Dosing | Cibinqo® (abrocitinib)

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Adverse event reporting can be found at the bottom of the page

Information on how to access Cibinqo®▼ (abrocitinib) prescribing information and adverse event reporting can be found at the bottom of the page.
Updated Safety Recommendation - Abrocitinib should only be used if no suitable treatment alternatives are available in patients: 65 years of age and older, patients with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers), patients with malignancy risk factors (e.g. current malignancy or a history of malignancy). (Cibinqo Summary of Product Characteristics)

Starting your patients on Cibinqo: dosing and administration¹

Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.¹

Cibinqo 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

Cibinqo is contraindicated in patients with:¹

• Hypersensitivity to the active substance or to any of the excipients.

• Active serious systemic infections, including tuberculosis

• Severe hepatic impairment

• Pregnancy and breast-feeding

Abrocitinib should only be used if no suitable treatment alternatives are available in patients:¹

65 years of age and older;
patients with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
patients with malignancy risk factors (e.g. current malignancy or a history of malignancy)

Use in patients 65 years of age and older¹

Considering the increased risk of major adverse cardiovascular events (MACE), malignancies, serious infections, and all-cause mortality in patients 65 years of age and older, as observed in a large randomised study of another janus kinase (JAK) inhibitor, abrocitinib should only be used in these patients if no suitable treatment alternatives are available.

Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis.¹

Method of administration:¹

Cibinqo is taken orally once daily with or without food at approximately the same time each day.

In patients who experience nausea, taking Cibinqo with food may improve nausea.

Tablets should be swallowed whole with water and should not be split, crushed or chewed because these methods have not been studied in clinical trials.

The recommended starting dose of Cibinqo is 100mg or 200mg once daily based on individual characteristics¹:

A starting dose of 100mg once daily is recommended for adolescents (12 to 17 years old),and for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular events (MACE) and malignancy. If the patient does not respond adequately to 100mg once daily, the dose can be increased to 200mg once daily (see below)
A dose of 200mg once daily may be appropriate for patients who are not at higher risk of VTE, MACE and malignancy with high disease burden or for patients with an inadequate response to 100mg once daily. Upon disease control, dose should be decreased to 100mg once daily. If disease control is not maintained after dose reduction, re-treatment with 200mg once daily can be considered.

The lowest effective dose for maintenance should be considered. Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks.

Cibinqo can be used with or without medicated topical therapies for atopic dermatitis.¹

Treatment Initiation¹
Treatment should not be initiated in patients with a platelet count <150 x 10³/mm³, an absolute lymphocyte count (ALC) <0.5 x 10³/mm³, an absolute neutrophil count (ANC) <1 x 10³/mm³, or a haemoglobin value <8 g/dL¹

Dose interruption¹

If a patient develops a serious infection, sepsis or opportunistic infection, dose interruption should be considered until the infection is controlled.

Interruption of dosing may be needed for management of laboratory abnormalities.

Missed doses¹

If a dose is missed, patients should be advised to take the dose as soon as possible unless it is less than 12 hours before the next dose, in which case the patient should not take the missed dose. Thereafter, dosing should be resumed at the regular scheduled time.

Clinically significant Interactions¹

In patients receiving strong inhibitors of cytochrome P450 (CYP) 2C19 (e.g. fluvoxamine, fluconazole, fluoxetine and ticlopidine), the recommended starting dose of Cibinqo should be reduced by half to 100 mg or 50 mg once daily.

The use of Cibinqo is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g. rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin).

See the Summary of Product Characteristics for full information.

Lactose¹

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Fertility, pregnancy and lactation¹

Women of childbearing potential¹

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.

Pregnancy¹

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.

Breast-feeding¹

There are no data on the presence of abrocitinib in human milk, the effects on the breast-fed infant, or the effects on milk production. Abrocitinib was secreted in milk of lactating rats. A risk to newborns/infants cannot be excluded and Cibinqo is contraindicated during breast-feeding.

Fertility¹

Based on the findings in rats, oral administration of Cibinqo may result in temporary reduced fertility in females of reproductive potential. The effects on female rat fertility were reversible 1 month after cessation of abrocitinib oral administration.

Dosing in Special Populations¹

Elderly

For patients 65 years of age and older, the recommended dose is 100 mg once daily.¹

Paediatrics

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.¹ Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.¹

Renal impairment¹

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Mild impairment (eGFR 60 to <90 mL/min)	Moderate impairment (eGFR 30 to <60 mL/min)	Severe impairment (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

Elderly

Cibinqo has not been studied in patients with end-stage renal disease (ESRD) on renal replacement therapy.¹

Hepatic impairment¹

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Mild impairment (Child Pugh A)	Moderate impairment (Child Pugh B)	Severe impairment (Child Pugh C)
No dose adjustment required	No dose adjustment required	Not studied, must not be used (contraindication)

Example

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PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.

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Practical considerations

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Patient resources

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CYP=cytochrome P450; eGFR=estimated glomerular filtration rate

Prescribing information:
Cibinqo (abrocitinib) Prescribing Information

References:

Cibinqo (abrocitinib) Summary of Product Characteristics.

PP-CIB-GBR-1741. February 2025

Cibinqo Risk Minimisation Programme (RMP) materials, including a Patient Card and Prescriber Brochure, are available from https://www.medicines.org.uk/emc/product/12874/rmms. Patients treated with Cibinqo should be given the Patient Card.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk 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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