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Crisaborole: Drug information

Crisaborole: Drug information
(For additional information see "Crisaborole: Patient drug information" and see "Crisaborole: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Eucrisa
Brand Names: Canada
  • Eucrisa
Pharmacologic Category
  • Phosphodiesterase-4 Enzyme Inhibitor, Topical;
  • Topical Skin Product
Dosing: Adult
Atopic dermatitis

Atopic dermatitis: Topical: Apply a thin film to affected area(s) 2 times daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Crisaborole: Pediatric drug information")

Atopic dermatitis, mild to moderate

Atopic dermatitis, mild to moderate: Infants ≥3 months, Children, and Adolescents: Topical: Apply a thin film to affected area(s) 2 times daily.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Eucrisa: 2% (60 g, 100 g) [contains edetate (edta) calcium disodium, propylene glycol]

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Eucrisa: 2% (30 g, 60 g, 100 g) [contains edetate (edta) calcium disodium, propylene glycol]

Administration: Adult

For topical use only; not for ophthalmic, oral, or intravaginal use.

Administration: Pediatric

For topical use only; not for ophthalmic, oral, or intravaginal use. Wash hands before and after use; apply in thin layer to affected area.

Use: Labeled Indications

Atopic dermatitis: Topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients ≥3 months of age.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%: Local: Application site pain (4%)

<1%: Dermatologic: Urticaria

Frequency not defined: Hypersensitivity: Hypersensitivity reaction

Postmarketing: Dermatologic: Allergic contact dermatitis

Contraindications

Hypersensitivity to crisaborole or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Hypersensitivity reactions have been reported, including contact urticaria. Severe pruritus, swelling, or erythema (at the application site or at a distant site) may be indicative of hypersensitivity. Discontinue immediately for signs of hypersensitivity.

Warnings: Additional Pediatric Considerations

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).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Riociguat: Crisaborole may enhance the hypotensive effect of Riociguat. Management: Riociguat is contraindicated with nonselective phosphodiesterase (PDE) inhibitors and PDE type 5 inhibitors. Other types of PDE inhibitors are not contraindicated, but caution is advised and patients should be monitored for hypotension. Risk C: Monitor therapy

Pregnancy Considerations

Adverse effects were not observed in animal reproduction studies, except with high oral doses which also produced maternal toxicity.

Breastfeeding Considerations

It is not known if crisaborole is excreted in breast milk; however, it is absorbed systemically following topical application. According to the manufacturer, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of infant exposure, the benefits of breast-feeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Signs of hypersensitivity

Mechanism of Action

Inhibits phosphodiesterase 4 (PDE-4) and results in increased intracellular cyclic adenosine monophosphate (cAMP) levels.

Pharmacokinetics

Protein binding: 97%

Metabolism: Hepatic to 2 inactive metabolites via hydrolysis and oxidation

Pricing: US

Ointment (Eucrisa External)

2% (per gram): $13.84

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.

Brand Names: International
  • Staquis (AU, HR, IL)


For country code abbreviations (show table)
  1. American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  2. Eucrisa Ointment 2% (crisaborole) [prescribing information]. New York, NY: Pfizer Labs; April 2020.
  3. Eucrisa (crisaborole) [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada ULC; May 2021.
  4. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
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