▼CIBINQO® (abrocitinib)|Dosing| PfizerPro Ireland

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About CIBINQO

Efficacy

Overview

Efficacy of CIBINQO + Medicated Topicals

Efficacy of CIBINQO Without Medicated Topicals

Reduction in Risk of Flares

Long-term Efficacy Results

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Glossary

Safety

Safety Profile

Safety Considerations

Lab Abnormalities

Dosing & Monitoring

Dosing &
Monitoring

Dosing

Lab Monitoring

Click here for CIBINQO Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

Dosing

Dosing adjustments

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Starting your patients on CIBINQO¹

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

Dosing considerations

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 patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular event (MACE) and malignancy (see section 4.4 of the Summary of Product Characteristics). 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.

The lowest effective dose for maintenance should be considered.

For patients 65 years of age and older, the recommended dose is 100 mg once daily (see section 4.4 of the SmPC)

See dosing adjustments

CIBINQO can be used with or without medicated topical therapies

CIBINQO can be taken with or without food at approximately the
same time each day

In patients who experience nausea, taking CIBINQO with food may improve nausea

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.

Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks

CIBINQO 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 is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, active serious systemic infections (including tuberculosis), severe hepatic impairment, and pregnancy and breast-feeding
Women of reproductive potential should be advised to use effective contraception during treatment and for 1 month following the final dose of CIBINQO
If a patient develops a serious infection, sepsis, or opportunistic infection, dose interruption should be considered until the infection is controlled
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) <1.2 x 10³/mm³, or a haemoglobin (Hb) value <10 g/dL

Your patients may require dosing adjustments with CIBINQO¹

Not an exhaustive list of drug-drug interactions; the label must be reviewed in order to understand other potential drug-drug interactions with CIBINQO.

In patients receiving acid reducing agents (e.g. antacids, proton pump inhibitors and H2 receptor antagonists), 200 mg once daily dose of CIBINQO should be considered.

Caution should be exercised for concomitant use of abrocitinib with dabigatran. Caution should be exercised as the levels of P-gp substrates with a narrow therapeutic index, such as digoxin, may increase. Caution should be exercised when using CIBINQO concomitantly with narrow therapeutic index medicines that are primarily metabolised by CYP2C19 enzyme (e.g. S-mephenytoin and clopidogrel). Dose adjustment may be required for other medicines primarily metabolised by CYP2C19 enzyme in accordance with their product information (e.g. citalopram, clobazam, escitalopram and selumetinib).

CIBINQO was studied in patients with mild (Child Pugh A) and moderate (Child Pugh B) hepatic impairment. CIBINQO must not be used in patients with severe (Child Pugh C) hepatic impairment.

eGFR=estimated glomerular filtration rate; CYP=cytochrome P450.

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Learn More about CIBINQO

About CIBINQO

Take On Moderate-to-Severe AD With CIBINQO

Discover the efficacy of CIBINQO

See Efficacy Overview

Prescribing information

Please see the CIBINQO Summary of Product Characteristics for more information.

Reference:

CIBINQO Summary of Product Characteristics

▼ 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 of the SmPC for how to report adverse reactions.

Dosing & Monitoring

Take On Moderate-to-Severe AD With CIBINQO

Discover the efficacy of CIBINQO

See Efficacy Overview

Legal Category: S1A
Further information is available upon request

PP-CIB-IRL-0094 June 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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PP-UNP-IRL-0176. January 2023

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