15/22. Tapinarof- (VTAMA)- (May 2022)- To treat psoriasis
Indication:
BRIEF SUMMARY-
TAPINAROF- (May 2022)
Indn- To Treat Psoriasis
Comp- - Cream, 1% (3) Each gram of VTAMA cream contains 10 mg of tapinarof. Apply a thin layer of VTAMA cream to affected areas once daily.
ADR- Most common adverse reactions (incidence = 1%) in subjects treated with VTAMA cream were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
CI- None.
Pat Inform-
Apply cream once daily to psoriasis skin lesions only and avoid unaffected areas of skin.
• Wash hands after application unless cream is for treatment of the hands.
• Advise patients that cream is for external use only.
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U.S. APPROVED DRUGS SURING 2022
Serial No 15
Name- VTAMA
Active Ingredient - Tapinarof
Pharmacological Classification- To Treat Psoriasis
Date of Approval- 5/23/22
HIGHLIGHTS OF PRESCRIBING INFORMATION-
These highlights do not include all the information needed to use VTAMA® cream safely and effectively.
See full prescribing information for VTAMA. VTAMA (tapinarof) cream, for topical use
Initial U.S. Approval: 2022
INDICATIONS AND USAGE-
VTAMA cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.
Adverse Reaction:
ADVERSE REACTIONS-
Most common adverse reactions (incidence = 1%) in subjects treated with VTAMA cream were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
Contra-Indications:
CONTRAINDICATIONS-
None.
Dosages/ Overdosage Etc:
DOSAGE AND ADMINISTRATION-
• Apply a thin layer of VTAMA cream to affected areas once daily.
• VTAMA cream is not for oral, ophthalmic, or intravaginal use.
DOSAGE FORMS AND STRENGTHS-
- Cream, 1% (3) Each gram of VTAMA cream contains 10 mg of tapinarof.
Patient Information:
PATIENT COUNSELING INFORMATION-
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Administration Instructions
• Apply VTAMA cream once daily to psoriasis skin lesions only and avoid unaffected areas of skin.
• Wash hands after application unless VTAMA cream is for treatment of the hands.
• Advise patients that VTAMA cream is for external use only.
Marketed by:
Dermavant Sciences Inc., 3780 Kilroy Airport Way, Long Beach, CA 90806
VTAMA is a registered trademark of Dermavant Sciences, GmbH or its affiliates.
U.S. Patents: www.dermavant.com/patents
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1 Mechanism of Action-
Tapinarof is an aryl hydrocarbon receptor (AhR) agonist. The specific mechanisms by which VTAMA cream exerts its therapeutic action in psoriasis patients are unknown.
2. Pharmacodynamics
Pharmacodynamics of VTAMA cream are unknown.
Cardiac Electrophysiology
At the approved recommended dosage, VTAMA does not prolong the QTc interval to any clinically relevant extent.
3. Pharmacokinetics
Absorption-
No accumulation was observed with repeat topical application. Plasma concentration of tapinarof was below the quantifiable limits (BQL) of the assay (lower limit of quantification was 50 pg/mL) in 68% of the pharmacokinetic samples.
Distribution
Human plasma protein binding of tapinarof is approximately 99% in vitro.
Elimination
Metabolism
Tapinarof is metabolized in the liver by multiple pathways including oxidation, glucuronidation, and sulfation
in vitro.
Drug Interaction Studies
In Vitro Studies
Cytochrome P450 (CYP) Enzymes: Tapinarof is not an inhibitor of CYP2B6, CYP2C8, CYP2C9, CYP2C19,
CRP2D6 or CYP3A4/5. Tapinarof is not an inducer of CYP1A2, CYP2B6 or CYP3A4.
Transporter Systems: Tapinarof is not an inhibitor of BCRP, MATE1, MATE-2K, OAT1, OAT3, OATP1B1,
OATP1B3, OCT1, OCT2, or P-gp. Tapinarof is not a substrate for BCRP, OATP1B1, OATP1B3, or P-gp.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
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 268 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.
2. Lactation
Risk Summary
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 VTAMA cream and any potential adverse effects on the breastfed infant from VTAMA cream or from the underlying maternal condition.
3.Pediatric Use-
Safety and efficacy of VTAMA cream have not been established in pediatric subjects with psoriasis under 18 years of age.
4. Geriatric Use-
Of the 683 subjects exposed to VTAMA 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.