What are the necessary steps before initiating Rinvoq (upadacitinib) therapy?

From the Guidelines

Before starting Rinvoq (upadacitinib), it is crucial to undergo thorough screening tests and evaluations to minimize the risk of adverse effects and ensure the best possible outcome in terms of morbidity, mortality, and quality of life. To initiate Rinvoq therapy safely, several key steps must be taken:

• Screening for active tuberculosis (TB) with a TB skin or blood test is necessary, as well as screening for other infections like hepatitis B and C 1.
• Complete blood work is required to assess liver function, kidney function, and blood cell counts, given the potential for Rinvoq to cause leukopenia and other hematologic effects 1.
• Checking cholesterol levels is also important since Rinvoq can affect lipid levels, potentially increasing the risk of cardiovascular events 1.
• A thorough review of all current medications, including over-the-counter drugs and supplements, is essential to avoid harmful interactions 1.
• Discussing vaccination status is critical, as being up-to-date on immunizations is recommended before starting immunosuppressive therapy like Rinvoq 1.
• For women of childbearing age, a pregnancy test is necessary because Rinvoq is not recommended during pregnancy due to its potential risks 1. These precautions are vital because Rinvoq, a JAK inhibitor, suppresses parts of the immune system to reduce inflammation, which can increase the risk of infections, major adverse cardiovascular events, and other side effects that require careful monitoring 1.

From the FDA Drug Label

● Active and latent tuberculosis (TB) infection evaluation - If positive, treat for TB prior to RINVOQ/RINVOQ LQ use [see Warnings and Precautions (5. 1)]. ● Viral hepatitis screening in accordance with clinical guidelines – RINVOQ/RINVOQ LQ initiation is not recommended in patients with active hepatitis B or hepatitis C [see Warnings and Precautions (5. 1)]. ● A complete blood count – RINVOQ/RINVOQ LQ initiation is not recommended in patients with an absolute lymphocyte count less than 500 cells/mm3, absolute neutrophil count less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL [see Dosage and Administration (2.13) and Warnings and Precautions (5. 8)]. ● Baseline hepatic function: RINVOQ/RINVOQ LQ initiation is not recommended for patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. ● Pregnancy Status: Verify the pregnancy status of females of reproductive potential prior to starting treatment [see Warnings and Precautions (5.9) and Use in Specific Populations (8. 1,8.3)]. Update immunizations according to current immunization guidelines [see Warnings and Precautions (5.10)].

Before starting Rinvoq, the following evaluations and actions should be considered:

• Tuberculosis (TB) screening: Evaluate for active and latent TB infection and treat if positive.
• Viral hepatitis screening: Screen for hepatitis B and C in accordance with clinical guidelines.
• Complete blood count: Check for adequate lymphocyte, neutrophil, and hemoglobin levels.
• Baseline hepatic function: Assess hepatic function and avoid use in patients with severe hepatic impairment.
• Pregnancy status: Verify pregnancy status in females of reproductive potential.
• Immunizations: Update immunizations according to current guidelines 2.

From the Research

Pre-Treatment Requirements for Rinvoq (Upadacitinib)

Before starting Rinvoq, several factors should be considered:

• Hepatic impairment: Studies have shown that mild and moderate hepatic impairment has no clinically relevant effect on upadacitinib pharmacokinetics 3.
• Cardiovascular risk: Patients with higher cardiovascular risk (aged ≥50 years, ≥1 CV risk factor) may be at increased risk of major adverse cardiovascular events (MACE), malignancy, and venous thromboembolism (VTE) 4.
• Lipid profile: Upadacitinib may increase low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) levels, but its effect on cardiovascular disease risk is unclear 5.
• Concomitant medications: The safety and efficacy of upadacitinib in combination with other medications, such as tumor necrosis factor inhibitors (TNFis) or other Janus kinase inhibitors (JAKis), should be considered 6.
• Patient demographics: Older patients (≥65 years old) and those prescribed upadacitinib as first-line advanced therapy or monotherapy may have different treatment outcomes 6.

Key Considerations

• Patients should be closely monitored for signs of infection, malignancy, and cardiovascular events while taking upadacitinib 4, 5.
• The potential benefits and risks of upadacitinib should be weighed carefully, particularly in patients with higher cardiovascular risk or those taking concomitant medications 4, 6.
• Regular follow-up and assessment of disease activity and treatment response are essential to optimize treatment outcomes 6.