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Is Rinvoq a High Risk Medication? Understanding the Benefits and Warnings

3 min read

Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor used to treat several chronic inflammatory diseases. The FDA requires a boxed warning, also known as a 'black box' warning, for Rinvoq due to potentially serious or life-threatening risks. So, is Rinvoq a high risk medication?

Quick Summary

Rinvoq is considered a high-risk medication due to its FDA black box warning. This warning highlights increased risks of serious infections, major heart events, cancer, blood clots, and death.

Key Points

  • Black Box Warning: Rinvoq has an FDA black box warning for serious infections, mortality, cancer, major adverse cardiovascular events (MACE), and thrombosis.

  • High-Risk Category: Due to its black box warning and mechanism of action as an immunosuppressant, Rinvoq is considered a high-risk medication.

  • JAK Inhibitor: Rinvoq is a Janus kinase (JAK) inhibitor that works by blocking signals inside cells that cause inflammation in autoimmune diseases.

  • Serious Side Effects: Beyond the boxed warnings, risks include gastrointestinal perforations and significant changes in blood counts, liver enzymes, and cholesterol.

  • Patient Monitoring: Patients on Rinvoq require regular monitoring for infections and changes in lab tests before and during treatment.

  • Benefit vs. Risk: The decision to use Rinvoq is a careful balance between its effectiveness in treating severe conditions and its significant potential risks.

  • Specific Patient Populations: The risks for MACE, mortality, and blood clots are particularly noted for patients aged 50 and older with at least one cardiovascular risk factor.

In This Article

What is Rinvoq and How Does It Work?

Rinvoq (upadacitinib) is an oral Janus kinase (JAK) inhibitor, not a biologic, that reduces immune system activity within cells to decrease inflammation. It blocks specific JAK enzymes, primarily JAK1, interrupting signaling pathways involved in autoimmune disease inflammation. This action helps alleviate symptoms like pain and stiffness.

Rinvoq is approved for several moderate to severe inflammatory conditions, often when other treatments like TNF blockers haven't been effective. These include Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Atopic Dermatitis (Eczema), Ulcerative Colitis (UC), Crohn's Disease, Ankylosing Spondylitis (AS), Non-radiographic axial spondyloarthritis (nr-axSpA), Giant Cell Arteritis (GCA), and Polyarticular Juvenile Idiopathic Arthritis (pJIA).

The Black Box Warning: Why Rinvoq is High-Risk

The FDA has issued a black box warning for Rinvoq and other JAK inhibitors due to serious or life-threatening risks. This warning stems from a large safety study on another JAK inhibitor. Key risks in the black box warning include serious infections, mortality, malignancies, major adverse cardiovascular events (MACE), and thrombosis (blood clots). TB testing is usually done before treatment. For more details, refer to the {Link: RINVOQ Safety Profile https://www.rinvoqhcp.com/safety} and {Link: American College of Rheumatology https://rheumatology.org/patients/upadacitinib-rinvoq}.

Other Serious and Common Side Effects

Besides the black box warnings, Rinvoq has other significant side effects. These include gastrointestinal perforations, laboratory abnormalities, and hypersensitivity reactions. Common side effects include upper respiratory infections, nausea, and acne. Healthcare providers should monitor patients for these risks.

Rinvoq vs. Other Medications: A Comparison

Comparing Rinvoq to treatments like the TNF blocker Humira helps contextualize its risks.

Feature Rinvoq (upadacitinib) Humira (adalimumab)
Drug Class Janus Kinase (JAK) Inhibitor Tumor Necrosis Factor (TNF) Blocker
Administration Oral tablet, once daily Subcutaneous injection, every other week
Black Box Warning Yes, for serious infections, mortality, malignancy, MACE, and thrombosis Yes, for serious infections and malignancy
Key Side Effect Differences Higher rates of herpes zoster (shingles) and increased blood creatine phosphokinase (CPK). Injection-site reactions are common.
Cardiovascular Risk Increased risk of MACE specifically highlighted in the black box warning. Disease interactions include Congestive Heart Failure (CHF). MACE rates were found to be comparable to Rinvoq in one study.
Thrombosis Risk Increased risk specifically highlighted in the black box warning. No specific thrombosis warning, but can cause hematologic abnormalities. VTE rates were comparable to Rinvoq in one study.

Conclusion: Balancing Benefit and Risk

Based on its black box warning and potential for serious adverse effects, is Rinvoq a high risk medication? Yes, it is considered a high-risk drug. The decision to use Rinvoq requires a thorough discussion between the patient and healthcare provider to weigh its benefits for managing severe autoimmune diseases against its significant risks. For patients who haven't responded to other treatments, Rinvoq can improve symptoms and quality of life. This necessitates close monitoring for infections, cardiovascular events, cancers, and other complications. Patients must be aware of serious adverse event symptoms and seek prompt medical attention if they occur.


For more information from the manufacturer, visit {Link: RINVOQ.com https://www.rinvoq.com/side-effects}.

Frequently Asked Questions

Rinvoq has a black box warning for an increased risk of serious infections, higher all-cause mortality, malignancies (like lymphoma), major adverse cardiovascular events (MACE) such as heart attack and stroke, and thrombosis (blood clots).

Yes, Rinvoq is an immunosuppressant. It works by decreasing the activity of your immune system, which increases the risk for serious infections.

No, Rinvoq is not a biologic medication. It is a small molecule drug classified as a Janus kinase (JAK) inhibitor that is taken orally.

Rinvoq is used to treat various moderate to severe inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, atopic dermatitis (eczema), ulcerative colitis, Crohn's disease, and ankylosing spondylitis, among others.

Current or past smokers are at an additional increased risk for certain cancers (like lymphoma and lung cancer) and major cardiovascular events while taking Rinvoq. You should discuss this risk with your healthcare provider.

The most common side effects include upper respiratory tract infections (like the common cold), nausea, cough, fever, and acne.

Yes, the black box warning for Rinvoq notes an increased risk of major adverse cardiovascular events (MACE), including heart attack and stroke, especially in people 50 years and older with at least one heart disease risk factor.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.