Vtama

About Tapinarof

• Vtama received Food and Drug Administration (FDA) approval on May 24th, 2022.
• Vtama, is an aryl hydrocarbon receptor agonist prescribed for adults for the topical management of plaque psoriasis.
• The specific mechanisms by which Vtama cream elicits its therapeutic effects in patients with psoriasis are currently undetermined.
• Obtaining advice from a healthcare professional is vital for precise diagnosis and proper management.
• Plaque psoriasis (psoriasis vulgaris) is a persistent autoimmune condition characterized by accelerated cell reproduction, resulting in the formation of thick, scaly patches known as plaques on the skin. 
• These plaques commonly manifest on the elbows, back, knees, and scalp. In more severe instances, plaque psoriasis can extend to affect the entire body, including the face, feet, genitals (penis, vagina, vulva), hands, and legs.
• Plaque psoriasis manifests with distinctive symptoms such as raised, discolored plaques in shades of red, brown, gray, or purple, often accompanied by a white or silvery surface. These plaques may exhibit cracks (fissures), leading to bleeding, and are commonly associated with itchiness. Additionally, individuals with plaque psoriasis may experience irritation or pain.

Strength: 

Vtama cream, 1%, is available with each gram containing 10 mg of tapinarof.

Recommended Dosage:

• Apply a thin layer of Vtama cream once daily to the affected areas as directed by your healthcare provider. 
• Do not use Vtama cream orally, in the eyes, or intravaginally. 
• Follow your healthcare provider’s instructions precisely, applying the cream only to psoriasis skin lesions and avoiding unaffected areas. 

Important:

After applying Tapinarof cream, wash your hands unless using it for your hands. If someone else applies it for you, they should also wash their hands. Inform your healthcare provider about all medications, including prescriptions, over-the-counter drugs, vitamins, and herbal supplements.

Warnings & Precautions

• Vtama may cause eye irritation, particularly if applied near the eyes; hence, it is essential to avoid contact with the eyes and thoroughly wash hands after application. 
• While severe allergic reactions are rare, immediate medical attention should be sought if hives, swelling, difficulty breathing, or dizziness occur. 
• Common but usually mild and temporary local skin reactions such as burning, stinging, itching, and redness may occur; it is advisable to inform your doctor if they worsen or persist. 
• To prevent potential interactions, inform your doctor about all medications, including prescription, over-the-counter, and herbal supplements. 
• Discuss any pre-existing medical conditions, as certain conditions may increase the risk of side effects. 
• If you have an open wound or infection in the treatment area, consult your doctor before using Vtama .

Common Vtama Side Effects:

• Folliculitis
• Nasopharyngitis
• Contact dermatitis
• Headache
• Pruritus
• Influenza
• Eye irritation
• Flu-like symptoms
• Dryness and flaking
• Burning, stinging, itching

Use in Specific Population

• Insufficient data are available to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes associated with Vtama cream use in pregnant women. 
• The presence of Vtama in human milk, its effects on the breastfed infant, and its impact on milk production remain unknown. 
• The safety and efficacy of Vtama cream have not been established in pediatric subjects under 18 years with psoriasis. 
• Clinical trials showed no overall differences in efficacy, safety, or tolerability between elderly and younger adult subjects.

Storage and Handling

• Store between 20°C to 25°C (68°F to 77°F) with excursions allowed between 15°C and 30°C (59°F and 86°F). 
• Avoid freezing and protect from excessive heat exposure. 
• Keep out of reach of children.