For active ankylosing spondylitis (AS) in adult TNFi-IR patients1
For active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation in adult TNFi-IR patients1

WELL-STUDIED
SAFETY PROFILE
11 YEARS OF CLINICAL EXPERIENCE
ACROSS 7 INDICATIONS1,2,*
RA, PSA, AS,
NR-AXSPA, AD, UC & CD

>13,000
patients in 25 global clinical trials across US-approved indications, including pediatrics 12+ years in AD1,2,†

>37,700
patient-years of exposure to
RINVOQ 15, 30, or 45 mg2,†

>7.5 years
max. exposure in RA (~4.2 years median) to RINVOQ 15 mg as of 8/15/232,‡

SAFETY PROFILE IN AS AND NR-AXSPA3-5

Adverse events of
special interest6-9

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SELECT-AXIS 1, SELECT-AXIS 2 Study 1, and SELECT-AXIS 2 Study 2: Week 14 Safety Data

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR9

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.

Adverse events of
special interest3-5

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SELECT-AXIS 2 Study 1, and SELECT-AXIS 2 Study 2: Week 52 Safety Data

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.

Safety profile in AS and nr-axSpA at 2 years14,15

Data from SELECT-AXIS 2 Study 1 (AS, bDMARD-IR) and SELECT-AXIS 2 Study 2 (nr-axSpA, mixed*)

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SELECT-AXIS 2 Study 1, and SELECT-AXIS 2 Study 2: Week 104 Safety Data

*Mixed=67% bDMARD-naïve and 33% bDMARD-IR.10

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.14,15

bVTE includes deep vein thrombosis (DVT) and pulmonary embolism (PE).14,15

cMACE: Defined as cardiovascular death, myocardial infarction, and stroke.14,15

dIBD defined as inflammatory bowel disease, colitis ulcerative, ulcerative colitis, colitis, Crohn’s disease, ulcerative proctitis, or proctitis.16

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.

 

SAFETY CONSIDERATIONS

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

 

 

WARNINGS AND PRECAUTIONS

LONG-TERM
SAFETY DATA
ACROSS
7 INDICATIONS1,2

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Safety Table of Long-Term Safety Data Across 7 Indications
  RHEUMATOLOGY DERMATOLOGY GASTROENTEROLOGY
  RA PsA AS nr-axSpA AD UC CD
TEAE OF SPECIAL INTERESTa (E/100 PY unless otherwise noted) RINVOQ 15 mg RINVOQ 15 mg RINVOQ 30 mg RINVOQ 15 mg RINVOQ 30 mg RINVOQ 15 mg RINVOQ 30 mg
(N=3209, PY=11,661.5) (N=907, PY=2,823.7) (N=596, PY=1,022.2) (N=286, PY=388.4) (N=1337, PY=3,823) (N=1346, PY=4,076.9) (N=285, PY=622.7) (N=291, PY=721.9) (N=221, PY=329.5) (N=760, PY=1,371.2)
INFECTIONS                    
Serious infection 3.6 3.3 2.4 1.3 2.2 2.6 2.9 4.4 3.6 6.7
Opportunistic infection
(excluding TB and herpes zoster)
0.3 0.4 0.2 0.3 1.7 2.2 0.3 0.6 0.6 0.4
Active TB <0.1 0 0 0 <0.1 <0.1 0 0 0 <0.1
Herpes zoster 3.2 3.1 3.1 2.6 3.1 5.5 4.3 6.6 2.7 5.0
MALIGNANCYb                    
Malignancy (excluding NMSC) 0.7 0.7 0.2 0.3 0.3 0.4 0.6 0.6 0.6 0.9
Lymphoma <0.1 0.1c <0.1c 0.3 <0.1 <0.1 0 0 0 0.1
NMSC 0.4 0.7 0.3 0.3 0.4 0.3 0 1.0 0 0.6
CARDIOVASCULAR EVENTSb                    
Adjudicated MACEd 0.3 0.4 0.2 0.5 0.2 <0.1 0 0.4 0 0.1
Adjudicated VTEe 0.4 0.2 0.3 0.8 0.1 0.1 0.5 0.6 0 0.3
GASTROENTEROLOGICAL EVENTSb                    
Adjudicated gastrointestinal perforations <0.1 <0.1 0 0 0 <0.1 0 0 0.9 0.5

Overall, the safety profile observed in patients with active AS and nr-axSpA treated with RINVOQ 15 mg is consistent with the safety profile observed in patients with RA and PsA.1

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.

RINVOQ is taken once daily.1

Well-studied
Safety Profile

Most Common Adverse Reactions from RINVOQ clinical trials

ANKYLOSING SPONDYLITIS10

Most Common Adverse Reactions from SELECT-AXIS 2 Study 1 (14 Weeks)

Adverse reactions reported in >2% of ankylosing spondylitis patients treated with
RINVOQ 15 mg from the placebo-controlled study.10

AS Common adverse events

aAS patients could be on background NSAIDs. 

Infections

  • In the placebo-controlled study SELECT-AXIS 2 Study 1 through 14 weeks, infections were reported in 13% of patients treated with placebo and 15% of patients treated with RINVOQ 15 mg.6

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, and rash.1

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.1

NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS13

Most Common Adverse Reactions from SELECT-AXIS 2 Study 2 (14 Weeks)

Adverse reactions reported in >2% of non-radiographic axial spondyloarthritis patients
treated with RINVOQ 15 mg from the placebo-controlled study.13

nr-axSpA common adverse events

anr-axSpA patients could be on background NSAIDs.

Infections

  • In the placebo-controlled study SELECT-AXIS 2 Study 2 through 14 weeks, infections were reported in 23% of patients treated with placebo and 23% of patients treated with RINVOQ 15 mg.9

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, and rash.1

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.1

PSORIATIC ARTHRITIS17

Most Common Adverse Reactions from SELECT‑PsA 1 and SELECT‑PsA 2 (24 Weeks)

Adverse reactions reported in >1% of psoriatic arthritis patients treated with
RINVOQ 15 mg pooled from the placebo‑controlled studies.17

PsA common adverse events

aPsA patients could be on background non-biologic DMARDs.1

Infections

  • In the placebo-controlled studies SELECT-PsA 1 and SELECT-PsA 2 through 24 weeks, infections were reported in 33.5% of patients treated with placebo and 37.5% of patients treated with RINVOQ 15 mg.20

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, and rash.1

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.1

RHEUMATOID ARTHRITIS1

Most Common Adverse Reactions from SELECT-BEYOND,
SELECT-COMPARE, and
SELECT-NEXT (12 Weeks)1

Adverse reactions reported in ≥1% of moderate to severe rheumatoid arthritis
patients treated with RINVOQ 15 mg pooled from the placebo‑controlled studies.

RA common adverse events

aRA patients were on background MTX or csDMARDs.

bURTI includes: acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection.

Infections

  • In the placebo-controlled studies SELECT-COMPARE, SELECT-NEXT, and SELECT-BEYOND through 12/14 weeks, infections were reported in 20.9% of patients treated with placebo and 27.4% of patients treated with RINVOQ 15 mg.18
  • In the 12-month exposure dataset, the incident rate of infection was 83.8 per 100 patient years for patients treated with RINVOQ 15 mg.18

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, and rash.1

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.1

Lab Monitoring
and
DOSING
considerations1

Lab Monitoring

TREATMENT WITH RINVOQ SHOULD NOT BE INITIATED, OR SHOULD BE INTERRUPTED IF:

Absolute neutrophil count
<1000 cells/mm3*

Absolute lymphocyte count
<500 cells/mm3*

Hemoglobin levels
<8 g/dL*

Liver enzyme elevations
and a
drug-induced liver
injury is suspected*

Patient has or 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.

  

In RA, PsA, AS, and nr-axSpA:

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

RINVOQ is not recommended in patients with:1

  • active hepatitis B or hepatitis C
  • severe hepatic impairment (Child-Pugh C)

RINVOQ has not been studied in end-stage renal disease (eGFR<15 mL/min/1.73 m2).

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.

Lab Abnormalities from the Package Insert1

Neutropenia: Decreases in absolute neutrophil count (<1000 cells/mm3) were associated with RINVOQ treatment.

Lymphopenia: Decreases in lymphocyte count (<500 cells/mm3) were reported with RINVOQ treatment.

Anemia: Hemoglobin decreases below 8 g/dL were reported with RINVOQ treatment.

Lipid Elevations: Increases in lipid parameters including total cholesterol, triglycerides, LDL, and 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: Increased incidences in liver enzyme elevations were associated with RINVOQ compared to placebo.

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