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1 X 30 million cells
Alofisel should only be administered by specialist physicians experienced in the diagnosis and treatment of conditions for which Alofisel is indicated.
A single dose of Alofisel consists of 120 million cells supplied in 4 vials. Each vial contains 30 million cells in 6 mL of suspension. The full content of the 4 vials must be administered for the treatment of up to two internal openings and up to three external openings. This means that with a dose of 120 million cells it is possible to treat up to three fistula tracts that open to the perianal area.
The efficacy or safety of repeat administration of Alofisel has not been established.
Elderly: Data on the use of darvadstrocel in the elderly population are limited, however, given the cell-based nature of darvadstrocel and its local administration route it is not expected that the benefit-risk profile of darvadstrocel in elderly patients will differ from that observed in non-elderly patients. Therefore, no dose adjustment is required in elderly patients.
Hepatic or renal impairment: Data on the use of darvadstrocel in patients with hepatic or renal impairment are not available, however, given the cell-based nature of darvadstrocel and its local administration route it is not expected that the benefit-risk profile of darvadstrocel in hepatically or renally impaired patients will differ from that observed in non-hepatically or non-renally impaired patients. Therefore, no dose adjustment is required in hepatically or renally impaired patients.
Paediatric population: The safety and efficacy of darvadstrocel in children and adolescents aged 0 to 17 years have not yet been established. No data are available.
Treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used only after conditioning of the fistulas.
Hypersensitivity to the active substance or to any of the excipients or to bovine serum.
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Alofisel may contain trace amounts of benzylpenicillin and streptomycin. This should be considered in patients with known hypersensitivity to these classes of antibiotics.
Local anaesthesia is not recommended due to the unknown effect of local anaesthetics on the injected cells.
The injection of any substance other than sodium chloride 9 mg/mL (0.9%) (e.g. hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions) through the fistula tracts is not allowed before, during, or after the injection of Alofisel as these may compromise the viability of the cells and, therefore, may affect the effectiveness of the treatment.
Alofisel is indicated only for injection in the fistula tract tissue. Alofisel must not be administered using a needle thinner than 22G. Thinner gauge needles can cause cell disruption during injection, and may compromise cell viability and therefore may affect efficacy of treatment.
As Alofisel is a living stem cell therapy it cannot be sterilized, and therefore could contain potentially infected biological material although the risk is considered to be low and controlled in the manufacturing. Patients should be followed up for potential signs of infection after administration.
Conditioning reactions: Conditioning of fistulas has been associated with proctalgia and procedural pain.
Anal abscess, proctalgia, anal fistula, procedural pain.
See prescribing information for full details.
No in vivo interaction studies have been performed.
In vitro interaction studies have shown that the cell viability and immunomodulatory function of this drug is not affected by the presence of clinically-relevant concentrations of conventional therapies for Crohn’s disease (infliximab, methotrexate and azathioprine).
The injection of any substance other than sodium chloride 9 mg/mL (0.9%) (e.g. hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions) through the fistula tracts and use of local anaesthesia is not recommended due to the unknown effect on the injected cells.
Pregnancy and Lactation
Pregnancy: There are no data from the use of darvadstrocel in pregnant women. Darvadstrocel is not recommended during pregnancy and in women of childbearing potential not using contraception. See prescribing information for full details.
Lactation: As a precautionary measure, darvadstrocel is not recommended for administration during breast-feeding.
No case of overdose has been reported.
Compatibility: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Storage: Store between 15ºC and 25ºC. Keep the product within the secondary packaging (cardboard box) and inside the shipping container at all times until its administration, to maintain the required temperature. Preserve the container away from heat and direct light sources and do not refrigerate or freeze. Do not irradiate or otherwise sterilise.
Patient information brochure: The marketing of Alofisel is subject to a risk management plan (RMP) including a ‘Patient information brochure’. The ‘Patient information brochure’, emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the brochure before starting treatment.
Prescriber guide: This product is marketed with prescriber guide providing important safety information. Please ensure you are familiar with this material as it contains important safety information.