HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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CIBINQO (abrocitinib)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
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
Boxed Warning
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS
Serious Infections
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Indications and Usage
1 INDICATIONS AND USAGE
CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe...
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Dosage and Administration
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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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
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- 50 mg: Pink, oval, film-coated tablet debossed with "PFE" on one side and "ABR 50" on the other.
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- 100 mg: Pink, round, film-coated tablet debossed with "PFE" on one side and "...
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Contraindications
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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Warnings and Precautions
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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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
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- Serious Infections [see Warnings and Precautions...
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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
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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Clinical Studies
14 CLINICAL STUDIES
The efficacy of CIBINQO as monotherapy and in combination with background topical corticosteroids was evaluated in 3 randomized, double-blind, placebo-controlled trials [Trial-AD-1 (NCT03349060), Trial-AD...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
CIBINQO is supplied as:
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Medication Guide
This Medication Guide has been approved by the U.S. Food and Drug... |
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Other
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
For Medical...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.