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
US-MULT-230356
US-MULT-230356
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
IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor
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 15 mg extended-release tablets
National Drug Code (NDC) number:1
0074‑2306‑30
Awarded the Arthritis Foundation Ease of Use Commendation,2 our innovative bottle cap includes:
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
<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:
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.
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
*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
RINVOQ is indicated for the treatment of:
Limitations of Use: RINVOQ is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (bDMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis or Crohn’s disease, or with potent immunosuppressants such as azathioprine and cyclosporine.
REFERENCES
US-MULT-221344
