For moderate to severe ulcerative colitis (UC) in adult TNFi-IR patients.1

SAFETY PROFILE ACROSS 4 INDICATIONS1

RINVOQ is a JAK Inhibitor approved in rheumatology, dermatology, and gastroenterology1

 16

phase 3 clinical trials,
establishing a breadth of
experience across indications1-4*

 

 15,788

patient-years of exposure to
RINVOQ 15 or 30 mg5,6†

 

 >9,900

patients in global clinical trials across US-approved indications, including pediatrics 12+ years in AD1-3,7‡

~9 YEARS

of clinical trial
experience across
indications8

 

*Includes U-ACHIEVE Induction, U-ACCOMPLISH Induction, U-ACHIEVE Maintenance and the long-term extension study for UC; SELECT-EARLY, SELECT-MONOTHERAPY,
SELECT-NEXT, SELECT-COMPARE, SELECT-BEYOND, and SELECT-CHOICE for RA; SELECT-PsA 1 and SELECT-PsA 2 for PsA; MEASURE UP 1, MEASURE UP 2, AD UP and HEADS UP for AD.

Includes 10,115.4 patient-years in RA trials and 2504.6 patient-years in PsA trials as of 06/2020, 2787.6 patient-years in AD trials as of 11/2020, and 381.1 patient-years in one Phase 2b and three
Phase 3 (U-ACHIEVE Induction, U-ACCOMPLISH Induction and U-ACHIEVE Maintenance) UC trial5,6,9

RA: RINVOQ 15 mg, upadacitinib 30 mg; PsA: RINVOQ 15 mg, upadacitinib 30 mg; AD: RINVOQ 15 mg and RINVOQ 30 mg; UC: RINVOQ 15 mg, 30 mg, and 45 mg. RINVOQ 15 mg is the approved dose in RA & PsA; RINVOQ 15 mg, and 30 mg are the approved doses in AD; RINVOQ 15 mg, 30 mg and 45 mg are the approved doses in UC.1-3,7

AD=atopic dermatitis; IR=intolerance or inadequate response; JAK=Janus kinase; PsA=psoriatic arthritis; PYs=patient-years; RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis

Well-Studied

Pooled induction safety data up to Week 810,11*

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Adverse reactions

AbbVie is conducting long-term safety studies, including post-marketing studies, to continue to evaluate the safety of RINVOQ. Certain adverse events may require longer observation periods and larger patient exposure to ascertain risk.

Adverse reaction rates observed in clinical trials and LTE studies may not predict rates observed in clinical practice.

 

Long-term safety up to Week 5210,11

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Maintenance safety

AbbVie is conducting long-term safety studies, including post-marketing studies, to continue to evaluate the safety of RINVOQ. Certain adverse events may require longer observation periods and larger patient exposure to ascertain risk.

Adverse reaction rates observed in clinical trials and LTE studies may not predict rates observed in clinical practice.

 

SAFETY CONSIDERATIONS

Consider the benefits and risks for the individual patient prior to initiating therapy with RINVOQ.

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing infections that may lead to hospitalization or death. These infections include tuberculosis (TB) and invasive fungal, bacterial, viral, and other infections due to opportunistic pathogens. 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.

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 to 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 cardiovascular 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.

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.

Non-melanoma skin cancers 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 cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular 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 REACTIONS

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 perforations have been reported in clinical studies with RINVOQ. Monitor RINVOQ-treated patients who may be at risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis or taking NSAIDs). 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).

Lymphopenia: Absolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ clinical studies.

Anemia: Decreases in hemoglobin levels to
<8 g/dL were reported in RINVOQ clinical studies.

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.

Liver enzyme elevations: Treatment with RINVOQ was associated with increased incidence of liver enzyme elevation compared to placebo.

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.

Common adverse events

Pooled induction: Adverse reactions reported in ≥2% of patients1*

Adverse reactions

aComposed of several similar terms

bElevated liver enzymes composed of elevated ALT, AST, GGT, ALP, liver transaminases, hepatic enzymes, bilirubin, drug-induced liver injury and cholestasis

Other adverse reactions reported in less than 2% of patients in the RINVOQ 45 mg group and at a higher rate than in the placebo group through Week 8 included herpes zoster and pneumonia.

Adverse reaction rates observed in clinical trials and LTE studies may not predict rates observed in clinical practice.

Adverse reactions reported in ≥2% of patients1†

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Adverse reactions

aComposed of several similar terms

bElevated liver enzymes composed of elevated ALT, AST, GGT, ALP, liver transaminases, hepatic enzymes, bilirubin, drug-induced liver injury and cholestasis

Adverse reaction rates observed in clinical trials and LTE studies may not predict rates observed in clinical practice.

Safety across indications

Long-term safety data across indications

Long-term exposure inclusive of 11,440 patient years1,5,6,9*

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Long-term safety

*As of 06/2020 for RA & PsA, and 11/2020 for AD

In UC studies: Includes 1 Phase 3 trial.

In RA Studies: Includes 6 Phase 3 trials. 

In PsA studies: Includes 2 Phase 3 trials.

In AD studies: Includes safety data from 3 Phase 3 trials, including adults and adolescents. 

Adverse reaction rates observed in clinical trials and LTE studies may not predict rates observed in clinical practice.

Lab monitoring

Lab monitoring and dosing considerations

Perform lab testing for:

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Lab monitoring

INTERRUPT IF PATIENT DEVELOPS A SERIOUS OR OPPORTUNISTIC INFECTION

*Treatment can be initiated or restarted after levels return above specified values, drug-induced liver injury diagnosis is excluded, or infection is controlled.1

Lab abnormalities across doses from the placebo-controlled induction and maintenance studies1,12

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Lab abnormalities

Lipid Elevations: RINVOQ treatment was associated with increases in lipid parameters including total cholesterol, LDL cholesterol, and HDL cholesterol in placebo-controlled induction and maintenance studies.

Committed to AbbVie’s legacy of reliable access and patient support

Committed to AbbVie’s legacy of reliable access and patient support