August 2025
Atopic dermatitis: Children ≥2 years and Adolescents: Topical: Apply a thin layer to affected areas once daily.
There are no specific dosage adjustments provided in the manufacturer's labeling.
There are no specific dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Tapinarof: Drug information")
Atopic dermatitis: Topical: Apply a thin layer to the affected area once daily.
Plaque psoriasis: Topical: Apply a thin layer to the affected area once daily; the treatment period in clinical trials was up to 12 weeks (Ref).
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: Topical: No dosage adjustment necessary for any degree of kidney dysfunction (minimal systemic absorption (Ref)) (Ref).
Hemodialysis, intermittent (thrice weekly): Topical: No supplemental dose or dosage adjustment necessary (minimal systemic absorption (Ref)) (Ref).
Peritoneal dialysis: Topical: No dosage adjustment necessary (minimal systemic absorption (Ref)) (Ref).
CRRT: Topical: No dosage adjustment necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): Topical: No dosage adjustment necessary (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults, unless otherwise noted.
>10%:
Dermatologic: Folliculitis (children, adolescents, adults: 9% to 20%)
Respiratory: Nasopharyngitis (11%), upper respiratory tract infection (children, adolescents, adults: 12%)
1% to 10%:
Dermatologic: Contact dermatitis (7%), pruritus (3%)
Gastrointestinal: Abdominal pain (children, adolescents, adults: 1%), vomiting (children, adolescents, adults: 2%)
Infection: Influenza (2%)
Local: Application-site reaction (children, adolescents, adults: 4%)
Nervous system: Headache (children, adolescents, adults: 4%)
Neuromuscular & skeletal: Limb pain (children, adolescents, adults: 2%)
Otic: Ear disease (children: 2%; including otitis externa, otitis media)
Respiratory: Asthma (children, adolescents, adults: 2%), lower respiratory tract infection (children, adolescents, adults: 5%)
<1%: Dermatologic: Urticaria
There are no contraindications listed in the manufacturer's labeling.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol and/or sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol and/or benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP ["Inactive" 1997]; Zar 2007).
Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Vtama: 1% (60 g) [contains benzoic acid, edetate (edta) disodium, polysorbate 80, propylene glycol]
No
Cream (Vtama External)
1% (per gram): $30.20
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Topical: Cream: For topical use only; not for oral, ophthalmic, or intravaginal use. Apply in a thin layer to affected area(s). Wash hands after application (unless using for treatment of the hands).
Topical: For topical use only; not for oral, ophthalmic, or intravaginal use. Apply as a thin layer to the affected area. Wash hands after use (unless used for treatment of the hands).
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Do not freeze. Protect from exposure to excessive heat.
Treatment of atopic dermatitis (FDA approved in ages ≥2 years and adults); treatment of plaque psoriasis (FDA approved in adults).
None known.
There are no known significant interactions.
Adverse events were not observed in animal reproduction studies following SUBQ administration.
Disease severity in atopic dermatitis.
Binds to and activates the aryl hydrocarbon receptor (AhR), a ligand-dependent transcription factor that regulates cytokine and skin-barrier-protein expression and antioxidant activity (Lebwohl 2021). The specific mechanism of action is not known (manufacturer's labeling).
Absorption: Minimally absorbed; serum concentrations range from undetectable to 0.9 ± 1.4 ng/mL on day 1 and 0.12 ± 0.15 ng/mL on day 29 (Jett 2022).
Protein binding: 99% (in vitro).
Metabolism: Hepatic, via multiple pathways (oxidation, glucuronidation, and sulfation) in vitro.
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
