Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 5mg/vial
Prevention of Thrombocytopenia
50 mcg/kg SC qDay for 10-21 days
Renal Impairment
CrCl <30 mL/min: 25 mcg/kg SC qDay for 10-21 days (postnadir platelet count > 50,000/cu.mm
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)
Safety & efficacy not established
Adverse 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%)
Warnings
Contraindications
Hypersensitivity
Cautions
Discontinue permanently if anaphylactic reaction
Atrial arrhythmias, CHF, aggressively hydrated patients, history of stroke/TIA, papilledema (risk of blindness)
Risk of severe but reversible fluid retention
Risk of papilledema, especially in children
Anemia appears 3 days after initiating treatment & resolves about 2 wk after discontinuation
Dosing for longer than 21 days not recommended
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Not known if excreted in breast milk; not recommended
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
Mechanism of Action
Recombinant Interleukin-11, thrombopoietic growth factor; stimulates thrombopoiesis & maturation, which results in proliferation of megakaryocyte progenitors and subsequently increases platelet production
Pharmacokinetics
Bioavailability: 80%
Excretion: Urine (primarily)
Half-Life: 5-9 hr
Peak plasma time: 1-6 hr
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Formulary
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