Abrocitinib (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- CIBINQO
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 atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Limitations of Use CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.
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 and Precautions (5.7) , Drug Interactions (7.2), and Clinical Pharmacology (12.2)].
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: •Serious Infections [see Warnings and Precautions (5.1)] •Mortality [see Warnings and Precautions (5.2)] •Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions (5.3)] •Major Adverse Cardiovascular Events [see Warnings and Precautions (5.4)] •Thrombosis [see Warnings and Precautions (5.5)] •Laboratory Abnormalities [see Warnings and Precautions (5.7) ]
Mechanism of Action
CIBINQO is a Janus kinase (JAK) inhibitor. Abrocitinib reversibly inhibits JAK1 by blocking the adenosine triphosphate (ATP) binding site. In a cell-free isolated enzyme assay, abrocitinib was selective for JAK1 over JAK2 (28-fold), JAK3 (>340-fold), and tyrosine kinase (TYK) 2 (43-fold), as well as the broader kinome. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known. Both the parent compound and the active metabolites inhibit JAK1 activity in vitro with similar levels of selectivity.
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 recommendations.