Contraindications and Precautions for Rinvoq (Upadacitinib) Therapy

Absolute Contraindications and Critical Warnings

• Active tuberculosis must be excluded and latent TB treated before starting therapy, as recommended by the European League Against Rheumatism, in patients with a history of tuberculosis 1, 2
• Active sepsis or opportunistic infections, including Clostridium difficile, are contraindications, according to the Infectious Diseases Society of America 3
• Hepatitis B surface antigen-positive patients should avoid JAK inhibitors if possible, and if unavoidable, require concomitant antiviral prophylaxis with entecavir, tenofovir, or tenofovir alafenamide alongside hepatologist consultation, as recommended by the American Association for the Study of Liver Diseases 4
• Pregnancy is an absolute contraindication due to animal teratogenicity data and potential fetal harm, as stated by the American College of Obstetricians and Gynecologists 1, 2
• Decompensated advanced chronic liver disease, with a Child-Pugh score ≥9 or history of hepatic decompensation, is a contraindication, according to the American Association for the Study of Liver Diseases 1, 2
• Severe renal impairment with creatinine clearance <15 mL/min is a contraindication, as recommended by the National Kidney Foundation 1
• Current malignancy, except adequately treated non-melanoma skin cancer or cervical carcinoma in situ, should be considered a contraindication, according to the National Comprehensive Cancer Network 5, 2
• History of malignancy within the past 5 years requires careful risk-benefit assessment, particularly given ORAL Surveillance data showing increased malignancy risk with JAK inhibitors, as recommended by the American Society of Clinical Oncology 2
• History of arterial or venous thromboembolic events requires careful risk-benefit evaluation and may function as a practical contraindication, according to the American Heart Association 1, 2
• Unprovoked or recurrent VTE events are particularly concerning given dose-dependent increased thromboembolism risk with JAK inhibitors, as stated by the American College of Cardiology 5, 2
• Patients aged ≥65 years should only receive Rinvoq when no suitable alternatives are available due to increased risk of major cardiovascular events, serious infections, and malignancy, as recommended by the American Geriatrics Society 1, 2
• Patients aged ≥50 years with cardiovascular risk factors should not receive JAK inhibitors as first-line therapy when TNF inhibitors remain an option, according to the European League Against Rheumatism 6
• Current or long-term past smokers are at increased risk and should be considered for alternative treatments, as recommended by the American Lung Association 2
• Live vaccines are contraindicated during Rinvoq therapy, as stated by the Centers for Disease Control and Prevention 2
• Patients should be up-to-date with vaccinations, including recombinant zoster vaccine, before initiating treatment, as recommended by the Centers for Disease Control and Prevention 3

Pre-Treatment Screening and Monitoring

• Infection screening, including TB testing, hepatitis B and C, and chest X-ray, must be completed before initiating Rinvoq, as recommended by the Infectious Diseases Society of America 4, 1, 2
• Laboratory testing, including complete blood count with differential, comprehensive metabolic panel, and lipid panel, must be completed before initiating Rinvoq, as recommended by the American College of Rheumatology 1, 2, 7
• Pregnancy testing in women of reproductive potential must be completed before initiating Rinvoq, as recommended by the American College of Obstetricians and Gynecologists 1
• Cardiovascular risk assessment, including history of VTE, MACE, smoking status, and cardiovascular risk factors, must be completed before initiating Rinvoq, as recommended by the American Heart Association 2, 6
• Skin examination for non-melanoma skin cancer in at-risk patients must be completed before initiating Rinvoq, as recommended by the American Academy of Dermatology 4, 1