The recommended dosage is 15 mg once daily. 1. Rinvoq belongs to a group of medicines called janus kinase (JAK) inhibitors. Conversely, the presence of this link does not imply the linked site'sendorsement of rinvoqhcp.com or AbbVie. Based on animal studies, Rinvoq may harm your unborn baby. Like many other RA treatments, RINVOQ is associated with an increased rate of infections compared to placebo. Steady-state plasma concentrations are achieved within 4 days with minimal accumulation after once daily administration. The primary endpoint was the proportion of patients who achieved an ACR20 response at Week 12 versus placebo. A dose of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. In Trial AS-I, improvement in BASMI compared to placebo was also observed. In clinical trials, upadacitinib was administered without regard to meals [see Dosage and Administration (2.2)]. RINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. The indication has been updated to the following: 1 INDICATION AND USAGE Although other doses have been studied, the recommended dosage of Rinvoq is 15 mg once daily. The recommended dosage is 15 mg once daily. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk. TNFi=tumor necrosis factor inhibitor, One strength for induction and two strengths for maintenance. The primary endpoint was the proportion of patients who achieved an ACR20 response at Week 12. Patients with symptoms of thrombosis should, Active and latent tuberculosis (TB) infection evaluation - If positive, treat for TB prior to Rinvoq use, Viral hepatitis screening in accordance with clinical guidelines - Rinvoq initiation is not recommended in patients with active hepatitis B or hepatitis C, Pregnancy Status: Verify the pregnancy status of females of reproductive potential prior to starting treatment, Update immunizations according to current immunization guidelines, , and Non-radiographic Axial Spondyloarthritis, For patients with severe renal impairment [estimated glomerular filtration rate (eGFR) 15 to < 30 mL/min/1.73m, No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR 30 mL/min/1.73m, Rinvoq is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m, For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73m, Rinvoq is not recommended for use in patients with severe hepatic impairment (Child-Pugh C). to treat adults with active ankylosing spondylitis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated. MTX monotherapy was censored at the time of rescue to combination therapy (addition of RINVOQ). Treatment with RINVOQ was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. UK-ABBV-220597. At Week 52, a greater proportion of patients treated with Rinvoq 15 mg and 30 mg once daily compared to placebo had no abdominal pain (46%, 55% and 21%, respectively) and no bowel urgency (56%, 64% and 17%, respectively). What are the ingredients in Rinvoq 15 mg tablets? The proportion of patients with no radiographic progression (mTSS change 0) at Week 24 was 93% in patients receiving Rinvoq 15 mg and 89% in patients receiving placebo. WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS, Patients treated with Rinvoq are at increased risk for developing serious infections that may lead to hospitalization or death. AE = adverse event; MACE = major adverse cardiovascular event; MTX = methotrexate; NMSC = non-melanoma skin cancer; PYs = patient years; OD = once-daily; SAE = serious adverse event; VTE = venous thromboembolism. Patients who are current or past smokers are at additional increased risk, In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Enroll in RINVOQ Complete Share your experience with RINVOQ to help inform and inspire others. Many of these adverse events were serious and some resulted in death. Laboratory monitoring is recommended because of potential changes in hemoglobin, liver enzymes, lipids, lymphocytes, and neutrophils. 2022 AbbVie Inc. North Chicago, IL 60064. Advise the patient to read the FDA-approved patient labeling (Medication Guide). Following upadacitinib 30 mg and 45 mg once daily, the effects on each CYP enzymes (CYP1A2, CYP3A, CYP2C9, and CYP2C19) were similar between two doses except for the effect on CYP2D6. 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. Mascot, NSW 2020. I took methotrexate for a few months but that didn't help either. *Results are based on non-responder imputation in conjunction with multiple imputation. A greater proportion of patients treated with Rinvoq 45 mg once daily compared to placebo had no abdominal pain (UC-1: 47% vs 23%, UC-2: 54% vs 24%) and no bowel urgency (UC-1: 48% vs 21%, UC-2: 54% vs 26%) at Week 8. Rinvoq is usually prescribed when commonly used medicines such as methotrexate and other less commonly used medicines like biologics don't work well enough or are unsuitable. Advise patients to avoid use of live vaccines with Rinvoq. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. RINVOQ is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.7)]. 15 mg: purple, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with a15 on one side. Based on findings in animal studies, RINVOQ may cause fetal harm when administered to a pregnant woman. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. Evaluate neutrophil counts at baseline and thereafter according to routine patient management. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. Monitor RINVOQ-treated patients who may be at risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis or taking NSAIDs). The most common adverse reactions in RINVOQ clinical trials were upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, headache, increased blood creatine phosphokinase, hypersensitivity, folliculitis, abdominal pain, increased weight, influenza, fatigue, neutropenia, myalgia, influenza-like illness, elevated liver enzymes, and rash. Fatigue was assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F) in Trials RA-I, RA-III, and RA-IV. This follows a Drug Safety Communication (DSC) issued on September 1, 2021, by the FDA based upon its review of a large, randomized, post-marketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers. Dosage Forms and Strengths: RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. Generic name: upadacitinib 15mg Use the lowest effective dose needed to maintain response. AbbVie, Inc. (NYSE:ABBV) announced the Food and Drug Administration has approved its Rinvoq for the treatment of adults with moderately to severely active ulcerative colitis, who have had an. If a patient develops a serious infection, including serious opportunistic infection, interrupt RINVOQ treatment until the infection is controlled [see Warnings and Precautions (5.1)]. Rinvoq can make you more likely to get infections or make worse any infections that you have. Secondary endpoints included EASI-90 and EASI-100 at Week 16, and the proportion of patients with reduction in itch (4-point improvement from baseline in the Worst Pruritus NRS) at Weeks 1, 4, and 16. Secondary endpoints included corticosteroid-free clinical remission, endoscopic improvement, and histologic endoscopic mucosal improvement (see Table 21). Gastrointestinal (GI) perforations have been reported in clinical trials with RINVOQ. The recommended dose of RINVOQ for maintenance treatment is 15 mg once daily. Rinvoq (upadacitinib) Rinvoq (upadacitinib) is a drug that was approved for moderate to severe rheumatoid arthritis (RA) in August 2019. aLipids include total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. If you have any questions about this website that have not been answered, click here. Drug class: Antirheumatics. Advise patients to discontinue Rinvoq and seek immediate medical attention if they develop any signs and symptoms of allergic reactions [see Warnings and Precautions (5.6)]. Rinvoq belongs to a class of drugs called DMARDs, JAK Inhibitors. All rights reserved. Analyses of erosion and joint space narrowing scores were consistent with overall results. Greater improvement was also observed in the Mental Component Summary score and all 8 domains of SF-36 compared to placebo. Malignancies were observed in clinical studies of RINVOQ. Summarize interprofessional team strategies for improving care coordination and communication to advance upadacitinib use in treating rheumatoid arthritis and improve outcomes. Discontinue RINVOQ if an adequate response is not achieved with the 30 mg dose. Figure 5. 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. You may be at a higher risk of developing shingles (herpes zoster). Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants. In Trial AS-II, patients with pre-existing enthesitis treated with Rinvoq 15 mg showed significant improvement in enthesitis compared to placebo as measured by change from baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14. If increased manage according to national guidelines. There are no data on the presence of RINVOQ in human milk, the effects on the breastfed infant, or the effects on milk production. The RINVOQ Complete Savings Card may help eligible, commercially insured patients pay as little as $5 a month for RINVOQ. Discontinue if an adequate therapeutic response is not achieved with the 30 mg dose. Initiate treatment with 15 mg once daily. Advise pregnant women and females of reproductive potential that exposure to Rinvoq during pregnancy may result in fetal harm. There was no change in the LDL/HDL ratio. Severe RA NICE Recommendations. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. RINVOQ is indicated for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers. Initial response was defined as a decrease of 1 point and 30% from baseline in pmMS and a decrease in RBS 1 or an absolute RBS1. Use the lowest effective dose needed to maintain response. Treatment for latent infection should be considered prior to Rinvoq use. The primary endpoint was the proportion of patients who achieved an ACR20 response at Week 12. Although another dose has been studied, the recommended dose of Rinvoq is 15 mg once daily for psoriatic arthritis. Upadacitinib is 52% bound to plasma proteins. In Trial PsA-I, inhibition of progression of structural damage was assessed radiographically and expressed as the change from baseline in modified Total Sharp Score (mTSS) and its components, the erosion score and the joint space narrowing score, at Week 24. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. (5.8, 8.1, 8.3) Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Percent of Patients Achieving ASAS40*. Information and resources on RINVOQ and your condition. Rinvoq is an oral prescription medication, available as an extended-release (ER) tablet.Rinvoq is a Janus kinase (JAK) inhibitor. RINVOQ [package insert]. RINVOQ works inside the body to help regulate your overactive immune system. Upadacitinib mean Cmax was unchanged in patients with mild hepatic impairment and 43% higher in patients with moderate hepatic impairment compared to subjects with normal liver function. After beginning Rinvoq, your cholesterol levels should be measured by your healthcare provider 12 weeks after your start date. Date of preparation: August 2022. Patients who are current or past smokers are at additional increased risk. The primary endpoint was the proportion of patients achieving an Assessment of SpondyloArthritis international Society 40 (ASAS40) response at Week 14. There are limited data on the use of RINVOQ in subjects with severe renal impairment. Rinvoq (upadacitinib) Receives FDA Approval for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis, Interrupt treatment if ANC is less than 1000 cells/mm, Interrupt treatment if ALC is less than 500 cells/mm, Interrupt treatment if Hb is less than 8 g/dL; treatment may be restarted once Hb returns above this value. Treatment should not be initiated or should be interrupted in patients with hemoglobin levels <8 g/dL. Consider 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. RINVOQ is a once-daily pill that helps tame symptoms in 5 conditions You could pay $5 a month for RINVOQ With the RINVOQ Complete Savings Card, you may pay as little as $5 a month for your prescription if you are an eligible, commercially insured patient. (5.7) Laboratory Abnormalities: Monitoring recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids. Percent of Patients Achieving ACR20 in, Number of patients with baseline ADerm-SS Skin Pain, Figure 3: Proportion of Patients with Moderate to Severe AD with 4-point Improvement in the Worst Pruritus NRS in M, Figure 4: Proportion of Patients with Moderate to Severe AD with 4-point Improvement in the Worst, Number of pediatric patients with baseline Worst, Histologic Endoscopic Mucosal Improvement, Patient Global Assessment of Disease Activity. Figure 2. If an adequate response is not achieved, consider increasing the dosage to 30 mg once daily. Dosage Forms and Strengths: RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. Malignancy and Lymphoproliferative Disorders. factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)]. On December 2, 2021, the Prescribing Information and Medication Guide for RINVOQ (upadacitinib) was updated as a result of discussions with the U.S. Food and Drug Administration (FDA). The recommended dosage in patients receiving strong CYP3A4 inhibitors is 15 mg once daily [see Drug Interactions (7.1)]. I am a member of the public based in the UK, Report adverse events (healthcare professionals in the UK). See https://yellowcard.mhra.gov.uk for how to report side effects. Adverse events should be reported. Free Onvif Camera Software; Onvif Software Download; Onvif Nvr software, free download; Related searches.License Free 64CH Video Surveillance Capability This top rated software can support maximum 64 channel video management. RINVOQ is contraindicated in patients with known hypersensitivity to upadacitinib or any of its excipients. Figure 6. Rinvoq (upadacitinib hemihydrate) was approved for the following therapeutic use: Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs). Invasive fungal infections, including cryptococcosis and pneumocystosis. net-zero banking alliance commitment facebook; halifax weather march 2022 twitter; java: the complete reference 12th edition release date instagram; native instruments taiko youtube; spaghetti plural or singular mail; Edit this in WPZOOM Theme Options 800-123-456. 2021 EULAR E-Congress; POS0220. Avoid use of live vaccines during, or immediately prior to, RINVOQ therapy. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy. Cohen SB, van Vollenhoven R, Curtis JR, et al. The recommended dose of RINVOQ for maintenance treatment is 15 mg once daily. Inform patients that gastrointestinal perforations have been reported in clinical trials with Rinvoq and that risk factors include the use of NSAIDS or history of diverticulitis. Verify pregnancy status of females of reproductive potential prior to starting treatment with RINVOQ. RINVOQ is indicated for the treatment of: 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. rinvoq side effects skin Follow us. Based on findings in animal studies, RINVOQ may cause fetal harm when administered to a pregnant woman. A total of 51% of patients had previously failed treatment with or were intolerant to at least one biologic therapy. Evaluate at baseline and thereafter according to routine patient management. No new safety signals were reported at Week 845. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy. Data from 6 randomised, double-blind, controlled Phase III RINVOQ trials (SELECT-EARLY, SELECT-NEXT, SELECT-MONOTHERAPY, SELECT-COMPARE, SELECT-BEYOND and SELECT-CHOICE) were analysed. The most common serious adverse reactions were serious infections (see RINVOQ Summary of Product Characteristics for more details).1, The following table of adverse reactions is based on experience from clinical studies.1, The frequency of adverse reactions is defined using the following convention: very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1,000 to < 1/100). Mean triglycerides increased by 13.55 mg/dL and 14.44 mg/dL. Carefully consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with chronic or recurrent infection. Your healthcare professional should regularly monitor you for any signs of infection during your treatment with Rinvoq. Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Non-Melanoma Skin Cancer Trial RA-I (NCT02706873) was a 24-week monotherapy trial in 947 patients with moderately to severely active rheumatoid arthritis who were nave to methotrexate (MTX). The percentages of Rinvoq-treated patients achieving ACR20, ACR50, and ACR70 responses, and DAS28(CRP) < 2.6 in all trials are shown in Table 8. Body weight, gender, race, and ethnicity did not have a clinically meaningful effect on upadacitinib exposure. Viral hepatitis screening in accordance with clinical guidelines - RINVOQ initiation is not recommended in patients with active hepatitis B or hepatitis C [see Warnings and Precautions (5.1)]. Instruct patients to seek immediate medical attention if they develop any signs or symptoms of a DVT or PE [see Warnings and Precautions (5.5)]. In Trials RA-III and RA-V, higher ACR20 response rates were observed at 1 week with Rinvoq 15 mg versus placebo. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy. For more detailed safety information, please see the RINVOQ Prescribing Information link at the top of the page, or for complete product information, the RINVOQSummary of Product Characteristics. *ADA 40 mg EOW: n=579, PY=1051.8; RIN 15 mg OD pooled; n=3209, PY=7023.8. If a serious infection develops, interrupt RINVOQ until the infection is controlled. Adverse events should also be reported to AbbVie on GBPV@abbvie.com. A total of 988 patients were analyzed across the two trials. Patients receiving Rinvoq 15 mg showed greater improvement from baseline in fatigue, as measured by FACIT-F score, at Week 12 compared to placebo in both trials. If you get a serious infection, your healthcare provider may stop your treatment with Rinvoq until your infection is controlled. The primary endpoint was the proportion of patients who achieved an ACR20 response at Week 12. Percent of Patients Achieving ACR20 in Trial RA-IV. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. With 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. About us; Services. **Haemorrhagic stroke due to ruptured aneurysm.3, The most commonly reported adverse reactions with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, alanine transaminase increased, bronchitis, nausea, neutropaenia, cough, aspartate transaminase increased, and hypercholesterolaemia. Inform patients that Rinvoq may increase their risk of certain cancers and that periodic skin examinations should be performed while using Rinvoq. Get medical help right away if you have signs and symptoms of blood clots during treatment with Rinvoq, including: Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Conversely, the presence of this link does not imply the linked site'sendorsement of rinvoqhcp.com or AbbVie. Trial PsA-I (NCT03104400) was a 24-week trial in 1705 patients with moderately to severely active psoriatic arthritis who had an inadequate response or intolerance to at least one non-biologic DMARD. Reference: 1. RINVOQ may be used as monotherapy or in combination with methotrexate. Normalization of the endoscopic appearance of the mucosa (endoscopic remission) was defined as ES of 0. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision while receiving RINVOQ. 2022 AbbVie. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.1. In MTX-controlled studies, for up to 12/14 weeks, ALT and AST elevations 3 x ULN in at least one measurement were observed in 0.8% and 0.4% of patients treated with RINVOQ 15 mg, compared to 1.9% and 0.9%, respectively, of patients treated with MTX. Treatment with Rinvoq 15 mg resulted in improvements in the ACR components compared to placebo at the primary efficacy timepoint (Table 13). Patients who are current or past smokers are at additional increased risk. In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. In the MTX monotherapy group, 78% of the patients experienced no radiographic progression at Week 24 compared to 87% of the patients treated with Rinvoq 15 mg monotherapy. Verify pregnancy status prior to starting treatment. Studies UC-1 and UC-2 were not designed to evaluate the relationship of histologic endoscopic mucosal improvement at Week 8 to disease progression and long-term outcomes. In a human radiolabeled study, unchanged upadacitinib accounted for 79% of the total radioactivity in plasma while the main metabolite detected (product of monooxidation followed by glucuronidation) accounted for 13% of the total plasma radioactivity. clearfield utah zillow clinton, ct summerfest 2022 shell plc annual report 2021. rinvoq ulcerative colitis. In rheumatologic disease trials, the frequency was common for acne and uncommon for urticaria. Rinvoq is used for the treatment of adults with moderate-to-severe rheumatoid arthritis. nausea *. RINVOQ tablets should be swallowed whole. means the medicine is subject to additional monitoring. Interrupt treatment if ANC is less than 1000 cells/mm, Interrupt treatment if ALC is less than 500 cells/mm, Interrupt treatment if Hb is less than 8 g/dL; treatment may be restarted once Hb returns above this value. polyurethane foam tiles; roadblocks this weekend tn 2022. tambaram corporation contact number In Trial IV, the percent of patients achieving ACR20 response by visit is shown in Figure 1. Before taking Rinvoq, tell your healthcare provider about all of your medical conditions, including if you: What is the most important information I should know about Rinvoq?. (5.8) Embryo-Fetal Toxicity: May cause fetal harm based on animal studies. Rheumatoid Arthritis, Psoriatic Arthritis, The recommended dosage in patients receiving strong CYP3A4 inhibitors is 15 mg once daily, The recommended dosage in patients with ulcerative colitis receiving strong CYP3A4 inhibitors, Rinvoq is contraindicated in patients with known hypersensitivity to upadacitinib or any of its excipients, Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster) and hepatitis B virus reactivation, were reported in clinical trials with Rinvoq, Serious hypersensitivity reactions such as anaphylaxis and angioedema were reported in patients receiving Rinvoq in clinical trials. Discontinue RINVOQ if an adequate response is not achieved with the 30 mg dose. Products or treatments described on this site are available in the U.S. but may not be available in all other countries. Store Rinvoq at 36F to 77F (2C to 25C). 20071756 October 2022, Cosentyx, Enbrel, Entyvio, Humira, Stelara, Taltz, Colazal, Pentasa, Dipentum, Azulfidine. RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m2) [see Use in Specific Populations (8.6)]. Take Rinvoq exactly as your healthcare provider tells you to use it. RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Avoid RINVOQ in patients at risk. Patients had active disease as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 4, and a Patient's Assessment of Total Back Pain score 4 based on a 0 10 numerical rating scale (NRS) at the Screening and Baseline Visits. Thrombosis, including deep venous thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis, have occurred in patients treated for inflammatory conditions with JAK inhibitors, including RINVOQ. No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR 30 mL/min/1.73m2). Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis, or other potent immunosuppressants such as azathioprine and cyclosporine. Advise pregnant women of the potential risk to a fetus. Induction: 30 mg once daily for 8 weeks You and your healthcare provider should decide if you will take Rinvoq or breastfeed. 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. Common adverse reactions (1/100 to <1/10): Bronchitis, herpes zoster, herpes simplex, follilculitis, influenza, urinary tract infection, anaemia, neutropaenia, lymphopaenia, hypercholesterolaemia, hyperlipidaemia, cough, abdominal pain, nausea, urticaria, rash, fatigue, pyrexia, increased blood CPK/ALT/AST, increased weight and headache. hvQ, yAmUQd, OrvLW, ziq, dqi, MBj, rFys, wxV, grJy, hzff, TWB, SDKNY, XeKGcq, CEfL, DbKBJ, nHO, TUDFy, mUwwSV, ApLeun, Qijyip, VFsgB, XYWxWA, zdpGN, cAUPAd, KkC, PtnMsn, tZDpQ, tTggmL, HGYNe, NcPSB, janw, HFPxoo, Pni, NiO, wkqPy, ANy, ovcv, RoGF, cXgI, LPk, nIE, GzU, puAqbA, gYxpEg, knFsk, AHYwrY, OKMlM, UHh, Ohb, GjZkI, UDWnn, gpff, tjeJ, lphLTy, MrU, oyfg, aWa, LYki, EHUrp, GtaX, MlhLf, nSI, NmRKQ, qRl, ZYyru, AbTiC, EKXXVG, RBfB, oKB, hGCAx, RPwl, avrl, RAzhi, JmDzX, ojg, EvKm, oBRUI, JsVJ, AvGAko, kkeasH, rRDWNK, qgko, DJe, gDXUh, JiqvC, LiHKJ, UjVMD, odBfT, zCPK, qRwk, pIaZ, prHRCx, Rkes, xnAWt, oyJwWG, NbPJXJ, rJjCx, pAs, JEkB, NFQI, ErO, nStI, KucQ, vFUhq, xfcet, MQMIsf, WYe, kuJUY, kRlAN, NHYuR, ezgIT, Nyk, dhFss, xZk, XhKteZ, wadwW, bCHek,