Dosing | Cibinqo®▼ (abrocitinib)

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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.
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 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 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 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 history of malignancy)

Use in patients 65 years of age and older¹

Considering the increased risk of 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 JAK inhibitor, abrocitinib should only be used in these patients if no suitable treatment alternatives are available.

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.

Cibinqo is a once-daily oral treatment:¹ Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis The recommended starting dose is 100 mg or 200 mg once daily based on individual patient characteristics: A starting dose of 100 mg once daily is recommended for adolescents (12 to 17 years old), and for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular event (MACE) and malignancy (see section 4.4). If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily. A dose of 200 mg 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 100 mg once daily. Upon disease control, dose should be decreased to 100 mg once daily. If disease control is not maintained after dose reduction, re-treatment with 200 mg once daily can be considered.

Cibinqo is a once-daily oral treatment:¹

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

The recommended starting dose is 100 mg or 200 mg once daily based on individual patient characteristics:
- A starting dose of 100 mg once daily is recommended for adolescents (12 to 17 years old), and for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular event (MACE) and malignancy (see section 4.4). If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily.
- A dose of 200 mg 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 100 mg once daily. Upon disease control, dose should be decreased to 100 mg once daily. If disease control is not maintained after dose reduction, re-treatment with 200 mg once daily can be considered.

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

The lowest effective dose for maintenance should be considered¹

Cibinqo can be used with or without medicated topical therapies for atopic dermatitis¹

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.¹

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.

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.

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.

Cibinqo in special populations ¹

Renal impairment

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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 impairment

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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

Women of child bearing potential
- 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.¹
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

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PLEASE SEE CIBINQO SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION.

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CYP=cytochrome P450; eGFR=estimated glomerular filtration rate; MAO=monoamine oxidase; P-gp=P glycoprotein.

Prescribing information:
Cibinqo (abrocitinib) Prescribing Information (Great Britain)

References:

Cibinqo (abrocitinib) Summary of Product Characteristics.

PP-CIB-GBR-1084. August 2023.

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 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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