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Upadacitinib

Serious Infections, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis

Serious Infections

  • Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1), Adverse Reactions (6.1)]. 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, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before RINVOQ use and during therapy. Treatment for latent infection should be considered prior to RINVOQ use.
           Invasive fungal infections, including cryptococcosis and pneumocystosis.
           Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
  • The risks and benefits of treatment with RINVOQ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
  • Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions (5.1)].

Malignancy

  • Lymphoma and other malignancies have been observed in patients treated with RINVOQ [see Warnings and Precautions (5.2)].

Major Adverse Cardiovascular Events

  • In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue RINVOQ in patients that have experienced a myocardial infarction or stroke [see Warnings and Precautions (5.4)].

Thrombosis

  • Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat 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 be promptly evaluated and treated appropriately [see Warnings and Precautions (5.3)].

Patient Counseling Information

Medication Guides

Patient Medication Guide - RINVOQ

Package Inserts

Upadacitinib

Updated March 2022