For active psoriatic arthritis (PsA) in adult TNFi‑IR patients1
One PillOnce a day
three rheumatology
indications1
RA, PsA and AS
IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor
A ONCE‑DAILY ORAL THERAPY1
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 36ºF to 77ºF (2ºC to 25ºC) 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
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
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 patients with severe hepatic impairement.
- 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 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
- A cytokine binds to a specific receptor on the cell surface...
- ...triggering JAK recruitment and activation inside the cell.
- The activated JAKs recruit and activate STATs...
- ...which in turn transmit the signal into the cell nucleus...
- ...initiating an inflammatory response that continues the cycle of pathologic inflammation.
*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.
*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
