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RINVOQ® (upadacitinib) 15 mg tablets logo. For adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable
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INDICATIONS & IMPORTANT SAFETY INFORMATION:

WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis

IMPORTANT SAFETY INFORMATION & INDICATION1

INDICATION1

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.

Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)

SERIOUS INFECTIONS

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.

Reported infections include:

  • 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.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

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.

MORTALITY

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.

MALIGNANCIES

Lymphoma and other malignancies have been observed in patients treated with RINVOQ.

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.

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. 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.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

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.

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. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

THROMBOSIS

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with JAK inhibitors used to treat inflammatory conditions. Many of these adverse events were serious and some resulted in death.

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.

HYPERSENSITIVITY

RINVOQ 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.

GASTROINTESTINAL PERFORATIONS

Gastrointestinal (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.

LABORATORY ABNORMALITIES

Neutropenia
Treatment 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.

Lymphopenia
Absolute 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.

Anemia
Decreases 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.

Lipids
Treatment 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.

Liver enzyme elevations
Treatment 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.

EMBRYO-FETAL TOXICITY

Based 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.

VACCINATION

Avoid 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.

MEDICATION RESIDUE IN STOOL

Reports 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.

LACTATION

There 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.

HEPATIC IMPAIRMENT

RINVOQ is not recommended for use in patients with severe hepatic impairment.

ADVERSE REACTIONS

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, rash, and anemia.

Inform 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.

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.

*Unless otherwise stated, “RINVOQ” in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ.

US-RNQ-240270

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© 2024 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. This website and the information contained herein is intended for use by US physicians only and is provided for informational purposes only.

MEASURE UP 1 AND 2 STUDY DETAILS

Study Design1-3
Selected Baseline Characteristics2,4

<<Swipe table to see more

Measure Up 1 and 2 study design.

MEASURE UP 1 (N=847) and MEASURE UP 2 (N=836) were phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled studies to evaluate the efficacy and safety of RINVOQ (15 mg or 30 mg) vs placebo over 16 weeks in adult and pediatric (≥12 years) patients with moderate to severe atopic dermatitis. Patients were randomized 1:1:1 to receive RINVOQ 15 mg, RINVOQ 30 mg, or placebo. Patients who completed the original 16-week, double-blind MEASURE UP studies entered the blinded extension treatment period. Following the completion of enrollment of MEASURE UP 1 and MEASURE UP 2, a supplemental study continued to enroll adolescent subjects until 180 adolescents were enrolled in MEASURE UP 1 and 180 adolescents were enrolled in MEASURE UP 2.

Co-primary endpoints:

  • Percentage of patients achieving EASI 75 at Week 16 vs placebo
  • Percentage of patients achieving a vIGA score of 0/1 at Week 16 vs placebo

Select ranked secondary endpoints:

  • Percentage of patients achieving worst pruritus NRS improvement ≥4 at Week 16
  • Percentage of patients achieving EASI 90 at Week 16
  • Percentage of patients achieving worst pruritus NRS improvement ≥4 at Week 4
  • Percentage of patients achieving EASI 75 at Week 2
  • Percentage of patients achieving worst pruritus NRS improvement ≥4 at Week 1
  • Percentage of patients achieving worst pruritus NRS improvement ≥4 at Day 3 (2 days after the first dose; RINVOQ 15 mg)
  • Percentage of patients achieving EASI 100 at Week 16

Key inclusion criteria:

  • Ages 12-75 years
  • Body weight of ≥40 kg at baseline for participants between ≥12 and <18 years of age
  • Chronic AD with onset of symptoms ≥3 years prior to baseline
  • Active moderate to severe AD defined by EASI ≥16, vIGA ≥3, BSA ≥10%, worst pruritus NRS ≥4
  • Candidate for systemic therapy or have recently required systemic therapy for AD
  • Inadequate response to TCS/TCI or documented systemic treatment for AD within 6 months prior to baseline
  • No prior exposure to dupilumab

 

AD=atopic dermatitis; BSA=body surface area; EASI=Eczema Area and Severity Index; Improvement in WP-NRS ≥4= improvement (reduction) in WP-NRS ≥4 points from baseline in patients with NRS >4 at baseline; QD=once a day; TCI=topical calcineurin inhibitor; TCS=topical corticosteroids; vIGA=Validated Investigator Global Assessment; WP-NRS=worst pruritus numerical rating scale.

REFERENCES:

  1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
  2. Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021;397(10290):2151-2168. doi:10.1016/S0140-6736(21)00588-2
  3. Data on File. ABVRRTI77060.
  4. Data on File. ABVRRTI73049.

<<Swipe table to see more

 

MEASURE UP 1

  

MEASURE UP 2
  Placebo (n=281)   RINVOQ® (upadacitinib) 15 mg (n=281)   RINVOQ 30 mg (n=285)   Placebo (n=278)   RINVOQ 15 mg (n=276)   RINVOQ 30 mg (n=282)
Female, % 49   44   46   45   44   43
Mean age, years 34   34   34   33   33   34
<18 years age, % 14   15   15   13   12   12
≥18 years age, % 86   85   85   87   88   88
Race,%                      
-White 65   65   67   70   67   70
-Black or African American 7   9   3   6   6   6
-Asian 25   22   25   20   24   22
Mean disease duration since diagnosis, years 21   21   20   21   19   21
Mean weight, kg 76   74   73   77   74   75
Mean BSA affected, % 46   49   47   48   45   47
Moderate vIGA-AD, % 56   55   54   45   46   45
Severe vIGA-AD, % 45   45   46   55   54   55
Mean EASI 29   31   29   29   29   30
Mean WP-NRS, weekly average 7   7   7   7   7   7

BSA=body surface area; EASI=Eczema Area and Severity Index; vIGA-AD=Validated Investigator Global Assessment for Atopic Dermatitis; WP-NRS=worst pruritus numerical rating scale.

REFERENCES:

  1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
  2. Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021;397(10290):2151-2168. doi:10.1016/S0140-6736(21)00588-2
  3. Data on File. ABVRRTI77060.
  4. Data on File. ABVRRTI73049.

US-RNQ-230377

FOOTNOTES & DEFINITIONS

AD=atopic dermatitis; BE=blinded extension; BSA=body surface area; COVID-19=coronavirus disease-2019; EASI=Eczema Area and Severity Index; ITT=intent-to-treat; NRI-C=nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; PBO=placebo; RCT=randomized controlled trial; vIGA=Validated Investigator Global Assessment; WP-NRS=worst pruritus numerical rating scale.

EASI 75=improvement of at least 75% in lesion extent and severity. EASI 90=improvement of at least 90% in lesion extent and severity. vIGA 0/1=clear or almost clear with at least 2 grades of reduction from baseline. Improvement in WP-NRS ≥4=improvement (reduction) in WP-NRS ≥4 points from baseline in patients with NRS >4 at baseline. WP-NRS 0/1=little to no itch on the WP-NRS (for patients with NRS >1 at baseline).1,4

US-RNQ-230377

Mean WP-NRS Improvement

Mean WP-NRS Improvement1

AS MEASURED BY MEAN PERCENT CHANGE FROM BASELINE WP-NRS SCORE
INTEGRATED MONOTHERAPY DATA FROM MEASURE UP 1 AND 2; ALL DATA ARE OBSERVED CASES

Mean itch improvement data.

DATA LIMITATIONS: Mean percent change from baseline in WP-NRS at all time points shown were prespecified, non-ranked endpoints, not controlled for multiplicity; thus, results cannot be considered statistically significant. There is potential for enrichment of these data as the RINVOQ patients include only those who were originally randomized to RINVOQ, completed the RCT, and enrolled in the blinded extension.

OC. A sub-analysis of the MEASURE UP blinded extension data including only patients who were originally randomized to RINVOQ, completed the RCT, and enrolled in the blinded extension.
OC=observed class; RCT=randomized controlled trial; WP-NRS=Worst Pruritus Numerical Rating Scale.

REFERENCE:

  1. Simpson EL, Papp KA, Blauvelt A, et al. Efficacy and safety of upadacitinib in patients with moderate to severe atopic dermatitis. Analysis of follow-up data from the Measure Up 1 and Measure Up 2 randomized clinical trials. JAMA Dermatol. 2022;158(4):404-413. doi:10.1001/jamadermatol.2022.0029

US-RNQ-230377

Mean EASI Improvement

Mean EASI Improvement1

AS MEASURED BY MEAN PERCENT CHANGE FROM BASELINE EASI SCORE
INTEGRATED MONOTHERAPY DATA FROM MEASURE UP 1 AND 2; ALL DATA ARE OBSERVED CASES

Mean skin clearance data.

DATA LIMITATIONS: Mean percent change from baseline in EASI at all time points shown were prespecified, nonranked endpoints, not controlled for multiplicity; thus, results cannot be considered statistically significant. There is potential for enrichment of these data as the RINVOQ patients include only those who were originally randomized to RINVOQ, completed the RCT, and enrolled in the blinded extension.

OC. A sub-analysis of the MEASURE UP blinded extension data including only patients who were originally randomized to RINVOQ, completed the RCT, and enrolled in the blinded extension.
EASI=Eczema Area and Severity Index; OC=observed cases; RCT=randomized controlled trial.

REFERENCE:

  1. Simpson EL, Papp KA, Blauvelt A, et al. Efficacy and safety of upadacitinib in patients with moderate to severe atopic dermatitis. Analysis of follow-up data from the Measure Up 1 and Measure Up 2 randomized clinical trials. JAMA Dermatol. 2022;158(4):404-413. doi:10.1001/jamadermatol.2022.0029

US-RNQ-230377

Footnotes & Definitions

aTEAE: 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

bRates shown are n/100 PY=number of subjects with at least 1 event per 100 PY.1

cReported as abnormal lymphocyte morphology and not confirmed to be lymphoma.1

dMACE defined as cardiovascular death, myocardial infarction, and stroke.1

eVTE: venous thromboembolism includes deep vein thrombosis (DVT) and pulmonary embolism (PE).1

AESI: 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.

AD=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.

REFERENCE:

  1. Data on File. ABVRRTI77110.

US-RNQ-230377

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INDICATIONS & IMPORTANT SAFETY INFORMATION: WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis

INDICATIONS & IMPORTANT SAFETY INFORMATION: WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis

INDICATIONS & IMPORTANT SAFETY INFORMATION: WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis

INDICATIONS & IMPORTANT SAFETY INFORMATION: WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis

IMPORTANT SAFETY INFORMATION & INDICATIONS1

INDICATIONS1

RINVOQ is indicated for the treatment of:

  • 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.
  • Active ankylosing spondylitis (AS) in adults who have had an inadequate response or intolerance to one or more TNF blockers.
  • 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.

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.

  • 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.

Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

  • Moderately to severely active ulcerative colitis (UC) in adults who have had an inadequate response or intolerance to one or more TNF blockers.
  • Moderately to severely active Crohn's disease (CD) in adults who have had an inadequate response or intolerance to one or more TNF blockers.

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.

RINVOQ/RINVOQ LQ is indicated for the treatment of:

  • 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.
  • 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.

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.

IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)

SERIOUS INFECTIONS

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.

Reported infections include:

  • 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.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

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.

MORTALITY

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.

MALIGNANCIES

Lymphoma and other malignancies have been observed in patients treated with RINVOQ.

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.

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. 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.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

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.

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. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

THROMBOSIS

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with JAK inhibitors used to treat inflammatory conditions. Many of these adverse events were serious and some resulted in death.

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.

HYPERSENSITIVITY

RINVOQ 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.

GASTROINTESTINAL PERFORATIONS

Gastrointestinal (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.

LABORATORY ABNORMALITIES

Neutropenia
Treatment 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.

Lymphopenia
Absolute 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.

Anemia
Decreases 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.

Lipids
Treatment 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.

Liver enzyme elevations
Treatment 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.

EMBRYO-FETAL TOXICITY

Based 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.

VACCINATION

Avoid 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.

MEDICATION RESIDUE IN STOOL

Reports 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.

LACTATION

There 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.

HEPATIC IMPAIRMENT

RINVOQ is not recommended for use in patients with severe hepatic impairment.

ADVERSE REACTIONS

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, rash, and anemia.

Inform 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.

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.

*Unless otherwise stated, “RINVOQ” in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ.

US-RNQ-240270

Please see full Prescribing Information.