VTAMA DRUG
- 1. VTAMA PRESENTED BY- VARSHA R WADNERE Vth YEAR PHARM D DOP- 24-08-2022
- 2. TABLE OF CONTENTS 1. Introduction 2. FDA approval 3. Description 4. Chemistry 5. Mechanism of action 6. Dose and administration 7. Dosage and strength 8. Pharmacokinetics 9. Pharmacodynamics 10. Special population 11. Adverse effects 12. Contraindications 13. Storage and handling 14. Cost of the drug 15. References
- 3. INTRODUCTION ➢VTAMA cream is a prescription medicine used on the skin (topical) to treat plaque psoriasis in adults. ➢It is the first unique topical medication to be launched for psoriasis in 25 years, according to a statement by Dermavant, Vtama's manufacturer. ➢The aryl hydrocarbon receptor (AhR) is a ligand-activated transcription factor that integrates environmental, dietary, microbial and metabolic cues to control complex transcriptional programmes in a ligand-specific, cell-type-specific manner. ➢Plays an important tumor-specific role in enhancing or inhibiting carcinogenesis, manages immune system.
- 4. FDAAPPROVAL ➢VTAMA was granted FDA approval on 23-05-2022
- 5. DESCRIPTION ➢Generic Name- Tapinarof ➢Pharmacological Class- Aryl hydrocarbon receptor {AhR} agonist. ➢VTAMA cream also contains the following inactive ingredients: benzoic acid, butylated hydroxytoluene {antioxidant}, citric acid monohydrate, diethylene glycol monoethyl ether, edetate disodium, emulsifying wax, medium-chain triglycerides, polyoxyl 2 stearyl ether, polyoxyl 20 stearyl ether, polysorbate 80, propylene glycol, purified water, and sodium citrate dihydrate.
- 6. CHEMISTRY ➢Tapinarof is a white to pale brown powder. ➢Chemically, tapinarof is 3, 5-dihydroxy-4-isopropyl-transstilbene. ➢Also known as (E)-2-isopropyl-5-styrylbenzene-1,3-diol, with the empirical formula C17H18O2, a molecular weight of 254.32, and the following structural formula.
- 7. 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. ➢The efficacy of tapinarof in psoriasis is attributed to its specific binding and activation of AhR, a ligand-dependent transcription factor, leading to the downregulation of proinflammatory cytokines, including interleukin 17, and regulation of skin barrier protein expression to promote skin barrier normalization.
- 8. DOSE AND ADMINISTRATION ➢Apply a thin layer of VTAMA cream to affected areas once daily. ➢VTAMA cream is not for oral, ophthalmic, or intravaginal use.
- 9. DOSAGE AND STRENGTH ➢Cream, 1% ➢Each gram of VTAMA cream contains 10 mg of tapinarof.
- 10. 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.
- 11. ➢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.
- 12. PHARMACODYNAMICS ➢Pharmacodynamics of VTAMA cream are unknown.
- 13. SPECIAL POPULATION ➢Pediatric Use The safety and effectiveness of VTAMA have not been established in pediatric patients. ➢Geriatric Use No overall differences in efficacy, safety, or tolerability were observed between elderly subjects and younger adult subjects in clinical trials.
- 14. ADVERSE EFFECTS ➢Folliculitis ➢Nasopharyngitis ➢Contact dermatitis ➢Headache ➢Pruritus ➢Influenza ➢Two (0.3%) subjects using VTAMA cream developed urticaria.
- 16. STORAGE AND HANDLING How supplied- 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 ➢Store at 20°C to 25°C (68°F to 77°F). ➢Do not freeze. ➢Protect from exposure to excessive heat. ➢Keep out of reach of children.
- 17. COST OF THE DRUG ➢ The cost for Vtama topical cream 1% is around $1,405 for a supply of 60 grams (1,12,219 INR).