Phosphodiesterase 4 Inhibitor

Eucrisa

Approved 14 Dec 2016TopicalOintment

Indications

EUCRISA is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. EUCRISA is a phosphodiesterase 4 inhibitor indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. ( 1 )

Contraindications

EUCRISA is contraindicated in patients with known hypersensitivity to crisaborole or any component of the formulation. [see Warnings and Precautions (5.1) ] Known hypersensitivity to crisaborole or any component of the formulation. ( 4 )

Warnings and precautions

Hypersensitivity reactions : If signs and symptoms of hypersensitivity occur, discontinue EUCRISA immediately and initiate appropriate therapy. ( 5.1 )

5.1Hypersensitivity Reactions

Hypersensitivity reactions, including contact urticaria, have occurred in patients treated with EUCRISA. Hypersensitivity should be suspected in the event of severe pruritus, swelling and erythema at the application site or at a distant site. If signs and symptoms of hypersensitivity occur, discontinue EUCRISA immediately and initiate appropriate therapy.

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Available data from case reports with EUCRISA use in pregnant women are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of crisaborole in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times, respectively, the maximum recommended human dose (MRHD) ( see Data ).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects in the U.S. general population is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data Rat and rabbit embryo-fetal development was assessed after oral administration of crisaborole.

At a glance

Brand name: Eucrisa
Active substance: crisaborole
Pharmacologic class: Phosphodiesterase 4 Inhibitor
Route: Topical
Dosage form: Ointment
Applicant: Anacor Pharms Inc
Status: Prescription
FDA approval: 14 Dec 2016
Application: NDA207695-001

Indications

Warnings and precautions

Hypersensitivity reactions : If signs and symptoms of hypersensitivity occur, discontinue EUCRISA immediately and initiate appropriate therapy. ( 5.1 )

5.1Hypersensitivity Reactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

The most common adverse reaction occurring in ≥1% in subjects is application site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two double-blind, vehicle-controlled clinical trials (Trial 1 and Trial 2), 1012 subjects 2 to 79 years of age with mild to moderate atopic dermatitis were treated with EUCRISA twice daily for 4 weeks.

The adverse reaction reported by ≥1% of EUCRISA-treated subjects is listed in Table 1. Table 1: Adverse Reaction Occurring in ≥1% of Subjects in Atopic Dermatitis Trials through Week 4 Adverse Reaction EUCRISA Twice Daily N=1012 n (%) Vehicle Twice Daily N=499 n (%) Application site pain Refers to skin sensations such as burning or stinging. 45 (4) 6 (1) Less common (<1%) adverse reactions in subjects treated with EUCRISA included contact urticaria [see Warnings and Precautions (5.1) ].

In one double-blind, vehicle-controlled trial including an initial open-label period (Trial 3), 497 subjects 3 months of age and older with mild to moderate atopic dermatitis received EUCRISA twice daily for up to 8 weeks. This was followed by a double-blind period, during which 135 subjects out of 270 randomized subjects received EUCRISA and 135 subjects received vehicle once daily for 52 weeks or until they developed a flare.

The adverse reactions observed in the open-label period were similar to the known safety profile of twice daily treatment with EUCRISA. The adverse reactions observed with once daily treatment were similar to vehicle [see Clinical Studies (14) ] .

6.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of EUCRISA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Skin and Subcutaneous: allergic contact dermatitis

Eucrisa

Indications

Contraindications

Warnings and precautions

5.1Hypersensitivity Reactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

At a glance

Two medicines in one question?

Eucrisa

Indications

Contraindications

Warnings and precautions

5.1Hypersensitivity Reactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

At a glance

Two medicines in one question?

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information