RINVOQ is indicated for the treatment of¹:

• Moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
• Active psoriatic arthritis (PsA) in adults who have had an inadequate response or intolerance to one or more TNF blockers.
• Active ankylosing spondylitis (AS) in adults who have had an inadequate response or intolerance to one or more TNF blockers.
• Active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation in adults 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 Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (bDMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

• Refractory, moderate to severe atopic dermatitis (AD) in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

• Moderately to severely active ulcerative colitis (UC) in adults who have had an inadequate response or intolerance to one or more TNF blockers.
• Moderately to severely active Crohn’s disease (CD) in adults 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 Crohn’s disease, or with potent immunosuppressants such as azathioprine and cyclosporine.

RINVOQ was evaluated in moderate to severe atopic dermatitis patients who^1,2:

• were between the ages of 12 and 75
• had ≥10% body surface area involvement
• had a vIGA score of 3 or 4
• had an EASI score ≥16
• had baseline worst pruritus NRS ≥4
• had inadequate response to TCS/TCI or documented systemic treatment for AD within 6 months prior to baseline

RINVOQ is indicated for 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.¹

In pivotal trials, EASI 75 and vIGA 0/1 responses were measured at Week 16, as early as Week 2. Reduced worst pruritus NRS ≥4 was measured at Week 16 with results observed in as little as 2 days after first dose.^1,2

In pivotal trials, many patients achieved co-primary endpoints EASI 75 and vIGA 0/1 at Week 16.¹

At Week 52 in a blinded to dose extension study, skin clearance rates, including vIGA 0/1, EASI 75, EASI 90 and itch reduction rates, were observed.^2,3

Common side effects reported in ≥1% of patients with RINVOQ in atopic dermatitis include: upper respiratory tract infection, acne, herpes simplex, headache, increased blood creatine phosphokinase, cough, hypersensitivity, folliculitis, nausea, abdominal pain, pyrexia, increased weight, herpes zoster, influenza, fatigue, neutropenia, myalgia, and influenza like illness.¹

These are not all the possible side effects of RINVOQ.¹

In the placebo-controlled portion of pivotal trials, 2% of patients on placebo (n=902), 10% of patients on RINVOQ 15 mg (N=899), and 16% of patients on RINVOQ 30 mg (N=906) experienced adverse events of acne.^1,4

99% of cases were mild or moderate in severity. Two events led to study discontinuation (1 each in the 15 mg and 30 mg groups).⁴

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.¹

RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.¹

For adults <65 years and pediatric patients 12+ years weighing at least 40 kg (88 lb), initiate treatment with RINVOQ 15 mg once-daily in pediatric patients (≥12 years, ≥40 kg) and adults <65 years of age. If an adequate response is not achieved, consider increasing the dosage to 30 mg once-daily. Discontinue RINVOQ if an adequate response is not achieved with the 30 mg dose. Use the lowest effective dose needed to maintain response. For patients ≥65 years, patients receiving strong CYP3A4 inhibitors, and patients with severe renal impairment (eGFR 15 to <30 mL/min/1.73m²), the recommended dose of RINVOQ is 15 mg once-daily. Coadministration of RINVOQ with strong CYP3A4 inducers is not recommended. RINVOQ is not recommended for use in patients with end stage renal disease (eGFR <15 mL/min/1.73m²). RINVOQ is not recommended for use in patients with severe hepatic impairment (Child-Pugh C).¹

RINVOQ is an oral tablet, taken as 1 pill with or without food. RINVOQ is an extended-release tablet so patients should not split, crush, or chew the tablets. Ensure tablet is taken whole.¹

Instruct patients to notify their healthcare provider if they repeatedly notice intact RINVOQ tablet or fragments in stool or ostomy output.

RINVOQ is administered orally as one pill, once a day, with or without food. Advise patients not to chew, crush, or split RINVOQ.¹

For patients with severe renal impairment [estimated glomerular filtration rate (eGFR) 15 to <30 mL/min/1.73m²] the recommended dosage is 15 mg once daily. No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR ≥30 mL/min/1.73m²). RINVOQ is not recommended for use in patients with end stage renal disease (eGFR <15 mL/min/1.73m²).¹

No dosage adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B). RINVOQ is not recommended for use in patients with severe hepatic impairment (Child-Pugh C).¹

There are screening and monitoring considerations with RINVOQ. Click below to see full monitoring considerations.¹

RINVOQ is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs) which modulate intracellular activity including gene expression.¹

RINVOQ modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. JAK enzymes transmit cytokine signaling through their pairing (eg, JAK1/JAK2, JAK1/JAK3, JAK1/TYK2, JAK2/JAK2, JAK2/TYK2). In a cell-free isolated enzyme assay, RINVOQ had greater inhibitory potency at JAK1 and JAK2 relative to JAK3 and TYK2. In human leukocyte cellular assays, RINVOQ inhibited cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2/JAK2 mediated STAT phosphorylation. However, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.¹

RINVOQ® Complete may be able to help eligible commercially insured patients experiencing initial coverage delays or denials access their prescribed therapy. 

Help may be available to commercially insured patients.

If eligible, the bridge is available for 24 months (rolling) or until the product is covered by the patient’s insurance, whichever is sooner. The bridge requires patient and HCP to attempt resolution for the insurance delay or denial once the patient’s plan has made a formulary decision and established a review process for coverage requests, including:

1. Submitting a PA
2. Submitting an appeal within 180 days if that PA is denied

(Full terms and conditions can be found on the RINVOQ Complete Enrollment Form)

You can request samples from a Rep.