STAQUIS Ointment (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Staquis 20 mg/g ointment.

2. Qualitative and quantitative composition

One g of ointment contains 20 mg of crisaborole. Excipients with known effect: Propylene glycol, 90 mg/g of ointment. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Ointment. White to off-white ointment.

4.1. Therapeutic indications

Staquis is indicated for treatment of mild to moderate atopic dermatitis in adults and paediatric patients from 2 years of age with ≤40% body surface area (BSA) affected.

4.2. Posology and method of administration

Posology Adults A layer of ointment is to be applied twice daily to affected areas. The ointment should only be applied to affected skin areas up to a maximum of 40% BSA. The ointment can be used on all ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

The ointment is not for ophthalmic, oral, or intravaginal use (see section 4.2). In cases of accidental exposure in the eyes or mucous membranes, the ointment should be thoroughly wiped off and/or rinsed ...

4.5. Interaction with other medicinal products and other forms of interaction

Neither crisaborole nor its two main metabolites are expected to cause drug interactions by induction or inhibition of cytochrome P450 (CYP) enzymes based on in vitro and in vivo data ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of crisaborole in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see ...

4.7. Effects on ability to drive and use machines

Staquis has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile The most common adverse reactions are application site reactions (6.0%), including application site pain, e.g., burning or stinging (4.4%). Generally, application site pain ...

4.9. Overdose

Overdose following cutaneous administration is unlikely. If too much of the ointment has been applied, the excess can be wiped off. In cases of accidental ophthalmic, oral mucosa, or intravaginal exposure, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Other dermatological preparations, agents for dermatitis, excluding corticosteroids ATC code: D11AH06 Mechanism of action Crisaborole is an anti-inflammatory benzoxaborole ...

5.2. Pharmacokinetic properties

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

5.3. Preclinical safety data

Preclinical data from studies conducted in vitro or in vivo by the oral and dermal routes of administration reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose ...

6.1. List of excipients

Paraffin, white soft Propylene glycol (E1520) Glycerol monostearate 40-55 (Type I) Paraffin, hard Sodium calcium edetate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years. After first opening the container: 1 year.

6.4. Special precautions for storage

Do not store above 25ºC. Do not freeze. Keep the tube tightly closed.

6.5. Nature and contents of container

Multi-layered laminate tube with a high density polyethylene tube head with a peel seal, and a white polypropylene cap closure. The exterior layer of the tube consists of seven layers (low-density polyethylene, ...

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

8. Marketing authorization number(s)

EU/1/19/1421/001 EU/1/19/1421/002 EU/1/19/1421/003 EU/1/19/1421/004

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 27 March 2020

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