For moderate to severe rheumatoid arthritis (RA) in adult TNFi-IR patients1

One pill
once a day
THREE RHEUMATOLOGY INDICATIONS1
RA, PsA AND AS

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

A ONCE-DAILY ORAL THERAPY
STUDIED WITH OR WITHOUT MTX IN RA1

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.
  • 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
Medicare Part D preferred coverage - RINVOQ has achieved XX% Medicare Part D coverage
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

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

Lab Monitoring
and
treatment considerations1

Lab monitoring Lab monitoring Lab monitoring

Treatment with RINVOQ should not be initiated, or should be interrupted if:

Absolute lymphocyte count <500 cells/mm3*; Absolute neutrophil count <1000 cells/mm3*; Hemoglobin levels <8 g/dL*; Elevated hepatic transaminases and drug-induced liver injury is suspected; Patient develops a serious infection* Absolute lymphocyte count <500 cells/mm3*; Absolute neutrophil count <1000 cells/mm3*; Hemoglobin levels <8 g/dL*; Elevated hepatic transaminases and drug-induced liver injury is suspected; Patient develops a serious infection* Absolute lymphocyte count <500 cells/mm3*; Absolute neutrophil count <1000 cells/mm3*; Hemoglobin levels <8 g/dL*; Elevated hepatic transaminases and drug-induced liver injury is suspected; Patient develops a serious infection*
  • RINVOQ initiation is not recommended in patients with active hepatitis B or hepatitis C.
  • RINVOQ is not recommended for 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.

In RA, PsA and AS:

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 RA3-7

Pro-inflammatory cytokines use immune signaling networks, such as the JAK-STAT pathway, to communicate with the cell nucleus. When dysregulated, as in RA, these signals increase the inflammatory response, leading to cycles of chronic inflammation, presenting as pain, swelling, and progressive joint destruction.

Overview of the JAK-STAT pathway3,4,6,8,9

  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 is a JAK inhibitor

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.

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

Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK‑1 vs JAK‑2, JAK‑3, and TYK‑2.1,*

EPO=erythropoietin; GH=growth hormone; GM‑CSF=granulocyte‑macrophage colony‑stimulating factor; IFN=interferon; IL=interleukin; JAK=Janus kinase; PsA=psoriatic arthritis; STAT=signal transducer and activator of transcription; TPO=thrombopoietin; TYK=tyrosine kinase

RINVOQ™ COMPLETE

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