STAQUIS Ointment Ref.[28063] Active ingredients: Crisaborole

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 with water.

Available data indicate that local skin reactions, such as burning or stinging, may be more likely to occur on sensitive skin areas (such as the face and neck).

Hypersensitivity

Hypersensitivity, including contact urticaria, has 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, Staquis should be discontinued immediately and appropriate therapy should be initiated.

Excipients with known effect

This medicine contains 90 mg propylene glycol in each gram of ointment.

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 (see section 5.2).

Based on in vitro data, concomitant administration of Staquis and CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir) or CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine) can increase systemic crisaborole concentrations (see section 5.2).

Staquis has not been evaluated in combination with other cutaneous medicinal products used to treat mild to moderate atopic dermatitis and co-application on the same skin areas is not recommended. Emollients may be used on other areas of skin not affected by atopic dermatitis; co-application of emollients with Staquis on the same skin areas is not recommended.

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 section 5.3). As a precautionary measure, it is preferable to avoid the use of Staquis during pregnancy.

Breast-feeding

Animal studies on milk excretion after topical application were not conducted. Staquis is systemically absorbed. It is unknown whether crisaborole or its metabolites or excipients are excreted in human milk following topical application of the ointment or has an effect on human milk production. The lack of clinical data during breast-feeding precludes a clear determination of the risk of Staquis to a breastfed infant. Therefore, because of the potential for adverse reactions in breastfed infants, Staquis should not be used in breast-feeding women.

Fertility

Reproduction studies in male or female rats using oral administration of crisaborole revealed no effects on fertility (see section 5.3).

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

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 was noted early in the treatment period and was transient in nature, resolving spontaneously.

Tabulated list of adverse reactions

Adverse reactions are ranked under headings of frequency, with the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Table 1. Adverse reactions:

¹ Refers to skin sensations such as burning or stinging.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Not applicable.