Dosing and uses of Stemgen (ancestim)
Adult dosage forms and strengths
powder for injection
- 1875mcg/vial
Increase the Number & Mobilization of Peripheral Blood Progenitor Cells
In conjunction with filgrastim
20 mcg/kg/day SC
Administration
Reconstitute with 1.2 mL sterlie water for injection to yield a concentration of 1.5 mg/mL with a withdrawable volume of 1 mL. Compatibility with saline or other diluents is unknown. During reconstitution, the vial contents may be gently swirled to avoid foaming during dissolution. Avoid excess or vigorous agitation
Pediatric dosage forms and strengths
Safety & efficacy not established
No increased adverse effects in clinical trials
Stemgen (ancestim) adverse (side) effects
Administered with filgrastim
>10%
Injection site reactions (92%)
Paresthesia (29%)
Respiratory symptoms (28%)
Distant skin reactions (21%)
Nausea (16%)
Headache (13%)
Dizziness (12%)
1-10%
Tachycardia (8%)
Warnings
Contraindications
Hypersensitivity to ancestim or to E. coli proteins (may cause life-threatening allergic reactions)
Cautions
SC only; not for IV
Premedicate with H1 & H2 antihistamines & a bronchodilator to minimize possibility of anaphylactoid reactions
Observe pts for 1 hr post-administration
Do not exceed dosage
Pregnancy and lactation
Pregnancy category: N/A, exercise caution
Lactation: no data, exercise caution
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 Stemgen (ancestim)
Half-Life
Absorption: 35-41 hr
Elimination: 2-5 hr
Peak Plasma
Time: 15-24 hr mean (range 8-36 hr)
Concentration:
- 5 mcg/kg dose: 3.6 ng/mL
- 10 mcg/kg dose: 4.9 ng/mL
- 25 mcg/mL dose: 13.7 ng/mL
Other Information
Metabolism: N/A
Excretion: urine (animal studies)
Mechanism of action
Recombinant human stem cell factor
