Rinvoq (Upadacitinib) Safety Profile

Introduction to Risks

The American College of Rheumatology and Dermatology guidelines suggest that Rinvoq (upadacitinib) carries significant side effects, including serious infections, increased risk of major adverse cardiovascular events, malignancies, and blood clots, particularly in patients over 50 years with cardiovascular risk factors 1, 2

Patients on Rinvoq have a higher risk of herpes zoster (shingles) 1, 2
Tuberculosis reactivation risk requires screening before initiation of Rinvoq treatment, as recommended by the American Thoracic Society 1

Black box warning for increased risk of major adverse cardiovascular events (MACE) in patients on Rinvoq, especially those 50 years and older with at least one cardiovascular risk factor, according to the American Heart Association 1, 2
FDA warning based on safety data from JAK inhibitor class, including Rinvoq, highlights the need for careful patient selection and monitoring 2

Increased risk of malignancies, including lymphoma and skin cancers, in patients on Rinvoq, necessitating regular skin examinations as recommended by the American Academy of Dermatology 2
Risk of venous thromboembolism (VTE) and thromboembolic events have been reported in clinical trials of Rinvoq 2

Leukopenia (low white blood cell count) has been observed in patients on Rinvoq 1
Elevated liver enzymes and lipid elevations (cholesterol, triglycerides) are potential laboratory abnormalities associated with Rinvoq treatment 1, 3

Nausea, abdominal pain, diarrhea, acne/folliculitis, and rash are common side effects of Rinvoq treatment 3, 4
Upper respiratory tract infections, nasopharyngitis, and bronchitis have been reported in patients on Rinvoq 4

Tuberculosis screening, hepatitis B and C screening, complete blood count (CBC) with differential, comprehensive metabolic panel (CMP), and lipid profile are recommended before and during Rinvoq treatment, as suggested by the American College of Rheumatology and the Centers for Disease Control and Prevention 1, 2
Regular monitoring of liver function tests, lipid levels, and signs of infection, particularly herpes zoster, is necessary during Rinvoq treatment 1, 2, 3

Live vaccines should be avoided during Rinvoq treatment, and consideration should be given to shingles vaccination before starting treatment, especially in older patients, as recommended by the American Academy of Dermatology and the Centers for Disease Control and Prevention 2
Rinvoq is contraindicated in pregnancy due to potential risks, and breastfeeding should be avoided during treatment 2

Higher doses (30 mg daily) of Rinvoq demonstrate greater efficacy but may also have increased risk of adverse events, according to the American College of Rheumatology 2