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
once a day
RA, PSA, AS AND NR-axSpA
IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor
A ONCE‑DAILY ORAL THERAPY1
Limitations of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.
- 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.
- 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 15 mg extended-release tablets
National Drug Code (NDC) number:1
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
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
Treatment with RINVOQ should not be initiated, or should be interrupted if:
Absolute neutrophil count
Absolute lymphocyte count
Liver enzyme elevations
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:
- 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
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.
*The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1
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