he reproduction toxicity studies did not reveal any untoward effects.
No effects on fertility parameters such as reproductive organs, menstrual cycle length, and/or hormones were observed in male and female cynomolgus monkeys that were administered tildrakizumab at doses resulting in >100 times the human exposure at the recommended clinical dose based on AUC.
In a pre- and postnatal development toxicity study in monkeys, no related increase in pregnancy loss was observed at exposures up to 85 times the human exposure at the recommended dose. No harmful effects were noted in neonates at maternal exposures up to 9 times the human exposure at the recommended dose. Two neonatal deaths from monkeys administered tildrakizumab at maternal exposure of 85 times the human exposure at the recommended dose were attributed to possible viral infection and considered of uncertain relationship to the treatment. The clinical significance of these findings is unknown.
6. Pharmaceutical particulars
6.1 List of excipients
L-Histidine
L-Histidine hydrochloride monohydrate
Polysorbate 80
Sucrose
Water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Unopened pre-filled syringe of Ilumetri may be removed from the refrigeration and stored up to 25°C for a single period of up to 30 days. Once removed from the refrigerator and stored under these conditions, discard after 30 days or by the expiry date printed on the container, whichever occurs first. A field for the date is provided on the carton to record the removal from refrigerator date.
Keep the pre-filled syringes in the outer carton in order to protect from light until the time of use.
Do not shake.
6.5 Nature and contents of container
1 mL solution in a type I glass pre-filled syringe with stainless steel 29G x ½” needle, covered with a needle shield and rigid needle shield of polypropylene with a fluropolymer lamination, plunger stopper assembled in a passive safety device.
Pack size of 1 pre-filled syringe or multipack of 2 pre-filled syringes.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Ilumetri is a sterile solution for injection in pre-filled syringe. The pre-filled syringes are for single use only.
Do not shake or freeze the pre-filled syringe. The pre-filled syringe should be taken out of the refrigerator 30 minutes before injecting to allow it to reach room temperature (up to 25°C).
Prior to use, a visual inspection of the pre-filled syringe is recommended. The liquid should be clear. Its colour may vary from colourless to slightly yellow. A small air bubble may be apparent: this is normal. Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown.
The instructions for using the pre-filled syringes, included with the package leaflet, must be followed carefully.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain
8. Marketing authorisation number(s)
EU/1/18/1323/001
EU/1/18/1323/002
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 19/September |
