Staquis

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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 

 

 

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. CLINICAL PARTICULARS 
 

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 skin areas except on the scalp. Use on the scalp has not been studied.  

 

The ointment can be used twice daily for up to 4 weeks per treatment course. If any signs and/or 

symptoms persist, or new areas affected with atopic dermatitis appear, further treatment course(s) can 

be used as long as the application does not exceed 40% BSA (see section 5.1).  
 

Use of the ointment should be discontinued if signs and/or symptoms on treated areas persist after 3 

consecutive treatment courses of 4 weeks each or if the signs and/or symptoms worsen during 

treatment. 

 



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Paediatric population  
 

For children and adolescents (2-17 years) the posology is the same as for adults. 

 

The safety and efficacy of Staquis in children less than 2 years of age has not been established. No 

data are available. 

 
Special populations 

 

Hepatic impairment 

Clinical studies in subjects with hepatic impairment have not been conducted. However, dosage 

adjustment is not expected to be necessary in subjects with mild to moderate hepatic impairment. 
 

Renal impairment 

Clinical studies in subjects with renal impairment have not been conducted. However, dosage 

adjustment is not expected to be necessary in this patient population. 

 
Elderly 

Atopic dermatitis is uncommonly observed in patients aged 65 years and over. Clinical studies of 

Staquis did not include sufficient numbers of subjects aged 65 years and over to determine whether 

they respond differently from younger subjects (see section 5.1). However, dosage adjustment is not 

expected to be necessary in this patient population. 

 
Method of administration  

 

The ointment is for cutaneous use only. 

 

The ointment is not for ophthalmic, oral, or intravaginal use (see section 4.4).  
 

Staquis has not been specifically studied under occlusion. However, clinical experience available for 

use of the ointment under occlusion (i.e., nappies or clothing) has not shown the necessity for any 

dosage adjustment. 

 
Patients should be instructed to wash their hands after applying the ointment, unless it is their hands 

that are being treated. If someone else applies the ointment to the patient, they too should wash their 

hands after application. 

 

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 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. 

 



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Excipients with known effect 
 

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

 

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 (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 sec tion 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.  

 

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 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). 

 
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 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 



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< 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 

Immune system disorders 

Uncommon Hypersensitivity 

Skin and subcutaneous tissue disorders 

Uncommon Urticaria contact 

General disorders and administration site conditions 

Common Application site reactions (e.g., application site 

pain1, application site pruritus, application site 
dermatitis, application site erythema, application 

site irritation, application site urticaria) 
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. 

 

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, the ointment should be 

thoroughly wiped off and/or rinsed with water (see sections 4.2 and 4.4). 

 

 
5. PHARMACOLOGICAL PROPERTIES 

 

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 phosphodiesterase-4 (PDE4) inhibitor that 
suppresses secretion of certain cytokines, such as tumour necrosis factor-α (TNF-α), interleukins 

(IL-2, IL-4, IL-5), and interferon gamma (IFNγ), and improves skin barrier function as measured by 

transepidermal water loss (TEWL). Crisaborole applied on atopic dermatitis lesions of patients 

reduces expression of atopic inflammation associated chemokines including CCL17, CCL18, and 

CCL22.  
 

Clinical efficacy and safety 

 

Two multicentre, randomised, double-blind, parallel-group, vehicle-controlled trials (Trials 1 and 2), 

identical in design, included a total of 1,522 subjects 2 to 79 years of age. 61.9% of subjects were 

2-11 years old, 24.4% of subjects were 12-17 years old, 13.3% of subjects were 18-64 years old, and 

0.5% of subjects were 65 years of age or older; the number of subjects ≥ 18 years of age was limited. 

The treatable BSA ranged from 5% to 95% (mean = 18.3%, standard deviation [SD] = 17.8%; 9.6% of 

subjects had > 40% treatable BSA); the trials did not include sufficient numbers of subjects with 

> 40% treatable BSA to determine the safety and efficacy of Staquis in this subpopulation. At baseline 

(pooled study data), 38.5% of the subjects had an Investigator’s Static Global Assessment (ISGA) 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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score of 2 (Mild), and 61.5% had an ISGA score of 3 (Moderate), in the overall assessment of atopic 

dermatitis (erythema, induration/papulation, and oozing/crusting) on a severity scale of 0 to 4.  

 

In both trials, subjects were randomised 2:1 to receive Staquis or vehicle applied twice daily for 

28 days. The primary efficacy endpoint was the proportion of subjects at Day 29 who achieved an 

ISGA grade of Clear (score of 0) or Almost Clear (score of 1) with at least a 2-grade improvement 

from baseline, comparing Staquis-treated subjects to vehicle-treated subjects. In both trials, a 

statistically significantly greater percentage of subjects achieved this endpoint in the Staquis-treated 

group compared with the vehicle-treated group. 

 

The secondary efficacy endpoints were the proportion of subjects at Day 29 with an ISGA grade of 

Clear or Almost Clear and the time to achieve an ISGA grade of Clear or Almost Clear with at least a 
2-grade improvement from baseline.  

 

The safety and efficacy of Staquis on sensitive skin areas (such as the face and neck) compared to 

nonsensitive skin areas (such as the arms and legs) were not separately assessed in the clinical trials.  

 
Efficacy results from the two trials are summarised in Tables 2 and 3. The Kaplan-Meier plots for the 

time to achieve an ISGA score of Clear or Almost Clear with at least a 2-grade improvement from 

baseline are provided in Figures 1 and 2. The log-rank test p-values for both trials were < 0.001. 

 

Table 2: Efficacy outcomes in subjects with mild to moderate atopic dermatitis 

 

Trial 1 Trial 2 

Staquis 

(N = 503) 

Vehicle 

(N = 256) 

Staquis 

(N = 513) 

Vehicle 

(N = 250) 

ISGA score of Clear or Almost 

Clear with at least a 2-grade 
improvement from baseline at 

Day 29 32.8% 25.4% 31.4% 18.0% 

  95% CIa (28.6, 37.0) (19.9, 30.9) (27.3, 35.5) (13.2, 22.9) 

  p-value 0.038b < 0.001b 

ISGA of Clear or Almost Clear 

at Day 29 51.7% 40.6% 48.5% 29.7% 

  95% CIa (47.2, 56.1) (34.4, 46.8) (44.1, 52.9) (23.9, 35.5) 

  p-value 0.005b < 0.001b 
a Confidence Interval (CI) from normal approximation. 
b p-value from a logistic regression (with Firth option) test with factors of treatment group and analysis centre after 
adjusted for multiple imputation. 

 



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Table 3: Post-hoc efficacy outcomes in subjects with mild to moderate atopic dermatitis with 
≤ 40% BSA affected 

 

Trial 1 Trial 2 

Staquis 

(N = 446) 

Vehicle 

(N = 231) 

Staquis 

(N = 465) 

Vehicle 

(N = 234) 

ISGA score of Clear or Almost 
Clear with at least a 2-grade 

improvement from baseline at 

Day 29 34.1% 25.5% 32.6% 18.8% 

  95% CIa (29.7, 38.6) (19.7, 31.3) (28.3, 36.9) (13.7, 24.0) 

  p-value 0.022b <0.0001b 

ISGA of Clear or Almost Clear 

at Day 29 53.8% 41.9% 51.0% 30.9% 

  95% CIa (49.1, 58.5) (35.3, 48.4) (46.4, 55.6) (24.8, 37.0) 

  p-value 0.0041b <0.0001b 

a Confidence Interval (CI) from normal approximation.  

b p-value from a logistic regression (with Firth option) test with factors of treatment group and analysis centre after 

adjusted for multiple imputation. 

 

Figure 1: Kaplan-Meier plot of Time to ISGA score of Clear or Almost Clear with at least a 

2-grade improvement from baseline for subjects with mild to moderate atopic dermatitis  

 

Trial 1 

 
 



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Trial 2 

 
 
Figure 2: Post-hoc Kaplan-Meier plot of Time to ISGA score of Clear or Almost Clear with 

at least a 2-grade improvement from baseline for subjects with mild to moderate atopic 

dermatitis with ≤ 40% BSA affected 

 

Trial 1 

 



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Trial 2 

 

The pooled primary efficacy results by race category are summarised in Table 4. 
 

Table 4: Summary of subjects achieving ISGA score of Clear or Almost Clear with at least a 

2-grade improvement from baseline at Day 29 by race category – Trial 1 and 2 pooled 

 Staquis (N = 1016) Vehicle (N = 506) 

Race Category n Rate n Rate 

American 

Indian or 

Alaska Native 

11 18.0% 5 0.0% 

Asian 52 17.7% 27 13.4% 

Black or 

African 

American 

285 32.1% 139 24.6% 

Native 

Hawaiian or 

Other Pacific 

Islander 

7 42.9% 8 17.0% 

White 617 33.5% 306 22.3% 

Other 44 31.9% 21 16.3% 

N = Number of subjects in each treatment group 

n = Number of subjects in each sub-group category by treatment group 

 

One multicentre, single-arm, open-label long-term safety trial (Trial 3) included a total of 517 subjects 

2 to 72 years of age (59.6% of subjects were 2-11 years old, 28.2% of subjects were 12-17 years old, 

11.8% of subjects were 18-64 years old, and 0.4% of subjects were 65 years of age or older) with a 5% 

to 95% treatable BSA. Subjects at participating investigator sites (a subset of sites that participated in 

Trials 1 and 2) who completed Trials 1 or 2 without safety events that precluded further treatment with 

Staquis were eligible. 

 

Subjects participated in the study in 28-day treatment courses for up to 48 weeks. Subjects received 

Staquis for a variable number of treatment courses intermittently based on disease severity as 

determined by the ISGA at the beginning of each 28-day treatment course: subjects received 

open-label treatment with Staquis twice daily (on-treatment when ISGA was Mild or worse [≥ 2]) or 

no treatment (off-treatment when the ISGA was Clear [0] or Almost Clear [1]). Discontinuation from 



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the study was to occur if there was no improvement in the subject’s ISGA after 3 consecutive 

treatment courses of treatment with Staquis. 

 

Trial 3 did not include an efficacy endpoint; Staquis efficacy response based on ISGA determined the 

extent of intermittent use of Staquis for up to 48 weeks. Overall, subjects received a mean of 

6.2 on-treatment courses (out of a possible 13 on-treatment courses including the 28-day treatment 

period in Trials 1 or 2). The mean number of consecutive on-treatment courses was 3.6 and the mean 

number of consecutive off-treatment courses was 2.5.  
 

QT study results 

 
Results from a thorough QT study of Staquis applied to 60% BSA in healthy volunteers did not 

demonstrate QT prolongation. Although healthy volunteers had lower crisaborole concentrations 

compared to patients with atopic dermatitis, clinical studies of Staquis did not identify any cardiac 

effects including prolongation of QT interval. 

 
Paediatric population 

 

The European Medicines Agency has deferred the obligation to submit the results of studies with 

Staquis in one or more subsets of the paediatric population for the treatment of atopic dermatitis (see 

section 4.2 for information on paediatric use). 
 

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 27% 

to 92%). In this study, subjects applied approximately 3 mg/cm2 of Staquis ointment (dose range was 

approximately 6 g to 30 g per application) twice daily for 8 days. Plasma concentrations were 

quantifiable in all subjects. The mean ± SD maximum plasma concentration (Cmax) and area under the 

concentration time curve from 0 to 12 hours post dose (AUC0-12) for crisaborole on Day 8 were 127 ± 
196 ng/mL and 949 ± 1240 ng*h/mL, respectively. Systemic concentrations of crisaborole were at 

steady state by Day 8. Based on the ratios of AUC0-12 between Day 8 and Day 1, the mean 

accumulation factor for crisaborole was 1.9. Systemic exposure (Cmax and AUC0-12) of crisaborole and 

its main metabolites increased with increasing % BSA treated.  

 
The studies were performed with a different formulation of crisaborole which, unlike Staquis, 

contained butylhydroxytoluene (BHT). In vitro permeation testing (IVPT) was performed in intact 

skin to support therapeutic equivalence between the BHT-containing and the no-added BHT 

formulations. Although the results were inconclusive and highly variable, a possible slight increase in 

permeation is not expected to influence the benefit-risk profile of the product in patients with up to 

40% BSA affected to a clinically relevant extent. 
 

Distribution 

 

Based on an in vitro study, crisaborole is 97% bound to human plasma proteins. 

 
Biotransformation and elimination 

 

Crisaborole is substantially metabolised into inactive metabolites. The main metabolite 

5-(4-cyanophenoxy)-2-hydroxyl benzylalcohol (metabolite 1), is formed via multiple CYP enzymes 

including CYP3A4, 1A2 and hydrolysis; this metabolite is further metabolised into downstream 
metabolites, among which 5-(4-cyanophenoxy)-2-hydroxyl benzoic acid (metabolite 2), formed via 

oxidation, is also a main metabolite. PK of metabolites 1 and 2 were assessed in the PK study 

described above and the systemic concentrations were at or near steady state by Day 8. Based on the 

ratios of AUC0-12 between Day 8 and Day 1, the mean accumulation factors for metabolites 1 and 2 



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were 1.7 and 6.3, respectively. The mean ± SD Cmax and AUC0-12 for metabolite 2 on Day 8 were 
1850 ± 1830 ng/mL and 18200 ± 18100 ng*h/mL, respectively. Renal excretion of metabolites is the 

major route of elimination. Approximately 25% of the radiolabelled dose was absorbed and 

predominantly excreted in the urine. 

 

Drug interactions 

 

Potential for crisaborole to influence the PK of other medicinal products 

In vitro studies using human liver microsomes indicated that under the conditions of clinical use, 

crisaborole and metabolite 1 are not expected to inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19, and 3A4.  

 

In vitro human liver microsomes studies for metabolite 2 showed that it did not inhibit activities of 

CYP2C19, 2D6, and 3A4; was a weak inhibitor of CYP1A2 and 2B6; and a moderate inhibitor of 

CYP2C8 and 2C9. The most sensitive enzyme, CYP2C9, was further investigated in a clinical trial 

using warfarin as a CYP2C9 substrate. The results of this study showed no drug interaction potential. 

 

In vitro studies indicate that under the condition of clinical use, crisaborole and metabolites 1 and 2 are 

not expected to induce CYP enzymes. 

 

Based on in vitro data, crisaborole is metabolised to some extent (<30%) via CYP3A4 and CYP1A2. 

Concomitant administration of Staquis and potent CYP3A4 or CYP1A2 inhibitors may result in 

increases in crisaborole systemic exposure. 

 

In vitro studies showed that crisaborole and metabolite 1 did not inhibit the activities of uridine 

diphosphate (UDP)-glucuronosyltransferase (UGT) 1A1, 1A4, 1A6, 1A9, 2B7, and 2B15. Metabolite 

2 did not inhibit UGT1A4, 1A6, 2B7, and 2B15. Metabolite 2 showed weak inhibition of UGT1A1; 

however, no clinically significant drug interactions are expected between crisaborole (and its 

metabolites) and UGT1A1 substrates at therapeutic concentrations. Metabolite 2 showed moderate 

inhibition of UGT1A9 and may result in a moderate increase of the concentrations of sensitive 

UGT1A9 substrates, such as propofol. A clinically relevant interaction between metabolite 2 and 

propofol is not anticipated due to the posology and method of administration of propofol (intravenous 

infusion or injection with titration to clinical effect for anaesthesia or sedation). Drug interaction 

studies with sensitive UGT1A9 substrates have not been conducted. 

 

In vitro studies indicate that under the condition of clinical use, crisaborole and metabolites 1 and 2 are 

not expected to cause clinically significant interactions with substrates of transporters such as 

P-glycoprotein, breast cancer resistance protein (BCRP) and organic anionic or cationic transporters. 

 
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 toxicity, genotoxicity, juvenile toxicity, or toxicity to reproduction and 

development.  
 

A drug-related increased incidence of benign granular cell tumours in the uterus with cervix and 

vagina (combined) was noted in crisaborole-treated female rats at oral doses approximately 2 times the 

mean human systemic exposure in maximum use conditions. The clinical relevance of this finding is 

unknown, however given the tumour type and benign status in a single species and single sex, the 
relevance to humans is considered to be low. 

 

 



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6. PHARMACEUTICAL PARTICULARS 
 

6.1 List of excipients 

 

Paraffin, white soft 

Propylene glycol (E 1520) 

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 25 ºC. 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, white high-density polyethylene, high-density polyethylene, low-density polyethylene, 

ethylene-acrylic acid, foil, and ethylene-acrylic acid). The inner lining consists of linear low-density 

polyethylene.  
 

Tubes of 2.5 g, 30 g, 60 g, and 100 g. Six tubes per carton for the 2.5 g tubes. One tube per carton for 

the 30 g, 60 g, and 100 g tubes.  

 

Not all tube sizes may be marketed.  

 
6.6 Special precautions for disposal 

 

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

requirements. 

 
 

7. MARKETING AUTHORISATION HOLDER 

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 



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8. MARKETING AUTHORISATION 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 AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

 

10. DATE OF REVISION OF THE TEXT 
 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 

 
  

http://www.ema.europa.eu/
http://www.ema.europa.eu/


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ANNEX II 

 

A. MANUFACTURERS RESPONSIBLE FOR BATCH 

RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 



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A.  MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 

Name and address of the manufacturers responsible for batch release 

 

Pfizer Service Company BVBA 

Hoge Wei 10 

1930 Zaventem 
Belgium 

 

Hospira UK Ltd. 

Horizon  

Honey Lane 
Hurley 

Maidenhead SL6 6RJ 

United Kingdom 

 

The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  

 

Medicinal product subject to medical prescription. 
 

 

C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

• Periodic safety update reports (PSURs) 
 

The requirements for submission of PSURs for this medicinal product are set out in the list of 

Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 

and any subsequent updates published on the European medicines web-portal. 
 

The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 

6 months following authorisation. 

 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   

 

• Risk management plan (RMP) 
 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 

marketing authorisation and any agreed subsequent updates of the RMP. 

 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached. 

  



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ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



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A. LABELLING 

  



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 

OUTER CARTON (2.5 g, 30 g, 60 g, 100 g) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Staquis 20 mg/g ointment 

crisaborole 
 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 
1 g of ointment contains 20 mg of crisaborole. 

 

 

3. LIST OF EXCIPIENTS 

 

Paraffin, white soft; propylene glycol (E 1520); glycerol monostearate 40-55 (Type I); paraffin, hard; 

sodium calcium edetate. 

 

Read the package leaflet before use. 

 
 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Ointment 
 

6 tubes (2.5 g) 

1 tube (30 g) 

1 tube (60 g) 

1 tube (100 g) 
 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 
Cutaneous use 

 

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 
 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 
 

 

8. EXPIRY DATE 

 
EXP 

 



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9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25 ºC. Do not freeze. 

 
Keep the tube tightly closed. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/19/1421/001 6 tubes (2.5 g) 

EU/1/19/1421/002 1 tube (30 g) 

EU/1/19/1421/003 1 tube (60 g) 

EU/1/19/1421/004 1 tube (100 g) 

 
 

13. BATCH NUMBER 

 

Lot 
 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

 

15. INSTRUCTIONS ON USE 

 

 
 

16. INFORMATION IN BRAILLE 

 
Staquis 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 



20 

SN 

NN 



21 

PARTICULARS TO APPEAR ON THE INNER PACKAGING  
 

TUBE (30 g, 60 g, 100 g) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Staquis 20 mg/g ointment 

crisaborole 
 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 
1 g of ointment contains 20 mg of crisaborole. 

 

 

3. LIST OF EXCIPIENTS 

 

Paraffin (white soft, hard); E 1520; glycerol monostearate; sodium calcium edetate. 

 

Read the package leaflet before use. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Ointment 

 
30 g 

60 g 

100 g 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Cutaneous use 

 
Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

 

8. EXPIRY DATE 

 

EXP 

 
 



22 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 25 ºC. Do not freeze. 

 

Keep the tube tightly closed. 
 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer Europe MA EEIG 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/19/1421/002 30 g 

EU/1/19/1421/003 60 g 

EU/1/19/1421/004 100 g 

 
 

13. BATCH NUMBER 

 

Lot 
 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 
 

 

15. INSTRUCTIONS ON USE 

 

 

 

16. INFORMATION IN BRAILLE 

 
 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

 



23 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 

TUBE (2.5 g) 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Staquis 20 mg/g ointment 

crisaborole 
Cutaneous use 

 

 

2. METHOD OF ADMINISTRATION 

 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

2.5 g 

 

 

6. OTHER 

 

  



24 

 
 

 

 

 

 

 
 

 

 

 

 
 

 

 

 

 
 

 

 

 

 

 
B. PACKAGE LEAFLET 



25 

Package leaflet: Information for the patient 
 

Staquis 20 mg/g ointment 

crisaborole 

 

This medicine is subject to additional monitoring. This will allow quick identification of new safety 

information. You can help by reporting any side effects you may get. See the end of section 4 for how 

to report side effects. 
 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor, pharmacist, or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  

- If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 
 

What is in this leaflet 

 

1. What Staquis is and what it is used for  

2. What you need to know before you use Staquis 

3. How to use Staquis 
4. Possible side effects  

5. How to store Staquis 

6. Contents of the pack and other information 

 

 
1. What Staquis is and what it is used for 

 

Staquis contains the active substance crisaborole. Staquis is used on the skin to control the symptoms 

of mild to moderate atopic dermatitis in adults and children from 2 years of age. Atopic dermatitis, 

also called atopic eczema, causes skin inflammation, redness, itchiness, dryness, and thickening in 
people prone to allergies. The ointment should not be used on more than 40% of your body surface 

area. 

 

Crisaborole, the active substance in Staquis, is thought to work by reducing inflammation and some 

effects of the immune system (the body’s defences). 
 

 

2. What you need to know before you use Staquis  

 

Do not use Staquis 

- if you are allergic to crisaborole or any of the other ingredients of this medicine (listed in 
section 6). 

 

Warnings and precautions  

Talk to your doctor or pharmacist before using Staquis. 

 

Staquis is not for use in the eyes, mouth, or vagina; therefore, take care not to get this ointment into 

these areas. If the ointment accidentally gets into these areas, thoroughly wipe off and/or rinse off the 
ointment with water. 

 

Stop using Staquis immediately and see your doctor if you get an allergic reaction. Symptoms include 

welts (hives), itching, swelling, and redness that are severe.   

 



26 

Skin reactions where this medicine is applied, such as burning or stinging, may be more likely to occur 
on sensitive skin areas such as the face and neck. 

 

Children 

Staquis has not been studied in children younger than 2 years of age; therefore, it should not be used in 

this group of children. Speak to your doctor, pharmacist, or nurse. 

 
Other medicines and Staquis 

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines .  

 

Some medicines can affect the levels of Staquis in your body. You should inform your doctor if you 

are taking medicines containing the following active substances:  
- ketoconazole, itraconazole (used to treat fungal infections) 
- erythromycin, clarithromycin, ciprofloxacin (used to treat infections) 
- ritonavir (used to treat HIV) 
- fluvoxamine (used to treat depression). 

 
Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor or pharmacist for advice before using this medicine. The effects of this medicine in 

pregnant women are not known; therefore, do not use Staquis in pregnancy unless you have checked 

with your doctor that you can use it. 

 

It is not known if Staquis passes into the milk after applying it to the skin. The effects of this medicine 

in breastfed infants are not known; therefore, Staquis should not be used if you are breast-feeding or 

are planning to breast-feed.  

 

Driving and using machines 

Staquis is unlikely to have an effect on your ability to drive and use machines. 

 
Staquis contains propylene glycol 

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

 

 

3. How to use Staquis 
 

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 

or pharmacist if you are not sure. 

 

Use in adults 
- Apply a layer of the ointment twice daily to affected areas of your skin. 
- This medicine can be used on all skin areas except on the scalp.  
- The ointment should only be used on up to 40% of your body surface area. 
- This medicine is for use on the skin only. 
- Wash your hands after applying this medicine, unless it is your hands that are being treated. If 

someone else applies this medicine to you, they should wash their hands after application. 
 

This medicine can be used twice daily for up to 4 weeks per treatment course. As instructed by your 

doctor, you can use further treatment course(s) if your atopic dermatitis is not controlled or appears on 

new areas as long as you do not apply the ointment to more than 40% of your body surface area. If 

your atopic dermatitis is still there after 12 weeks of therapy, or if your atopic dermatitis gets worse, 
stop using the medicine and see your doctor.  

 

Moisturisers (emollients) may be used on areas of the skin where Staquis is not applied.  Do not use 

other topical medicines (such as ointments, creams, lotions) on areas of the skin where Staquis is 

applied without asking your doctor.  

 



27 

Use in children and adolescents 

For children 2 years of age and older, and adolescents the instructions for use are the same as for 

adults. 

 

If you use more Staquis than you should 

If too much Staquis has been applied, the excess should be wiped off.  
 

If you forget to use Staquis 

If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then 

continue your normal dosing schedule. 

 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 

Allergic reactions may occur uncommonly. Allergic reactions include severe symptoms of: 

- hives 
- itching 
- swelling 
- redness. 

 

If you have an allergic reaction, stop using this medicine immediately and talk with your doctor or 

pharmacist.  

 
Other side effects may include: 

 

Common (may affect up to 1 in 10 people) 

- Skin reactions where this medicine is applied such as pain (burning or stinging), itching, rash, 
redness, irritation, and hives.  

 
The most common skin reaction, pain (burning or stinging), is usually mild to moderate and generally 

goes away after several applications. 

 

Uncommon (may affect up to 1 in 100 people) 

- Allergic reactions: includes severe symptoms of hives, itching, swelling, and redness.   
 

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 

 

 

5. How to store Staquis 

 
Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the tube and carton after “EXP”. The 

expiry date refers to the last day of that month. 

 

Do not store above 25 ºC. Do not freeze.  
 

Once opened, use the tube within 1 year. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


28 

Keep the tube tightly closed. 
 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 
 

What Staquis contains  

- The active substance is crisaborole. 
One g of ointment contains 20 mg of crisaborole. 

- The other ingredients are paraffin, white soft; propylene glycol (E 1520 [see section 2]); 
glycerol monostearate 40-55 (Type I); paraffin, hard; sodium calcium edetate. 

 

What Staquis looks like and contents of the pack  

Staquis is a white to off-white ointment. It is supplied in 2.5 g, 30 g, 60 g, and 100 g laminate tubes. 

There are six tubes per carton for the 2.5 g tubes. There is one tube per carton for the 30 g, 60 g, and 
100 g tubes. Not all tube sizes may be marketed.  

 

Each tube comes with a tube head with a peel seal, and a white cap closure. 

 

Marketing Authorisation Holder 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 
Manufacturer 

Pfizer Service Company BVBA 

Hoge Wei 10 

1930 Zaventem 

Belgium 

 
Hospira UK Ltd. 

Horizon  

Honey Lane 

Hurley 

Maidenhead SL6 6RJ 
United Kingdom 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 
België/Belgique/Belgien 

Pfizer S.A. / N.V. 

Tél/Tel: +32 (0)2 554 62 11 

Lietuva 

Pfizer Luxembourg SARL filialas Lietuvoje 

Tel. +3705 2514000 
 

България 

Пфайзер Люксембург САРЛ, 

Клон България 

Teл: +359 2 970 4333 

 

Luxembourg/Luxemburg 

Pfizer S.A. / N.V. 

Tél/Tel: +32 (0)2 554 62 11 

Česká republika 

Pfizer PFE, spol. s r.o. 

Tel: +420 283 004 111 

 

Magyarország 

Pfizer Kft. 

Tel: +36 1 488 3700 



29 

Danmark  

Pfizer ApS 

Tlf: +45 44 20 11 00 

 

Malta 

Vivian Corporation Ltd. 

Tel: +35621 344610 

 

Deutschland 

Pfizer Pharma GmbH 

Tel: +49 (0)30 550055-51000 

 

Nederland 

Pfizer bv 

Tel: +31 (0)10 406 43 01 

 

Eesti 

Pfizer Luxembourg SARL Eesti filiaal 

Tel: +372 666 7500 

 

Norge 

Pfizer Norge AS 

Tlf: +47 67 526 100 

 

Ελλάδα 

PFIZER EΛΛAΣ A.E. 

Τηλ.: +30 210 67 85 800 

 

Österreich 

Pfizer Corporation Austria Ges.m.b.H. 

Tel: +43 (0)1 521 15-0 

 

España 

Pfizer, S.L. 

Tel: +34 91 490 99 00 

 

Polska 

Pfizer Polska Sp. z o.o. 

Tel.: +48 22 335 61 00 

 

France 

Pfizer 

Tél +33 (0)1 58 07 34 40 

 

Portugal 

Pfizer Biofarmacêutica, Sociedade Unipessoal Lda 

Tel: (+351) 21 423 55 00 

 
Hrvatska 

Pfizer Croatia d.o.o. 

Tel: +385 1 3908 777 

 

Ireland 

Pfizer Healthcare Ireland 

Tel: +1800 633 363 (toll free) 

Tel: +44 (0)1304 616161 

 

România 

Pfizer Romania S.R.L 

Tel: +40 (0) 21 207 28 00 

 

Slovenija 

Pfizer Luxembourg SARL  

Pfizer, podružnica za svetovanje s področja 

farmacevtske dejavnosti, Ljubljana 

Tel: +386 (0)1 52 11 400 

 

Ísland 

Icepharma hf. 

Tel: +354 540 8000 

 

Slovenská republika 

Pfizer Luxembourg SARL, organizačná zložka 

Tel: +421 2 3355 5500 

 

Italia 

Pfizer S.r.l. 

Tel: +39 06 33 18 21 

 

Suomi/Finland 

Pfizer Oy 

Puh/Tel: +358 (0)9 430 040 

 

Κύπρος 

PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) 

T: +357 22 817690 

 

Sverige 

Pfizer Innovations AB 

Tel: +46 (0)8 550 520 00 

 

Latvija 

Pfizer Luxembourg SARL filiāle Latvijā 

Tel. +371 67035775 

 

United Kingdom 

Pfizer Limited 

Tel: +44 (0)1304 616161 

 

  

This leaflet was last revised in  

 

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET