crisaborole topical (Rx)

Brand and Other Names:Eucrisa
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical ointment

  • 2%

Atopic Dermatitis

Indicated for mild-to-moderate atopic dermatitis

Apply a thin layer topically to affected area(s) BID

Dosage Forms & Strengths

topical ointment

  • 2%

Atopic Dermatitis

Indicated for mild-to-moderate atopic dermatitis in children aged ≥2 yr

<2 years: Safety and efficacy not established

≥2 years: Apply a thin layer topically to affected area(s) BID

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Adverse Effects

1-10%

Application site pain, burning, or stinging (4%)

<1%

Contact urticaria

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Warnings

Contraindications

History of hypersensitivity to crisaborole or any component of the formulation

Cautions

Hypersensitivity reactions reported, including contact urticaria; signs and symptoms may include severe pruritus, swelling, and erythema at the application site or at a distant site; discontinue immediately and initiate appropriate therapy if hypersensitivity suspected (see Contraindications)

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Pregnancy

Pregnancy

There are no available data in pregnant women to inform the drug-associated risk for major birth defects and miscarriage

Crisaborole is systemically absorbed

Animal studies

  • No adverse developmental effects observed with oral administration in pregnant rats and rabbits during organogenesis at doses up to 5 and 3 times, respectively, the maximum recommended human dose (MRHD)

Lactation

Unknown if distributed in human breast milk

Crisaborole is systemically absorbed

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Phosphodiesterase (PDE)-4 inhibitor; results in increased intracellular cyclic adenosine monophosphate (cAMP) levels

The specific mechanism by which crisaborole exerts its therapeutic action for atopic dermatitis is not well defined, although cAMP is thought to decrease the proinflammatory response (eg, cytokine release) associated with atopic dermatitis

Absorption

Steady state: Achieved on Day 8

Peak plasma concentration (Day 8): 127 ng/mL

AUC (Day 8): 949 n·gh/mL

Distribution

Protein bound: 97%

Metabolism

Substantially metabolized into inactive metabolites

Major metabolites: 5-(4-cyanophenoxy)-2-hydroxyl benzyl alcohol (metabolite 1) is formed via hydrolysis; it is further metabolized into downstream metabolites, among which 5-(4-cyanophenoxy)-2-hydroxyl benzoic acid (metabolite 2), formed via oxidation, is also a major metabolite

Elimination

Excretion: Renal excretion of metabolites is the major route of elimination

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Administration

Topical Administration

Apply thin layer of ointment to affected areas BID

Wash hands after applying ointment, unless hands are being treated

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

Storage

Store at controlled room temperature 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

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Images

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.