Please see Important Safety Information, including BOXED WARNING on Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis.

Rheumatoid Arthritis

Psoriatic Arthritis

Ankylosing Spondylitis

Non-radiographic Axial Spondyloarthritis

Atopic Dermatitis

Ulcerative Colitis

Crohn’s Disease

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Plaque Psoriasis

Psoriatic Arthritis

Crohn's Disease

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Please see Important Safety Information, including BOXED WARNING on Serious Infections and Malignancy.

Hidradenitis Suppurativa

Juvenile Idiopathic Arthritis

Pediatric Crohn's Disease

Pediatric Ulcerative Colitis

Pediatric Uveitis

Uveitis (Adult)

Other Indications

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US-MULT-230356

Immunology Therapies

Full Prescribing Information

Patient Site

For moderate to severe rheumatoid arthritis (RA) in adult TNFi‑IR patients¹

Durable
remission
With or Without MTX^2-5

RINVOQ achieved DAS28-CRP<2.6* and DAS28-CRP≤3.2
(ranked secondary endpoints) at Week 12 or 14, with durable
remission and low disease activity rates out to ~5 years.^1,2,4,6,7

*Does not mean drug-free remission or complete absence of disease activity.
RINVOQ is indicated for TNFi-IR patients.

CRP=C-reactive protein; DAS28-CRP=28 joint disease activity score using C-reactive protein;
IR=intolerance or inadequate response; MTX=methotrexate; TNFi=tumor necrosis factor inhibitor

NRI Data from SELECT-BEYOND RINVOQ 15 mg + csDMARD (n=164), placebo + csDMARD (n=169) bDMARD-IR ACR20 65% vs 28% placebo* at Week 12 primary endpoint

*P<0.0001 RINVOQ vs Placebo

SELECT-BEYOND (STUDY RA-V):^1,8
12-week, randomized, double-blind, placebo-controlled study of 499 adult patients with moderate to severe RA who had an inadequate response or intolerance to bDMARDs. Patients on background csDMARDs were randomized to receive RINVOQ 15 mg once daily (n=164) or placebo (n=169). The primary endpoint was ACR20 response at Week 12.

NRI Data from SELECT-MONOTHERAPY RINVOQ 15 mg (n=217), cmtx (n=216) MTX-IR ACR20 68% vs 41% MTX* at Week 14 primary endpoint

*P<0.0001 RINVOQ vs MTX

RINVOQ IS INDICATED FOR TNFi-IR PATIENTS.

SELECT‑MONOTHERAPY (Study RA-II) Study Design Intro:^1,6
14‑week, randomized, double‑blind, active comparator‑controlled study of 648 adult patients with moderate to severe RA who had an inadequate response to MTX. The primary endpoint was ACR20 response at Week 14.

Remission & LDA RATES With
or Without MTX AT WEEKS 12 AND 14^1,6-8

REMISSION:
(DAS28-CRP<2.6*)

RINVOQ is indicated for TNFi-IR patients.

*Clinical remission does not mean drug-free remission or complete absence of disease activity

DATA LIMITATIONS: Data not labeled as a ranked secondary endpoint were prespecified nonranked endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.

LDA:
(DAS28-CRP≤3.2)

RINVOQ is indicated for TNFi-IR patients.

*Clinical remission does not mean drug-free remission or complete absence of disease activity

Durable Remission
rates with
or without
MTX OUT TO ~5 YEARS^2-5

SELECT‑BEYOND:
bDMARD-IR patients
ALL DATA ARE OBSERVED CASES
DAS28-CRP<2.6*

66% of RINVOQ + csDMARDs patients achieved clinical remission at Week 260

RINVOQ is indicated for TNFi-IR patients.

*Clinical remission does not mean drug-free remission or complete absence of disease activity

SELECT‑MONOTHERAPY:
MTX-IR patients
ALL DATA ARE OBSERVED CASES
DAS28-CRP<2.6*

71% of RINVOQ patients
achieved clinical remission at Week 260

RINVOQ is indicated for TNFi-IR patients.

*Clinical remission does not mean drug-free remission or complete absence of disease activity

RINVOQ is indicated for TNFi-IR patients.

*Clinical remission does not mean drug-free remission or complete absence of disease activity

In an As Observed (AO) analysis, patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

LTE LIMITATIONS: There is potential for enrichment of LTE data; unblinding patients may cause bias related to overall treatment effect.

Durable
LOW DISEASE ACTIVITY
rates With or Without MTX OUT TO ~5 YEARS^2-5

SELECT‑BEYOND:
bDMARD-IR patients
ALL DATA ARE OBSERVED CASES
LDA (DAS28-CRP≤3.2)

81% of RINVOQ + csDMARDs patients achieved LDA at
Week 260

RINVOQ is indicated for TNFi-IR patients.

SELECT‑MONOTHERAPY:
MTX-IR patients
ALL DATA ARE OBSERVED CASES
LDA (DAS28-CRP≤3.2)

89% of RINVOQ patients
achieved LDA at Week 260

RINVOQ is indicated for TNFi-IR patients.

In an As Observed (AO) analysis, patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

LTE LIMITATIONS: There is potential for enrichment of LTE data; unblinding patients may cause bias related to overall treatment effect.

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RINVOQ SAFETY DATA

Review the well-studied safety profile of RINVOQ,
including both short- and long-term analyses

SEE SAFETY PROFILE

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 psoriatic arthritis (PsA) in adults who have had an inadequate response or intolerance to one or more 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.

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

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 major adverse cardiovascular events (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 gastrointestinal 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 varicella zoster or prophylactic 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.

US-RNQ-230034

Please see full Prescribing Information.

REFERENCES

RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
Fleischmann R, Bessette L, Sparks J et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biologic DMARDs: results through 5 years from the SELECT-BEYOND study. Poster presented at: the American College of Rheumatology Convergence, November 10-14, 2022, Philadelphia, PA, USA.
Data on File. ABVRRTI74946.
Smolen JS, Emery P, Rigby W, et al. Upadacitinib as monotherapy in patients with rheumatoid arthritis and prior inadequate response to methotrexate: results at 260 weeks from the SELECT-MONOTHERAPY study. Poster presented at: The European Congress of Rheumatology, 31 May - 3 June 2023, Milan, Italy.
Data on File. ABVRRTI75990.
Smolen JS, Pangan AL, Emery P, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019;393(10188):2‌3‌0‌3-2‌3‌1‌1.
Data on File. ABVRRTI72945
Genovese MC, Fleischmann R, Combe B, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018;391(10139):2513-2524.

RA patients met ACR20 at Week 12 or 14 (Primary Endpoints) and Disease Control through Remission
(DAS28-CRP <2.6)* at Weeks 12 or 14 and observed up to 5 years. Explore the Data

*Clinical remission does not mean drug-free remission or complete absence of disease activity

Clinical Remission

Remission + LDA at Weeks 12 and 14

Remission out to ~5 years

LDA out to ~5 years

Safety Profile

Data Up to 12 Months

Long-term Exposure Data

Monitoring & Dose Interruptions

Important Safety Information

Access & Support

Commercial Access

RINVOQ Complete

How To Enroll Patients

Downloadable Resources

Dosing & MOA

Dosing

Monitoring

Mechanism of Action

Important Safety Information

Prescribing Information (English)

Información en español

INDICATIONS & LIMITATION OF USE¹

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

IMPORTANT SAFETY INFORMATION¹

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

SERIOUS INFECTIONS

IMPORTANT SAFETY INFORMATION¹

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

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

INDICATIONS & LIMITATION OF USE¹

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

IMPORTANT SAFETY INFORMATION¹

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

SERIOUS INFECTIONS

IMPORTANT SAFETY INFORMATION¹

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

SERIOUS INFECTIONS