Important safety information

Clinical use
RINVOQ should not be used in combination with other Janus kinase (JAK) inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
Caution should be used when treating geriatric patients with RINVOQ.

Most serious warnings and precautions
Serious infections: Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ until the infection is controlled. Reported infections include active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease; invasive fungal infections, including cryptococcosis and pneumocystosis; and bacterial, viral (including herpes zoster), and other infections due to opportunistic pathogens. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent infection prior to RINVOQ use. Do not initiate treatment in patients with active infections including chronic or localized infections. Carefully consider the risks and benefits of treatment prior to initiating therapy in patients with chronic or recurrent infections. Closely monitor patients for signs and symptoms of infection during and after treatment, including the possible development of TB in patients who tested negative for latent infection prior to initiating therapy.

Malignancies: Lymphoma and other malignancies have been observed in patients treated with RINVOQ.

Thrombosis: Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated with JAK inhibitors, including RINVOQ, for inflammatory conditions. Many of these adverse events were serious and some resulted in death. Consider the risks and benefits prior to treating patients who may be at increased risk. Patients with symptoms of thrombosis should discontinue RINVOQ treatment and should be promptly evaluated and treated appropriately.

Other relevant warnings and precautions

• Increases in lipid parameters, including total, low-density lipoprotein, and high-density lipoprotein cholesterol
• Gastrointestinal perforations
• Hematologic events
• Liver enzyme elevation
• Patients with active hepatitis B or C infection
• Patients with severe hepatic impairment
• Concomitant use with other potent immunosuppressants, biologic DMARDs, or other JAK inhibitors
• Immunizations
• Viral reactivation, including herpes (e.g., herpes zoster) and hepatitis B
• Malignancies
• Increases in creatine phosphokinase
• Monitoring and laboratory tests
• Pregnant women
• Reproductive health
• Breast-feeding
• Geriatrics (≥65 years of age)
• Asian patients

For more information
Please consult the Product Monograph at rinvoq.ca/pm for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-888-704-8271.

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