 21 days per treatment course is not recommended. Continuous dosing (2 to 13 weeks) in nonhuman primates produced joint capsule and tendon fibrosis, and periosteal hyperostosis. The relevance of these findings to humans is not clear.

The following severe or fatal adverse reactions have been reported in postmarketing experience in patients who received oprelvekin following bone marrow transplantation: fluid retention or overload (e.g., facial edema, pulmonary edema), capillary leak syndrome, pleural and pericardial effusion, papilledema, and renal failure.

Serious fluid retention resulting in peripheral edema, dyspnea on exertion, pulmonary edema, capillary leak syndrome, atrial arrhythmias, and exacerbation of preexisting pleural effusions are side effects caused by oprelvekin. Consequently, it should be used with caution in patients with clinical evidence of congestive heart failure, patients who may be susceptible to developing congestive heart failure, patients receiving aggressive hydration, patients with a history of heart failure who are well-compensated and receiving appropriate medical therapy, and patients who may develop fluid retention as a result of associated medical conditions or whose medical condition may be exacerbated by fluid retention. Fluid retention is reversible within several days after discontinuation of therapy. During dosing with oprelvekin, fluid balance should be monitored and appropriate medical management is recommended.

Pre-existing fluid collections, including pericardial effusions or ascites, should be evaluated. If medically indicated, drainage should be considered.

Moderate decreases in hemoglobin concentration, hematocrit, and red blood cell count (approximately 10% to 15%) without a decrease in red blood cell mass have been reported. These changes are mainly due to an increase in plasma volume (dilutional anemia) that is primarily related to renal sodium and water retention. The decrease in hemoglobin concentration typically begins within three to five days of the initiation of oprelvekin, and is reversible over approximately a week following discontinuation of oprelvekin therapy.

Oprelvekin use is associated with cardiovascular events including arrhythmias and pulmonary edema. Cardiac arrests has been reported, but the causal relationship to oprelvekin is uncertain. Use with caution in patients with a history of atrial arrhythmias, and only after consideration of the potential risks in relation to anticipated benefits. In clinical studies, cardiac events including atrial arrhythmias (atrial fibrillation or atrial flutter) have been reported in patients treated with oprelvekin. Arrhythmias were usually brief in duration; conversion to sinus rhythm typically occurred spontaneously or after rate-control drug therapy. Stroke has been reported in the setting of patients who develop atrial fibrillation/flutter while receiving oprelvekin. Patients with a history of stroke or transient ischemic attack may also be at increased risk for these events. The mechanism for induction of arrhythmias is unknown. In some patients, development of atrial arrhythmias may be due to increased plasma volume associated with fluid retention. In the postmarketing setting, ventricular arrhythmias have been reported, generally occurring within two to seven days of initiation of therapy.

Oprelvekin should be used with caution in patients with preexisting papilledema, or with tumors involving the central nervous system since it is possible that papilledema may worsen or develop during treatment. Papilledema has been reported in patients in clinical trials following repeated cycles of exposure. Changes in visual acuity and/or visual field defects ranging from blurring vision to blindness have been reported in patients with papilledema taking oprelvekin.

Sudden deaths have occurred in oprelvekin-treated patients receiving chronic diuretic therapy and ifosfamide who developed severe hypokalemia. Patients receiving chronic diuretic therapy should receive close monitoring of their fluid and electrolyte status.

Dialysis

Data not available

Other Comments

The subcutaneous injection should be administered as a single injection in the abdomen, thigh, or hip (or upper arm if no self-injecting).

In controlled trial oprelvekin (interleukin-11) was administered for 10 to 21 days.

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