Pinarof 1% Cream, 30g Tube

✔️ Side Effects

Most common adverse reactions (incidence ≥ 1%) in subjects treated with Tapisis cream were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.

✔️ Interaction

No hazardous interactions have been reported with other medicines.

✔️ Contraindications

Hypersensitive to any of its components.

✔️ Pregnancy & Lactation

Pregnancy

There are insufficient data on the use of Tapinarof Cream in pregnant women to determine any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
In animal studies, subcutaneous administration of Tapinarof to pregnant rats and rabbits during organ development did not cause harmful effects at exposure levels approximately 268 times (rats) and 16 times (rabbits) higher than the maximum recommended human dose (MRHD).
The baseline risk of major birth defects or miscarriage in the treated population is unknown. However, all pregnancies carry a background risk of fetal abnormalities, loss, or other adverse outcomes.

Lactation

Information regarding the presence of Tapinarof in human breast milk, its effects on breastfed infants, or its impact on milk production is currently unavailable.
Tapinarof has been detected in the offspring of lactating rats after subcutaneous administration to the mother, indicating that the drug passes into animal milk. Therefore, it is likely that Tapinarof may be present in human milk as well.
When prescribing Tapinarof Cream to breastfeeding women, clinicians should weigh the benefits of breastfeeding against the mother’s clinical need for treatment and the potential risks to the nursing infant from either Tapinarof exposure or the underlying maternal condition.

✔️ Pregnancy & Lactation

For external use only. Avoid use in the eyes, oral or intravaginal use. If there is any unusual allergic reaction with the use of Pinarof, then treatment should be discontinued and appropriate therapy should be instituted.

✔️ Storage:

Do not store above 30°C. Keep in a dry place. Protect from light and keep out of the reach of children.