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 patients1

Abbvie's commitment to
exceptional
access and patient
support

Get started with the
Enrollment & Prescription Form

RINVOQ is for moderate to severe rheumatoid arthritis (RA) in adult MTX-IR patients1

Exceptional 
national commercial
coverage* to
Rinvoq® (upadacitinib) as
a preferred first-line tim therapy1,2*

Preferred coverage* means first-line coverage with
no requirement of a prior TIM failure before starting RINVOQ

Preferred Commercial Coverage Preferred Commercial Coverage Preferred Commercial Coverage

Preferred coverage also could mean a STANDARD PRIOR AUTHORIZATION (PA) and APPEALS PROCESS, potential for one-time PA/appeal approval.

*Formulary Definitions: Coverage means placed on formulary without a single step edit through other biologics. For RINVOQ, this could include coverage on a non-preferred tier which may result in a higher out‑of‑pocket cost. Preferred/Step 1 means the product is placed on the plan's preferred formulary. Non-preferred products require a higher out‑of‑pocket cost or step edit, or are placed on a higher tier.
Based on formulary status under the pharmacy benefit.
Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
TIM=targeted immunomodulator

Preferred coverage also could mean a
STANDARD PRIOR AUTHORIZATION (PA)
and APPEALS PROCESS, potential for one-time PA/appeal approval.

National commercial plan formulary status under the pharmacy benefit in 20212

National commercial plan formulary status under the pharmacy benefit National commercial plan formulary status under the pharmacy benefit National commercial plan formulary status under the pharmacy benefit

Cimzia, Actemra, and Orencia are available as products on medical benefits plans.3-5

Most national and regional health plans may not approve non-preferred for patients who have shown clinical stability solely through the use of samples or other free goods.

The products here are not interchangeable and are not pharmaceutically equivalent or bioequivalent. They differ with respect to active and inactive ingredients, strength, dosage, indications, clinical efficacy, and clinical safety.

No conclusions regarding comparative safety or efficacy can be drawn from this information. Selection of a treatment regimen should be individualized for each patient based on factors including, but not limited to, product efficacy, adverse events, dosage and administration, potential for drug interactions, patients’ test results, and comorbid conditions.

*Formulary Definitions: Coverage means placed on formulary without a single step edit through other biologics. For RINVOQ, this could include coverage on a non-preferred tier which may result in a higher out‑of‑pocket cost. Preferred/Step 1 means the product is placed on the plan's preferred formulary. Non-preferred products require a higher out-of-pocket cost or step edit, or are placed on a higher tier. 
Based on formulary status under the pharmacy benefit.

Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
TIM=targeted immunomodulator

Please see HUMIRA full Prescribing Information.

Look up commercial insurance plans for RINVOQ in your area:

    Increasing 
    Medicare coverage to
    RINVOQ® (upadacitinib) as a preferred first-line tim therapy for appropriate patients2*

    *Formulary Definitions: Coverage means placed on formulary without a single step edit through other biologics. For RINVOQ, this could include coverage on a non‑preferred tier which may result in a higher out‑of‑pocket cost. Preferred/Step 1 means the product is placed on the plan's preferred formulary.
    Non‑preferred products require a higher out‑of‑pocket cost or step edit, or are placed on a higher tier. Based on formulary status under the pharmacy benefit.
    Disadvantaged means a restriction (eg, prior authorization, step edit, quantity limits, or other medical policies) to a product that is not applied consistently across the entire therapeutic class.
    TIM=targeted immunomodulator

    National Medicare Part D plan formulary status under the pharmacy benefit in 20212

    National commercial plan formulary status under the pharmacy benefit National commercial plan formulary status under the pharmacy benefit National commercial plan formulary status under the pharmacy benefit

    Cimzia, Actemra, and Orencia are available as products on medical benefits plans.3-5

    The products here are not interchangeable and are not pharmaceutically equivalent or bioequivalent. They differ with respect to active and inactive ingredients, strength, dosage, indications, clinical efficacy, and clinical safety.

    No conclusions regarding comparative safety or efficacy can be drawn from this information. Selection of a treatment regimen should be individualized for each patient based on factors including, but not limited to, product efficacy, adverse events, dosage and administration, potential for drug interactions, patients’ test results, and comorbid conditions.

    *Formulary Definitions: Coverage means placed on formulary without a single step edit through other biologics. For RINVOQ, this could include coverage on a non‑preferred tier which may result in a higher out‑of‑pocket cost. Preferred/Step 1 means the product is placed on the plan's preferred formulary.
    Non‑preferred products require a higher out‑of‑pocket cost or step edit, or are placed on a higher tier. Based on formulary status under the pharmacy benefit.
    Disadvantaged means a restriction (eg, prior authorization, step edit, quantity limits, or other medical policies) to a product that is not applied consistently across the entire therapeutic class.
    TIM=targeted immunomodulator

    Please see HUMIRA full Prescribing Information.

    Two products.
    One exceptional patient experience.

    RINVOQ™ COMPLETE
    HUMIRA® COMPLETE

    NURSE
    AMBASSADORS*

    Empower patients

    Our Nurse Ambassadors are the heart of RINVOQ Complete and HUMIRA Complete

    Nurse Ambassadors provide 1:1 support to help patients start and stay on track with their prescribed treatment plan, including:

    • Help patients understand the importance of following the treatment plan prescribed by their healthcare professional.
    • Committed to answering questions throughout the experience to help limit treatment disruptions.
    • Answer patients’ insurance questions and connect them with additional insurance expertise.
    • Identify ways for patients to save on prescription costs.

    ACCESS
    SPECIALISTS

    Insurance support when needed

    • Resource with expertise on Medicare and commercial plans at a national, local, and program level so that they can educate on potential options to consider based on each patient’s unique financial situation.
    • Can educate on payer prior authorization and appeal processes so you can determine the best access option for each patient’s unique situation.

    ACCESS & SAVINGS

    Help with access &
    treatment affordability

    COMPLETE can help your commercial patients save: 

    • With the Complete Savings Card, your eligible commercially insured patients may pay as little as $5 per month.
    • Complete may help eligible commercially insured patients experiencing initial coverage delays or denials access their prescribed therapy at no charge while coverage is established.

    Empowering Patients
    Nurse Ambassadors, In Their Own Words

    Have questions or need support over the phone?

    Call 1-877-COMPLETE (1‑800‑274‑6867)

    *Nurse Ambassadors are provided by AbbVie and do not provide medical advice or work under the direction of the prescribing healthcare professional (HCP). They are trained to direct patients to speak with their HCP about any treatment-related questions, including further referrals.

    RINVOQ Complete: Terms and Conditions apply. This benefit covers RINVOQ® (upadacitinib) alone or for RINVOQ plus one of the following medications: methotrexate, leflunomide (Arava®), or hydroxychloroquine (Plaquenil®). Eligibility: Available to patients with commercial prescription insurance coverage for RINVOQ who meet eligibility criteria. Co‑pay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government‑funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government‑funded healthcare program, patient will no longer be able to use the RINVOQ Complete Savings Card and patient must call RINVOQ Complete at 1.800.2RINVOQ to stop participation. Patients residing in or receiving treatment in certain states may not be eligible. Patients may not seek reimbursement for value received from the RINVOQ Complete program from any third-party payers. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. Patients who are members of insurance plans that claim to reduce or eliminate their patients' out-of-pocket co-pay, co-insurance, or deductible obligations for certain prescription drugs based upon the availability of, or patient's enrollment in, manufacturer sponsored co-pay assistance for such drugs (often termed "maximizer" programs) will have an annual maximum program benefit of $6,000.00 per calendar year. This assistance offer is not health insurance. To learn about AbbVie’s privacy practices and your privacy choices, visit www.abbvie.com/privacy.html

    HUMIRA Complete: Terms and Conditions apply. This benefit covers HUMIRA® (adalimumab) alone or, for rheumatology patients, HUMIRA plus one of the following medications: methotrexate, leflunomide (Arava®), or hydroxychloroquine (Plaquenil®). Eligibility: Available to patients with commercial prescription insurance coverage for HUMIRA who meet eligibility criteria. Copay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government‑funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government‑funded healthcare program, patient will no longer be able to use the HUMIRA Complete Savings card and patient must call HUMIRA Complete at 1-800-4HUMIRA to stop participation. Patients residing in or receiving treatment in certain states may not be eligible. Patients may not seek reimbursement for value received from the HUMIRA Complete Program from any third-party payers. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. Patients who are members of insurance plans that claim to reduce or eliminate their patients' out-of-pocket co-pay, co-insurance, or deductible obligations for certain prescription drugs based upon the availability of, or patient's enrollment in, manufacturer sponsored co-pay assistance for such drugs (often termed "maximizer" programs) will have an annual maximum program benefit of $6,000.00 per calendar year. This assistance offer is not health insurance. To learn about AbbVie’s privacy practices and your privacy choices, visit www.abbvie.com/privacy.html

    Arava® and Plaquenil® are registered trademarks of their respective owners.

    Program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be eligible to participate in program. Available to patients between the ages of 18-63 with commercial prescription insurance coverage who meet eligibility criteria. Eligibility: Patients must be diagnosed with moderate to severe rheumatoid arthritis, have a valid prescription for RINVOQ® and participate in a commercial insurance plan that has denied or not yet made a formulary decision for RINVOQ. Once the patient’s insurance plan has made a formulary decision and established a process for reviewing coverage requests for RINVOQ, continued eligibility for the program requires the submission of a Prior Authorization prior to the next scheduled dose and appeal of the coverage denial within 180 days. Program provides RINVOQ at no charge to patients for up to 2 years or until they receive insurance coverage approval, whichever occurs earlier. Offer subject to change or discontinuance without notice. This is not health insurance and program does not guarantee insurance coverage.

    How to enroll patients in the
    complete program

    Help patients get the support they need to start and stay
    on track with their prescribed treatment

    To enroll a patient in RINVOQ Complete:

    1

    Fill out the form with your patient
    This form enrolls your patient and can be used to initiate a prescription with your patient’s preferred specialty pharmacy.

    3

    Fax the form to 1-678-727-0690 and to the patient's chosen specialty pharmacy
    You will receive a call from an Access Specialist to discuss next steps. In addition, fax the form to your patient’s specialty pharmacy if using the Pharmacy Prescription in Section 9.

    2

    Fill out the patient support prescription in Section 6
    This may help your commercially insured patients get access to RINVOQ if they experience a delay or denial in their insurance coverage.*

    2

    Fill out the patient support prescription in
    Section 6

    This may help your commercially insured patients get access to RINVOQ if they experience a delay or denial in their insurance coverage.*

    3

    Fax the form to 1-678-727-0690 and to the patient's chosen specialty pharmacy
    You will receive a call from an Access Specialist to discuss next steps. In addition, fax the form to your patient’s specialty pharmacy if using the Pharmacy Prescription in Section 9.

    4

    Inform your patient that they have been enrolled
    Let your patient know that they will be receiving a call from their Nurse Ambassador.

    Please see HUMIRA full Prescribing Information.

    *Program is not available to patients receiving prescription reimbursement under any federal, state, or government‑funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government‑funded healthcare program, patient will no longer be eligible to participate in program. Available to patients between the ages of 18-63 with commercial prescription insurance coverage who meet eligibility criteria. Eligibility: Patients must be diagnosed with moderate to severe rheumatoid arthritis, have a valid prescription for RINVOQ® and participate in a commercial insurance plan that has denied or not yet made a formulary decision for RINVOQ. Once the patient’s insurance plan has made a formulary decision and established a process for reviewing coverage requests for RINVOQ, continued eligibility for the program requires the submission of a Prior Authorization prior to the next scheduled dose and appeal of the coverage denial within 180 days. Program provides RINVOQ at no charge to patients for up to 2 years or until they receive insurance coverage approval, whichever occurs earlier. Offer subject to change or discontinuance without notice. This is not health insurance and program does not guarantee insurance coverage.

    Nurse Ambassadors are provided by AbbVie and do not provide medical advice or work under the direction of the prescribing healthcare professional (HCP). They are trained to direct patients to speak with their HCP about any treatment-related questions, including further referrals.

    Complete app

    COMPLETE APP

    Track treatment

    The Complete App helps patients stay on track with their prescribed RINVOQ or HUMIRA treatment by helping them:

    • Access additional resources, including a savings card for those that are eligible
    • Set customized medication reminders
    • Log and share symptoms with HCPs
    • Log medication lot number and medication expiration date
    Download on the App Store
    Get it on Google Play

    COMPLETEPRO.COM

    Streamline the Rx process

    CompletePro.com enables seamless enrollment into RINVOQ Complete and HUMIRA Complete, and helps streamline the prescription process for your patients.

     

    With CompletePro.com, you can:

    • Request benefits verifications
    • Complete and submit prior authorizations
    • Send prescriptions to the patient’s specialty pharmacy of choice, with the option to include a savings card
    • Receive alerts for annual reauthorizations and renewals
    • Track and monitor where patients are in the prescription process

    Learn more about streamlining the prescription process with Complete Pro:

    RINVOQ SAFETY DATA

    Review the well-studied safety profile of RINVOQ,
    including both short- and long-term analyses

    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 INFORMATION

    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 druginduced 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.

    Dosage Forms and Strengths: RINVOQ is available in 15 mg extended-release tablets.

    US-UPAD-190033

    Please see full Prescribing Information.

    Please see full Prescribing Information.

    REFERENCES

    1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
    2. Data on file, AbbVie Inc. Payer-reported lives. January 2021.
    3. Cimzia [package insert]. Smyrna, GA: UCB Inc; 2019.
    4. Actemra [package insert]. South San Francisco, CA: Genentech, Inc; 2019.
    5. Orencia [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2019.

    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 INFORMATION

    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 druginduced 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.

    Dosage Forms and Strengths: RINVOQ is available in 15 mg extended-release tablets.

    US-UPAD-190033