Active

Psoriatic Arthritis

Active

Ankylosing Spondylitis

Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

Active

Psoriatic Arthritis

Moderate to Severe

Hidradenitis Suppurativa

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 MTX‑IR patients.1

Safety Data
from 5 robust
phase 3 trials1,a

>4350
patients evaluated
across treatment arms2,b

>4500
patient-years of
long-term
exposure
to RINVOQ 15 mg3
as of 6/30/19

~3.5 years
maximum and 2 years median
long-term
exposure to RINVOQ 15 mg3
as of 6/30/19

Clinical Trial Overview

SELECT‑EARLY (Study RA‑I) Study Design Intro:1,4
48‑week, double‑blind, active comparator‑controlled study of 947 adult patients with moderate to severe RA who were MTX‑naïve. Patients were randomized to receive RINVOQ 15 mg once daily (n=317) or MTX (n=314). The primary endpoint was ACR50 response at Week 12. At Week 26, non‑responding patients were rescued according to prespecified criteria.

SELECT‑MONOTHERAPY (Study RA‑II) Study Design Intro:1,5
14‑week, double‑blind, active comparator‑controlled study of 648 adult patients with moderate to severe RA who had an inadequate response to MTX. Patients were randomized to receive RINVOQ 15 mg once daily (n=217) or cMTX weekly (n=216). The primary endpoint was ACR20 response at Week 14.

SELECT‑NEXT (Study RA‑III) Study Design Intro:1,6
12‑week, double‑blind, placebo‑controlled study of 661 adult patients with moderate to severe RA who had an inadequate response to csDMARDs. Patients on background csDMARDs were randomized to receive RINVOQ 15 mg once daily (n=221) or placebo (n=221). The primary endpoint was ACR20 response at Week 12.

SELECT‑BEYOND (Study RA‑V) Study Design Intro:1,7
12‑week, double‑blind, placebo‑controlled study of 499 adult patients with moderate to severe RA who have had an inadequate response or intolerance to bDMARDs. Patients on background csDMARDs were randomized to receive RINVOQ 15 mg once daily (n=164) or placebo (n=169). The primary endpoint was ACR20 response at Week 12.

SELECT‑COMPARE (Study RA‑IV) Study Design Intro:1,8
48‑week, double‑blind, active comparator‑controlled study of 1629 adult patients with moderate to severe RA who had an inadequate response to MTX. Patients on background MTX were randomized to receive RINVOQ 15 mg once daily (n=651), placebo (n=651), or adalimumab 40 mg EOW (n=327). The primary endpoint was ACR20 response at Week 12 vs Placebo. Prespecified blinded rescue protocol occurred at weeks 14, 18, 22, or 26.

Well-studied
  safety profile1

Across 5 robust Phase 3 clinical trials

Adverse Events of Special Interest1,9,10

Short-term safety data Short-term safety data Short-term safety data

Patients could advance or switch to RINVOQ from placebo, or be rescued to RINVOQ from active comparator or placebo as early as Week 12 depending on the study design.1

TEAE=treatment emergent adverse event is defined as any adverse event with an onset date on or after the first dose of study drug and no more than 30 days after the last dose of study drug if subject discontinued study drug prematurely.9,10

Now with up to ~3.5 years
of long-term exposure3

RINVOQ 15 mg median long-term exposure is 2 years

Adverse Events of Special Interest3,11-13

Data as of June 30, 2019

Phase 3 Program AEs

Maximum exposure: ~3.5 years
Median exposure: 2 years
>4500 patient years

Consistent safety profile of adverse events observed in long-term analysis3

Adverse Events of Special Interest Adverse Events of Special Interest Adverse Events of Special Interest

Patients could advance or switch to RINVOQ from placebo, or be rescued to RINVOQ from active comparator or placebo as early as Week 12 depending on the study design.1

Adverse reaction rates observed in clinical trials and LTE studies may not predict the rates observed in clinical practice.

SELECT-COMPARE was not designed to evaluate safety outcomes between RINVOQ and HUMIRA. Thus, no safety comparison can be made based upon this presentation.

Please see HUMIRA full Prescribing Information.

*Included RINVOQ monotherapy and combination therapy with csDMARDs across 5 trials1

Infections were identified by the investigator as serious if they met one or more of the following seriousness criteria; death, life-threatening, hospitalization (initial or prolonged), disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage, or other serious important medical events.15

TEAE=treatment emergent adverse event, defined as an adverse event with an onset date on or after the first dose of oral study drug and up to 30 days after last dose of RINVOQ or 70 days for HUMIRA.13

Please see HUMIRA full Prescribing Information.

A Closer Look at Adverse Events3

Data as of June 30, 2019

Phase 3 Program AEs

Maximum exposure: ~3.5 years
Median exposure: 2 years
>4500 patient years

Long-term safety data: Infections3,11,13

SWIPE  >>

Long-term safety data: INFECTIONS

Serious Infections: Pneumonia was the most common serious infection reported for RINVOQ 15 mg QD (0.7 E/100 PYs)14
Opportunistic Infection: Oral candidiasis was the most frequent opportunistic infection event reported for RINVOQ 15 mg QD (0.4 E/100 PYs)14
Herpes Zoster: Most of the herpes zoster cases were non-serious (95%) and involved a single dermatome (71%) for RINVOQ 15 mg QD.3 The risk of herpes zoster is increased in patients taking RINVOQ 15 mg QD and in some cases can be serious1

SERIOUS INFECTIONS:1 Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Monitor patients closely for the development of infections during and after treatment.
VACCINATION:1 Use of live, attenuated vaccines during, or immediately prior to, RINVOQ therapy is not recommended. Prior to initiating RINVOQ, it is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, in agreement with current immunization guidelines.

Long-term safety data: Malignancy3,12,13

SWIPE  >>

Long-term safety data: MALIGNANCY

NMSC: NMSCs with >1 event in patients receiving RINVOQ were basal cell carcinoma and squamous cell carcinoma of the skin.3

MALIGNANCY:1 Lymphoma and other malignancies have been observed in patients treated with RINVOQ. Consider the risks and benefits of treatment prior to initiating therapy in patients with a known malignancy or in patients who develop a malignancy.

Long-term safety data: Cardiovascular Events3,13

SWIPE  >>

Long-term safety data: CARDIOVASCULAR EVENTS

VTE: Venous thromboembolic events include deep vein thrombosis (DVT) and pulmonary embolism (PE).3,13
MACE: Major adverse cardiovascular events, defined as cardiovascular death (includes acute myocardial infarction, sudden cardiac death, heart failure, cardiovascular procedure-related death, death due to cardiovascular hemorrhage, fatal stroke, pulmonary embolism and other cardiovascular causes), non-fatal myocardial infarction and non-fatal stroke.13

THROMBOSIS:1 DVT, PE, and arterial thrombosis have occurred in patients treated with JAK inhibitors used to treat inflammatory conditions. Many of these were serious and some resulted in death. Consider the risks and benefits prior to treating patients who may be at increased risk.

Long-term safety data: Gastroenterological Events12,13

SWIPE  >>

Long-term safety data: GASTROENTEROLOGICAL EVENT

GI: 6 GI perforation events were observed in the RINVOQ 15 mg QD pooled dataset.12

GI PERFORATIONS:1 GI perforations have been reported in clinical studies with RINVOQ, although the role of JAK inhibition in these events is not known. Use with caution in patients who may be at increased risk.

Patients could advance or switch to RINVOQ from placebo, or be rescued to RINVOQ from active comparator or placebo as early as Week 12 depending on the study design.1

Adverse reaction rates observed in clinical trials and LTE studies may not predict the rates observed in clinical practice.

SELECT-COMPARE was not designed to evaluate safety outcomes between RINVOQ and HUMIRA. Thus, no safety comparison can be made based upon this presentation.

Please see HUMIRA full Prescribing Information.

*Included RINVOQ monotherapy and combination therapy with MTX across 5 trials.1

Infections were identified by the investigator as serious if they met one or more of the following seriousness criteria; death, life-threatening, hospitalization (initial or prolonged), disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage, or other serious important medical events.15

TEAE=treatment emergent adverse event, defined as an adverse event with onset on or after first dose of study drug and up to 30 days after last dose of RINVOQ or 70 days for HUMIRA.13

Please see HUMIRA full Prescribing Information.

Well-studied
  safety profile1

Common Adverse Reactions

Common adverse events Common adverse events Common adverse events

Infections

  • In the placebo‑controlled studies SELECT‑COMPARE, SELECT‑NEXT, and SELECT‑BEYOND through 12/14 weeks, infections were reported in 20.9% of patients treated with placebo and 27.4% in patients treated with RINVOQ 15 mg.9
  • In the 12 month pooled safety datac, the incidence rate of infection was 83.8* per 100 patient years for patients treated with RINVOQ 15 mg.1,9

aPatients were on background MTX or csDMARDS.
bURTI includes: acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection
cSELECT-EARLY, SELECT-MONOTHERAPY, SELECT-NEXT, and SELECT-BEYOND
*615/733.6 (n/PYS)

Monitoring and treatment
considerations1

RINVOQ Lab Monitoring RINVOQ Lab Monitoring RINVOQ 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*

*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: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 for viral hepatitis and monitoring for reactivation should be performed in accordance with clinical guidelines before starting and during therapy with RINVOQ.

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.

Lab abnormalitiesfrom the Controlled Period
of the Phase 3 program (Week 12 or 14)1

Neutropenia: Decreases in absolute neutrophil count (<1000 cells/mm3) occurred in 1.1% of patients treated with RINVOQ in the first 3 months of exposure.

Lymphopenia: Decreases in lymphocyte counts (<500 cells/mm3) occurred in 0.9% of patients treated with RINVOQ in the first 3 months of exposure.

Anemia: Hemoglobin decreases below 8 g/dL in at least one measurement occurred in <0.1% of patients treated with RINVOQ in the first 3 months of exposure.

Lipid Elevations: Increases in lipid parameters including total cholesterol, triglycerides, low‑density lipoproteins (LDL), and high‑density lipoproteins (HDL) were observed in patients treated with RINVOQ. Elevations in LDL and HDL cholesterol peaked by Week 8 and remained stable thereafter.

Liver Enzyme Elevations: Increases in liver enzyme levels >3 times the upper limit of normal (ULN) were observed in patients treated with RINVOQ.

Creatine Phosphokinase Elevations: Increases in creatine phosphokinase (CPK) levels >5 times the upper limit of normal were observed in patients treated with RINVOQ. Most elevations >5x ULN were transient and did not require treatment discontinuation.

RINVOQ™ COMPLETE

Discover how RINVOQ Complete can provide
exceptional access and product support

IMPORTANT SAFETY INFORMATION & INDICATION1

INDICATION1

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

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.

IMPORTANT SAFETY INFORMATION1

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 immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ until the infection is controlled.

Reported infections include:

  • 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 infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Carefully consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCY

Lymphoma and other malignancies have been observed in patients treated with RINVOQ. Consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or in patients who develop a malignancy. NMSCs have been reported in patients treated with RINVOQ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions. Many of these adverse events were serious and some resulted in death. Consider the risks and benefits prior to treating patients who may be at increased risk. Patients with symptoms of thrombosis should be promptly evaluated.

GASTROINTESTINAL PERFORATIONS

Gastrointestinal perforations have been reported in clinical studies with RINVOQ, although the role of JAK inhibition in these events is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with nonsteroidal anti-inflammatory drugs (NSAIDs). RINVOQ should be used with caution in patients who may be at increased risk for gastrointestinal perforation. Promptly evaluate patients presenting with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES

Neutropenia

Treatment with RINVOQ was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3). Treatment with RINVOQ is not recommended in patients with an ANC <1000 cells/mm3. Evaluate neutrophil counts at baseline and thereafter according to routine patient management.

Lymphopenia

Absolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ clinical studies. Treatment with RINVOQ is not recommended in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Anemia

Decreases in hemoglobin levels to <8 g/dL were reported in RINVOQ clinical studies. Treatment should not be initiated or should be interrupted in patients with hemoglobin levels <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

Lipids

Treatment with RINVOQ was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Manage patients according to clinical guidelines for the management of hyperlipidemia. Evaluate 12 weeks after initiation of treatment and thereafter according to the clinical guidelines for hyperlipidemia.

Liver enzyme elevations

Treatment with RINVOQ was associated with increased incidence of liver enzyme elevation compared to placebo. Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are observed during routine patient management and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.

EMBRYO-FETAL TOXICITY

Based on animal studies, RINVOQ may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RINVOQ and for 4 weeks after the final dose. Verify pregnancy status of females of reproductive potential prior to starting treatment with RINVOQ.

VACCINATION

Use of live, attenuated vaccines during, or immediately prior to, RINVOQ therapy is not recommended. Prior to initiating RINVOQ, patients should be brought up to date on all immunizations, including prophylactic zoster vaccinations, in agreement with current immunization guidelines.

LACTATION

There are no data on the presence of RINVOQ in human milk, the effects on the breastfed infant, or the effects on milk production. Available data in animals have shown the excretion of RINVOQ in milk. Advise patients that breastfeeding is not recommended during treatment with RINVOQ and for 6 days after the last dose.

HEPATIC IMPAIRMENT

RINVOQ is not recommended in patients with severe hepatic impairment.

ADVERSE REACTIONS

The most common adverse reactions in RINVOQ clinical trials (≥1%) were: upper respiratory tract infection, nausea, cough, and pyrexia.

US-RNQR-200725

Please see full Prescribing Information.

Please see full Prescribing Information.

REFERENCES

  1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
  2. Cohen S, Van Vollenhoven R, Winthrop K, et al. Safety Profile of Upadacitinib in Rheumatoid Arthritis: Integrated Analyses From the SELECT Phase 3 Clinical Program. Poster presented at: The European Congress of Rheumatology, 12‑15 June 2019, Madrid, Spain.
  3. Cohen S, Van Vollenhoven R, Curtis J. et. al. Safety Profile of Upadacitinib Up to 3 Years of Exposure in Patients With Rheumatoid Arthritis. Poster presented at: The European Congress of Rheumatology, 3‑6 June 2020, E‑Congress.
  4. Van Vollenhoven R, Takeuchi T, Pangan AL, et al. Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-naïve Patients with Moderately to Severely Active Rheumatoid Arthritis (SELECT‑EARLY): A Randomized, Double‑blind, Active‑comparator, Multi‑center, Multi‑country Trial. Arthritis & Rheumatology. 2020. doi:10.1002/art.41384.
  5. Smolen JS, Pangan AL, Emery P, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT‑MONOTHERAPY): a randomised, placebo‑controlled, double‑blind phase 3 study. Lancet. 2019;393(10188):2303‑2311.
  6. Burmester GR, Kremer JM, Van den Bosch F, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease‑modifying anti‑rheumatic drugs (SELECT‑NEXT): a randomised, double‑blind, placebo‑controlled phase 3 trial. Lancet. 2018;391(10139):2‍5‍0‍3‑‍2‍5‍1‍2‍.
  7. Genovese MC, Fleischmann R, Combe B, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease‑modifying anti‑rheumatic drugs (SELECT‑BEYOND): a double‑blind, randomised controlled phase 3 trial. Lancet. 2018;391(10139):2513‑2524.
  8. Fleischmann R, Pangan AL, Song I‑H, et al. Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double‑Blind, Randomized Controlled Trial. Arthritis Rheumatol. 2019;71(11):1788‑1800.
  9. Data on File. ABVRRTI69047.
  10. Data on File. ABVRRTI71258.
  11. Data on File. ABVRRTI70194.
  12. Data on File. ABVRRTI70151.
  13. Data on File. ABVRRTI70591.
  14. Winthrop K, Calabrese LH, Van den Bosch F, et al. Characterization of serious infections with upadacitinib in patients with rheumatoid arthritis. Poster presented at: The European Congress of Rheumatology, 3-6 June, 2020, E‑Congress.
  15. US Food & Drug Administration Web Site. https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event. Accessed April 14, 2020.

INDICATION & LIMITATION OF USE1

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

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.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MALIGNANCY, 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 & INDICATION1

WARNING: SERIOUS INFECTIONS, MALIGNANCY, 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 immunosuppressants

INDICATION & LIMITATION OF USE1

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

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.

IMPORTANT SAFETY INFORMATION1

WARNING: SERIOUS INFECTIONS, MALIGNANCY, 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 & INDICATION1

WARNING: SERIOUS INFECTIONS, MALIGNANCY, 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 immunosuppressants

IMPORTANT SAFETY INFORMATION & INDICATION1

INDICATION1

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

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.

IMPORTANT SAFETY INFORMATION1

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 immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ until the infection is controlled.

Reported infections include:

  • 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 infection prior to RINVOQ use.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

Carefully consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCY

Lymphoma and other malignancies have been observed in patients treated with RINVOQ. Consider the risks and benefits of treatment with RINVOQ prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or in patients who develop a malignancy. NMSCs have been reported in patients treated with RINVOQ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions. Many of these adverse events were serious and some resulted in death. Consider the risks and benefits prior to treating patients who may be at increased risk. Patients with symptoms of thrombosis should be promptly evaluated.

GASTROINTESTINAL PERFORATIONS

Gastrointestinal perforations have been reported in clinical studies with RINVOQ, although the role of JAK inhibition in these events is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with nonsteroidal anti-inflammatory drugs (NSAIDs). RINVOQ should be used with caution in patients who may be at increased risk for gastrointestinal perforation. Promptly evaluate patients presenting with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES

Neutropenia

Treatment with RINVOQ was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3). Treatment with RINVOQ is not recommended in patients with an ANC <1000 cells/mm3. Evaluate neutrophil counts at baseline and thereafter according to routine patient management.

Lymphopenia

Absolute lymphocyte counts (ALC) <500 cells/mm3 were reported in RINVOQ clinical studies. Treatment with RINVOQ is not recommended in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Anemia

Decreases in hemoglobin levels to <8 g/dL were reported in RINVOQ clinical studies. Treatment should not be initiated or should be interrupted in patients with hemoglobin levels <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

Lipids

Treatment with RINVOQ was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Manage patients according to clinical guidelines for the management of hyperlipidemia. Evaluate 12 weeks after initiation of treatment and thereafter according to the clinical guidelines for hyperlipidemia.

Liver enzyme elevations

Treatment with RINVOQ was associated with increased incidence of liver enzyme elevation compared to placebo. Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are observed during routine patient management and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.

EMBRYO-FETAL TOXICITY

Based on animal studies, RINVOQ may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RINVOQ and for 4 weeks after the final dose. Verify pregnancy status of females of reproductive potential prior to starting treatment with RINVOQ.

VACCINATION

Use of live, attenuated vaccines during, or immediately prior to, RINVOQ therapy is not recommended. Prior to initiating RINVOQ, patients should be brought up to date on all immunizations, including prophylactic zoster vaccinations, in agreement with current immunization guidelines.

LACTATION

There are no data on the presence of RINVOQ in human milk, the effects on the breastfed infant, or the effects on milk production. Available data in animals have shown the excretion of RINVOQ in milk. Advise patients that breastfeeding is not recommended during treatment with RINVOQ and for 6 days after the last dose.

HEPATIC IMPAIRMENT

RINVOQ is not recommended in patients with severe hepatic impairment.

ADVERSE REACTIONS

The most common adverse reactions in RINVOQ clinical trials (≥1%) were: upper respiratory tract infection, nausea, cough, and pyrexia.

US-RNQR-200725