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Ruxolitinib Cream

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

Serious Infections

  • Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. 
  •  Reported infections include:
        Active tuberculosis, which may present with pulmonary or extrapulmonary disease. 
        Invasive fungal infections, including candidiasis and pneumocystosis. 
        Bacterial, viral, and other infections due to opportunistic pathogens.
  • Avoid use of OPZELURA in patients with an active, serious infection, including localized infectns. If a serious infection develops, interrupt OPZELURA until the infection is controlled.
  • The risks and benefits of treatment with OPZELURA 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 OPZELURA [see Warnings and Precautions (5.1)].

Mortality

  • Higher rate of all-cause mortality, including sudden cardiovascular death have been observed in patients treated with oral Janus kinase inhibitors for inflammatory conditions [see Warnings and Precautions (5.2)].

Malignancies

  • Lymphoma and other malignancies have been observed in patients treated with Janus kinase inhibitors for inflammatory conditions [see Warnings and Precautions (5.3)].

Major Adverse Cardiovascular Events (MACE)

  • Higher rate of MACE (including cardiovascular death, myocardial infarction, and stroke) has been observed in patients treated with Janus kinase inhibitors for inflammatory conditions [see Warnings and Precautions (5.4)].

Thrombosis

  • Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis has been observed at an increased incidence in patients treated with oral Janus kinase inhibitors for inflammatory conditions compared to placebo. Many of these adverse reactions were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated [see Warnings and Precautions (5.5)].

Patient Counseling Information

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Ruxolitinib Cream

Updated October 2021