Cibinqo Tablet

Abrocitinib 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 Abrocitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants. Abrocitinib 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. Limitation of Use: Abrocitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed warning. SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. - Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Discontinue treatment with Abrocitinib 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. - Higher rate of all-cause mortality, including sudden cardiovascular death, with another JAK inhibitor vs. TNF blockers in rheumatoid arthritis (RA) patients. Abrocitinib is not approved for use in RA patients. - Malignancies have occurred with Abrocitinib. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. - MACE has occurred with Abrocitinib. Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients. - Thrombosis has occurred with Abrocitinib. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. Serious Infections Patients treated with Abrocitinib may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infections reported with Abrocitinib were herpes simplex, herpes zoster, and pneumonia. If a serious or opportunistic infection develops, discontinue Abrocitinib and control the infection. Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions: - Active tuberculosis, which may present with pulmonary or extrapulmonary disease. treat latent TB prior to use. - Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. - Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens. Avoid use of Abrocitinib in patients with an active, serious infection including localized infections. The risks and benefits of treatment with Abrocitinib should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Abrocitinib, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

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 Abrocitinib 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 Abrocitinib 200 mg and greater than Abrocitinib 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. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Abrocitinib was evaluated in four randomized, placebo-controlled clinical trials (2 monotherapy, 1 combination therapy with topical corticosteroid, and 1 dose-ranging) and one long-term extension trial in subjects with moderate to severe atopic dermatitis (AD). A total of 1623 subjects with moderate to severe atopic dermatitis were treated with Abrocitinib in these clinical trials representing 1428 patient-years of exposure. There were 634 subjects with at least 1 year of exposure to Abrocitinib. In the placebo-controlled clinical trials, a total of 1198 subjects were exposed to Abrocitinib with 608 subjects receiving Abrocitinib 100 mg once daily and 590 subjects receiving Abrocitinib 200 mg once daily for up to 16 weeks. The median age of subjects was 33.0 years, 124 subjects (8.1%) were 12 to less than 18 years old and 94 subjects (6.1%) were 65 years of age or older. The majority of subjects were White (68.7%) and male (53.9%). Adverse reactions occurring at ≥1% in any of the treated groups and at a higher rate than in the placebo group are presented in Table 3. A total of 61 (5.1%) subjects treated with Abrocitinib were discontinued from the trials due to adverse reactions. The safety profile of Abrocitinib in the monotherapy and the combination trial(s) were similar. Table 3. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.