CIBINQO How Supplied/Storage and Handling (abrocitinib) | Pfizer Medical Information - US

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.

16 HOW SUPPLIED/STORAGE AND HANDLING

CIBINQO is supplied as:

Dosage Form	Strength	Description	Bottle Size (number of tablets)	NDC Number
Tablets	50 mg	Pink, oval tablet debossed with "PFE" on one side and "ABR 50" on the other.	30 count bottle	0069-0235-30
Tablets	100 mg	Pink, round tablet debossed with "PFE" on one side and "ABR 100" on the other.	30 count bottle	0069-0335-30
Tablets	200 mg	Pink, oval tablet debossed with "PFE" on one side and "ABR 200" on the other.	30 count bottle	0069-0435-30

Store CIBINQO at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in original package. The container closure system is child resistant.

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

Pfizer samples (for eligible HCPs)

Requests for samples of prescription medications can be made by contacting Pfizer for Professionals at 1-800-505-4426 or by visiting the PfizerPro website www.pfizerpro.com.
Report an adverse event or concern about the quality of a Pfizer product

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:
Pfizer Safety Reporting Site
*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.
If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly by visiting www.fda.gov/medwatch or by calling (800)-332-1088.
Assistance programs (for eligible patients)

Pfizer RxPathways connects eligible patients to a range of assistance programs that offer insurance support, co-pay help, and medicines for free or at a savings. Patients and physicians can contact RxPathways at (866) 706-2400 or visit the website for more information on these programs www.pfizerrxpathways.com.
Resources

Show All Hide All

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...

Read more

Did you find an answer to your question? Yes No

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

Serious Infections

...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

2 DOSAGE AND ADMINISTRATION

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

Perform the following tests and evaluations prior to...

Read more

Did you find an answer to your question? Yes No

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"...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

5 WARNINGS AND PRECAUTIONS

5.1 Serious Infections

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

Read more

Did you find an answer to your question? Yes No

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

Serious Infections [see Warnings and Precautions (5.1)...

Read more

Did you find an answer to your question? Yes No

7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on CIBINQO

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

...

Read more

Did you find an answer to your question? Yes No

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

CIBINQO is a Janus kinase (JAK) inhibitor.

Abrocitinib reversibly inhibits JAK1 by blocking the adenosine...

Read more

Did you find an answer to your question? Yes No

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Read more

Did you find an answer to your question? Yes No

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-...

Read more

Did you find an answer to your question? Yes No

16 HOW SUPPLIED/STORAGE AND HANDLING

CIBINQO is supplied as:

...

Read more

Did you find an answer to your question? Yes No

Medication Guide CIBINQO (Si BINK oh) (abrocitinib) tablets, for oral use
This...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

Did you find an answer to your question? Yes No

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985^*

*Contact Medical Information.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

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:

Pfizer Safety Reporting Site

*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.

FDA Medwatch

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.