[{"_1":2,"_67":-5,"_68":-5},"loaderData",{"_3":4,"_12":13},"root",{"_5":-5,"_6":7,"_8":9,"_10":11},"user","recaptchaSiteKey","6Ler9Q4rAAAAAIntb4jBhAbPRXMJSQVneAzxg5M8","sentryTrace","9d624389565f9dfa42ad35136973a2fb-6fcd67c83646c3ff-0","sentryBaggage","sentry-environment=production,sentry-public_key=fbef35ac88c344bffa6f98009cf3736c,sentry-trace_id=9d624389565f9dfa42ad35136973a2fb,sentry-org_id=4505908219871232,sentry-sampled=false,sentry-sample_rand=0.8949966201343891,sentry-sample_rate=0.5","routes/domain.$domainId",{"_14":15,"_63":64,"_5":-5,"_65":66},"domain",{"_16":17,"_14":18,"_19":20,"_21":22,"_23":24,"_25":26,"_27":28,"_29":-5,"_30":-5,"_31":-5,"_32":33,"_43":44,"_49":50,"_61":62},"id","cmizk0tw50006ju02yczi75m4","www.rinvoqhcp.com","screenshotPath","sites/www.rinvoqhcp.com/screenshot.jpg","htmlPath","sites/www.rinvoqhcp.com/index.html","metaDescription","Learn about RINVOQ® (upadacitinib), approved for RA, PsA, AS, nr-axSpA, pJIA, GCA, AD, UC, and CD. See full Prescribing Information and Important Safety Information, including BOXED WARNING.","importantText","RINVOQ® (upadacitinib) - Official Healthcare Professional Site \n\nClose\n\n[\n\n![](/content/dam/global/brand-explorer-product-rinvoq.png)\n\n\n\n](https://www.rinvoqhcp.com/)\n\n**Please see Important Safety Information, including BOXED WARNING on Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis.**\n\n* * *\n\n[Rheumatoid Arthritis](https://www.rinvoqhcp.com/rheumatoid-arthritis)\n\n[Psoriatic Arthritis](https://www.rinvoqhcp.com/psoriatic-arthritis)\n\n[Ankylosing Spondylitis](https://www.rinvoqhcp.com/axspa)\n\n[Non-radiographic Axial Spondyloarthritis](https://www.rinvoqhcp.com/axspa)\n\n[Giant Cell Arteritis](https://www.rinvoqhcp.com/giant-cell-arteritis)\n\n[Atopic Dermatitis](https://www.rinvoqhcp.com/atopic-dermatitis)\n\n[Ulcerative Colitis](https://www.rinvoqhcp.com/ulcerative-colitis)\n\n[Crohn’s Disease](https://www.rinvoqhcp.com/crohns-disease)\n\n[Visit RINVOQhcp.com](https://www.rinvoqhcp.com/)\n\n[\n\n![](/content/dam/global/brand-explorer-product-skyrizi.png)\n\n\n\n](https://www.skyrizihcp.com)\n\n* * *\n\n[Plaque Psoriasis](https://www.skyrizihcp.com/dermatology)\n\n[Psoriatic Arthritis](https://www.skyrizihcp.com/rheumatology)\n\n[Ulcerative Colitis](https://www.skyrizihcp.com/gastroenterology/ulcerative-colitis)\n\n[Crohn's Disease](https://www.skyrizihcp.com/gastroenterology/crohns-disease)\n\n[Visit SKYRIZIhcp.com](https://www.skyrizihcp.com/)\n\n[\n\n![](/content/dam/global/brand-explorer-product-humira.png)\n\n\n\n](https://www.humirapro.com)\n\n**Please see Important Safety Information, including BOXED WARNING on Serious Infections and Malignancy.**\n\n* * *\n\n[Hidradenitis Suppurativa](https://www.humirapro.com/hidradenitis-suppurativa)\n\n[Juvenile Idiopathic Arthritis](https://www.humirapro.com/jia)\n\n[Pediatric Crohn's Disease](https://www.humirapro.com/pediatric-crohns-disease)\n\n[Pediatric Ulcerative Colitis](https://www.humirapro.com/pediatric-ulcerative-colitis)\n\n[Pediatric Uveitis](https://www.humirapro.com/uveitis-pediatric)\n\n[Uveitis (Adult)](https://www.humirapro.com/uveitis)\n\n[Other Indications](https://www.humirapro.com/)\n\n[Visit HUMIRApro.com](https://www.humirapro.com/)\n\n**US-MULT-250253**\n\n[\n\n](http://www.abbvie.com \"brand explorer logo\")\n\nImmunology Therapies\n\nContact Medical Info\n\n[Full Prescribing Information](/prescribinginfo)\n\n[Patient Site](/patientsite)\n\n[Skip to Main Content](#main-content)\n\n[![RINVOQ® (upadacitinib) 15 mg tablets logo.](/content/dam/rinvoqhcpivy/images/logo/rinvoq-logo_white.png \"RINVOQ® (upadacitinib) 15 mg tablets logo.\")](/)\n\n[](/search-results)\n\n* [Rheumatology](/rheumatology)\n* [Dermatology](/dermatology)\n* [Gastroenterology](/gastroenterology)\n* [Safety](/safety)\n* [Dosing & Lab Monitoring](/dosing-lab-monitoring)\n* [Support & Resources](#)\n \n * [RINVOQ Complete Support](/patient-support)\n * [Resources & Forms](/resources)\n * [Access](/access)\n * [Contact a Rep](/contact-a-rep)\n \n* [MOA](/mechanism-of-action)\n\n### INDICATIONS & IMPORTANT SAFETY INFORMATION:\n\nWARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis\n\nREACH FOR RINVOQ AND \nCHALLENGE \nTREATMENT GOALS\n==================================================\n\n ![Approved First-Line For Giant Cell Arteritis (GCA).](/content/dam/rinvoqhcpivy/images/rheumatology/approved_gca_bug.png)\n\n### Rheumatology1\n\n[Rheumatoid Arthritis](/rheumatoid-arthritis)\n\nfor moderate to severe adult TNFi-IR patients\n\n[Psoriatic Arthritis](/psoriatic-arthritis)\n\nfor adult TNFi-IR patients\n\n[Ankylosing Spondylitis](/axspa)\n\nfor adult TNFi-IR patients\n\n[Non-radiographic Axial \nSpondyloarthritis](/axspa)\n\nfor adult TNFi-IR patients with objective signs of inflammation\n\n[Giant Cell Arteritis](/giant-cell-arteritis)\n\nfor adult patients\n\n ![RINVOQ® (upadacitinib) and RINVOQ® (upadacitinib) LQ 1 mg/mL oral solution logos.](/content/dam/rinvoqhcpivy/images/icons/rheum-peds-lq-combo.png)\n\n[Polyarticular Juvenile Idiopathic Arthritis](/content/dam/rinvoqhcpivy/docs/digital-rheum-pediatric-core-leave-behind-sp.pdf)\n\nfor pediatric TNFi-IR patients 2+ years\n\n[Juvenile Psoriatic Arthritis](/content/dam/rinvoqhcpivy/docs/digital-rheum-pediatric-core-leave-behind-sp.pdf)\n\nfor pediatric TNFi-IR patients 2+ years\n\n### Dermatology1\n\n[Atopic Dermatitis](/atopic-dermatitis)\n\nfor moderate to severe patients 12+ years not adequately controlled with other systemic drug products, including biologics\n\n### Gastroenterology1\n\n[Crohn’s Disease](/crohns-disease)\n\nfor moderate to severe adult TNFi-IR patients\n\n[Ulcerative Colitis](/ulcerative-colitis)\n\nfor moderate to severe adult TNFi-IR patients\n\nAbbVie's Commitment to Exceptional Patient Support\n--------------------------------------------------\n\n ![](/content/dam/rinvoqhcpivy/images/icons/icon-notebook-black.svg)\n\n**RINVOQ® Complete** \nto help patients start and stay on track with their prescribed treatment plan\n\n[Learn About RINVOQ Complete](/patient-support)\n\n ![](/content/dam/rinvoqhcpivy/images/icons/icon-folder-black.svg)\n\n**Resources & Forms** \nexplore resources and download the forms you need to get started\n\n[Download Resources & Forms](/resources)\n\nIR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor.\n\n### IMPORTANT SAFETY INFORMATION & INDICATIONS1\n\n### INDICATIONS1\n\n**RINVOQ is indicated for the treatment of:**\n\n* **Moderately to severely active rheumatoid arthritis (RA)** in adults who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.\n* **Active ankylosing spondylitis (AS)** in adults who have had an inadequate response or intolerance to one or more TNF blockers.\n* **Active non-radiographic axial spondyloarthritis (nr-axSpA)** with objective signs of inflammation in adults who have had an inadequate response or intolerance to TNF blocker therapy.\n* **Giant cell arteritis (GCA)** in adults.\n\n**Limitations of Use:** RINVOQ is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (bDMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.\n\n* **Refractory, moderate to severe atopic dermatitis (AD)** in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.\n\n**Limitations of Use:** RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.\n\n* **Moderately to severely active ulcerative colitis (UC)** in adults who have had an inadequate response or intolerance to one or more TNF blockers.\n* **Moderately to severely active Crohn's disease (CD)** in adults who have had an inadequate response or intolerance to one or more TNF blockers.\n\n**Limitations of Use:** RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis or Crohn’s disease, or with potent immunosuppressants such as azathioprine and cyclosporine.\n\n**RINVOQ/RINVOQ LQ is indicated for the treatment of:**\n\n* **Active psoriatic arthritis (PsA)** in adults and pediatric patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.\n* **Active polyarticular juvenile idiopathic arthritis (pJIA)** in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.\n\n**Limitations of Use:** RINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, bDMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.\n\n### IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)\n\n### SERIOUS INFECTIONS\n\n**Patients treated with RINVOQ\\* are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ until the infection is controlled.**\n\n**Reported infections include:**\n\n* **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent TB infection prior to RINVOQ use.**\n* **Invasive fungal infections, including cryptococcosis and pneumocystosis.**\n* **Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.**\n\n**Carefully consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**\n\n### MORTALITY\n\n**In a large, randomized, postmarketing safety study comparing another Janus kinase (JAK) inhibitor with tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients ≥50 years old with at least one cardiovascular (CV) risk factor, a higher rate of all-cause mortality, including sudden CV death, was observed with the JAK inhibitor.** Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ.\n\n### MALIGNANCIES\n\n**Lymphoma and other malignancies have been observed in patients treated with RINVOQ.**\n\n**In a large, randomized, postmarketing safety study comparing another JAK inhibitor with TNF blockers in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer \\[NMSC\\]), lymphomas, and lung cancer (in current or past smokers) was observed with the JAK inhibitor. Patients who are current or past smokers are at additional increased risk.**\n\nWith RINVOQ, consider the benefits and risks for the individual patient prior to initiating or continuing therapy, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers. NMSCs have been reported in patients treated with RINVOQ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. Advise patients to limit sunlight exposure by wearing protective clothing and using sunscreen.\n\n### MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)\n\n**In a large, randomized, postmarketing study comparing another JAK inhibitor with TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with the JAK inhibitor. Patients who are current or past smokers are at additional increased risk. Discontinue RINVOQ in patients that have experienced a myocardial infarction or stroke.**\n\nConsider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ, particularly in patients who are current or past smokers and patients with other CV risk factors. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.\n\n### THROMBOSIS\n\n**Thromboses, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated for inflammatory conditions with JAK inhibitors, including RINVOQ. Many of these adverse events were serious and some resulted in death.**\n\n**In a large, randomized, postmarketing study comparing another JAK inhibitor to TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a higher rate of thrombosis was observed with the JAK inhibitor. Avoid RINVOQ in patients at risk. Patients with symptoms of thrombosis should discontinue RINVOQ and be promptly evaluated.**\n\n### HYPERSENSITIVITY\n\nRINVOQ is **contraindicated** in patients with known hypersensitivity to upadacitinib or any of its excipients. Serious hypersensitivity reactions, such as anaphylaxis and angioedema, were reported in patients receiving RINVOQ in clinical trials. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.\n\n### GASTROINTESTINAL PERFORATIONS\n\nGastrointestinal (GI) perforations have been reported in clinical trials with RINVOQ. Monitor RINVOQ-treated patients who may be at risk for GI perforation (e.g., patients with a history of diverticulitis and patients taking NSAIDs or corticosteroids). Promptly evaluate patients presenting with new onset abdominal pain for early identification of GI perforation.\n\n### LABORATORY ABNORMALITIES\n\n**Neutropenia** \nTreatment with RINVOQ was associated with an increased incidence of neutropenia (absolute neutrophil count \\[ANC\\] <1000 cells/mm3). Treatment with RINVOQ is not recommended in patients with an ANC <1000 cells/mm3. Evaluate neutrophil counts at baseline and thereafter according to routine patient management.\n\n**Lymphopenia** \nAbsolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ-treated patients. Treatment with RINVOQ is not recommended in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.\n\n**Anemia** \nDecreases in hemoglobin levels to <8 g/dL were reported in RINVOQ-treated patients. Treatment should not be initiated or should be interrupted in patients with hemoglobin levels <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.\n\n**Lipids** \nTreatment with RINVOQ was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Manage patients according to clinical guidelines for the management of hyperlipidemia. Evaluate patients 12 weeks after initiation of treatment and thereafter according to the clinical guidelines for hyperlipidemia.\n\n**Liver enzyme elevations** \nTreatment with RINVOQ was associated with increased incidence of liver enzyme elevation compared to placebo. Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are observed during routine patient management and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.\n\n### EMBRYO-FETAL TOXICITY\n\nBased on findings in animal studies, RINVOQ may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RINVOQ and for 4 weeks after the final dose. Verify pregnancy status of females of reproductive potential prior to starting treatment with RINVOQ.\n\n### VACCINATION\n\nAvoid use of live vaccines during, or immediately prior to, RINVOQ therapy. Prior to initiating RINVOQ, patients should be brought up to date on all immunizations, including prophylactic varicella zoster or herpes zoster vaccinations, in agreement with current immunization guidelines.\n\n### MEDICATION RESIDUE IN STOOL\n\nReports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. Most reports described anatomic or functional GI conditions with shortened GI transit times. Instruct patients to contact their healthcare provider if medication residue is observed repeatedly. Monitor patients clinically and consider alternative treatment if there is an inadequate therapeutic response.\n\n### LACTATION\n\nThere are no data on the presence of RINVOQ in human milk, the effects on the breastfed infant, or the effects on milk production. Available data in animals have shown the excretion of RINVOQ in milk. Advise patients that breastfeeding is not recommended during treatment with RINVOQ and for 6 days after the last dose.\n\n### HEPATIC IMPAIRMENT\n\nRINVOQ is not recommended for use in patients with severe hepatic impairment.\n\n### ADVERSE REACTIONS\n\nThe most common adverse reactions in RINVOQ clinical trials were upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, headache, peripheral edema, increased blood creatine phosphokinase, hypersensitivity, folliculitis, abdominal pain, increased weight, influenza, fatigue, neutropenia, myalgia, influenza-like illness, elevated liver enzymes, rash, and anemia.\n\nInform patients that retinal detachment has been reported in clinical trials with RINVOQ. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision while receiving RINVOQ.\n\n**Dosage Forms and Strengths:** RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. RINVOQ LQ is available in a 1 mg/mL oral solution.\n\n\\*Unless otherwise stated, “RINVOQ” in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ.\n\nUS-RNQ-250017\n\nPlease see full [Prescribing Information](https://www.rxabbvie.com/pdf/rinvoq_pi.pdf \"Full Prescribing Information\").\n\nREFERENCE:\n\n1. RINVOQ \\[package insert\\]. North Chicago, IL: AbbVie Inc.\n\n* [Important Safety Information](#abbv_use_statement)\n* [Prescribing Information (English)](https://www.rxabbvie.com/pdf/rinvoq_pi.pdf)\n* [Información en Español](https://www.rxabbvie.com/pdf/rinvoq_pi_spa.pdf)\n* [Contact Medical Information](#)\n\n* [Site Map](/site-map)\n* [Accessibility Statement](https://www.abbvie.com/accessibility-statement.html)\n* [Contact Us](https://www.abbvie.com/contactus.html)\n* [Terms of Use](https://www.abbvie.com/terms-of-use.html)\n* [Privacy Notice](https://privacy.abbvie/privacy-policies/us-privacy-policy.html)\n* [Cookies Settings](javascript:void\$0\$ \"Cookie Settings\")\n* [Your Privacy Choices](https://abbviemetadata.my.site.com/AbbvieDSRM)\n\n© 2025 AbbVie. All rights reserved. RINVOQ® and its design are registered trademarks of AbbVie Biotechnology Ltd. If you have any questions about this website that have not been answered, [click here](https://www.abbvie.com/contactus.html). This website and the information contained herein is intended for use by US physicians only and is provided for informational purposes only.\n\nUS-RNQR-240780\n\n[](https://www.abbvie.com/)\n\nFootnotes & Definitions\n-----------------------\n\naTEAE: treatment-emergent adverse event, defined as an adverse event with onset on or after first dose of study drug and up to 30 days after last dose of RINVOQ or placebo.1\n\nbRates shown are n/100 PY=number of subjects with at least 1 event per 100 PY.1\n\ncReported as abnormal lymphocyte morphology and not confirmed to be lymphoma.1\n\ndMACE defined as cardiovascular death, myocardial infarction, and stroke.1\n\neVTE: venous thromboembolism includes deep vein thrombosis (DVT) and pulmonary embolism (PE).1\n\nAESI: adverse event of special interest, defined as an adverse event with onset on or after first dose of study drug and up to 30 days after last dose of RINVOQ.\n\nAD=atopic dermatitis; AS=ankylosing spondylitis; CD=Crohn's disease; E/100 PY=events per 100 patient‑years; pJIA=polyarticular juvenile idiopathic arthritis; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; nr-axSpA=non-radiographic axial spondyloarthritis; PsA=psoriatic arthritis; PY=patient-year; RA=rheumatoid arthritis; TB=tuberculosis; UC=ulcerative colitis; VTE=venous thromboembolism.\n\n**REFERENCE:**\n\n1. Data on File. ABVRRTI77110.\n\nUS-RNQ-230377\n\nYou are about to enter a site that is for US Healthcare Professionals Only.\n---------------------------------------------------------------------------\n\nBy selecting \"Yes\" below, you certify that you are a Healthcare Professional and that you wish to proceed to the Healthcare Professionals Only section on the AbbVie Medical Information site. Products or treatments described on this site are available in the US but may not be available in all other countries. I am a licensed Healthcare Professional and wish to proceed to the Healthcare Professionals Only AbbVie Medical Information Site.\n\nConversely, the presence of this link does not imply the linked site's endorsement of rinvoqhcp.com or AbbVie.\n\n**Do you wish to leave this site?**\n\n[Yes](https://www.abbviemedinfo.com/)\n\nNo\n\nUS-RNQ-230377\n\nExit Site\n---------\n\nYou are leaving an AbbVie website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility. \n\nConversely, the presence of this link does not imply the linked site's endorsement of rinvoqhcp.com or AbbVie.\n\n### Do you wish to leave this site?\n\n[Yes](https://npiregistry.cms.hhs.gov/)\n\nNo\n\n \n\n**INDICATIONS & IMPORTANT SAFETY INFORMATION: WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis**\n\n**INDICATIONS & IMPORTANT SAFETY INFORMATION: WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis**\n\n**INDICATIONS & IMPORTANT SAFETY INFORMATION: WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis**\n\n**INDICATIONS & IMPORTANT SAFETY INFORMATION: WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis**\n\n### IMPORTANT SAFETY INFORMATION & INDICATIONS1\n\n### INDICATIONS1\n\n**RINVOQ is indicated for the treatment of:**\n\n* **Moderately to severely active rheumatoid arthritis (RA)** in adults who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.\n* **Active ankylosing spondylitis (AS)** in adults who have had an inadequate response or intolerance to one or more TNF blockers.\n* **Active non-radiographic axial spondyloarthritis (nr-axSpA)** with objective signs of inflammation in adults who have had an inadequate response or intolerance to TNF blocker therapy.\n* **Giant cell arteritis (GCA)** in adults.\n\n**Limitations of Use:** RINVOQ is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (bDMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.\n\n* **Refractory, moderate to severe atopic dermatitis (AD)** in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.\n\n**Limitations of Use:** RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.\n\n* **Moderately to severely active ulcerative colitis (UC)** in adults who have had an inadequate response or intolerance to one or more TNF blockers.\n* **Moderately to severely active Crohn's disease (CD)** in adults who have had an inadequate response or intolerance to one or more TNF blockers.\n\n**Limitations of Use:** RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis or Crohn’s disease, or with potent immunosuppressants such as azathioprine and cyclosporine.\n\n**RINVOQ/RINVOQ LQ is indicated for the treatment of:**\n\n* **Active psoriatic arthritis (PsA)** in adults and pediatric patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.\n* **Active polyarticular juvenile idiopathic arthritis (pJIA)** in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.\n\n**Limitations of Use:** RINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, bDMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.\n\n### IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)\n\n### SERIOUS INFECTIONS\n\n**Patients treated with RINVOQ\\* are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ until the infection is controlled.**\n\n**Reported infections include:**\n\n* **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent TB infection prior to RINVOQ use.**\n* **Invasive fungal infections, including cryptococcosis and pneumocystosis.**\n* **Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.**\n\n**Carefully consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**\n\n### MORTALITY\n\n**In a large, randomized, postmarketing safety study comparing another Janus kinase (JAK) inhibitor with tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients ≥50 years old with at least one cardiovascular (CV) risk factor, a higher rate of all-cause mortality, including sudden CV death, was observed with the JAK inhibitor.** Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ.\n\n### MALIGNANCIES\n\n**Lymphoma and other malignancies have been observed in patients treated with RINVOQ.**\n\n**In a large, randomized, postmarketing safety study comparing another JAK inhibitor with TNF blockers in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer \\[NMSC\\]), lymphomas, and lung cancer (in current or past smokers) was observed with the JAK inhibitor. Patients who are current or past smokers are at additional increased risk.**\n\nWith RINVOQ, consider the benefits and risks for the individual patient prior to initiating or continuing therapy, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers. NMSCs have been reported in patients treated with RINVOQ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. Advise patients to limit sunlight exposure by wearing protective clothing and using sunscreen.\n\n### MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)\n\n**In a large, randomized, postmarketing study comparing another JAK inhibitor with TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with the JAK inhibitor. Patients who are current or past smokers are at additional increased risk. Discontinue RINVOQ in patients that have experienced a myocardial infarction or stroke.**\n\nConsider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ, particularly in patients who are current or past smokers and patients with other CV risk factors. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.\n\n### THROMBOSIS\n\n**Thromboses, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated for inflammatory conditions with JAK inhibitors, including RINVOQ. Many of these adverse events were serious and some resulted in death.**\n\n**In a large, randomized, postmarketing study comparing another JAK inhibitor to TNF blockers in RA patients ≥50 years old with at least one CV risk factor, a higher rate of thrombosis was observed with the JAK inhibitor. Avoid RINVOQ in patients at risk. Patients with symptoms of thrombosis should discontinue RINVOQ and be promptly evaluated.**\n\n### HYPERSENSITIVITY\n\nRINVOQ is **contraindicated** in patients with known hypersensitivity to upadacitinib or any of its excipients. Serious hypersensitivity reactions, such as anaphylaxis and angioedema, were reported in patients receiving RINVOQ in clinical trials. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.\n\n### GASTROINTESTINAL PERFORATIONS\n\nGastrointestinal (GI) perforations have been reported in clinical trials with RINVOQ. Monitor RINVOQ-treated patients who may be at risk for GI perforation (e.g., patients with a history of diverticulitis and patients taking NSAIDs or corticosteroids). Promptly evaluate patients presenting with new onset abdominal pain for early identification of GI perforation.\n\n### LABORATORY ABNORMALITIES\n\n**Neutropenia** \nTreatment with RINVOQ was associated with an increased incidence of neutropenia (absolute neutrophil count \\[ANC\\] <1000 cells/mm3). Treatment with RINVOQ is not recommended in patients with an ANC <1000 cells/mm3. Evaluate neutrophil counts at baseline and thereafter according to routine patient management.\n\n**Lymphopenia** \nAbsolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ-treated patients. Treatment with RINVOQ is not recommended in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.\n\n**Anemia** \nDecreases in hemoglobin levels to <8 g/dL were reported in RINVOQ-treated patients. Treatment should not be initiated or should be interrupted in patients with hemoglobin levels <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.\n\n**Lipids** \nTreatment with RINVOQ was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Manage patients according to clinical guidelines for the management of hyperlipidemia. Evaluate patients 12 weeks after initiation of treatment and thereafter according to the clinical guidelines for hyperlipidemia.\n\n**Liver enzyme elevations** \nTreatment with RINVOQ was associated with increased incidence of liver enzyme elevation compared to placebo. Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are observed during routine patient management and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.\n\n### EMBRYO-FETAL TOXICITY\n\nBased on findings in animal studies, RINVOQ may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RINVOQ and for 4 weeks after the final dose. Verify pregnancy status of females of reproductive potential prior to starting treatment with RINVOQ.\n\n### VACCINATION\n\nAvoid use of live vaccines during, or immediately prior to, RINVOQ therapy. Prior to initiating RINVOQ, patients should be brought up to date on all immunizations, including prophylactic varicella zoster or herpes zoster vaccinations, in agreement with current immunization guidelines.\n\n### MEDICATION RESIDUE IN STOOL\n\nReports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. Most reports described anatomic or functional GI conditions with shortened GI transit times. Instruct patients to contact their healthcare provider if medication residue is observed repeatedly. Monitor patients clinically and consider alternative treatment if there is an inadequate therapeutic response.\n\n### LACTATION\n\nThere are no data on the presence of RINVOQ in human milk, the effects on the breastfed infant, or the effects on milk production. Available data in animals have shown the excretion of RINVOQ in milk. Advise patients that breastfeeding is not recommended during treatment with RINVOQ and for 6 days after the last dose.\n\n### HEPATIC IMPAIRMENT\n\nRINVOQ is not recommended for use in patients with severe hepatic impairment.\n\n### ADVERSE REACTIONS\n\nThe most common adverse reactions in RINVOQ clinical trials were upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, headache, peripheral edema, increased blood creatine phosphokinase, hypersensitivity, folliculitis, abdominal pain, increased weight, influenza, fatigue, neutropenia, myalgia, influenza-like illness, elevated liver enzymes, rash, and anemia.\n\nInform patients that retinal detachment has been reported in clinical trials with RINVOQ. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision while receiving RINVOQ.\n\n**Dosage Forms and Strengths:** RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. RINVOQ LQ is available in a 1 mg/mL oral solution.\n\n\\*Unless otherwise stated, “RINVOQ” in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ.\n\nUS-RNQ-250017\n\nPlease see full [Prescribing Information](https://www.rxabbvie.com/pdf/rinvoq_pi.pdf \"Full Prescribing Information\").\n\n \n\nAbbVie may use and disclose online usage data about you collected automatically through online tracking technologies such as cookies, pixels, and web beacons (collectively, “cookies”). 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