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Information on how to access Cibinqo®▼ (abrocitinib) prescribing information and adverse event reporting can be found at the bottom of the page.
1Cibinqo 200 mg and 100 mg is a once-daily oral treatment
- For most patients, particularly those with severe disease, 200 mg is the recommended starting dose
- 100 mg is the recommended starting dose for patients aged ≥65 years, for adolescents aged 12–17 years, and for those who have risk factors for developing an adverse reaction to Cibinqo or who are less likely to tolerate any adverse reactions
The dose may be decreased or increased based on tolerability and efficacy.
- Dose reduction can be considered after disease control is achieved in patients receiving 200 mg. Some patients may experience a disease flare after dose reduction. A higher risk of disease flare after dose reduction is associated with history of receiving systemic treatments for atopic dermatitis and extensive disease involving >50% of body surface area (BSA).
Cibinqo can be used with or without medicated topical therapies for atopic dermatitis
- Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 12 weeks.
- Some patients with initial partial response may subsequently improve with continued treatment beyond 12 weeks
Cibinqo can be taken with or without food at approximately the same time each day
- Taking Cibinqo with food may ease nausea if this is experienced by patients
Tablets should be swallowed whole with water and should not be split, crushed or chewed
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Cibinqo 200 mg and 100 mg is a once-daily oral treatment
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The dose may be decreased or increased based on tolerability and efficacy.
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Cibinqo can be used with or without medicated topical therapies for atopic dermatitis
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Cibinqo can be taken with or without food at approximately the same time each day
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• 50 mg dose is available for dose adjustments in special populations, e.g. moderate to severe renal impairment or in case of drug–drug interactions. See the full Summary of Product Characteristics for specific dose adjustment instructions. The 50 mg dose was not studied in clinical trials
PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION
- Hypersensitivity to the active substance or to any of the excipients listed in the Summary of Product Characteristics
- Active serious systemic infections, including tuberculosis (TB)
- Severe hepatic impairment
- Pregnancy
- There are no or limited amount of data on the use of abrocitinib in pregnant women. Studies in animals have shown reproductive toxicity. Abrocitinib has been shown to cause skeletal variations in the foetuses of pregnant rats and rabbits and to affect parturition and peri/postnatal development in rats. Cibinqo is contraindicated during pregnancy
- Breastfeeding
- There are no data on the presence of Cibinqo in human milk, the effects on the breast-fed infant, or the effects on milk production. Cibinqo was secreted in milk of lactating rats. A risk to newborns/infants cannot be excluded and Cibinqo is contraindicated during breastfeeding
| Mild (eGFR 60 to <90 mL/min) | Moderate (eGFR 30 to <60 mL/min) | Severe (eGFR <30 mL/min) |
|---|---|---|
| No dose adjustment required | The recommended dose of Cibinqo should be reduced by half to 100 mg or 50 mg once daily | 50 mg once daily is the recommended starting dose. The maximum daily dose is 100 mg |
Cibinqo has not been studied in patients with end-stage renal disease (ESRD) on renal replacement therapy.
| Mild | Moderate | Severe |
|---|---|---|
| No dose adjustment required | No dose adjustment required | Not studied, must not be used |
The recommended starting dose for patients ≥65 years of age is 100 mg once daily.
The recommended starting dose for adolescents (12–17 years old) is 100 mg once daily. The safety and efficacy of Cibinqo in children under 12 years of age have not yet been established. No data are available.
Women of reproductive potential should be advised to use effective contraception during treatment and for 1 month following the final dose of Cibinqo. Pregnancy planning and prevention for females of reproductive potential should be encouraged.
| Interaction | Examples | Clinical impact | Action |
|---|---|---|---|
| Strong CYP2C19 inhibitors | fluvoxamine, fluconazole, fluoxetine and ticlopidine | Increased exposure to Cibinqo moiety | Reduce dose of Cibinqo by half to 100 mg or 50 mg once daily |
| Strong CYP2C19 or CYP2C9 inducers | rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin | Decreased exposure to Cibinqo active moiety and may result in loss of or reduced clinical response | Concomitant use of Cibinqo is not recommended |
| MOA inhibitors | selegiline, isocarboxazid | Not studied in humans. Clinical impact not known | Caution should be exercised for concomitant use |
No clinically significant effects of Cibinqo were observed in drug interaction studies with oral contraceptives (e.g. ethinyl oestradiol/levonorgestrel).
In vitro, Cibinqo is an inhibitor of P-gp. Co-administration of dabigatran etexilate (a P-gp substrate), with a single dose of Cibinqo 200 mg increased dabigatran AUCinf and Cmax by approximately 53% and 40%, respectively, compared with administration alone. Caution should be exercised for concomitant use of Cibinqo with dabigatran.
The effect of Cibinqo on pharmacokinetics of other P-gp substrates has not been evaluated. Caution should be exercised as the levels of P-gp substrates with a narrow therapeutic index, such as digoxin and ciclosporin, may increase.
Learn more about monitoring patients on Cibinqo.
Access resources to help you support your patients on Cibinqo.
CYP=cytochrome P; eGFR=estimated glomerular filtration rate; MOA=monoamine oxidase; P-gp=P glycoprotein.
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 200 mg film-coated tablets.
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 100 mg film-coated tablets.
Cibinqo (abrocitinib) Prescribing Information (Great Britain) – 50 mg film-coated tablets.
References:
Cibinqo Risk Minimisation Programme (RMP) materials, including a Patient Card and Prescriber Brochure, are available from https://www.medicines.org.uk/emc. Patients treated with Cibinqo should be given the Patient Card.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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