oprelvekin (Neumega, Interleukin 11, il 11)

Dosing and uses of Neumega, Interleukin 11 (oprelvekin)

• Adult
• Pediatric

 

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