Drug Reference
Tapinarof
Other antipsoriatics for topical use
Rx only
Fact box
- Therapeutic class
- Other antipsoriatics for topical use
- Action class
- Aryl Hydrocarbon Receptor Agonist
- Mechanism
- Aryl Hydrocarbon Receptor Agonists
- Habit forming
- No
- Availability
- Prescription (Rx)
Brand names
Vtama
Available as
10 MG/ML · Topical Cream
FDA label sections are from openFDA and may not reflect the most recent labeling — confirm against the current DailyMed label.
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.
How it works
12.1 Mechanism of Action Tapinarof is an aryl hydrocarbon receptor (AhR) agonist. The specific mechanisms by which VTAMA cream exerts its therapeutic actions are unknown.
How to use / dosing
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 . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Plaque Psoriasis Clinical Trials In two randomized, double-blind, multicenter, vehicle-controlled clinical trials (PSOARING 1 and PSOARING 2), 1025 adults with plaque psoriasis were treated with VTAMA cream or received vehicle cream once daily for up to 12 weeks. Subjects ranged in age from 18 to 75 years, with an overall median age of 51 years. The majority of subjects were White (85%) and male (57%); and 85% identified as non-Hispanic or Latino. Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with VTAMA cream, and for which the rate exceeded the rate for vehicle. Table 1: Adverse Reactions Occurring in ≥1% of Adult Subjects with Plaque Psoriasis (and More Frequently than Vehicle) in the 12-week PSOARING 1 and PSOARING 2 Clinical Trials Adverse Reaction VTAMA cream N=683 n (%) Vehicle cream N=342 n (%) Folliculitis Folliculitis includes application site folliculitis and folliculitis 140 (20) 3 (1) Nasopharyngitis Nasopharyngitis includes nasopharyngitis, nasal congestion, pharyngitis, respiratory tract infection (RTI) viral, rhinorrhea, sinus congestion, upper RTI, and viral upper RTI 73 (11) 31 (9) Contact dermatitis Contact dermatitis includes dermatitis, contact dermatitis, hand dermatitis, and rash 45 (7) 2 (1) Headache Headache includes headache, migraine, and tension headache 26 (4) 5 (1) Pruritus Pruritus includes application site pruritus, pruritus, generalized pruritus, and genital pruritus 20 (3) 2 (1) Influenza Influenza includes influenza and influenza-like illness 14 (2) 2 (1) Two (0.3%) subjects using VTAMA cream developed urticaria. Adverse reactions leading to treatment discontinuation in >1% of subjects who received VTAMA cream were contact dermatitis (2.9%) and folliculitis (2.8%). In an open label safety trial (PSOARING 3), 763 subjects were treated for up to an additional 40 weeks after completing PSOARING 1 or PSOARING 2. In addition to the adverse reactions reported in the 12-week PSOARING 1 and PSOARING 2 clinical trials, the following adverse reactions were reported: urticaria (1.0%) and drug eruption (0.7%). Atopic Dermatitis Clinical Trials In two randomized, double-blind, multicenter, vehicle-controlled clinical trials (ADORING 1 and ADORING 2), 811 adult and pediatric subjects 2 years of age and older with atopic dermatitis were treated with VTAMA cream or received vehicle cream once daily for up to 8 weeks. Subjects ranged in age from 2 to 81 years, with an overall median age of 11 years. The majority (51%) of subjects were White, 31% were Black, 12% were Asian; 54% were female; and 78% of subjects identified as non-Hispanic or Latino. Table 2 presents adverse reactions that occurred in at least 1% of subjects treated with VTAMA cream, and for which the rate exceeded the rate for vehicle. Table 2: Adverse Reactions Occurring in ≥1% of Adult and Pediatric Subjects 2 Years and Older with Atopic Dermatitis (and More Frequently than Vehicle) in the 8 week ADORING 1 and ADORING 2 Clinical Trials Adverse Reaction VTAMA cream N=541 n (%) Vehicle cream N=270 n (%) Upper respiratory tract i
Safety advice
Conservative summary derived from FDA labeling — defaults to “consult your doctor” unless the label is explicit. Not a substitute for your clinician’s advice.
PregnancyUnsafe
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 ). 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. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryofetal development study in rats, tapinarof was administered by subcutaneous injection to pregnant animals at doses of 1.2, 6.9 and 34 mg/kg/day during the period of organogenesis. Tapinarof was not associated with embryofetal lethality or fetal malformations. Tapinarof increased the incidence of skeletal variations (incomplete ossification of nasal bones) at the dose of 34 mg/kg/day (264 times the MRHD based on AUC comparisons). In an embryofetal development study in rabbits, tapinarof was administered by subcutaneous injection to pregnant animals twice daily at doses of 0.3, 1, and 3 mg/kg/day during the period of organogenesis. Maternal toxicity as evidenced by decreased maternal body weight gain and associated increased post-implantation loss (embryolethality) was observed at 3 mg/kg/day. In addition, fetal skeletal variations were observed at 3 mg/kg/day. Tapinarof was not associated with embryofetal lethality or fetal malformations at doses up to 1 mg/kg/day (16 times the MRHD based on AUC comparison) or fetal malformations at doses up to 3 mg/kg/day (30 times the MRHD based on AUC comparison). In a second embryofetal development study in rabbits, tapinarof was administered by continuous subcutaneous infusion to pregnant animals at doses of 1, 2 and 3 mg/kg/day during the period of organogenesis. Tapinarof was not associated with embryofetal lethality or fetal malformations at doses up to 3 mg/kg/day (20 times the MRHD based on AUC comparison). In a prenatal and postnatal development study, tapinarof was administered by subcutaneous injection to pregnant rats at
BreastfeedingConsult your doctor
…doses of 1, 6 and 30 mg/kg/day beginning on gestation day 6 through lactation day 20.…
AlcoholNo information
No specific information in the FDA label.
DrivingNo information
No specific information in the FDA label.
KidneyNo information
No specific information in the FDA label.
LiverNo information
No specific information in the FDA label.
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Pediatric use
8.4 Pediatric Use Plaque Psoriasis The safety and efficacy of VTAMA cream for the topical treatment of plaque psoriasis have not been established in pediatric patients. Atopic Dermatitis The safety and efficacy of VTAMA cream for the topical treatment of atopic dermatitis have been established in pediatric patients 2 years of age and older. Use of VTAMA cream for this indication is supported by evidence from two adequate and well-controlled trials (ADORING 1 and ADORING 2), which included 654 pediatric subjects 2 years of age and older (436 of whom received VTAMA cream) with moderate to severe atopic dermatitis. Adverse reactions occurring more frequently in pediatric subjects compared to adults were upper respiratory tract infection and ear infection [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) and Clinical Studies (14.2) ]. The safety and efficacy of VTAMA cream for the topical treatment of atopic dermatitis have not been established in pediatric patients younger than 2 years of age. Juvenile Animal Toxicity Data In a juvenile animal toxicity study, tapinarof was administered by subcutaneous injection to juvenile rats at doses of 1, 10 and 20 mg/kg/day from postnatal day (PND) 7 to 21 and at doses of 1.5, 15, and 30 mg/kg/day from PND 22 to 77. The dose escalation conducted at PND 22 was implemented to maintain consistent systemic exposure across the duration of the dosing period. Renal pelvic dilatation was observed at doses greater than or equal to 15 mg/kg/day (165 times the MRHD based on AUC comparisons). No adverse effects in juvenile animals were noted at 1.5 mg/kg/day (11 times the MRHD based on AUC comparisons).
⚑ About half of pediatric medication use is off-label and not described in FDA labels — absence of pediatric information does not mean a medicine is unused or unsafe in children. Confirm with your clinician.
Current FDA labels (DailyMed)
Authoritative sources
Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.