Darvadstrocel interacts in the following cases:
The use of hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions through the fistula tracts is not allowed before, during, or after the injection of darvadstrocel as this may compromise cells viability and, therefore, may affect the effectiveness of the treatment.
There are no data from the use of darvadstrocel in pregnant women. Animal studies are not available with respect to reproductive toxicity. Darvadstrocel is not recommended during pregnancy and in women of childbearing potential not using contraception.
As a precautionary measure, darvadstrocel is not recommended for administration during breastfeeding.
No data are available.
Darvadstrocel has no or negligible influence on the ability to drive and use machines.
The most common treatment-emergent adverse events were anal abscess (darvadstrocel: 19.4% patients; control group: 13.7% patients), proctalgia (darvadstrocel: 14.6% patients; control group: 11.8% patients) and anal fistula (darvadstrocel: 10.7% patients; control group: 7.8% patients).
The following listing of adverse reactions is based on the clinical trial experience and is displayed by system organ class. The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Adverse reactions:
Common: Anal abscess
Common: Proctalgia*, Anal fistula
Common: Procedural pain*
* Conditioning reactions occurring up to seven days after the fistula cleaning for treatment administration.
Up to Week 52, 20 (19.4%) and 14 (13.7%) patients developed 21 and 19 anal abscess adverse events in the darvadstrocel and control groups, respectively, of which 4 and 5 adverse events in respective groups (3.9% patients in both groups) were of severe intensity. Up to Week 104, 15 (14.6%) and 8 (7.8%) patients developed 15 and 9 serious adverse events of anal abscess in the darvadstrocel and control groups, respectively.
Up to Week 52, 15 (14.6%) and 12 (11.8%) patients developed 20 and 17 proctalgia adverse events in the darvadstrocel and control groups, respectively, none of these events being serious in any group up to Week 104. There were no patients in darvadstrocel group with events of proctalgia of severe intensity and 3.9% patients with 4 events in the control group.
Up to Week 52, 11 (10.7%) and 8 (7.8%) patients developed 12 and 8 anal fistula adverse events in the darvadstrocel and control groups, respectively, none of these being of severe intensity. Up to Week 104, 5 (4.9%) and one (<1.0%) patients developed 5 and 1 anal fistula serious adverse events in the darvadstrocel and control groups, respectively.
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