Our Products

Please see Important Safety Information, including BOXED WARNING on Serious Infections and Malignancy.

Please see Important Safety Information, including BOXED WARNING on Serious Infections, Malignancy, and Thrombosis.

Rheumatology

Please see Important Safety Information, including BOXED WARNING on Serious Inflections and Malignancy.

Please see Important Safety Information, including BOXED WARNING on Serious Inflections, Malignancy, and Thrombosis.

Moderate to Severe

Rheumatoid Arthritis

Please see Important Safety Information, including BOXED WARNING on Serious Inflections and Malignancy.

Please see Important Safety Information, including BOXED WARNING on Serious Inflections, Malignancy, and Thrombosis.

Active

Psoriatic Arthritis

Active

Ankylosing Spondylitis

Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

Dermatology

Please see Important Safety Information, including BOXED WARNING on Serious Inflections and Malignancy.

Moderate to Severe

Chronic Plaque Psoriasis

Please see Important Safety Information, including BOXED WARNING on Serious Inflections and Malignancy.

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

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

US-IMM-190099

For moderate to severe rheumatoid arthritis (RA) in adult
MTX-IR patients¹

Abbvie's commitment to exceptional access and product experience

Get started with the
Enrollment & Prescription Form

Download the RINVOQ Complete Enrollment & Prescription Form

Commitment to working toward 100% commercial patient access

For patients with commercial insurance, preferred coverage* could mean:

PREDICTABLE ACCESS for commercial patients
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.

Access means the product is covered and not NDC blocked. Restrictions may apply.

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.

Please see HUMIRA full Prescribing Information.

Commercial patients not yet covered are eligible to RINVOQ from RINVOQ 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.^‡

Please see HUMIRA full Prescribing Information.

Empowering Patients
Nurse Ambassadors, In Their Own Words

Transcript

Have questions or need support over the phone?

Call 1-877-COMPLETE (1‑800‑274‑6867)

*Ambassadors do not provide medical advice and are trained to direct patients to speak with their healthcare professional 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. This is not health insurance.

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. This is not health insurance. Please see full Terms and Conditions.

Program Details: For eligible patients, the HUMIRA Complete Savings program offers up to $12,000 in annual savings, with a monthly benefit maximum of $1,200 and an expanded benefit of $9,000 during any two-month period in the benefit year.

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.

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

Practice Forms and Resources

Patient Forms and Resources

PRACTICE FORMS AND RESOURCES

To enroll a patient in RINVOQ Complete:

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.

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.*

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.

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

Get started with the enrollment & prescription form

RINVOQ Complete Enrollment & Prescription Form

HUMIRA Complete Enrollment & Prescription Form

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.

PATIENT FORMS AND RESOURCES

Once you and your patient fill in the Enrollment and Prescription Form, simply fax it to RINVOQ Complete or HUMIRA Complete and inform your patient that they will be receiving a call from their Nurse Ambassador. If you complete the Pharmacy Prescription, also fax it to your patient’s chosen specialty pharmacy.

Download the enrollment & prescription form

RINVOQ Complete Enrollment & Prescription Form

HUMIRA Complete Enrollment & Prescription Form

Please see HUMIRA full Prescribing Information.

ADDITIONAL RESOURCES

Benefits Verification Chart

Insurance Comparison Booklet

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 up medication reminders
Log symptoms
Log medication lot number and medication expiration date

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:

Transcript

Register now at COMPLETEPRO.COM

RINVOQ ACCESS AND REIMBURSEMENT FORMS

RINVOQ Complete is here to help your patients get timely access to RINVOQ. Along with requesting information from a RINVOQ Complete Access Specialist, you can download the forms you need to get started.

Templates

Appeals Letter

Formulary Exception Letter

Tiered Exception Letter

HIPAA Authorization Form

Medical Necessity Letter

INSTRUCTIONS

Here you can download helpful guidelines and tips for completing these templates.

Prior authorization instructions

Appeals letter instructions

Letter of medical necessity instructions

This information is for informational purposes only and is not intended to provide reimbursement or legal advice. The information presented here does not guarantee payment or coverage.

BILLING AND CODING

Coding Guide

SPECIALTY PHARMACY

Specialty Pharmacy Guide

See HUMIRA Access and Reimbursement Forms

Please see HUMIRA full Prescribing Information.

RINVOQ SAFETY DATA

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

SEE SAFETY PROFILE

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-UPAD-190033

Please see full Prescribing Information.

REFERENCES

RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
Data on file, AbbVie Inc. Payer reported lives. April 2020.

IMPORTANT SAFETY INFORMATION & INDICATION FOR
HUMIRA® (adalimumab)¹

INDICATION¹

Rheumatoid Arthritis (RA): HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

Juvenile Idiopathic Arthritis (JIA): HUMIRA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

Psoriatic Arthritis (PsA): HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.

Ankylosing Spondylitis (AS): HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Adult Crohn's Disease (CD): HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab..

Pediatric Crohn's Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.

Ulcerative Colitis (UC): HUMIRA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine. The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to anti-TNF agents.

Plaque Psoriasis (Ps): HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Hidradenitis Suppurativa (HS): HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

Uveitis: HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.

IMPORTANT SAFETY INFORMATION¹

SERIOUS INFECTIONS

Patients treated with HUMIRA 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.

Discontinue HUMIRA if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Do not start HUMIRA during an active infection, including localized infections.
Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
If an infection develops, monitor carefully and initiate appropriate therapy.
Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HUMIRA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy.
In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients.
Non-melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with HUMIRA.
In HUMIRA clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

Anaphylaxis and angioneurotic edema have been reported following HUMIRA administration. If a serious allergic reaction occurs, stop HUMIRA and institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
Exercise caution in patients who are carriers of HBV and monitor them during and after HUMIRA treatment.
Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HUMIRA after HBV treatment.

NEUROLOGIC REACTIONS

TNF blockers, including HUMIRA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
Exercise caution when considering HUMIRA for patients with these disorders; discontinuation of HUMIRA should be considered if any of these disorders develop.
There is a known association between intermediate uveitis and central demyelinating disorders.

HEMATOLOGIC REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with HUMIRA.
Consider stopping HUMIRA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise caution and monitor carefully.

AUTOIMMUNITY

Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

Patients on HUMIRA should not receive live vaccines.
Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HUMIRA therapy.
Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to HUMIRA in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

The most common adverse reactions in HUMIRA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

Please see full Prescribing Information

Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

IMPORTANT SAFETY INFORMATION & INDICATION FOR HUMIRA® (adalimumab)¹

INDICATION¹

HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

IMPORTANT SAFETY INFORMATION¹

SERIOUS INFECTIONS

Discontinue HUMIRA if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Do not start HUMIRA during an active infection, including localized infections.
Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
If an infection develops, monitor carefully and initiate appropriate therapy.
Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HUMIRA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy.
In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients.
Non-melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with HUMIRA.
In HUMIRA clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

Anaphylaxis and angioneurotic edema have been reported following HUMIRA administration. If a serious allergic reaction occurs, stop HUMIRA and institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
Exercise caution in patients who are carriers of HBV and monitor them during and after HUMIRA treatment.
Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HUMIRA after HBV treatment.

NEUROLOGIC REACTIONS

TNF blockers, including HUMIRA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
Exercise caution when considering HUMIRA for patients with these disorders; discontinuation of HUMIRA should be considered if any of these disorders develop.
There is a known association between intermediate uveitis and central demyelinating disorders.

HEMATOLOGIC REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with HUMIRA.
Consider stopping HUMIRA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise caution and monitor carefully.

AUTOIMMUNITY

Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

Patients on HUMIRA should not receive live vaccines.
Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HUMIRA therapy.
Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to HUMIRA in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

The most common adverse reactions in HUMIRA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

Please see full Prescribing Information

Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

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

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 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

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

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 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

IMPORTANT SAFETY INFORMATION¹

SERIOUS INFECTIONS

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.

MALIGNANCY

THROMBOSIS

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

Neutropenia

Lymphopenia

Anemia

Lipids

Liver enzyme elevations

EMBRYO-FETAL TOXICITY

VACCINATION

LACTATION

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.

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Rheumatology

Moderate to Severe

Rheumatoid Arthritis

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Psoriatic Arthritis

Active

Ankylosing Spondylitis

Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

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Moderate to Severe

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Pediatric Crohn's Disease

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IMPORTANT SAFETY INFORMATION & INDICATION1

INDICATION1

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

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IMPORTANT SAFETY INFORMATION & INDICATION FOR HUMIRA® (adalimumab)1

INDICATION1

IMPORTANT SAFETY INFORMATION1

Footnotes and Definitions

ACR Response Criteria1,2

Reference:

Study Design & Baseline Characteristics

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PRIMARY ENDPOINT1

SELECT RANKED SECONDARY ENDPOINTS2

SELECT PRESPECIFIED NONRANKED ENDPOINTS3,9,10

DATA LIMITATIONS

BASELINE CHARACTERISTICS3,11

REFERENCES

Study Design & Baseline Characteristics

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Primary Endpoint1

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IMPORTANT SAFETY INFORMATION & INDICATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

IMPORTANT SAFETY INFORMATION & INDICATION FOR
HUMIRA® (adalimumab)¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

ACR Response Criteria^1,2

PRIMARY ENDPOINT¹

SELECT RANKED SECONDARY ENDPOINTS²

SELECT PRESPECIFIED NONRANKED ENDPOINTS^3,9,10

BASELINE CHARACTERISTICS^3,11

Primary Endpoint¹

Select Ranked Secondary Endpoints^3,6

SELECT PRESPECIFIED NONRANKED ENDPOINTS^3,6

Baseline Characteristics³

Primary Endpoint¹

Ranked Secondary Endpoints^3,8

Select prespecified
nonranked endpoints^2,3,9,10

Baseline Characteristics³

Primary Endpoint¹

Select Ranked Secondary Endpoints^5,6

Select Prespecified nonranked endpoints⁶

Baseline Characteristics⁵

Primary Endpoint¹

Ranked Secondary Endpoints^6,7

Select Prespecified nonranked endpoints⁷

Baseline Characteristics⁶

IMPORTANT SAFETY INFORMATION & INDICATION FOR HUMIRA® (adalimumab)¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

Primary Endpoint¹

Ranked Secondary Endpoints¹

Baseline Characteristics¹

IMPORTANT SAFETY INFORMATION & INDICATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹