Adverse reactions occurring in ≥1% of patients during the 8-week pivotal studies, ADORING 1 and ADORING 21,2
There are no label restrictions on topical use. No-to-minimal irritation, even on affected sensitive skin areas such as the face, neck, and skin folds based on local tolerability scores.*‡1,6
The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis treated with VTAMA cream were upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.
No Boxed Warning or contraindications.1
No drug-drug interactions.1
No label restrictions on topical use and can be applied to all affected skin areas.*1
No-to-minimal systemic absorption.2
No-to-minimal stinging or burning based on local tolerability scores.†6
*Not for oral, ophthalmic, or intravaginal use.
†Patient/caregiver-reported tolerability scores (0-4) assessed the presence and degree of burning/stinging and of itching at the application sites, from (0) none to (1) slight, (2) mild, (3) moderate, or (4) strong/severe.6
‡Investigator-assessed tolerability scores (0–4) were assessed using the LTS which evaluated the presence and overall degree of irritation across application sites (including dryness, erythema, and peeling), from (0) no irritation to (1) mild, (2) moderate, (3) severe, or (4) very severe.
Indications: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for:
Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: red raised bumps around the hair pores (folliculitis), pain or swelling in the nose and throat (nasopharyngitis), skin rash or irritation, including itching and redness, peeling, burning, or stinging (contact dermatitis), headache, itching (pruritus), and flu (influenza).
Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, red raised bumps around the hair pores (folliculitis), lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and stomach-area (abdominal) pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.