Drugs List

Therapeutic Indications

Uses

Fistulating Crohn's disease

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.

Administration

For intralesional injection only, under anaesthesia (general or regional).

Before administration ensure characterisation of the patient's fistulas prior to treatment. Exclude abscesses and confirm that the local mucosal disease is mild or inactive.

In case of an abscess, incision and drainage are needed, and setons should be placed, if appropriate, in accordance with routine surgical procedures.

Administer only after conditioning of the fistula.

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Exclude abscess prior to treatment
Treatment to be initiated and supervised by a specialist
Avoid dyes through fistula tract
Record name and batch number of administered product
Monitor patient for signs of serious infection
Advise patient to report incidences of fever
Female: Ensure adequate contraception during treatment

Needles thinner than 22G can cause cell disruption during injection, and may compromise cell viability and therefore efficacy of treatment.

Hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions should not be used through the fistula tracts before, during or after the injection of darvadstrocel as this may compromise the cells viability and therefore the effectiveness of the treatment.

Ensure cells are not injected into the lumen of the fistula tracts to avoid leakage of cells.

There is currently limited experience with the efficacy or safety of repeat administration of darvadstrocel.

Local anaesthesia is not recommended due to the unknown effect of local anaesthetics on the injected cells.

May contain trace amounts of gentamicin or benzylpenicillin and streptomycin.

Pregnancy and Lactation

Pregnancy

Darvadstrocel is contraindicated during pregnancy.

The manufacturer does not recommend using darvadstrocel during pregnancy and in women of childbearing potential not using any contraception. At the time of writing there is no data from the use of darvadstrocel during pregnancy. Animal studies are not available with respect to reproductive toxicity.

Lactation

Darvadstrocel is contraindicated during breastfeeding.

The manufacturer advises that as a precautionary measure that darvadstrocel is not recommended during breastfeeding. At the time of writing there is no data from the use of darvadstrocel when breastfeeding.

Side Effects

Anal abscess
Anal fistula
Procedural pain
Proctalgia

Presentation

Parenteral formulations of darvadstrocel.

Darvadstrocel is an expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue.

Drugs List

Therapeutic Indications

Uses

Fistulating Crohn's disease

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.

Dosage

Adults

Administration

For intralesional injection only, under anaesthesia (general or regional).

Before administration ensure characterisation of the patient's fistulas prior to treatment. Exclude abscesses and confirm that the local mucosal disease is mild or inactive.

In case of an abscess, incision and drainage are needed, and setons should be placed, if appropriate, in accordance with routine surgical procedures.

Administer only after conditioning of the fistula.

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Exclude abscess prior to treatment
Treatment to be initiated and supervised by a specialist
Avoid dyes through fistula tract
Record name and batch number of administered product
Monitor patient for signs of serious infection
Advise patient to report incidences of fever
Female: Ensure adequate contraception during treatment

Needles thinner than 22G can cause cell disruption during injection, and may compromise cell viability and therefore efficacy of treatment.

Hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions should not be used through the fistula tracts before, during or after the injection of darvadstrocel as this may compromise the cells viability and therefore the effectiveness of the treatment.

Ensure cells are not injected into the lumen of the fistula tracts to avoid leakage of cells.

There is currently limited experience with the efficacy or safety of repeat administration of darvadstrocel.

Local anaesthesia is not recommended due to the unknown effect of local anaesthetics on the injected cells.

May contain trace amounts of gentamicin or benzylpenicillin and streptomycin.

Pregnancy and Lactation

Pregnancy

Darvadstrocel is contraindicated during pregnancy.

The manufacturer does not recommend using darvadstrocel during pregnancy and in women of childbearing potential not using any contraception. At the time of writing there is no data from the use of darvadstrocel during pregnancy. Animal studies are not available with respect to reproductive toxicity.

Lactation

Darvadstrocel is contraindicated during breastfeeding.

The manufacturer advises that as a precautionary measure that darvadstrocel is not recommended during breastfeeding. At the time of writing there is no data from the use of darvadstrocel when breastfeeding.

Side Effects

Anal abscess
Anal fistula
Procedural pain
Proctalgia

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: June 2021

Reference Sources

Summary of Product Characteristics: Alofisel 5 million cells/mL suspension for injection. Takeda UK Ltd. Revised November 2020.