Chemical formula: C₂₆H₂₉N₃O₃ Molecular mass: 431.536 g/mol
There are no or limited amount of data from the use of tirbanibulin in pregnant women. Studies in animals have shown reproductive toxicity.
Tirbanibulin ointment is not recommended during pregnancy and in women of childbearing potential not using contraception.
It is unknown whether tirbanibulin/metabolites are excreted in human milk.
A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tirbanibulin ointment therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
No human data on the effect of tirbanibulin ointment on fertility are available. In a non-clinical fertility and early embryonic development study in rats, changes considered indicative of male fertility toxicity occurred.
Tirbanibulin ointment has no or negligible influence on the ability to drive and use machines.
The most frequently reported adverse reactions are local skin reactions. Local skin reactions included erythema (91%), flaking/scaling (82%), crusting (46%), swelling (39%), erosion/ulceration (12%), and vesiculation/pustulation (8%) at the application site. Furthermore, application site pruritus (9.1%) and pain (9.9%) have been reported in the treatment area.
The following table lists the adverse reactions that were reported in clinical studies. Frequencies are defined as: 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); not known (frequency cannot be estimated from the available data).
| MedDRA System Organ Class | Preferred term | Frequency |
|---|---|---|
| General disorders and administration site conditions | Application site erythema | Very common |
| Application site exfoliation (flaking and scaling) | Very common | |
| Application site scab (crusting) | Very common | |
| Application site swelling | Very common | |
| Application site erosion (includes ulcer) | Very common | |
| Application site paina | Common | |
| Application site pruritus | Common | |
| Application site vesicles (includes pustules) | Common |
a Application site pain includes pain, tenderness, stinging, and burning sensation at the application site.
Most local skin reactions were transient and mild to moderate in severity. Following the application of tirbanibulin ointment, the incidences of local skin reactions with a severity grade greater than baseline were erythema (91%), flaking/scaling (82%), crusting (46%), swelling (39%), erosion/ulceration (12%), and vesiculation/pustulation (8%). Severe local skin reactions occurred at an overall incidence of 13%. Severe local skin reactions that occurred at an incidence >1% were: flaking/scaling (9%), erythema (6%), and crusting (2%). None of the local skin reactions required treatment.
Overall, local skin reactions peaked 8 days after starting the treatment and typically resolved within 2 to 3 weeks after completion of treatment with tirbanibulin ointment.
Events of application site pruritus and pain were mild to moderate in severity, transient in nature (mostly occuring during the first 10 days since the start of treatment), and the majority did not require treatment.
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