EUCRISA Ointment (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Pfizer Laboratories Div Pfizer Inc

Λέξεις κλειδιά

55724-211

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1. Indications and Usage

EUCRISA is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.

2. Dosage and Administration

Apply a thin layer of EUCRISA twice daily to affected areas. EUCRISA is for topical use only and not for ophthalmic, oral, or intravaginal use.

3. Dosage Forms and Strengths

Ointment: 20 mg of crisaborole per gram (2%) of white to off-white ointment.

4. Contraindications

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

5. Warnings and Precautions

5.1 Hypersensitivity Reactions Hypersensitivity reactions, including contact urticaria, have occurred in patients treated with EUCRISA. Hypersensitivity should be suspected in the event of severe pruritus, ...

6.1. Clinical 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 ...

6.2. Postmarketing 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 ...

8.1. Pregnancy

Risk Summary There is no available data with EUCRISA in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, there were no adverse ...

8.2. Lactation

Risk Summary There is no information available on the presence of EUCRISA in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production after topical application ...

8.4. Pediatric Use

The safety and effectiveness of EUCRISA have been established in pediatric patients ages 3 months and older for topical treatment of mild to moderate atopic dermatitis. Use of EUCRISA in this age group ...

8.5. Geriatric Use

Clinical studies of EUCRISA did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects.

11. Description

EUCRISA contains 2% crisaborole (w/w) in a petrolatum-based, white to off-white ointment and is for topical use. The active ingredient, crisaborole, is a phosphodiesterase-4 (PDE-4) inhibitor. Crisaborole ...

12.1. Mechanism of Action

Crisaborole is a phosphodiesterase 4 (PDE-4) inhibitor. PDE-4 inhibition results in increased intracellular cyclic adenosine monophosphate (cAMP) levels. The specific mechanism(s) by which crisaborole ...

12.2. Pharmacodynamics

Cardiac Electrophysiology At therapeutic doses, EUCRISA ointment is not expected to prolong QTc to any clinically relevant extent.

12.3. Pharmacokinetics

Absorption The PK of EUCRISA were investigated in 33 pediatric subjects 2 to 17 years of age with mild to moderate atopic dermatitis and a mean ± SD body surface area (BSA) involvement of 49 ± 20% (range ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In an oral carcinogenicity study in Sprague-Dawley rats, oral doses of 30, 100, or 300 mg/kg/day crisaborole were administered to rats once daily. A crisaborole-related increased incidence of benign granular ...

14. Clinical Studies

Two multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials (Trials 1 and 2) treated a total of 1522 subjects 2 to 79 years of age (86.3% of subjects were 2 to 17 years of age) ...

16.1. How Supplied

EUCRISA is a white to off-white ointment containing 2% crisaborole and is supplied in 60 g and 100 g laminate tubes. 60 g tube: NDC 55724-211-21 100 g tube: NDC 55724-211-11

16.2. Storage and Handling

Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F). [see USP Controlled Room Temperature]. Keep tube tightly closed.

17. Patient Counseling Information

Advise the patient or caregivers to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Advise patients to discontinue EUCRISA and seek medical attention immediately ...