Patients who are current or past smokers are at additional increased risk. In a large, randomized, postmarketing study comparing another JAK inhibitor with TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) was observed with the JAK inhibitor. Advise patients to limit sunlight exposure by wearing protective clothing and using sunscreen.
#RINVOQ COPAY CARD SKIN#
Periodic skin examination is recommended for patients who are at increased risk for skin cancer. NMSCs have been reported in patients treated with RINVOQ. With RINVOQ, consider the benefits and risks for the individual patient prior to initiating or continuing therapy, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers. In a large, randomized, postmarketing safety study comparing another JAK inhibitor with TNF blockers in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer ), lymphomas, and lung cancer (in current or past smokers) was observed with the JAK inhibitor. Lymphoma and other malignancies have been observed in patients treated with RINVOQ. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ. In a large, randomized, postmarketing safety study comparing another Janus kinase (JAK) inhibitor with tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients ≥50 years old with at least one cardiovascular (CV) risk factor, a higher rate of all-cause mortality, including sudden CV death, was observed with the JAK inhibitor. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.Ĭarefully consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with chronic or recurrent infection.Invasive fungal infections, including cryptococcosis and pneumocystosis.Consider treatment for latent TB infection prior to RINVOQ use. Test patients for latent TB before RINVOQ use and during therapy. Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease.If a serious infection develops, interrupt RINVOQ until the infection is controlled. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. IMPORTANT SAFETY INFORMATION SERIOUS INFECTIONS Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis, or with other potent immunosuppressants such as azathioprine and cyclosporine. Moderately to severely active ulcerative colitis in adults who have had an inadequate response or intolerance to one or more TNF blockers.Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants. Refractory, moderate to severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.Limitations of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended. Active ankylosing spondylitis in adults who have had an inadequate response or intolerance to one or more TNF blockers.
Active psoriatic arthritis in adults who have had an inadequate response or intolerance to one or more TNF blockers.Moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one or more TNF blockers.
RINVOQ is indicated for the treatment of: IMPORTANT SAFETY INFORMATION & INDICATIONS 1 INDICATIONS 1
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