For moderate to severe rheumatoid arthritis (RA) in adult TNFi‑IR patients1
For active psoriatic arthritis (PsA) in adult TNFi‑IR patients1
For active ankylosing spondylitis (AS)
in adult TNFi‑IR patients1

One pill
once a day
three INDICATIONS1

RA, PSA AND AS

IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor

A ONCE‑DAILY ORAL THERAPY1

RINVOQ is a 15 mg extended-release pill.1

RINVOQ is indicated for the treatment of:

  • Moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one
    or more TNF blockers.
  • Active psoriatic arthritis in adults who have had an inadequate response or intolerance to one or more TNF blockers.
  • Active ankylosing spondylitis in adults who have had an inadequate response or intolerance to one or more TNF blockers.

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.

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.

For your adult TNFi-IR patients with moderately to severely active RA, adult TNFi-IR patients with active PsA, and adult TNFi-IR patients with active AS:1

  • Recommended dosage of RINVOQ is 15 mg once daily.1
  • Take one pill 1 time a day with or without food.
  • Swallow pill whole. Do not split, crush, or chew.
  • Store at 36˚F to 77˚F (2˚C to 25˚C) 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

RINVOQ 15 mg extended-release tablets
National Drug Code (NDC) number:1
0074230630

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

AS=ankylosing spondylitis; DMARD=disease-modifying antirheumatic drug; JAK=Janus kinase; IR=intolerance or inadequate response; PsA=psoriatic arthritis;
RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor

Lab Monitoring and treatment
considerations1

Lab monitoring

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*

  • RINVOQ initiation is not recommended in patients with active hepatitis B or hepatitis C.
  • RINVOQ is not recommended for use in patients with severe hepatic impairment.
  • RINVOQ has not been studied in patients with end-stage renal disease.
  • Discontinue RINVOQ in patients that have experienced a myocardial infarction or stroke.
  • Avoid RINVOQ in patients that may be at increased risk for thrombosis. Discontinue RINVOQ
    and promptly evaluate patients with symptoms of thrombosis.

*Treatment can be initiated or restarted after levels return above specified values, drug-induced liver injury diagnosis is excluded, or infection is controlled.

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

Serious Infections:1 Closely monitor patients for the development of signs and symptoms of infection during and after treatment with RINVOQ.

Tuberculosis (TB):1 Test patients for latent and active TB prior to initiation. If positive, treat prior to RINVOQ use. Monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.

Viral Reactivation:1 Screening and monitoring for viral hepatitis and herpes zoster reactivation should be performed in accordance with clinical guidelines before starting and during therapy with RINVOQ. If a patient develops herpes zoster, consider temporarily interrupting RINVOQ until the episode resolves.

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.

Embryo-Fetal Toxicity:1 Based on animal studies, RINVOQ may cause fetal harm when administered to pregnant women. Verify pregnancy status prior to starting treatment. Advise women to use effective contraception during and for 4 weeks after completion of treatment.

Vaccinations:1 Update immunizations, including varicella zoster or prophylactic herpes zoster, according to current immunization guidelines prior to initiation. Avoid use of live vaccines during, or immediately prior to, RINVOQ therapy.

Rinvoq is a JAK inhibitor1

Why JAKs are important in AS3,5-8

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, 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

  1. A cytokine binds to a specific receptor on the cell surface...
  2. ...triggering JAK recruitment and activation inside the cell.
  3. The activated JAKs recruit and activate STATs...
  4. ...which in turn transmit the signal into the cell nucleus...
  5. ...initiating an inflammatory response that continues the cycle of pathologic inflammation.
JAK and cytokine pairings

*The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1

Rinvoq inhibits JAK

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.

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; STAT=signal transducer and activator of transcription; TPO=thrombopoietin;
TYK=tyrosine kinase

RINVOQ® COMPLETE

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RINVOQ Complete can
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