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CIBINQO (abrocitinib)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

CIBINQO Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

Serious Infections

...

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1 INDICATIONS AND USAGE

CIBINQO is indicated for the treatment of adults with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics...

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Testing, Evaluations, and Procedures Prior to Treatment Initiation

Perform the following tests and evaluations prior to...

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3 DOSAGE FORMS AND STRENGTHS

  • 50 mg: Pink, oval, film-coated tablet debossed with "PFE" on one side and "ABR 50" on the other.
  • 100 mg: Pink, round, film-coated tablet debossed with "PFE" on one side and "ABR 100"...
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4 CONTRAINDICATIONS

CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment [see Warnings...

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5 WARNINGS AND PRECAUTIONS

5.1 Serious Infections

The most frequent serious infections reported in clinical studies with CIBINQO for atopic dermatitis were herpes...

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7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on CIBINQO

Table 4 includes drugs with clinically significant drug interactions affecting CIBINQO.

...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is...

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10 OVERDOSAGE

There is no experience regarding human overdosage with CIBINQO. There is no specific antidote for overdose with CIBINQO. In case of an overdose, call Poison Control Center at 1-800-222-1222 for latest...

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11 DESCRIPTION

CIBINQO (abrocitinib) tablets contain the free base of abrocitinib, a Janus kinase (JAK) inhibitor, for oral administration.

Abrocitinib is a white to pale colored powder with the following chemical name...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

CIBINQO is a Janus kinase (JAK) inhibitor.

Abrocitinib reversibly inhibits JAK1 by blocking the adenosine...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year oral carcinogenicity study in rats, abrocitinib increased the...

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14 CLINICAL STUDIES

The efficacy of CIBINQO as monotherapy and in combination with background topical corticosteroids were evaluated in 3 randomized, double-blind, placebo-controlled trials [Trial-AD-1 (NCT03349060), Trial-...

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16 HOW SUPPLIED/STORAGE AND HANDLING

CIBINQO is supplied as:

...
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Medication Guide
CIBINQO (Si BINK oh)
(abrocitinib)
tablets, for oral use
This...
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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

For Medical Information about CIBINQO, please...

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