Indications

Indication: Vtapa 1% cream is indicated for the topical treatment of plaque psoriasis in adults. Always use this medicine as advised by a registered physician.

Pharmacology

Active Ingredient: Tapinarof.

Mechanism of Action: Tapinarof is an Aryl hydrocarbon Receptor (AhR) agonist. The specific mechanisms by which Tapinarof cream exerts its therapeutic action in psoriasis patients are unknown.

Dosage and Administration

Application: Apply a thin layer of Tapinarof cream to affected areas once daily.

Hand Care: Wash hands after application, unless the cream is used for treating the hands.

Usage Limit: Tapinarof cream is not for oral, ophthalmic, or intravaginal use.

Pediatric Use: Safety and efficacy of Tapinarof cream have not been established in pediatric subjects with psoriasis under 18 years of age. Always use this medicine as advised by a registered physician.

Interaction

Drug Interactions: No hazardous interactions have been reported with other medicines.

Contraindications

Contraindication: Hypersensitivity to any of its components.

Side Effects

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

Pregnancy and Lactation

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 in to the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in huma n 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 ma ternal condition.

Precautions and Warnings

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

Therapeutic Class

Class: Miscellaneous topical agents.

Storage Conditions

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