Select therapeutic use:

Arthritis/rheumatic disorders:

Indications for: RINVOQ

Active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), or moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to 1 or more TNF blockers. Active non-radiographic axial spondyloarthritis (nraxSpA) in adults with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.

Limitations of Use:

Not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (eg, azathioprine, cyclosporine).

Adult Dosage:

Swallow whole. ≥18yrs: 15mg once daily. Concomitant strong CYP3A4 inhibitors: 15mg once daily; monitor. Dose interruption: see full labeling.

Children Dosage:

<18yrs: not established.

Boxed Warning:

Serious infections. Mortality. Malignancy. Major adverse cardiovascular events (MACE). Thrombosis.

RINVOQ Warnings/Precautions:

Increased risk of serious infections (eg, TB, bacterial, viral, invasive fungal, or other opportunistic pathogens). Avoid in active, serious, or localized infections. Consider the risks/benefits in chronic, recurrent, or history of serious or opportunistic infections. Travel to, or residence in, areas with endemic TB or mycoses. Conditions that predispose to infection. Test/treat latent TB infection prior to and per applicable guidelines during therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of herpes virus or hepatitis occurs; interrupt treatment if serious or opportunistic infection. Screen for viral hepatitis before starting therapy. RA patients age ≥50yrs with ≥1 CV risk factor treated with another JAK inhibitor: increased rate of all-cause mortality (including sudden CV death), MACE (CV death, MI, stroke), or thrombosis. Discontinue in those with previous MI or stroke, or with symptoms of thrombosis. Avoid in those with increased risk for thrombosis. Increased rate of malignancies (esp. lymphomas, lung cancers). Consider benefits/risks prior to or continuing therapy (esp. smokers, with other CV risk factors, or with a known malignancy). GI perforation risk (eg, history of diverticulitis). Perform periodic skin exam in those with skin cancer risk. Update immunizations based on current guidelines prior to initiation. Do not initiate therapy if lymphocytes <500cells/mm3, ANC <1000cells/mm3, or hemoglobin <8g/dL. Monitor lymphocytes, neutrophils, and hemoglobin at baseline, then periodically thereafter. Routinely monitor liver enzymes; interrupt therapy if ALT/AST elevated and drug-induced liver injury is suspected. Monitor lipids 12 weeks following initiation and manage hyperlipidemia. Severe hepatic impairment, ESRD (atopic dermatitis, UC): not recommended. Severe renal impairment (atopic dermatitis, UC): see Adult. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 6 days after the last dose).

RINVOQ Classification:

Janus kinase (JAK) inhibitor.

RINVOQ Interactions:

Avoid concomitant live vaccines. Concomitant biologic DMARDs or potent immunosuppressants (eg, azathioprine, cyclosporine): not recommended. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole); see Adult. Antagonized by strong CYP3A4 inducers (eg, rifampin); not recommended. Caution with NSAIDs.

Adverse Reactions:

Upper respiratory tract infections, herpes zoster or simplex, bronchitis, nausea, cough, pyrexia, acne, headache; other serious or opportunistic infections, cytopenias, liver enzyme or lipid elevations, non-melanoma skin cancer, hypersensitivity reactions.

Generic Drug Availability:

NO

How Supplied:

Ext-rel tabs 15mg, 30mg—30; 45mg—28

Pricing for RINVOQ

15mg tablet (Qty: 30)
Appx. price $5600
GoodRx

Atopic dermatitis:

Indications for: RINVOQ

In adults 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.

Limitations of Use:

Not recommended in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

Adult Dosage:

Swallow whole. ≥12yrs (≥40kg): Initially 15mg once daily; if inadequate response, consider increasing to 30mg once daily. Use lowest effective dose needed to maintain response. For elderly (≥65yrs), severe renal impairment (CrCl <30mL/min), or concomitant strong CYP3A4 inhibitors: 15mg once daily. Dose interruption: see full labeling.

Children Dosage:

<12yrs: not established.

Boxed Warning:

Serious infections. Mortality. Malignancy. Major adverse cardiovascular events (MACE). Thrombosis.

RINVOQ Warnings/Precautions:

Increased risk of serious infections (eg, TB, bacterial, viral, invasive fungal, or other opportunistic pathogens). Avoid in active, serious, or localized infections. Consider the risks/benefits in chronic, recurrent, or history of serious or opportunistic infections. Travel to, or residence in, areas with endemic TB or mycoses. Conditions that predispose to infection. Test/treat latent TB infection prior to and per applicable guidelines during therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of herpes virus or hepatitis occurs; interrupt treatment if serious or opportunistic infection. Screen for viral hepatitis before starting therapy. RA patients age ≥50yrs with ≥1 CV risk factor treated with another JAK inhibitor: increased rate of all-cause mortality (including sudden CV death), MACE (CV death, MI, stroke), or thrombosis. Discontinue in those with previous MI or stroke, or with symptoms of thrombosis. Avoid in those with increased risk for thrombosis. Increased rate of malignancies (esp. lymphomas, lung cancers). Consider benefits/risks prior to or continuing therapy (esp. smokers, with other CV risk factors, or with a known malignancy). GI perforation risk (eg, history of diverticulitis). Perform periodic skin exam in those with skin cancer risk. Update immunizations based on current guidelines prior to initiation. Do not initiate therapy if lymphocytes <500cells/mm3, ANC <1000cells/mm3, or hemoglobin <8g/dL. Monitor lymphocytes, neutrophils, and hemoglobin at baseline, then periodically thereafter. Routinely monitor liver enzymes; interrupt therapy if ALT/AST elevated and drug-induced liver injury is suspected. Monitor lipids 12 weeks following initiation and manage hyperlipidemia. Severe hepatic impairment, ESRD (atopic dermatitis, UC): not recommended. Severe renal impairment (atopic dermatitis, UC): see Adult. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 6 days after the last dose).

RINVOQ Classification:

Janus kinase (JAK) inhibitor.

RINVOQ Interactions:

Avoid concomitant live vaccines. Concomitant biologic DMARDs or potent immunosuppressants (eg, azathioprine, cyclosporine): not recommended. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole); see Adult. Antagonized by strong CYP3A4 inducers (eg, rifampin); not recommended. Caution with NSAIDs.

Adverse Reactions:

Upper respiratory tract infections, acne, herpes simplex, headache, increased blood creatine phosphokinase, cough, folliculitis, nausea, abdominal pain, pyrexia, increased weight, herpes zoster, influenza, fatigue, neutropenia, myalgia, influenza-like illness; other serious or opportunistic infections, cytopenias, liver enzyme or lipid elevations, non-melanoma skin cancer, hypersensitivity reactions.

Generic Drug Availability:

NO

How Supplied:

Ext-rel tabs 15mg, 30mg—30; 45mg—28

Pricing for RINVOQ

15mg tablet (Qty: 30)
Appx. price $5600
GoodRx

Colorectal disorders:

Indications for: RINVOQ

Moderately to severely active ulcerative colitis (UC) in adults who have had an inadequate response or intolerance to 1 or more TNF blockers.

Limitations of Use:

Not recommended in combination with other JAK inhibitors, biological therapies for UC, or with potent immunosuppressants (eg, azathioprine, cyclosporine).

Adult Dosage:

Swallow whole. ≥18yrs: Induction: 45mg once daily for 8 weeks. Maintenance: 15mg once daily; may consider 30mg once daily for refractory, severe or extensive disease (discontinue if inadequate response with 30mg dose). Use lowest effective dose needed to maintain response. For severe renal impairment (CrCl 15–<30mL/min), mild to moderate hepatic impairment, concomitant strong CYP3A4 inhibitors: 30mg once daily for 8 weeks (induction); 15mg once daily (maintenance). Dose interruption: see full labeling.

Children Dosage:

<18yrs: not established.

Boxed Warning:

Serious infections. Mortality. Malignancy. Major adverse cardiovascular events (MACE). Thrombosis.

RINVOQ Warnings/Precautions:

Increased risk of serious infections (eg, TB, bacterial, viral, invasive fungal, or other opportunistic pathogens). Avoid in active, serious, or localized infections. Consider the risks/benefits in chronic, recurrent, or history of serious or opportunistic infections. Travel to, or residence in, areas with endemic TB or mycoses. Conditions that predispose to infection. Test/treat latent TB infection prior to and per applicable guidelines during therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of herpes virus or hepatitis occurs; interrupt treatment if serious or opportunistic infection. Screen for viral hepatitis before starting therapy. RA patients age ≥50yrs with ≥1 CV risk factor treated with another JAK inhibitor: increased rate of all-cause mortality (including sudden CV death), MACE (CV death, MI, stroke), or thrombosis. Discontinue in those with previous MI or stroke, or with symptoms of thrombosis. Avoid in those with increased risk for thrombosis. Increased rate of malignancies (esp. lymphomas, lung cancers). Consider benefits/risks prior to or continuing therapy (esp. smokers, with other CV risk factors, or with a known malignancy). GI perforation risk (eg, history of diverticulitis). Perform periodic skin exam in those with skin cancer risk. Update immunizations based on current guidelines prior to initiation. Do not initiate therapy if lymphocytes <500cells/mm3, ANC <1000cells/mm3, or hemoglobin <8g/dL. Monitor lymphocytes, neutrophils, and hemoglobin at baseline, then periodically thereafter. Routinely monitor liver enzymes; interrupt therapy if ALT/AST elevated and drug-induced liver injury is suspected. Monitor lipids 12 weeks following initiation and manage hyperlipidemia. Severe hepatic impairment, ESRD (atopic dermatitis, UC): not recommended. Severe renal impairment (atopic dermatitis, UC): see Adult. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 6 days after the last dose).

RINVOQ Classification:

Janus kinase (JAK) inhibitor.

RINVOQ Interactions:

Avoid concomitant live vaccines. Concomitant biologic DMARDs or potent immunosuppressants (eg, azathioprine, cyclosporine): not recommended. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole); see Adult. Antagonized by strong CYP3A4 inducers (eg, rifampin); not recommended. Caution with NSAIDs.

Adverse Reactions:

Upper respiratory tract infections, increased blood creatine phosphokinase, acne, neutropenia, rash; other serious or opportunistic infections, cytopenias, liver enzyme or lipid elevations, non-melanoma skin cancer, hypersensitivity reactions.

Generic Drug Availability:

NO

How Supplied:

Ext-rel tabs 15mg, 30mg—30; 45mg—28

Pricing for RINVOQ

15mg tablet (Qty: 30)
Appx. price $5600
GoodRx