Tapinarof
Generic Name: tapinarof
Brand Names:
Vtama
11 DESCRIPTION VTAMA (tapinarof) cream contains tapinarof as the active ingredient. Tapinarof is an aryl hydrocarbon receptor agonist. Tapinarof is a white to pale brown powder. Chemically, tapinarof is 3, 5-dihydroxy-4-isopropyl- trans -stilbene, also known as (E)-2-isopropyl-5-styrylbenzene-1,3-diol, with the empirical formula C 17 H 18 O 2 , a molecular weight of 254.32, and the following structural formula.
Overview
11 DESCRIPTION VTAMA (tapinarof) cream contains tapinarof as the active ingredient. Tapinarof is an aryl hydrocarbon receptor agonist. Tapinarof is a white to pale brown powder. Chemically, tapinarof is 3, 5-dihydroxy-4-isopropyl- trans -stilbene, also known as (E)-2-isopropyl-5-styrylbenzene-1,3-diol, with the empirical formula C 17 H 18 O 2 , a molecular weight of 254.32, and the following structural formula.
Uses
1 INDICATIONS AND USAGE VTAMA cream, 1% is an aryl hydrocarbon receptor agonist indicated for: the topical treatment of plaque psoriasis in adults. ( 1.1 ) the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older. ( 1.2 ) 1.1 Plaque Psoriasis VTAMA ® cream is indicated for the topical treatment of plaque psoriasis in adults. 1.2 Atopic Dermatitis VTAMA cream is indicated for the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.
Dosage
2 DOSAGE AND ADMINISTRATION Apply a thin layer of VTAMA cream to affected areas once daily. Wash hands after application, unless VTAMA cream is for treatment of the hands. VTAMA cream is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of VTAMA cream to affected areas once daily. ( 2 ) VTAMA cream is not for oral, ophthalmic, or intravaginal use. ( 2 )
Side Effects
6 ADVERSE REACTIONS In plaque psoriasis, the most common adverse reactions (incidence ≥ 1%) were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza. ( 6.1 ) In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) were upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings
4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary The available data on VTAMA 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 264 and 16 times, respectively, the maximum recommended human dose (MRHD) ( see Data ).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING VTAMA (tapinarof) cream, 1% is a white to off-white cream. Each gram of VTAMA cream contains 10 mg of tapinarof. It is supplied in the following size: 60 g laminated tubes: NDC 81672-5051-1 Storage and Handling: - Store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].
Frequently Asked Questions
What is Tapinarof used for?▼
1 INDICATIONS AND USAGE VTAMA cream, 1% is an aryl hydrocarbon receptor agonist indicated for: the topical treatment of plaque psoriasis in adults. ( 1.1 ) the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older. ( 1.2 ) 1.1 Plaque Psoriasis VTAMA ® cream is indicated for the topical treatment of plaque psoriasis in adults. 1.2 Atopic Dermatitis VTAMA cream is indicated for the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.
What are the side effects of Tapinarof?▼
6 ADVERSE REACTIONS In plaque psoriasis, the most common adverse reactions (incidence ≥ 1%) were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza. ( 6.1 ) In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) were upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Tapinarof during pregnancy?▼
8.1 Pregnancy Risk Summary The available data on VTAMA 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 264 and 16 times, respectively, the maximum recommended human dose (MRHD) ( see Data ).
What are the important warnings for Tapinarof?▼
4 CONTRAINDICATIONS None. None. ( 4 )
Related Medications
Olbas Analgesic Salve
olbas analgesic salve
Dosage form: SALVE. Active ingredients: PEPPERMINT OIL (6.525 kg/6.525kg). Category: BULK INGREDIENT.
Meijer Athletes Foot Liquid
meijer athletes foot liquid
Purpose Antifungal
Enclomiphene Citrate
enclomiphene citrate
Dosage form: POWDER. Active ingredients: ENCLOMIPHENE CITRATE (35 kg/35kg). Category: BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.