Abrocitinib

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. CIBINQO is a Janus kinase (JAK) inhibitor 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.

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.

• For recommended testing, evaluations, and procedures prior to CIBINQO initiation, see Full Prescribing Information. • Recommended dosage is 100 mg orally once daily. • 200 mg orally once daily is recommended for those patients who are not responding to 100 mg once daily. • Moderate renal impairment: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. • CYP2C19 poor metabolizer: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. • For dosage modifications for certain adverse reactions, see Full Prescribing Information.

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

Boxed warning: Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Discontinue treatment with CIBINQO if serious or opportunistic infection occurs. Test for latent TB before and during therapy, treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative latent TB test. • Hypoglycemia in Patients with Diabetes: Consider increased monitoring of blood glucose, advise diabetic patients to notify their healthcare provider if they develop signs and symptoms of hypoglycemia. • Laboratory Abnormalities: Laboratory monitoring is recommended due to potential changes in platelets, lymphocytes, and lipids. • Immunizations: Avoid use of live vaccines immediately prior to, during and immediately after CIBINQO treatment.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections • Mortality • Malignancy and Lymphoproliferative Disorders • Major Adverse Cardiovascular Events • Thrombosis • Laboratory Abnormalities Most common adverse events (≥1% with CIBINQO 100 mg) are nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, impetigo, oropharyngeal pain, hypertension, influenza, gastroenteritis, and dermatitis contact. Most common adverse reactions (≥1% with CIBINQO 200 mg and greater than CIBINQO 100 mg) are nausea, headache, herpes simplex, increased blood creatine kinase, dizziness, urinary tract infection, acne, vomiting, gastroenteritis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia.

• Strong Inhibitors of CYP2C19: The recommended dosage is 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. • Moderate to Strong Inhibitors of Both CYP2C19 and CYP2C9, or Strong or Moderate CYP2C19 or CYP2C9 Inducers: Avoid concomitant use. • Certain P-gp Substrates or Certain CYP2C19 Substrates: Monitor or titrate dosage of P-gp substrates or CYP2C19 substrates where small concentration changes may lead to serious or life-threatening toxicities.

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).