Consumer medicine information

1. Why am I using Staquis?

Staquis contains the active ingredient crisaborole. Staquis is an ointment used on the skin (topical) to treat mild to moderate eczema (atopic dermatitis) in adults and children 2 years of age and older. This medicine belongs to a group of medicines called phosphodiesterase-4 inhibitors.
For more information, see Section 1. Why am I using Staquis? in the full CMI.

2. What should I know before I use Staquis?

Do not use if you have ever had an allergic reaction to crisaborole or any of the ingredients listed at the end of the CMI under Section 7.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Staquis? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Staquis and affect how it works. Do not use Staquis together with other eczema (atopic dermatitis) medicines.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Staquis?

• Staquis is for use on skin (topical use) only.

• Apply a thin layer of Staquis to the affected areas twice a day, for example, once in the morning and once in the evening. Follow the instructions provided and use Staquis until your doctor tells you to stop.

5. What should I know while using Staquis?

6. Are there any side effects?

The most common side effect of Staquis is application site pain, such as burning or stinging. Staquis may cause allergic reactions at or near the application site, hives or itching, redness or swelling at the application site. If you have any of these symptoms, stop using Staquis and tell your doctor immediately. You may need urgent medical attention.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Crisaborole.

2 Qualitative and Quantitative Composition

Staquis contains 2% (w/w) crisaborole in a paraffin-based, ointment and is for topical use. The active ingredient, crisaborole, is a phosphodiesterase-4 (PDE-4) inhibitor. Each gram of Staquis contains 20 mg of crisaborole.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Staquis is a white to off-white ointment containing 20 mg of crisaborole per gram (2% w/w) crisaborole.

4 Clinical Particulars

4.9 Overdose

There has been no experience of overdose with Staquis. Overdose following topical administration is unlikely. If too much Staquis has been applied, the excess can be wiped off.
Staquis is not for oral use. Oral ingestion may lead to adverse effects associated with systemic administration. If oral ingestion occurs, medical advice should be sought.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Crisaborole revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and human lymphocyte chromosomal aberration assay) and one in vivo genotoxicity test (rat micronucleus assay).
Carcinogenicity. 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 drug-related increased incidence of benign granular cell tumours in the uterus with cervix or vagina (combined) was noted in 300 mg/kg/day crisaborole administered female rats (2 times the MRHD on an AUC comparison basis). Given the tumour type and benign nature in a single species and single sex, the relevance to humans is considered to be low.
In a dermal carcinogenicity study in CD-1 mice, topical doses of 2%, 5% and 7% crisaborole ointment were administered once daily. No drug-related neoplastic findings were noted at topical doses up to 7% crisaborole ointment (equal to the MRHD on an AUC comparison basis).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Crisaborole is described chemically as 5-(4-cyanophenoxy)-1,3-dihydro-1-hydroxy-[2,1]-benzoxaborole. The empirical formula is C₁₄H₁₀BNO₃ and the molecular weight is 251.1 g/mol.
Crisaborole drug substance is freely soluble in common organic solvents such as isopropyl alcohol and propylene glycol, and insoluble in water.
Chemical structure. The structural formula is represented below:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCRISAB.gif CAS number. 906673-24-3.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/STAQUIST.gif