Guide to Reimbursement and Patient Support for …...reimbursement request submitted to your private...

FDA-APPROVED

INFLECTRA is a trademark of Pfizer Inc.Pfizer enCompass is a trademark of Pfizer Inc.

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Please see Important Safety Information and Indications on pages 12-15, and full Prescribing Information, including BOXED WARNING and Medication Guide, available at InflectraHCP.com.

Pfizer enCompass®: Guide to Reimbursement

and Patient Support for INFLECTRA®

http://labeling.pfizer.com/ShowLabeling.aspx?id=9271


https://labeling.pfizer.com/ShowLabeling.aspx?id=9271&section=medguide

http://InflectraHCP.com

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Pfizer is committed to offering reimbursement and patient support for patients who have been prescribed INFLECTRA®

(infliximab-dyyb) for Injection. As part of this commitment, we have developed Pfizer enCompass®.

In this guide, you will find the following offered through Pfizer enCompass, including information on:

• Reimbursement support available to minimize patient access barriers

• Patient support offered for eligible uninsured and underinsured Pfizer enCompass patients

• How to access and utilize the secure Pfizer enCompass Provider Portal to enroll patients online in Pfizer enCompass

Reimbursement and patient support information are also available at www.pfizerencompass.com.

For questions about how Pfizer enCompass can help patients access INFLECTRA, please contact Pfizer enCompass to speak to an Access Counselor at 1-844-722-6672.

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For more information on INFLECTRA, visit www.inflectrahcp.com

1-844-722-6672Monday–Friday

9 am–8 pm ET

Fax 1-844-482-4482

Pfizer enCompassP.O. Box 220040

Charlotte, NC 28222

Website for Healthcare Providers (HCPs)

and Patientswww.pfizerencompass.com





http://www.pfizerencompass.com

http://www.inflectrahcp.com


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Pfizer enCompass has a secure Provider Portal at www.pfizerencompassonline.com for healthcare providers (HCPs) and their staff. The portal allows the convenience of online, real-time access to Pfizer enCompass support and resources through electronic submission of requests for a variety of Pfizer enCompass support, including patient insurance benefit verifications (BVs) and tracking the progress of patient requests.

To get started, select one of the following options:

Visit www.pfizerencompassonline.com and click “Register Now”

Pfizer enCompass® Provider Portal

Call Pfizer enCompass at 1-844-722-6672 to speak to an Access Counselor about getting started with the Provider Portal

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24/7 access to information and resources

The Pfizer enCompass website is a centralized resource to access information about Pfizer enCompass reimbursement and patient support as well as important information on coverage, coding, and payment of Pfizer’s Food and Drug Administration (FDA)-approved biosimilar products.

The following can be accessed through the Pfizer enCompass website:

To get started, visit www.pfizerencompass.com

Introducing the Pfizer enCompass Website

Reimbursement support information and resources

Billing and coding information for each FDA-approved Pfizer biosimilar

Pfizer enCompass information including co-pay assistance and free drug assistance for eligible patients

Brochures and FAQs along with downloadable and writeable PDF versions of forms

Direct link to the secure Pfizer enCompass Provider Portal





http://www.pfizerencompassonline.com

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Pfizer enCompass offers reimbursement and patient support intended to help patients navigate the reimbursement process, including:

After Pfizer enCompass completes a BV, Pfizer enCompass will provide a Summary of Patient Insurance Benefits that may include the following information (see sample Summary beginning on page 9):

• Complete patient insurance benefits information for INFLECTRA, including:

– Coding requirements: INFLECTRA may be billed with a product-specific Q code

– Coverage limitations and restrictions

– Patient out-of-pocket and cost-sharing requirements

– Prior authorization and predetermination requirements, if applicable

– Determination of specific insurance benefit that provides coverage for INFLECTRA (ie, medical and/or pharmacy benefit)

Pfizer enCompass will fax a Summary of Patient Insurance Benefits approximately 2 business days after you submit a BV request.

Verifying patient insurance

benefits/confirming patient insurance

benefits

Prior authorization assistance and following up

with claims submission

Researching patient support alternatives

HCPs may request a benefit verification (BV) on behalf of their patient in 3 ways:• Enroll the patient electronically through the secure Provider Portal at www.pfizerencompassonline.com• Download an editable PDF of the Pfizer enCompass Enrollment Form for INFLECTRA, either from the Pfizer

enCompass website at www.pfizerencompass.com or the Provider Portal at www.pfizerencompassonline.com, and fax or mail the form to Pfizer enCompass

• Call Pfizer enCompass at 1-844-722-6672 Monday-Friday, 9 am–8 pm ET

Pfizer enCompass® Support

Verifying Patient Insurance Benefits Verifying patient’s insurance coverage for INFLECTRA is the first step toward reimbursement and access for patients.

Identifying patient support programs for

eligible insured, uninsured, and

underinsured patients

Insurance verification is the ultimate responsibility of the HCP. The information included here is not a guarantee of insurance coverage or reimbursement. All benefit information is subject to the insured patient’s plan at the time support is rendered.








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Prior Authorization AssistancePfizer enCompass is available to work with a patient’s HCP and health insurer to assist the patient through the prior authorization process, if prior authorization is required, by:

• Researching and identifying prior authorization requirements and necessary supporting documentation

• Prepopulating the payer’s prior authorization form with the patient’s demographic information and sending it to the patient’s HCP for completion and submission to the payer

• Monitoring and following up on the prior authorization request after the HCP has submitted to the patient’s insurance until a final determination is made

Follow-up With Claims SubmissionGeneral Coding and Billing AssistancePfizer enCompass Access Counselors may provide general billing and coding guidance based on a payer’s published policies, including information about the specific Q code for INFLECTRA. Additional coding and billing information may be available at www.pfizerencompass.com or by registering and logging in to the Pfizer enCompass Provider Portal at www.pfizerencompassonline.com.

Claims AssistancePfizer enCompass Access Counselors are available to assist with:

• Status review for pending claims

• Research of underpaid and denied claims

Appeals AssistancePfizer enCompass Access Counselors are committed to supporting eligible patients through the reimbursement process. If the patient’s claim is denied, Pfizer enCompass can provide support with the appeal process* where appropriate by:

• Investigating the plan’s reason(s) for denying a claim or prior authorization request and determining if and how a denied claim may be appealed

• Providing a sample letter of appeal, if requested

• Monitoring and following up on the status of an appeal until a final outcome is received

Alternate Funding ResearchAccess Counselors can research alternate coverage options for uninsured and underinsured patients, and, if an alternate coverage source is identified, an Access Counselor will assist the patient with understanding the application process. Access Counselors can follow-up with the patient to determine the status.

For certain eligible patients, if Pfizer enCompass identifies an alternate source of funding, Pfizer enCompass can provide temporary free product from the Pfizer Patient Assistance Program†‡ while they apply.

Patient SupportPfizer has developed programs that provide financial assistance to eligible patients if they need help getting access to Pfizer *Appeals assistance is provided only for patients with FDA-approved indications.†Patient eligibility is determined by Patient Assistance Program criteria, which are subject to change. Other eligibility criteria may apply.‡The Pfizer Patient Assistance Program is a joint program of Pfizer Inc and the Pfizer Patient Assistance Foundation™. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc, with distinct legal restrictions.

Pfizer enCompass® Support (Continued)

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Pfizer offers programs that provide financial assistance to eligible patients if they need help getting access to their Pfizer medicine. The various programs may assist eligible patients without health insurance and patients with health insurance needing assistance with out-of-pocket costs, such as co-pays or coinsurances for INFLECTRA.

Pfizer enCompass Co-Pay Assistance Program for INFLECTRAThe Pfizer enCompass Co-Pay Assistance Program for INFLECTRA provides eligible, commercially insured patients assistance of up to $20,000 per calendar year for claims received by the program. Eligible enrolled patients may pay as little as $0 for each INFLECTRA treatment. Federal and State health care beneficiaries not eligible. Private insurance only. The co-pay program covers only drug costs, not procedures, administration fees, or office visits. Please see full Terms and Conditions below.

The HCP and patient may complete and fax or mail the Pfizer enCompass Enrollment Form to Pfizer enCompass to verify the patient’s eligibility for the program. If the patient is approved for the program, the patient and HCP will both receive confirmation letters with identification cards and instructions for submitting claims.

Assignment of BenefitsPatients have the option to consent to assign co-pay assistance benefits to the HCP. If the patient consents, the HCP will submit the patient’s co-pay claim to the Pfizer enCompass Co-Pay Assistance Program on the patient’s behalf. The HCP will receive reimbursement directly from the INFLECTRA Co-Pay Assistance Program for approved co-pay claims.

Claim SubmissionIf the HCP does not submit a co-pay claim, or if a pharmacy dispensed the prescription, the patient or pharmacy can submit a co-pay claim to the program.

Go to www.pfizerencompass.com or the Provider Portal at www.pfizerencompassonline.com for more information about the co-pay program or to download forms.

Terms and ConditionsBy using this program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions below:

The Pfizer enCompass Co-Pay Assistance Program for INFLECTRA is not valid for patients that are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”). Patient must have private insurance. Program offer is not valid for cash-paying patients. With this program, eligible patients may pay as little as $0 co-pay per INFLECTRA treatment, subject to a maximum benefit of $20,000 per calendar year for out-of-pocket expenses for INFLECTRA including co-pays or coinsurances. The amount of any benefit is the difference between your co-pay and $0. After the maximum of $20,000 you will be responsible for the remaining monthly out-of-pocket costs. Patient must have private insurance with coverage of INFLECTRA. This offer is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other private health or pharmacy benefit programs. You must deduct the value of this assistance from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf. You are responsible for reporting use of the program to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the program, as may be required. You should not use the program if your insurer or health plan prohibits use of manufacturer co-pay assistance programs. This program is not valid where prohibited by law. This program cannot be combined with any other savings, free trial or similar offer for the specified prescription. This program is not health insurance. This program is good only in the U.S. and Puerto Rico. This program is limited to 1 per person during this offering period and is not transferable. No other purchase is necessary. Data related to your redemption of the program assistance may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other assistance redemptions and will not identify you. Pfizer reserves the right to rescind, revoke or amend this program without notice. This program may not be available to patients in all states. For more information about Pfizer, visit www.pfizer.com. For more information about the Pfizer enCompass Co-Pay Assistance Program, call Pfizer enCompass at 1-844-722-6672, or write to Pfizer enCompass Co-Pay Assistance Program, P.O. Box 220040, Charlotte, NC 28222. Program terms will expire at the end of each calendar year. Before the calendar year ends, you will receive information and eligibility requirements for continued participation.

Pfizer enCompass® Support (Continued)

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Process to Enroll Patients to Obtain Pfizer enCompass® Support

Patient is prescribed treatment with INFLECTRA1

HCP initiates enrollment into Pfizer enCompass by: • Completing the Pfizer enCompass Enrollment Form for INFLECTRA, available at

wwwpfizerencompass.com or www.pfizerencompassonline.com

• Enrolling the patient electronically through the Pfizer enCompass Provider Portal at www.pfizerencompassonline.com

• Calling Pfizer enCompass at 1-844-722-6672 Monday-Friday, 9 am–8 pm ET

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Pfizer enCompass Access Counselor performs a BV based on the patient’s information provided on the Enrollment Form• Access Counselor faxes a Summary of Patient Insurance Benefits within 2 business days of

receipt of the fully completed Enrollment Form• If the Summary of Patient Insurance Benefits indicates the need for prior authorization, Pfizer

enCompass will provide prior authorization information and pre-determination information (when available), and instructions for submission

• Based on the patient’s insurance benefits, the HCP may order INFLECTRA via specialty pharmacy or acquire it via buy-and-bill

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Pfizer enCompass Access Counselor will refer eligible patients in need of assistance with out-of-pocket expenses for INFLECTRA to appropriate patient support options (ie, co-pay assistance for those with commercial insurance or free medication for eligible uninsured or underinsured patients experiencing financial hardship).

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HCP and patient schedule treatment• If accessing INFLECTRA via a specialty pharmacy, the HCP will schedule an appointment based

on the product delivery schedule

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HCP administers treatment6

HCP prepares and submits the claim for INFLECTRA to patient’s insurance• As the HCP prepares the insurer’s required claim form for a patient, Pfizer enCompass can provide

billing and coding information and monitor claim status after the claim is submitted

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Getting Started With INFLECTRA

If participating in the Co-pay Assistance Program for INFLECTRA, the HCP or patient will submit the Pfizer enCompass Co-Pay Assistance Program for INFLECTRA Claim Form by following theinstructions on the form and providing the explanation of benefits

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Patient Support Programs Available for Eligible Uninsured and Underinsured Patients

Pfizer Patient Assistance Program*†

Drug Replacement Program (DRP) Uninsured Patients Underinsured Patients

Description

Replaces the INFLECTRA

used for eligible, insured patients whose claims are denied and appeals are unsuccessful. Patients must enroll prior to treatment

If eligible for DRP, eligible patients will be transitioned to the Pfizer Patient Assistance Program for future treatments if both a claim and an appeal are denied

Provides INFLECTRA free for 12 months to eligible patients who have no prescription coverage. Patients must enroll prior to treatment

Patients can re-apply if they still need assistance at the end of their enrollment period

Provides INFLECTRA for free through the end of a calendar year to eligible patients who have insurance but have difficulty with cost-sharing obligations required by their insurance plan. Patients must enroll prior to treatment

Patients can re-apply if they still need assistance at the end of their enrollment period

Insurance type

Patient may be insured through any health insurance program

Patient must not have insurance coverage for INFLECTRA

Patient may be insured through any health insurance program

Eligibility requirements

Patient must:• Complete an application• Live in the United States (or its

territories) • Be treated by a licensed HCP• Be treated in an outpatient

setting• Meet income criteria and

provide proof of income • Submit required documentation

Patient must:• Have no prescription coverage

for INFLECTRA• Not be eligible (or have been

denied) for any available alternate coverage options

• Complete an application• Live in the United States (or its



provide proof of income

Patient must:• Have insurance• Not be eligible (or have been

denied) for any available alternate coverage options

• Complete an application• Live in the United States (or its



provide proof of income

*Patient eligibility is determined by Patient Assistance Program criteria, which are subject to change. Other eligibility criteria may apply. †The Pfizer Patient Assistance Program is a joint program of Pfizer Inc and the Pfizer Patient Assistance Foundation™. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc, with distinct legal restrictions.

To apply for the Pfizer Patient Assistance Program for Pfizer enCompass® Patients, patients and their HCPs may complete an application by the following:

• Online through the Pfizer enCompass Provider Portal at www.pfizerencompassonline.com

• Downloading, completing, and faxing an application available on the Pfizer enCompass website or the Provider Portal

• Calling 1-844-722-6672 to request an application from an Access Counselor

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Following initiation of a BV, Pfizer enCompass® will fax a Summary of Patient Insurance Benefits, including a cover letter confirming the patient name, date of birth, and Pfizer enCompass Record ID. The letter will also include information for contacting Pfizer enCompass, should the HCP have questions regarding patient insurance benefits.

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Sample Summary of Patient Insurance Benefits

Pfizer enCompass®

Tel: 1-844-722-6672 Fax: 1-844-482-4482

Summary of Patient Insurance Benefits for INFLECTRA® (infliximab-dyyb) for Injection

August 1, 2018 John Smith, MD Regional Medical Center 123 Main Street Anywhere, USA 01234 RE: Patient Name: John Doe Patient Date of Birth: 06/15/1969 Pfizer enCompass Record ID: BS00002N Dear Treating Provider, MD: Pfizer enCompass has researched your patient’s insurance benefits for treatment with INFLECTRA. We have included a Summary of Patient Insurance Benefits that explains coverage for INFLECTRA based on the findings of our research. Please note that this is not a guarantee of payment and does not take the place of written policy information. Pfizer enCompass is also available to assist patients with the following for John Doe:

• Additional benefit investigations, should your patient’s insurance coverage change

• Prior authorization and reauthorization assistance, when required by the insurance company, and outcome tracking

• Appeals assistance, when prior authorization or a claim has been denied • Billing and coding support and claims tracking • Payer policy research • Referrals to financial assistance programs for patients with limited or no

coverage

If you have any questions about this letter or the following Summary of Patient Insurance Benefits, please contact Pfizer enCompass at 1-844-722-6672. We are available Monday–Friday, 9 AM–8 PM ET. Sincerely, Pfizer enCompass Access Counselor

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SAMPLE





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Pfizer enCompass® Tel: 1-844-722-6672 Fax: 1-844-482-4482

Summary of Patient Insurance Benefits for INFLECTRA® (infliximab-dyyb) for Injection

Insurance verification is the ultimate responsibility of the provider. The information included here is not a guarantee of insurance coverage or reimbursement. All benefit information is subject to the insured patient’s plan at the time services are rendered. Under no circumstances shall Pfizer enCompass be held responsible or liable for payment of any claims, benefits, or cost. Any coding information included in this document is provided for informational purposes only, is subject to change, and should not be construed as legal advice. Providers should exercise independent clinical judgment when selecting codes and submitting claims to accurately reflect the services and products furnished to the specific patient.

Primary Medical Benefit Coverage Details (Physician Purchase/Buy and Bill) Coverage Available: Yes Deductible: Co-pay/Coinsurance: OOP Max:

Individual: $1300 ($1300 Met) Product: 20% Individual: $2,250 ($589 Met) Family: N/A (N/A Met) Office Visit: 20% Family: N/A (N/A Met)

Prior Authorization Required: Yes Prior Authorization Process: Prior authorization is required and is currently not on file. Please provide clinical notes, treatment regimen, patient name and policy # on the request and call Medical Review at (222) 222-2222. Processing time is 3 to 5 business days. Additional Coverage Details: Admin, INFLECTRA and office visit, if billed, are subject to a $1300 deductible, ($1300 met) 20% coinsurance, up to a $2,250 out-of-pocket max ($589.62 met-deductible included). Once met, coverage increases to 100% of the contracted rate. No referral required. Payer-Suggested Coding Options: Q5103 for INFLECTRA (infliximab-dyyb) for Injection with NDC#0069-0809-01.

Patient Name: John Doe Date Verified: August 1, 2018

Patient Date of Birth: 06/15/1969 Prescribing Physician: John Smith, MD Site of Care: Physician Office

Pfizer enCompass Record ID: BS00002N Diagnosis Code(s) Requested: M06.09

ATTN: John Smith, MD

Primary Payer: XYZ Insurance Plan Name: PPO

Benefit Type: Medical INFLECTRA Coverage

Payer Type: Private Commercial Plan Type: PPO

Out-of-Pocket Max: $2,250 ($589 Met)

Verified With: Jonathan Ref #1567 Claims Address: XYZ Insurance PO Box 1234 Anywhere, USA 01234

Policy Number: W123456798

Annual Benefit Cap: N/A

Group Number: 1234567890123 Lifetime Maximum: N/A Policy Effective Date: 01/01/2015 Payer Phone: (888)888-8888 Self-Funded: Yes

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SAMPLE

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Sample Summary of Patient Insurance Benefits (Continued)

This section will specify the benefit type for which INFLECTRA may be obtained.

This section will contain details specific to this benefit type. Details including patient out-of-pocket costs, prior authorization requirements, coverage details, and coding suggestions may be found in this section.

See www.pfizerencompass.com

for specific coding information.





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Pfizer enCompass® Tel: 1-844-722-6672 Fax: 1-844-482-4482

Primary Medical Benefit Coverage Details (Specialty Pharmacy/AOB) Coverage Available: Yes Deductible: Co-pay/Coinsurance: OOP Max:

Individual: $1300 ($1300 Met) Product: 20% Individual: $2,250 ($589 Met) Family: N/A (N/A Met) Office Visit: 20% Family: N/A (N/A Met)

Prior Authorization Required: Yes Prior Authorization Process: Prior authorization is required and is currently not on file. Please provide clinical notes, treatment regimen, patient name and policy # on the request and call Medical Review at (222) 222-2222. Processing time is 3 to 5 business days. Additional Coverage Details: Admin, INFLECTRA, and office visit, if billed, are subject to a $1300 deductible ($1300 met), 20% coinsurance, up to a $2250 out-of-pocket max ($589.62 met-deductible included). Once met, coverage increases to 100% of the contracted rate. No referral required. XYZ Specialty Pharmacy, (777) 777-7777. Payer-Suggested Coding Options: The specialty pharmacy will bill for INFLECTRA.

Primary Pharmacy Coverage Details Coverage Available: Yes Deductible: Co-pay/Coinsurance: OOP Max:

Individual: $1300 ($1300 Met) Retail Co-pay/Coinsurance: Undisclosed

Individual: $2,250 ($589 Met)

Mail Order Co-pay/Coinsurance: Undisclosed

Family: N/A (N/A Met) Office Visit: 20% Family: N/A (N/A Met) Prior Authorization Required: Yes Prior Authorization Process: Prior authorization is required for INFLECTRA and is currently not on file. Please contact Medical Review at (222) 222-2222 to provide clinical notes and treatment regimen as well as the patient name and policy #. Processing time is 24-48 hours. Notification method is fax. Additional Coverage Details: Benefits for INFLECTRA are undisclosed until prior authorization has been obtained. Admin and office visit, if billed, are subject to a $1300 deductible ($1300 met), 20% coinsurance, up to a $2,250 out-of-pocket max ($589.62 met-deductible included). Once met, coverage increases to 100% of the contracted rate. No referral required. ABC Pharmacy (333) 333-3333. Payer-suggested Coding Options: The pharmacy will bill for INFLECTRA.

PP-PAT-USA-0964 © 2019 Pfizer Inc. All rights reserved. Printed in USA/January 2019

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SAMPLE

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Sample Summary of Patient Insurance Benefits (Continued)

These sections will include the same information. Details will include patient out-of-pocket costs, prior authorization requirements, coverage details, and coding suggestions.





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Please see full Prescribing Information, including BOXED WARNING and Medication Guide, available at InflectraHCP.com.

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SERIOUS INFECTIONSPatients treated with infliximab products 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 INFLECTRA® (infliximab-dyyb) if a patient develops a serious infection or sepsis.

Reported infections include:• Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or

extrapulmonary disease. Patients should be tested for latent TB before INFLECTRA® use and during therapy.1,2 Treatment for latent infection should be initiated prior to INFLECTRA® use.

• Invasive fungal infections including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered 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.

The risks and benefits of treatment with INFLECTRA® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with INFLECTRA®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.

Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab products included pneumonia, cellulitis, abscess, and skin ulceration.

MALIGNANCIESLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.

Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with INFLECTRA®, especially in these patient types.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

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MALIGNANCIES (Continued)In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including infliximab products, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with infliximab products was similar to that expected in the general population, whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

A population-based retrospective cohort study found a 2- to 3-fold increase in the incidence of invasive cervical cancer in women with rheumatoid arthritis treated with infliximab compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between infliximab products and cervical cancer cannot be excluded. Periodic screening should continue in women treated with infliximab products.

CONTRAINDICATIONSINFLECTRA® is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. INFLECTRA® should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue INFLECTRA® if new or worsening CHF symptoms appear. INFLECTRA® should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product.

HEPATITIS B REACTIVATIONTNF inhibitors, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating INFLECTRA®. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing INFLECTRA® for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with INFLECTRA®. Discontinue INFLECTRA® in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of INFLECTRA® and monitor patients closely.

HEPATOTOXICITYSevere hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported rarely in patients receiving infliximab products postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, INFLECTRA® should be discontinued, and a thorough investigation of the abnormality should be undertaken.

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HEMATOLOGIC EVENTSCases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported in patients receiving infliximab products. The causal relationship to infliximab therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of INFLECTRA® in patients who develop significant hematologic abnormalities.

HYPERSENSITIVITYInfliximab products have been associated with hypersensitivity reactions that differ in their time of onset. Anaphylaxis, acute urticaria, dyspnea, and hypotension have occurred in association with infusions of infliximab products. Medications for the treatment of hypersensitivity reactions should be available.

CARDIOVASCULAR AND CEREBROVASCULAR REACTIONS DURING AND AFTER INFUSIONSerious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of infliximab infusion. Cases of transient visual loss have been reported during or within 2 hours of infusion of infliximab. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.

NEUROLOGIC EVENTSTNF inhibitors, including infliximab products, have been associated in rare cases with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering INFLECTRA® in patients with these disorders and consider discontinuation if these disorders develop.

AUTOIMMUNITYTreatment with infliximab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment with INFLECTRA® if symptoms of a lupus-like syndrome develop.

ADVERSE REACTIONSIn clinical trials with infliximab products, the most common adverse reactions occurring in >10% of patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.

USE WITH OTHER DRUGSConcomitant use of INFLECTRA® with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as INFLECTRA® is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.






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LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTSLive vaccines or therapeutic infectious agents should not be given with INFLECTRA® due to the possibility of clinical infections, including disseminated infections.

Bring pediatric patients up to date with all vaccinations prior to initiating INFLECTRA®. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to infliximab products.

INDICATIONSCrohn’s Disease• Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to

severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy

• Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD

Pediatric Crohn’s Disease• 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 conventional therapy

Ulcerative Colitis• Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating

corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

Rheumatoid Arthritis• Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in

patients with moderately to severely active rheumatoid arthritis, in combination with methotrexate

Ankylosing Spondylitis• Reducing signs and symptoms in patients with active ankylosing spondylitis

Psoriatic Arthritis• Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical

function in patients with psoriatic arthritis

Plaque Psoriasis• Treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for

systemic therapy and when other systemic therapies are medically less appropriate

• INFLECTRA® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician

References:2. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis

infection. Am J Respir Crit Care Med. 2000;161:S221-S247.2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.





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