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Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

Active

Psoriatic Arthritis

Moderate to Severe

Hidradenitis Suppurativa

Refractory, Moderate to Severe

Atopic Dermatitis

Gastroenterology

Moderate to Severe

Crohn's Disease

Moderate to Severe

Pediatric Crohn's Disease

Moderate to Severe

Ulcerative Colitis

Moderate to Severe

Pediatric Ulcerative Colitis

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

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

One PillOnce a day
two indications

 

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.

Limitation 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.1

For your adult TNFi-IR patients with moderately to severely active RA and adult TNFi-IR patients with active PsA

  • Recommended dose is 15 mg once daily.
  • Advise patients to take one pill at about the same time each day.
  • Tablet should be swallowed whole. Advise patients not to chew, crush, or split the tablet.
  • Can be taken with or without food.
  • 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
National Drug Code (NDC) number:1
0074‑2306‑30

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

IR=inadequate response or intolerance; 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 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.

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 has not been studied in subjects with end‑stage renal disease.1

RINVOQ is not recommended for use in patients with severe 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 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.

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.

Rinvoq is a JAK inhibitor1

Why JAKs are important in PsA3-6

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 PsA, these signals increase the inflammatory response, leading to cycles of chronic inflammation, presenting as pain, swelling, progressive joint destruction and skin symptoms.3,5,6

Overview of the JAK-STAT pathway3,4,7

  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.

*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

Discover how
RINVOQ Complete can
provide
exceptional access
and product support

IMPORTANT SAFETY INFORMATION & INDICATIONS1

INDICATIONS1

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.

Limitation 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.

SERIOUS INFECTIONS

  • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent TB infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

REFERENCES

  1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
  2. Bradley Fain W. Abbvie Child Resistant Special Feature Closure Packaging Evaluation Report of Consumer Product Accessibility for Users with Arthritis. Intuitive Design Applied Research Institute, Atlanta GA (2017).
  3. Jamilloux Y, El Jammal T, Vuitton L, Gerfaud-Valentin M, Kerever S, Sève P. JAK inhibitors for the treatment of autoimmune and inflammatory diseases. Autoimmun Rev. 2019 Nov;18(11):102390.
  4. Banerjee S, Biehl A, Gadina M, Hasni S, Schwartz DM. Erratum to: JAK‑STAT Signaling as a Target for Inflammatory and Autoimmune Diseases: Current and Future Prospects. Drugs. 2017;77(11):1261.
  5. Virtanen AT, Haikarainen T, Raivola J, Silvennoinen O. Selective JAKinibs: Prospects in Inflammatory and Autoimmune Diseases. BioDrugs. 2019;33(1):15‑32.
  6. Salaffi F, Giacobazzi G, Di Carlo M. Chronic Pain in Inflammatory Arthritis: Mechanisms, Metrology, and Emerging Targets—A Focus on the JAK-STAT Pathway. Pain Research and Management. 2018;2018:1‑14.
  7. Winthrop KL. The emerging safety profile of JAK inhibitors in rheumatic disease. Nat Rev Rheumatol. 2017;13(5):320.
  8. Patterson H, Nibbs R, McInnes I, Siebert S. Protein kinase inhibitors in the treatment of inflammatory and autoimmune diseases. Clinical & Experimental Immunology. 2014;176(1):1‑10.
  9. Parmentier JM, Voss J, Graff C, et al. In vitro and in vivo characterization of the JAK1 selectivity of upadacitinib (ABT-494). BMC Rheumatol. 2018;2:23.

INDICATIONS & LIMITATION OF USE1

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.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

INDICATIONS & LIMITATION OF USE1

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.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCIES, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant

IMPORTANT SAFETY INFORMATION & INDICATIONS1

INDICATIONS1

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.

Limitation 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.

SERIOUS INFECTIONS

  • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before RINVOQ use and during therapy. Consider treatment for latent TB infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS