Systemic Therapy Program
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Disease Group



Cancer Type

Document Type

Drug Monographs
Treatment Regimens
Scientific Name:
ANCESTIM
Brand Name(s):
Stemgen®

Drug Monograph

Pharmacology

Mechanism of Action

An analogue of endogenous human stem cell factor (SCF), also called c-kit ligand, steel factor and mast-cell growth factor. In combination with other cytokines, SCF induces proliferation and increases receptiveness to lineage commitment of primitive and mature hematopoietic progenitors. Ancestim alone is not sufficient to increase peripheral blood progenitor cells (PBPC) but when administered in combination with filgastrim, it synergistically increases the number of PBPC’s in the peripheral blood.
It also acts synergistically with other hematopoietic growth factors, including sargramostim (Leukine), erythropoietin (epoetin alfa), interleukin-3, interleukin-6, and interleukin-7.

Pharmacokinetics

Oral Absorption
No information
Distribution:
after I.V.: primarily to plasma and kidneys initially, with subsequent rapid loss from all tissues.  Excretion in breast-milk unknown.
cross blood brain barrier?  No information
Vd:  No information
PPB: No information
Metabolism:  
degradation to lower molecular weight products
metabolite(s): active, inactive- No information
Excretion:  
90% cleared by the kidney;
urine: not quantifiable using ELISA
t½: Elimination: 2-5 hours; Termination: 35-41 hours
Cl: 35 to 40 mL/hour/kg

Side Effects

IMMEDIATE ONSET
• allergic reactions (rash, respiratory symptoms, itching) (15%)

EARLY ONSET (days to weeks)
• urticaria, angioedema, hypotension, anaphylactic-type reaction (rare)

Therapeutics

Approved Indications

• Stem cell transplantation- Mobilization of stem cells to peripheral blood for apheresis (use in combination with Filgrastim).

Routes

Only SC injection
Premedication with H1 and H2 antihistamines and a bronchodilator (b-agonist, e.g. salbutamol).

IV Compatibility

Sterile water for injection.

Dosing

Injection:
• 20µg/Kg/day SC until WBC adequate for apheresis
• Administer in a separate site from the Filgrastim dose
Do not administer by IV injection

Contraindications

• Patients with a history of anaphylaxis, asthma, recurrent urticaria, recurrent angioedema, or mast cell disease; • Known hypersensitivity to Escherichia coli-derived proteins, ancestim, or any component of the product

Monitoring

Clinical Monitoring

RECOMMENDED CRITERIA
• Observation for hypersensitivity reaction during and for 30 minutes after injection (emergency treatment readily available)

Hypersensitivity/Allergy
0. None
1. Transient rash, fever <38oC
2. Urticaria, fever > 38oC, mild bronchospasm
3. Serum sickness, bronchospasm, requires parenteral medications
4. Anaphylaxis
Rated In Response To Patient Reaction

SUGGESTED CRITERIA
NO ADDITIONAL TOXICITY RATINGS

Extravasation Hazard

No information; potential for interaction with drugs, which may potentiate the release of histamine or other mast cell mediators, is unknown.

Significant Interactions

No information; potential for interaction with drugs, which may potentiate the release of histamine or other mast cell mediators, is unknown.

Product Information

Commercial Product Description

Vials of 1875mg Ancestim for reconstitution- Keep refrigerated.

Pharmaceutical Considerations

Injection:
Single-use vials containing 1875 µg ancestim as a lyophilized powder.  Preservative-free.  Sterile Water for Injection included in product packaging. Store in refrigerator at 2-8oC; do not freeze.  Any vial stored at room temperature for 72 hours or longer should be discarded.

Preparation:
Reconstitute with 1.2mL Sterile Water for Injection to a final concentration of 1500 µg/mL ancestim, with a withdrawable volume of 1mL.  Add SWFI to side of vial when reconstituting, and gently swirl vial to dissolve powder. Do not shake vial to prevent foaming of final solution. 

Reconstituted Solution for Injection:
Use immediately for dose injection.  May store in refrigerator at 2-8oC for up to 24 hours; do not freeze.  Solution may be brought to room temperature before administration to patient.  Use each vial once only; do not repuncture vial after initial dose withdrawn.

Note

GUIDELINES:

Visit the Cancer Care Nova Scotia website (www.cancercare.ns.ca) for the guideline on Ancestim for stem cell transplantation
• Go to "Additional Information" tab (above) for links to CCNS Cancer Drug Guidelines

Availability & Funding

Administrative Information (Nova Scotia)

• CCNS Provincial Formulary Status- Specialized Level • Capital Health Only • Go to "Additional Information" tab (above) for links to Provincial Formulary of • Pharmacare Formulary Status- Non-Formulary