Tapinarof

Miscellaneous topical agents

This cream contains Tapinarof as the active ingredient. Tapinarof is an Aryl hydrocarbon Receptor (AhR) agonist. The specific mechanisms by which Tapinarof cream exerts its therapeutic action in psoriasis patients are unknown.

Apply a thin layer of Tapina cream to affected areas once daily. Wash hands after application, unless Tapina cream is for treatment of the hands. Tapina cream is not for oral, ophthalmic, or intravaginal use.

 

Pediatric Use: Safety and efficacy of Tapina cream have not been established in pediatric subjects with psoriasis under 18 years of age.

 

Geriatric Use: 683 subjects exposed to Tapina cream in the PSOARING 1 or PSOARING 2 clinical trials, 99 (14.5%) were 65 years of age and older, including 8 (1.2%) subjects who were 75 years of age and older. No overall differences in efficacy, safety, or tolerability were observed between elderly subjects and younger adult subjects in clinical trials.

No hazardous interactions have been reported with other medicines.

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

Pregnancy: The available data on Tapinarof cream use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of Tapinarof to pregnant rats and rabbits during the period of organogenesis resulted in no significant adverse effects at doses 268 and 16 times, respectively, the maximum recommended human dose (MRHD). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes. Lactation: No data are available regarding the presence of Tapinarof in human milk or the effects of Tapinarof on the breastfed infant or on milk production. Tapinarof was detected in rat offspring following subcutaneous administration to pregnant female rats which suggests that tapinarof was transferred into the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tapinarof cream and any potential adverse effects on the breastfed infant from Tapinarof cream or from the underlying maternal condition.

None

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

Safe and effective