Rinvoq (upadacitinib)
An approved treatment for Giant Cell Arteritis.
The same compound appears under different names depending on the context. Here is how to identify Upadacitinib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Upadacitinib
- Brand name
- Rinvoq
- Development code
- ABT-494
- Drug class
- JAK inhibitor
- Manufacturer
- AbbVie
- How it's taken
- For GCA, 15 mg by mouth once a day together with a tapering course of steroids; once steroids are stopped, Rinvoq 15 mg can be continued alone.
A once-daily extended-release tablet that the FDA approved for adults with giant cell arteritis (GCA) on April 28, 2025, taken with a tapering course of steroids and continued alone once steroids stop. In its main trial, 46% of people on Rinvoq with a 26-week steroid taper stayed in sustained remission from week 12 to week 52, against 29% on placebo with a 52-week taper. It carries a boxed warning for serious infections, death, cancer, major heart events and blood clots.
Where Upadacitinib fits
Rinvoq joins tocilizumab (Actemra), approved for GCA in May 2017, as a way to shorten steroid use, and it is the only one of the 2 taken as a pill. Its GCA trial compared it with placebo, not with tocilizumab.
How Upadacitinib works
In GCA, the immune system inflames the walls of large and medium arteries, including the temporal and other arteries of the head and the aorta[4]. Immune cells drive that inflammation by sending signals called cytokines, and many of those signals are passed along inside the cell by enzymes called Janus kinases (JAKs). Upadacitinib blocks JAK enzymes so the signals are not passed on, and in lab tests it blocked JAK1-driven signals more strongly than JAK2-driven ones[1]. The GCA trial authors note that this blocks signaling by several cytokines, including interleukin-6 and interferon-gamma[5]. The goal is to control the arteritis so steroids can be tapered sooner and stopped.
Mechanism: Oral Janus kinase (JAK) inhibitor that blocks JAK enzymes inside immune cells, interrupting the signals of several inflammatory cytokines
Side effects and safety
- Allergic reactions. Anaphylaxis and angioedema have been reported. Do not take Rinvoq if allergic to upadacitinib or its ingredients.
- Stomach or bowel tears. Seek care for new belly pain, especially with a history of diverticulitis or while taking NSAIDs or steroids.
- Low blood sugar in diabetes. Severe hypoglycemia has been reported after starting JAK inhibitors in people with diabetes; blood sugar may need closer checks.
- Lab changes. Low neutrophils, lymphocytes or hemoglobin, higher cholesterol and liver enzyme rises. Treatment is not started or is paused if counts fall too low.
- Harm to an unborn baby. Use effective birth control during treatment and for 4 weeks after the last dose. Breastfeeding is not recommended during treatment and for 6 days after the last dose.
- Live vaccines. Avoid live vaccines during or just before treatment, and bring vaccines, including shingles vaccine, up to date first.
- Tuberculosis testing before starting and during treatment
- Hepatitis B and C screening before starting
- Blood counts at baseline and during treatment; not started or paused if lymphocytes are below 500, neutrophils below 1,000 or hemoglobin below 8 g/dL
- Cholesterol about 12 weeks after starting
- Liver enzymes at baseline and during treatment
- Pregnancy status before starting
- Periodic skin exams for people at higher risk of skin cancer
Rinvoq carries a boxed warning. It raises the risk of serious infections that can lead to hospitalization or death, including tuberculosis, invasive fungal infections and shingles, mostly in people also taking immune-suppressing drugs such as methotrexate or steroids, so people are tested for tuberculosis before and during treatment. Lymphoma and other cancers have occurred on Rinvoq. In a large safety study of another JAK inhibitor in people with rheumatoid arthritis, that drug had higher rates of death (including sudden cardiac death), cancer (including lymphoma and lung cancer), major heart events (heart attack, stroke or cardiovascular death) and blood clots than TNF-blocker drugs; the death, heart and clot findings were in people 50 or older with at least 1 heart risk factor, and current or past smokers faced extra risk. Blood clots in the legs, lungs and arteries, some fatal, have also occurred with JAK inhibitors including Rinvoq, so it should be avoided in people at high clot risk and stopped if clot symptoms appear, and it is stopped after a heart attack or stroke. Other warnings cover allergic reactions, tears in the stomach or bowel, low blood sugar in people with diabetes, lab changes (low blood counts, higher cholesterol, liver enzyme rises) and harm to an unborn baby. In the 52-week GCA trial, side effects seen in at least 5% on Rinvoq 15 mg, against placebo, were upper respiratory infections (21.5% against 20.5%), headache (16.3% against 11.6%), fatigue (9.1% against 5.4%), swelling of the legs or feet (8.6% against 2.7%), cough (7.2% against 3.6%), anemia (6.7% against 2.7%), rash (5.7% against 2.7%), shingles (5.3% against 2.7%) and nausea (5.3% against 3.6%). Vein clots occurred at similar rates (3.9 against 4.3 per 100 patient-years), while 2 patients on Rinvoq had arterial clots against none on placebo[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Upadacitinib
For GCA, 15 mg by mouth once a day together with a tapering course of steroids; once steroids are stopped, Rinvoq 15 mg can be continued alone. The tablet is swallowed whole, not split, crushed or chewed, with or without food. No dose change is needed for kidney impairment or mild to moderate liver impairment, but it is not recommended with severe liver impairment (Child-Pugh C). Strong CYP3A4 inducers such as rifampin are not recommended, and grapefruit should be avoided. Before starting, doctors check for tuberculosis and hepatitis, check blood counts and liver tests, confirm pregnancy status and update vaccines. It is not recommended with other JAK inhibitors, biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine[1].
Availability and cost
Only available as the brand-name product.
Help paying for Rinvoq
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
RINVOQ Complete Savings Card: eligible commercially insured patients may pay as little as $0 a month. Maximum annual benefit of $14,000 per calendar year. Under the terms, patients whose plans use an accumulator or copay maximizer program are not eligible, and AbbVie may stop support after no more than $4,000 if it finds a maximizer program. Not valid with Medicare, Medicaid, TRICARE, VA, DoD or other government coverage.
For: private insurance · source - Insurance and case manager help
RINVOQ Complete Insurance Specialists explain coverage and look for savings options regardless of insurance type at 1-800-2RINVOQ (1-800-274-6867).
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source - Other support
For people on Medicare, the page points to the government Extra Help program and says that if you are not eligible for Extra Help, Rinvoq may still be available at no additional cost; call an Insurance Specialist to learn more.
For: Medicare · source - Free medicine program
Patients who are uninsured or otherwise unable to pay may be eligible for AbbVie's patient assistance program, myAbbVie Assist.
For: no insurance, underinsured · source
Good to know: A RINVOQ Complete Rebate is also offered on rinvoq.com for commercially insured patients whose pharmacy does not accept the card. The myAbbVie Assist page on abbvie.com blocked automated access, so the free-drug offer is sourced to AbbVie's April 29, 2025 GCA approval release; income limits were not checked.
No charity fund for this condition is open right now. Funds reopen when they receive new donations; the foundations let you sign up to be told when one opens.
Access and eligibility
For GCA, approved for adults. SELECT-GCA enrolled people 50 or older with new-onset or relapsing GCA. Not recommended with other JAK inhibitors, biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine, or with severe liver impairment, and it should not be started during an active serious infection.
Source: RINVOQ Complete savings and support
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
The GCA approval rested on SELECT-GCA (NCT03725202), a Phase 3 trial of 428 adults 50 or older with new-onset or relapsing GCA, randomized to Rinvoq 15 mg, upadacitinib 7.5 mg or placebo for 52 weeks. Everyone took steroids: the upadacitinib groups tapered to zero over 26 weeks and the placebo group over 52 weeks. Sustained remission from week 12 to week 52, the main goal, was reached by 46.4% on Rinvoq 15 mg against 29.0% on placebo. Sustained complete remission, which also required normal blood inflammation markers (ESR and CRP), was reached by 37.1% against 16.1%. The total steroid dose over the year was lower on Rinvoq, a median of 1,615 mg against 2,882 mg[1]. The 7.5 mg dose did not beat placebo on the main goal and is not an approved GCA dose. The trial was published in the New England Journal of Medicine in 2025[5].
Development history
AbbVie discovered and developed upadacitinib, studied under the code ABT-494[6][4]. The FDA first approved Rinvoq on August 16, 2019 for rheumatoid arthritis[3]. Its other approved uses now include psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis and polyarticular juvenile idiopathic arthritis[1]. The FDA approved it for adults with giant cell arteritis on April 28, 2025[2], and AbbVie announced the approval the next day, calling Rinvoq the first and only oral JAK inhibitor approved for GCA[4]. Tocilizumab (Actemra), an injected IL-6 receptor blocker, has been approved for GCA since May 22, 2017[7].
Explore Giant Cell Arteritis trials
Other Giant Cell Arteritis treatments
GCA is treated first with high-dose glucocorticoids (steroids) that are tapered over months. Medicines approved to use alongside the taper include tocilizumab (Actemra), an IL-6 receptor blocker given under the skin weekly or every other week or by IV infusion every 4 weeks, and upadacitinib (Rinvoq), a daily pill.
Common questions about Upadacitinib
▸What is Upadacitinib (Rinvoq)?
A once-daily extended-release tablet that the FDA approved for adults with giant cell arteritis (GCA) on April 28, 2025, taken with a tapering course of steroids and continued alone once steroids stop. In its main trial, 46% of people on Rinvoq with a 26-week steroid taper stayed in sustained remission from week 12 to week 52, against 29% on placebo with a 52-week taper. It carries a boxed warning for serious infections, death, cancer, major heart events and blood clots.
▸How does Upadacitinib work?
In GCA, the immune system inflames the walls of large and medium arteries, including the temporal and other arteries of the head and the aorta[4]. Immune cells drive that inflammation by sending signals called cytokines, and many of those signals are passed along inside the cell by enzymes called Janus kinases (JAKs). Upadacitinib blocks JAK enzymes so the signals are not passed on, and in lab tests it blocked JAK1-driven signals more strongly than JAK2-driven ones[1]. The GCA trial authors note that this blocks signaling by several cytokines, including interleukin-6 and interferon-gamma[5]. The goal is to control the arteritis so steroids can be tapered sooner and stopped.
▸What are the side effects of Upadacitinib?
Rinvoq carries a boxed warning. It raises the risk of serious infections that can lead to hospitalization or death, including tuberculosis, invasive fungal infections and shingles, mostly in people also taking immune-suppressing drugs such as methotrexate or steroids, so people are tested for tuberculosis before and during treatment. Lymphoma and other cancers have occurred on Rinvoq. In a large safety study of another JAK inhibitor in people with rheumatoid arthritis, that drug had higher rates of death (including sudden cardiac death), cancer (including lymphoma and lung cancer), major heart events (heart attack, stroke or cardiovascular death) and blood clots than TNF-blocker drugs; the death, heart and clot findings were in people 50 or older with at least 1 heart risk factor, and current or past smokers faced extra risk. Blood clots in the legs, lungs and arteries, some fatal, have also occurred with JAK inhibitors including Rinvoq, so it should be avoided in people at high clot risk and stopped if clot symptoms appear, and it is stopped after a heart attack or stroke. Other warnings cover allergic reactions, tears in the stomach or bowel, low blood sugar in people with diabetes, lab changes (low blood counts, higher cholesterol, liver enzyme rises) and harm to an unborn baby. In the 52-week GCA trial, side effects seen in at least 5% on Rinvoq 15 mg, against placebo, were upper respiratory infections (21.5% against 20.5%), headache (16.3% against 11.6%), fatigue (9.1% against 5.4%), swelling of the legs or feet (8.6% against 2.7%), cough (7.2% against 3.6%), anemia (6.7% against 2.7%), rash (5.7% against 2.7%), shingles (5.3% against 2.7%) and nausea (5.3% against 3.6%). Vein clots occurred at similar rates (3.9 against 4.3 per 100 patient-years), while 2 patients on Rinvoq had arterial clots against none on placebo[1].
▸How is Upadacitinib taken?
For GCA, 15 mg by mouth once a day together with a tapering course of steroids; once steroids are stopped, Rinvoq 15 mg can be continued alone. The tablet is swallowed whole, not split, crushed or chewed, with or without food. No dose change is needed for kidney impairment or mild to moderate liver impairment, but it is not recommended with severe liver impairment (Child-Pugh C). Strong CYP3A4 inducers such as rifampin are not recommended, and grapefruit should be avoided. Before starting, doctors check for tuberculosis and hepatitis, check blood counts and liver tests, confirm pregnancy status and update vaccines. It is not recommended with other JAK inhibitors, biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine[1].
▸Is Upadacitinib FDA approved?
Yes, Upadacitinib (Rinvoq) is FDA approved (2019) for the treatment of Giant Cell Arteritis.
▸Is Rinvoq approved for giant cell arteritis?
Yes. The FDA approved Rinvoq 15 mg once daily for adults with giant cell arteritis on April 28, 2025, and AbbVie announced it the next day. It is taken with a tapering course of steroids and can be continued alone once steroids stop.
▸Can I stop steroids on Rinvoq for GCA?
That is the aim. In SELECT-GCA, people on Rinvoq 15 mg tapered steroids to zero over 26 weeks, and 46.4% stayed in sustained remission from week 12 to week 52, against 29.0% on placebo with a 52-week taper. The label allows Rinvoq 15 mg to continue alone after steroids stop. Your rheumatologist sets the taper schedule.
▸What does the Rinvoq boxed warning mean?
It warns about serious infections, including tuberculosis, and about higher rates of death, cancer, heart attack, stroke and blood clots seen with another JAK inhibitor compared with TNF blockers in people with rheumatoid arthritis, mostly those 50 or older with a heart risk factor. Lymphoma, other cancers and blood clots have occurred with Rinvoq too. Your doctor will test for tuberculosis and hepatitis first and weigh these risks, especially if you smoke or have heart disease.
▸How is Rinvoq different from Actemra for GCA?
Rinvoq is a once-daily pill that blocks JAK enzymes inside immune cells, while Actemra (tocilizumab) blocks the IL-6 receptor and is given as an injection under the skin or an IV infusion. Both are approved for adults with GCA alongside a steroid taper. Each was tested against placebo, not against the other, so neither label shows one working better.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2026-06. RINVOQ (upadacitinib) extended-release tablets and RINVOQ LQ oral solution: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2966aec7-2ef0-923c-d8ff-fe1a957bf095
- U.S. Food and Drug Administration · 2025-04-28. NDA 211675/S-025 supplement approval (giant cell arteritis). https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211675Orig1s025ltr.pdf
- U.S. Food and Drug Administration · 2019-08-16. NDA 211675 approval letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211675Orig1s000ltr.pdf
- AbbVie · 2025-04-29. RINVOQ (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis (GCA). https://news.abbvie.com/2025-04-29-RINVOQ-R-upadacitinib-Receives-U-S-FDA-Approval-for-Giant-Cell-Arteritis-GCA
- New England Journal of Medicine · 2025. A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis. https://www.nejm.org/doi/full/10.1056/NEJMoa2413449
- ClinicalTrials.gov. SELECT-GCA: upadacitinib in giant cell arteritis. https://clinicaltrials.gov/study/NCT03725202
- U.S. Food and Drug Administration · 2017-05-22. BLA 125472/S-024 supplement approval (Actemra subcutaneous, giant cell arteritis). https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125472Orig1s024ltr.pdf
- AbbVie. RINVOQ Cost Support and Savings Card. https://www.rinvoq.com/resources/save-on-rinvoq-costs