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
One pill,
once a day1
IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor
A ONCE‑DAILY ORAL THERAPY1
Limitations of Use: RINVOQ is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (bsDMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
- RINVOQ is a 15 mg extended-release pill.1
- Take one pill 1 time a day with or without food.
- Advise patients to avoid food or drink containing grapefruit during treatment with RINVOQ.
- Swallow pill whole. Do not split, crush, or chew.
- Instruct patients to notify their healthcare provider if they repeatedly notice intact RINVOQ tablet or fragments in stool or ostomy output.
- Store at 36ºF to 77ºF (2ºC to 25ºC) in the original bottle in order to protect from moisture.
- In clinical trials, RINVOQ mean terminal elimination half-life ranged from 8-14 hours.
![RINVOQ pill bottle and tablet](/content/dam/rinvoqhcp/images/ankylosing-spondylitis/dosing/pill-bottle.png)
RINVOQ 15 mg extended-release tablets
National Drug Code (NDC) number:1
0074‑2306‑30
ONE
EASY-TO-OPEN
BOTTLE
Awarded the Arthritis Foundation Ease of Use Commendation,2 our innovative bottle cap includes:
- Wide, easy-to-grip texture
- Embedded tool that seamlessly punctures the foil liner to simplify medication access
![Arthritis Foundation Ease of Use Commendation](/content/dam/rinvoqhcp/images/ankylosing-spondylitis/dosing/EOU-PMS419.jpg)
AS=ankylosing spondylitis; DMARD=disease-modifying antirheumatic drug; JAK=Janus kinase; IR=intolerance or inadequate response; nr-axSpA=non-radiographic axial spondyloarthritis; PsA=psoriatic arthritis; RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor
Lab Monitoring
and
dosing considerations1
![Lab monitoring](/content/dam/rinvoqhcp/images/ankylosing-spondylitis/dosing/lab-monitoring-mobile.png)
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 for patients with:
- 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.
Rinvoq is a JAK
inhibitor1
Why JAKs are important in AS and nr-axSpA3-11
Pro-inflammatory cytokines use immune signaling networks, such as the JAK-STAT pathway, to communicate with the cell nucleus.3-5 When dysregulated, as in AS and nr-axSpA, these signals increase the inflammatory response, leading to cycles of chronic inflammation, presenting as back pain and morning stiffness.3,5-8
Overview of the JAK-STAT pathway3,4,9
- A cytokine binds to a specific receptor on the cell surface...
- ...triggering JAK recruitment and activation inside the cell.
- The activated JAKs recruit and activate STATs...
- ...which in turn transmit the signal into the cell nucleus...
- ...initiating an inflammatory response that continues the cycle of pathologic inflammation.
![JAK and cytokine pairings](/content/dam/rinvoqhcp/images/ankylosing-spondylitis/dosing/moa-left-callout.png)
*The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1
![RINVOQ inhibits JAK](/content/dam/rinvoqhcp/images/ankylosing-spondylitis/dosing/jak-callout.png)
By inactivating JAK, RINVOQ is thought to block the recruitment, phosphorylation, and activation of STATs preventing the pro‑inflammatory cytokine signal from reaching the nucleus and inhibiting pro-inflammatory processes associated with the JAK‑STAT pathway.1,10,11
Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3 and TYK-2.1,*
AS=ankylosing spondylitis; EPO=erythropoietin; GH=growth hormone; GM-CSF=granulocyte-macrophage colony-stimulating factor; IFN=interferon; IL=interleukin; JAK=Janus kinase; nr‑axSpA=non-radiographic axial spondyloarthritis; STAT=signal transducer and activator of transcription; TPO=thrombopoietin; TYK=tyrosine kinase
![RINVOQ® COMPLETE](/content/dam/rinvoqhcp/images/psoriatic-arthritis/psa-global/rinvoq-complete.png)