What is Rinvoq (upadacitinib) for?

Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with:^[1,2]

• Moderate to severe active rheumatoid arthritis (RA)
• Psoriatic arthritis
• Atopic dermatitis
• Ulcerative colitis
• Ankylosing spondylitis (AS)

It is used for patients with RA for whom disease-modifying anti-rheumatic medicines (DMARDs) or methotrexate did not work well enough. It can be used on its own (monotherapy) or with methotrexate.^[1,2]

It is available in extended-release tablet form each containing 15 mg of upadacitinib.^[1]

How does Rinvoq (upadacitinib) work?

RA is a disease in which the body’s immune system attacks healthy tissue to cause inflammation and pain in joints.^[3]

The active substance in Rinvoq, upadacitinib, acts on enzymes known as Janus kinases (JAK). These enzymes play an important role in the process of inflammation that is seen in rheumatoid arthritis.^[3]

By blocking JAK1’s action, upadacitinib helps reduce the inflammation and other symptoms of RA. It helps in reducing pain, tiredness, stiffness and swelling in the joints. It can slow down damage to the bone and cartilage in the joints.^[3]

Where has Rinvoq (upadacitinib) been approved?

Rinvoq (upadacitinib) was approved for the treatment of adults with:

• Moderate to severe active RA by:
  • The Food and Drug Administration (FDA), US on August 16, 2019.^[4]
  • The European Medicines Agency (EMA), Europe on December 16, 2019.^[5]
  • The Pharmaceuticals and Medical Devices Agency (PMDA), Japan on May 27, 2021
  • The Food and Drug Administration (FDA), USA on January 20, 2022.^[7]
• Psoriatic arthritis
• Atopic dermatitis
• Ulcerative colitis

On December 11, 2020, the EMA recommended the approval of Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis and for adults with active ankylosing spondylitis.^[6]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Rinvoq (upadacitinib) taken?

The standard dosage is:^[1]

• One 15 mg tablet taken once daily with or without food.

Rinvoq (upadacitinib) may be used alone or in combination with methotrexate or other nonbiologic DMARDs.^[1]

Before starting with treatment, the treating doctor should test you for tuberculosis and other serious infections using a blood test.^[1]

The treatment may be interrupted in case of certain side effects, including a drop in blood cell counts.^[1]

Complete information about Rinvoq (upadacitinib) dosage (modifications) and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Rinvoq (upadacitinib)?

Common adverse reactions

The most common side effects (≥1% of patients) listed in the prescribing information include:^[1]

• Upper respiratory tract infections (common cold, sinus infections)
• Nausea
• Cough
• Fever

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Serious infections
• Lymphoma and other malignancies
• Thrombosis

Use in a specific population

Rinvoq (upadacitinib) can cause fetal harm when administered to a pregnant woman; it is advised to avoid pregnancies and breastfeeding.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [FDA]: Rinvoq (upadacitinib) [PDF] AbbVie, Aug 16, 2019

2. Full prescribing information [EMA]: Rinvoq (upadacitinib) [PDF] AbbVie, Dec 18, 2019

3. A review of upadacitinib in rheumatoid arthritis
Tanaka Y, Modern Rheumatology, Jul 13, 2020

4. AbbVie Receives FDA Approval of RINVOQ™ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to Severe Rheumatoid Arthritis
AbbVie Press release, Aug 16, 2019

5. AbbVie Receives European Commission Approval of RINVOQ™ (upadacitinib) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis
AbbVie press release, Dec 18, 2019

6. CHMP Recommends the Approvals of RINVOQ™ (Upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis and Ankylosing Spondylitis
AbbVie press release, Dec 11, 2020

7. FDA approves Janus kinase inhibitors Rinvoq and Cibinqo despite safety concerns
Press release, Jan 2022