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
Adverse events of
special interest5-8
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*Mixed=67% bDMARD-naïve & 33% bDMARD-IR11
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 interest9,10,18
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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
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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=10782.7) | (N=907, PY=2426.4) | (N=596, PY=939.1) | (N=286, PY=323.9) | (N=1340, PY=3055.3) | (N=1353, PY=3231.0) | (N=285, PY=504.1) | (N=291, PY=549.7) | (N=221, PY=295.8) | (N=739, PY=1179.2) | |
INFECTIONS | ||||||||||
Serious infection | 3.6 | 3.9 | 2.6 | 0.9 | 2.2 | 2.8 | 3.6 | 4.5 | 3.0 | 7.1 |
Opportunistic infection (excluding TB and herpes zoster) |
0.3 | 0.4 | 0.2 | 0 | 1.8 | 2.4 | 0.4 | 0.5 | 0.7 | 0.4 |
Active TB | <0.1 | 0 | 0 | 0 | <0.1 | <0.1 | 0 | 0 | 0 | <0.1 |
Herpes zoster | 3.2 | 3.1 | 2.8 | 1.9 | 3.1 | 5.8 | 4.8 | 6.4 | 3.0 | 4.8 |
MALIGNANCYb | ||||||||||
Malignancy (excluding NMSC) | 0.7 | 0.7 | 0.2 | 0.3 | 0.4 | 0.3 | 0.4 | 0.5 | 0.7 | 0.9 |
Lymphoma | <0.1 | 0.1c | 0.1c | 0.3 | <0.1 | <0.1 | 0 | 0 | 0 | 0.2 |
NMSC | 0.4 | 0.7 | 0.2 | 0.3 | 0.4 | 0.3 | 0 | 1.1 | 0 | 0.5 |
CARDIOVASCULAR EVENTSb | ||||||||||
Adjudicated MACEd | 0.3 | 0.2 | 0.1 | 0.3 | <0.1 | <0.1 | 0 | 0.4 | 0 | 0.2 |
Adjudicated VTEe | 0.4 | 0.2 | 0.3 | 0.6 | <0.1 | <0.1 | 0.8 | 0.7 | 0 | 0.3 |
GASTROENTEROLOGICAL EVENTSb | ||||||||||
Adjudicated gastrointestinal perforations | <0.1 | <0.1 | 0 | 0 | 0 | 0 | 0 | 0 | 0.3 | 0.4 |
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.
Well-studied
Safety Profile
Most Common Adverse Reactions from RINVOQ clinical trials
ANKYLOSING SPONDYLITIS11
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.11
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.5
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 SPONDYLOARTHRITIS12
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.12
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.8
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 ARTHRITIS13
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.13
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.14
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.
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.15
- 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.15
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
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/1.73m2).
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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