Instructions for use (PI)

Introduction

Staquis® (crisaborole 2%) is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.1

 

Dosing schedule and preparation

Apply a thin layer of Staquis® twice daily to affected area.1

Staquis® is for topical use only and not for ophthalmic, oral or intravaginal use.1

Staquis® can be applied to the skin anywhere on the face and body, and on all skin tones.2

If signs and symptoms of hypersensitivity occur, discontinue Staquis® immediately and initiate appropriate therapy.1

 

Product specifications

Each gram of Staquis® contains 20 mg of crisaborole (2%).1

Staquis® is a white to off-white ointment containing 2% crisaborole and is supplied in 30g and 60g laminate tubes in Israel.1

 

Storage and handling

Store below 25°C and keep tube tightly closed.1

The expiry date of the product is indicated on the packaging materials.1

 

IMPORTANT SAFETY INFORMATION AND INDICATION

 

Indication: Staquis® is indicated for topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

Contraindication: Staquis® is contraindicated in patients with known hypersensitivity to crisaborole or any component of the formulation.

Warnings and precautions: Hypersensitivity reactions, including contact urticaria, have occurred in patients treated with Staquis®.
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 Staquis® immediately and initiate appropriate therapy.

Adverse reaction: The adverse reaction reported by ≥1% of Staquis®-treated subjects in the clinical studies was application site pain (4%; skin sensations such as burning or stinging).

For further information please refer to Staquis® (crisaborole) latest approved prescribing information