oprelvekin (Neumega, Interleukin 11, il 11)
Classes: Biological Response Modulators; Hematopoietic Growth Factors
Dosing and uses of Neumega, Interleukin 11 (oprelvekin)
Adult dosage forms and strengths
powder for injection
- 5mg/vial
Prevention of Thrombocytopenia
50 mcg/kg SC qDay
Renal Impairment
CrCl <30 mL/min: 25 mcg/kg SC qDay
Administration
Initiate 6-24 hours after completion of chemotherapy, discontinue >2 days before next chemotherapy session
Continue dose until Plt >50,000/cu.mm
Reconstitute vial with 1 mL sterile water for injection (without preservative, supplied) to obtain a 5 mg/mL solution, dissolve by gentle swirling
Use within 3 hours of reconstitution (reconstituted solution may be refrigerated but do NOT freeze)
Pediatric dosage forms and strengths
powder for injection
- 5mg/vial
>8 months old: 75-100 mcg/kg SC qDay
Neumega, Interleukin 11 (oprelvekin) adverse (side) effects
>10%
Nausea
Vomiting (77%)
Edema (59%)
Neutropenic fever (48%)
Dyspnea (48%)
Mucositis (43%)
Diarrhea (43%)
Rhinitis (42%)
Headache (41%)
Dizziness (38%)
Fever (36%)
Insomnia (33%)
Cough (29%)
Rash (25%)
Pharyngitis (25%)
Tachycardia (20%)
Vasodilatation (19%)
Palpitations (14%)
Syncope (13%)
Atrial fibrillation (12%)
1-10%
Pleural effusions (10%)
Papilledema (2%)
Anti-oprelvekin antibody formation (1%)
Frequency not defined
Additional ADR's probably due to chemotherapy
Warnings
Contraindications
Hypersensitivity
Myeloablative chemotherapy (no benefit, more toxicity)
Cautions
Discontinue permanently if anaphylactic rxn
Atrial arrhythmias, CHF, aggressively hydrated pts, history of stroke/TIA, papilledema (risk of blindness)
Risk of severe but reversible fluid retention
Risk of papilledema, esp in children
Anemia appears 3 d of starting tx & resolves about 2 wk after discontinuation
Dosing beyond 21 d per Tx not recommended
Pregnancy and lactation
Pregnancy category: C
Lactation: not known if excreted in breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Neumega, Interleukin 11 (oprelvekin)
Half-Life: 6.9 hr
Peak Plasma:
Time: 3.2 hr
Concentration: 17.4 ng/mL
Other Information
Bioavailability: 80%
Clearance: 30.8 ng/mL
Mechanism of action
Recombinant Interleukin-11, thrombopoietic growth factor; stimulates proliferation & maturation of megakaryocytes
