NEUMEGA® (oprelvekin)
Delayed once. NEUMEGA next.
NEUMEGA is a recombinant human interleukin-11 (rhIL-11) that has been evaluated in patients at high risk of developing severe thrombocytopenia (TCP), with solid tumors or lymphoma, who were undergoing myelosuppressive chemotherapy.1
NEUMEGA® (oprelvekin) Product Information
Indication
NEUMEGA is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. NEUMEGA is not indicated following myeloablative chemotherapy. The safety and effectiveness of NEUMEGA have not been established in pediatric patients.
Clinical research has found that NEUMEGA
- May prevent severe TCP in patients at high risk for developing severe TCP
- Reduced the need for platelet transfusions following myelosuppressive chemotherapy2
- Demonstrated effectiveness in patients who have experienced severe thrombocytopenia following the previous chemotherapy cycle2
- May help prevent the need for chemotherapy dose delays and reductions
Please see Important Safety Information, including Boxed Warning, below.
Please see full Prescribing
Information 
, including Boxed Warning, for NEUMEGA® (oprelvekin)
(NEUMEGA vial and 1 mL Sterile Water for Injection, USP diluent, in pre-filled syringe).
Please see full Prescribing
Information , including Boxed Warning, for NEUMEGA® (oprelvekin)
(NEUMEGA vial and 1 mL Sterile Water for Injection, USP diluent, in vial).
Document is in PDF (portable document format). PDF files require Adobe® Reader®; click here to download this free program.
Help keep patients on schedule with NEUMEGA
Studies suggest that patients receiving NEUMEGA were more likely to receive the next cycle of chemotherapy on time.1
Negative platelet trends can cause scheduling delays.3
- Start NEUMEGA early (6 to 24 hours after chemotherapy) in your patients at high risk for severe TCP
- When platelets trend down, prescribe NEUMEGA in the next cycle to help keep chemotherapy on schedule
Dose NEUMEGA properly
| Action | Timetable | Restrictions |
|---|---|---|
| Initiate | 6 to 24 hours post chemo | Stop at least 2 days before next cycle. |
| Dose | 50 µg/kg once daily DO NOT ROUND UP.* |
Subcutaneously |
| Duration | Until post-nadir count is ≥ 50,000/µL† |
Do not exceed 21 days.‡ |
* The recommended dose of NEUMEGA in adults with severe renal impairment (creatinine clearance <30 mL/min)
is 25 µg/kg. Rounding up may cause an increase in toxicity.
† In controlled clinical trials, doses were administered in courses of 10 to 21 days.
‡ Monitor platelet counts periodically to assess optimal duration of therapy.
Please see Important Safety Information, including Boxed Warning, below.
Please see full Prescribing
Information , including Boxed Warning, for NEUMEGA® (oprelvekin)
(NEUMEGA vial and 1 mL Sterile Water for Injection, USP diluent, in pre-filled syringe).
Please see full Prescribing
Information , including Boxed Warning, for NEUMEGA® (oprelvekin)
(NEUMEGA vial and 1 mL Sterile Water for Injection, USP diluent, in vial).
Document is in PDF (portable document format). PDF files require Adobe® Reader®; click here to download this free program.
NEUMEGA Important Safety Information
NEUMEGA has caused allergic or hypersensitivity reactions, including anaphylaxis. Administration of NEUMEGA should be permanently discontinued in any patient who develops an allergic or hypersensitivity reaction (see WARNINGS, CONTRAINDICATIONS, ADVERSE REACTIONS and ADVERSE REACTIONS, Immunogenicity).
- Serious adverse reactions have been associated with NEUMEGA administration, including allergic or hypersensitivity reactions and anaphylaxis. NEUMEGA is known to cause serious fluid retention that can result in peripheral edema, dyspnea, pulmonary edema, capillary leak syndrome, atrial arrhythmias (some with strokes), dilutional anemia, and exacerbation of pre-existing pericardial or pleural effusions.
- NEUMEGA should be used with caution in patients with congestive heart failure (CHF), at risk of developing CHF, or with a history of heart failure. Other more common adverse events include mild to moderate fluid retention, tachycardia, conjunctival redness, and papilledema. Changes in visual acuity and/or visual field defects ranging from blurred vision to blindness can occur in patients with papilledema taking NEUMEGA.
- In post-marketing surveillance, ventricular arrhythmias have been reported.
- Dose adjustments are recommended for patients with severe renal impairment.
- In randomized studies, most adverse events were reversible within several days following discontinuation of NEUMEGA.
Please see full Prescribing
Information , including Boxed Warning, for NEUMEGA® (oprelvekin)
(NEUMEGA vial and 1 mL Sterile Water for Injection, USP diluent, in pre-filled syringe).
Please see full Prescribing
Information , including Boxed Warning, for NEUMEGA® (oprelvekin)
(NEUMEGA vial and 1 mL Sterile Water for Injection, USP diluent, in vial).
Document is in PDF (portable document format). PDF files require Adobe® Reader®; click here to download this free program.
References:
- Kaye JA. FDA licensure of NEUMEGA® to prevent severe chemotherapy-induced thrombocytopenia. Stem Cells. 1998;16(suppl 2):207-223.
- Tepler I, Elias L, Smith JW II, et al. A randomized placebo-controlled trial of recombinant human interleukin-11 in cancer patients with severe thrombocytopenia due to chemotherapy. Blood. 1996;87:3607-3614.
- Gordon MS, McCaskill-Stevens WJ, Battiato LA, et al. A phase I trial of recombinant human interleukin-11 (Neumega rhIL-11 growth factor) in women with breast cancer receiving chemotherapy. Blood. 1996;87:3615-3624.
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Wyeth Reimbursement Assistance
Questions concerning reimbursement for NEUMEGA can be directed to the Wyeth Oncology Reimbursement Support Program at 866-Wyeth-Onc (993-8466)