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Darvadstrocel — Description, Dosage, Side Effects | PillsCard
Rx
Darvadstrocel
5 mln komórek/ml, Zawiesina do wstrzykiwań
INN: Darvadstrocelum
Data updated: 2026-04-13
Available in:
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Form
Zawiesina do wstrzykiwań
Dosage
5 mln komórek/ml
Route
doogniskowa
Storage
—
About This Product
Manufacturer
User Reviews
Reviews reflect personal experiences and are not medical advice. Always consult your doctor.
Takeda Pharma A/S (Irlandia)
Composition
Darvadstrocelum
ATC Code
L04AX08
Source
URPL
Alofisel contains darvadstrocel — an advanced therapy medicinal product (ATMP) consisting of allogeneic expanded adipose-derived mesenchymal stromal cells (eASCs) at 5 million cells per mL, supplied as a suspension for local injection. Darvadstrocel cells exert local immunomodulatory and anti-inflammatory effects: they suppress activated T-lymphocyte proliferation, reduce pro-inflammatory cytokine release (TNF-alpha, IFN-gamma, IL-6, IL-17) and promote tissue remodelling and fistula tract closure. ATC class L04AX08 (other immunosuppressants). It is administered by a qualified surgeon as a single local injection into the wall of the perianal fistula tract during a defined surgical procedure including curettage and internal-opening closure.
⚠️ Warnings
Administered only by gastrointestinal/colorectal surgeons trained in the dedicated injection technique, in a centre with the prescribed surgical infrastructure. The product must be used within the manufacturer-specified shelf life from preparation and cannot be re-frozen. Active anorectal abscess must be drained before treatment. Concomitant systemic immunosuppressants and biologics are usually maintained at stable doses; do not change Crohn's medication around the procedure unless clinically required. Pregnancy: do not use unless clearly required. Long-term safety data including rare malignancy or immunogenicity signals are still accumulating.
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