1 INDICATIONS AND USAGE
RINVOQ is a Janus kinase (JAK) inhibitor indicated for the treatment of:
Adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. (1.1)
Limitations of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.1)
Adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.(1.2)
Limitation
s
of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.2)
Adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with othersystemic drug products, including biologics, or when use of those therapies are inadvisable. (1.3)
Limitations of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants. (1.3)
Adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers. (1.4)
Limitations of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis, or with potent
immunosuppressants such as azathioprine and cyclosporine. (1.4)
Adults with moderately to severely active Crohns disease who have had an inadequate response or intolerance to one or more TNF blockers. (1.5)
Limitations of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for Crohns disease, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.5)
Adults with active ankylosing spondylitiswho have had an inadequate response or intolerance to one or more TNF blockers. (1.6)
Limitations of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.6)
Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy. (1.7)
Limitations of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. (1.7)
1.1 Rheumatoid Arthritis
RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
1.2 Psoriatic Arthritis
RINVOQ is indicated for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
1.3 Atopic Dermatitis
RINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
1.4 Ulcerative Colitis
RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for ulcerative colitis, or with potent immunosuppressants such as azathioprine and cyclosporine.
1.5 Crohns Disease
RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohns disease who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for Crohns disease, or with potent immunosuppressants such as azathioprine and cyclosporine.
1.
6
Ankylosing Spondylitis
RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
1.
7
Non-radiographic Axial Spondyloarthritis
RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.