RINVOQ should not be used in combination with other Janus kinase (JAK) inhibitors, immunomodulating biologics (e.g. biologic DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
Pediatrics (<18 years of age): The safety and efficacy of RINVOQ in children and adolescents aged 0 to less than 18 years with RA, PsA or AS have not yet been established. No data are available; therefore, RINVOQ should not be used in this pediatric population.
The safety and efficacy of RINVOQ in adolescents weighing <40 kg and in children aged 0 to less than 12 years with AD have not yet been established. No data are available; therefore, RINVOQ should not be used in this pediatric patient population.
Geriatrics (≥65 years of age): 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. An increase in malignancies, including lung cancer, were observed in RA patients ≥50 years with at least one additional cardiovascular (CV) risk factor who were taking a different JAK inhibitor, compared with tumour necrosis factor (TNF) inhibitors. Caution should be applied when using RINVOQ in geriatric patients, patients who are current or past smokers, and patients with other malignancy risk factors.
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. RA patients ≥50 years with ≥1 additional CV risk factor had a higher rate of all-cause mortality and thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis in a clinical trial with a different JAK inhibitor compared to TNF inhibitors. Consider the risks and benefits prior to treating patients who may be at increased risk for thrombosis. Discontinue RINVOQ and promptly evaluate patients with symptoms of thrombosis.
Major adverse cardiovascular events: Major adverse CV events, including non-fatal myocardial infarction, were observed more frequently in RA patients ≥50 years with ≥1 additional CV risk factor in a clinical trial with a different JAK inhibitor compared to TNF inhibitors. Caution should be applied when using RINVOQ in geriatric patients, patients who are current or past smokers, and patients with other CV risk factors.
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
- Hypersensitivity reactions
- Patients with severe hepatic impairment
- Concomitant use with other potent immunosuppressants, biologic DMARDs, or other JAK inhibitors
- Viral reactivation, including herpes (e.g. herpes zoster) and hepatitis B
- Malignancies, including NMSC
- Increases in creatine phosphokinase
- Monitoring and laboratory tests
- Pregnant women
- Reproductive health
- Geriatrics (≥65 years of age)
- Pediatrics (<12 years of age in AD; <18 years of age in RA, PsA, AS)
- 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.
- Clinical significance has not been established.
- Please see Product Monograph for additional dosing and administration information.
DMARD: disease-modifying antirheumatic drug; JAK: Janus kinase; MTX: methotrexate.