Vtama (tapinarof)

No dosing information is available for this tab.

Tapinarof 1% cream is applied topically to affected areas of the skin once daily. Tapinarof cream is not for ophthalmic, oral, or intravaginal use. Hands should be washed after applying the cream to psoriatic skin lesions, unless the cream is used for the treatment of the hands.

Store the cream at 20-25degreesC with excursions permitted between 15-30degreesC. Do not freeze; protect from excessive heat exposure.

No dosing information is available for this tab.

No formal drug interaction studies have been conducted with tapinarof to date. In vitro studies indicate that tapinarof does not inhibit cytochrome P-450 (CYP) isoenzymes 2B6, CYP2C8, CYP2C9, CYP2C19, CYPD26, or CYP3A4/5. Tapinarof does not induce CYP1A2, CYP2B6, or CYP3A4. In vitro, tapinarof does not inhibit P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporter (OAT) 1, OAT3, organic cation transporter (OCT) 1, OCT2, organic anion transporting polypeptide (OATP) 1B1, OATP1B3, multidrug and toxin extrusion (MATE) 1, or MATE-2K. Tapinarof is not a substrate for P-gp, BCRP, OATP1B1, or OATP1B3.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

The most common adverse reactions experienced in at least 1% of patients treated with tapinarof cream include folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.

More Frequent

• Acute abdominal pain
• Lower respiratory infection

Rare or Very Rare

• Urticaria

More Frequent

• Asthma
• Contact dermatitis
• Folliculitis
• Headache disorder
• Infection of ear
• Influenza
• Pain in extremities
• Pharyngitis
• Pruritus of skin
• Upper respiratory infection
• Vomiting

Rare or Very Rare

• Skin rash

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Safety and effectiveness of tapinarof are not established in pediatric patients with psoriasis under 18 years of age.

Available data on the use of tapinarof in pregnancy are not sufficient to evaluate for a drug-associated risk of adverse effects. Animal reproductive data indicate that subcutaneous administration of tapinarof to pregnant rats and rabbits during organogenesis at doses 268 and 16 times the maximum recommended human dose (MRHD), respectively, resulted in no significant adverse outcomes.

It is not known whether tapinarof is present in human milk. The effects of tapinarof on the breastfed infant, or on milk production are not known. Following subcutaneous administration to pregnant rats, tapinarof was detected in rat offspring, suggesting that tapinarof transfers into the milk of lactating rats. The presence of a drug in animal milk means it is likely that it will be present in human milk. Consider the benefits of breastfeeding along with the mother's clinical need for the drug, and the potential for adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients. The manufacturer states that no overall differences in efficacy, safety, or tolerability of tapinarof were observed in geriatric patients compared to younger adults in clinical trials.

In the primary efficacy studies, 14.5% of patients were 65 years of age and older, which included 1.2% who were 75 years of age and older. In these studies no overall differences in response were detected in efficacy, safety, or tolerability between geriatric patients and younger adult patients.