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

Safety data
18 CLINICAL TRIALS
ACROSS 5 INDICATIONS1-6,*
RA, PsA, AS, AD & UC

>10,500
patients in global clinical trials across US‑approved indications, including pediatrics 12+ years in AD1-4,6,

>18,500
patient-years of exposure to RINVOQ 15 or 30 mg3,6-10,

~5.5 years
max. exposure beginning in RA (~3.5 yrs median) to RINVOQ 15 mg as of 6/30/217,11,§

Well-studied
  safety profile1

Data from 5 robust Phase 3 clinical trials

Adverse Events of Special Interest1,14

Short-term safety data Short-term safety data Short-term safety data

Patients could advance or switch to RINVOQ from placebo, or be rescued
to RINVOQ from active comparator or placebo as early as Week 12
depending on the study design.1

TEAE=treatment emergent adverse event is defined as any adverse event with an onset date on or after the first dose of study drug and no more than 30 days after the last dose of study drug if subject discontinued study drug prematurely.14

SAFETY CONSIDERATIONS

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

WARNINGS & PRECAUTIONS

consistent SAFETY PROFILE OF AEs
OBSERVED IN LONG-TERM ANALYSIS7,11

RINVOQ 15 mg median long-term exposure is ~3.5 years

Adverse Events of Special Interest

Data as of June 30, 20217,11

Phase 3 Program AEs exposure in RA to RINVOQ 15 mg:

Maximum exposure: ~5.5 years
Median exposure: ~3.5 years
>9,000 patient-years

Adverse Events of Special Interest Adverse Events of Special Interest Adverse Events of Special Interest

In RA studies, patients could advance or switch to RINVOQ from placebo, or be rescued to RINVOQ from active comparator or placebo as early as Week 12 depending on the study design.1

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

ADVERSE REACTIONS: The most common adverse reactions in RA RINVOQ clinical trials (≥1%) were upper respiratory tract infections, nausea, cough, pyrexia, pneumonia, herpes zoster, herpes simplex, and oral candidiasis.1

*Included RINVOQ monotherapy and combination therapy with csDMARDs across 6 trials.1,18

Infections were identified by the investigator as serious if they met one or more of the following seriousness criteria; death, life-threatening, hospitalization (initial or prolonged), disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage, or other serious important medical events.19

TEAE=treatment-emergent adverse event, defined as an adverse event with an onset date on or after the first dose of oral study drug and up to 30 days after last dose of RINVOQ.14

WELL-STUDIED SAFETY DATA ACROSS 5 INDICATIONS3,7-12,20
Adverse Events of Special Interest Adverse Events of Special Interest Adverse Events of Special Interest

Adverse reaction rates observed in clinical trials may not fully characterize the risks of RINVOQ. Certain adverse events may require longer observation periods and longer-term patient exposure to ascertain risk.

AbbVie is conducting the 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.

In RA studies: Includes 6 phase 3 trials as of 06/2021.
In PsA studies: Includes 2 phase 3 trials as of 06/2020.
In AS studies: Includes 1 phase 2/3 trial as of 11/2020 for SELECT-AXIS 1.
In AD studies: Includes safety data from 3 phase 3 trials including adults and
adolescents as of 11/2020.
In UC studies: Includes 1 phase 3 trial as of 04/2021. Includes those who responded
to 45 mg induction dose to RINVOQ at Week 8.

TEAE=treatment-emergent adverse event, defined as an adverse event with an onset date on or after the first dose of oral study drug and up to 30 days after last dose of RINVOQ.14

Well-studied
  safety profile1

Common Adverse Reactions

Common adverse events Common adverse events Common adverse events

Infections

  • In the placebo‑controlled studies 
    SELECT-BEYOND, SELECT-NEXT, and
    SELECT-COMPARE through 12/14 weeks, infections were reported in 20.9% of patients treated with placebo and 27.4% in patients treated with RINVOQ 15 mg.21
  • In the 12 month pooled safety data, the incidence rate of infection was 83.8 per 100 patient-years for patients treated with RINVOQ 15 mg.1,21

aPatients were on background MTX or csDMARDS.
bURTI includes: acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection.

Lab Monitoring and treatment
considerations1

Lab monitoring Lab monitoring Lab monitoring

Treatment with RINVOQ should not be initiated, or should be interrupted if:

Absolute lymphocyte count <500 cells/mm3*; Absolute neutrophil count <1000 cells/mm3*; Hemoglobin levels <8 g/dL*; Elevated hepatic transaminases and drug-induced liver injury is suspected; Patient develops a serious infection* Absolute lymphocyte count <500 cells/mm3*; Absolute neutrophil count <1000 cells/mm3*; Hemoglobin levels <8 g/dL*; Elevated hepatic transaminases and drug-induced liver injury is suspected; Patient develops a serious infection* Absolute lymphocyte count <500 cells/mm3*; Absolute neutrophil count <1000 cells/mm3*; Hemoglobin levels <8 g/dL*; Elevated hepatic transaminases and drug-induced liver injury is suspected; Patient develops a serious infection*
  • RINVOQ initiation is not recommended in patients with active hepatitis B or hepatitis C.
  • RINVOQ is not recommended for patients with severe hepatic impairment.
  • RINVOQ has not been studied in patients with end-stage renal disease.
  • Discontinue RINVOQ in patients that have experienced a myocardial infarction or stroke.
  • Avoid RINVOQ in patients that may be at risk for thrombosis. Discontinue RINVOQ and promptly evaluate patients with symptoms of thrombosis.

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

In RA, PsA, and AS:

No dose adjustment is required for mild, moderate, or severe renal impairment.1

No dose adjustment is required for mild or moderate hepatic impairment.1

Serious Infections:1 Closely monitor patients for the development of signs and symptoms of infection during and after treatment with RINVOQ.

Tuberculosis(TB):1 Test patients for latent and active TB prior to initiation. If positive, treat prior to RINVOQ use. Monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.

Viral Reactivation:1 Screening and monitoring for viral hepatitis and herpes zoster reactivation should be performed in accordance with clinical guidelines before starting and during therapy with RINVOQ. If a patient develops herpes zoster, consider temporarily interrupting RINVOQ until the episode resolves.

HYPERSENSITIVITY:1 RINVOQ is contraindicated in patients with known hypersensitivity to upadacitinib or any of its excipients. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.

Embryo-Fetal Toxicity:1 Based on animal studies, RINVOQ may cause fetal harm when administered to pregnant women. Verify pregnancy status prior to starting treatment. Advise women to use effective contraception during and for 4 weeks after completion of treatment.

VACCINATIONS:1 Update immunizations, including varicella zoster or prophylactic herpes zoster, according to current immunization guidelines prior to initiation. Avoid use of live vaccines during, or immediately prior to, RINVOQ therapy.

Lab abnormalitiesfrom the Controlled Period
of the RA Phase 3 program
(Week 12 or 14)1

Neutropenia: Decreases in absolute neutrophil count (<1000 cells/mm3) occurred in 1.1% of patients treated with RINVOQ in the first 3 months of exposure.

Lymphopenia: Decreases in lymphocyte counts (<500 cells/mm3) occurred in 0.9% of patients treated with RINVOQ in the first 3 months of exposure.

Anemia: Hemoglobin decreases below 8 g/dL in at least one measurement occurred in <0.1% of patients treated with RINVOQ in the first 3 months of exposure.

Lipid Elevations: Increases in lipid parameters including total cholesterol, triglycerides, low‑density lipoproteins (LDL), and high‑density lipoproteins (HDL) were observed in patients treated with RINVOQ. Elevations in LDL and HDL cholesterol peaked by Week 8 and remained stable thereafter.

Liver Enzyme Elevations: Increases in liver enzyme levels >3 times the upper limit of normal (ULN) were observed in patients treated with RINVOQ.

Creatine Phosphokinase Elevations: Increases in creatine phosphokinase (CPK) levels >5 times the upper limit of normal were observed in patients treated with RINVOQ. Most elevations >5x ULN were transient and did not require treatment discontinuation.

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