Access
and Support

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Janssen CarePath

Your one source for access, affordability, and treatment support for your patients

Access Support

Access support

to help navigate payer processes

Janssen CarePath helps verify insurance coverage for your patients taking Infliximab and provides reimbursement information.

Online benefits investigation and prior authorization support at JanssenCarePathPortal.com
Affordability Support

Affordability support

to help your patients start and stay on the treatment you prescribe

Janssen CarePath can help you find out what affordability assistance may be available for your patients taking Infliximab

Comprehensive Provider Portal to enroll eligible patientsin the Janssen CarePath Savings Program and more at JanssenCarePathPortal.com
Treatment Support

Treatment support

to help your patients get informed and stay on Infliximab

Janssen CarePath provides additional support to your patients, including patient education, web-based resources, and personalized reminders

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Call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728), Monday-Friday, 8:00 am to 8:00 pm ETMultilingual phone support available

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Sign Up or Log In to the Provider Portal at JanssenCarePathPortal.com

The Janssen CarePath Savings Program for REMICADE® and Infliximab

The Janssen Care Path Savings Program for REMICADE® now covers Infliximab.

Add Infliximab to the patient account from your patient dashboard on the Provider Portal.

Request a Benefits Investigation for Infliximab and follow the steps to initiate the BI process.

Eligible patients who have been prescribed Infliximab are automatically enrolled in the Janssen CarePath Savings Program for REMICADE® and Infliximab and can use their Savings Program card for program benefits for Infliximab.

The patient will NOT need to obtain a replacement card for the combined Savings Program.

All Savings Program details for REMICADE® are the same for Infliximab:

  • Eligible patients will continue to pay $5 for each dose, with a $20,000 maximum program benefit per calendar year
  • If the patient has used a portion of their maximum program benefit per calendar year for REMICADE®, the remaining amount can be used for Infliximab

Getting started is easy at JanssenCarePathPortal.com

Provider Portal offers a customizable patient dashboard with real-time status updates

Janssen CarePath Provider Portal

  • Benefits investigations and prior authorizations
  • Enroll eligible patients in Savings Program
  • View Savings Program transactions

We understand that navigating payer processes and finding cost support options may seem complicated at times. That's why we've created an enhanced Provider Portal experience.

Janssen Care Path

With a Provider Portal account you can:

  • Request benefits investigations and prior authorizations in real time
  • Review the status of benefits investigations
  • Initiate prior authorizations without benefits investigations
  • Enroll your eligible, commercially insured patients in the Janssen CarePath Savings Program
  • View and help manage patients’ Savings Program benefits as requested by enrolled patients
  • Receive notifications when new information is available, or action is required on the Portal

Create a Provider Portal account at JanssenCarePathPortal.com

  • Complete required information, include your practice locations, add administrators and staff to your site, and set communication preferences

Complete the Business Associate Agreement (BAA) for your practice (one time only)

  • The completed BAA allows you to use the Provider Portal without requiring individual patient authorization
    • You can execute the BAA within the Portal and receive immediate verification and access to the Portal, or
    • You can download the BAA at JanssenCarePath.com and upload the signed document via the Portal or fax to the number provided on the form

OR

Secure patient authorization (for each patient)

  • Invite each patient to create an online account at MyJanssenCarePath.com to secure patient authorization, or
  • You can download the Patient Authorization Form at JanssenCarePath.com and upload the signed document via the Portal or fax to the number provided on the form

Now you are ready to use the Provider Portal.

Patient insurance benefits investigation and other Janssen CarePath program offerings are provided by third-party service providers for Janssen CarePath, under contract with Johnson & Johnson Health Care Systems Inc. on behalf of Actelion Pharmaceuticals US, Inc., Janssen Biotech, Inc., Janssen Pharmaceuticals, Inc., and Janssen Products, LP (Janssen). The availability of information and assistance may vary based on the Janssen medication, geography and other program differences. Janssen CarePath assists healthcare providers (HCPs) in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer, and patient information provided by the HCP under appropriate authorization following the provider’s exclusive determination of medical necessity. This information and assistance are made available as a convenience to patients, and there is no requirement that patients or HCPs use any Janssen product in exchange for this information or assistance. Janssen assumes no responsibility for and does not guarantee the quality, scope, or availability of the information and assistance provided. The third-party service providers, not Janssen, are responsible for the information and assistance provided under this program. Each HCP and patient is responsible for verifying or confirming any information provided. All claims and other submissions to payers should be in compliance with all applicable requirements.

INFUSION SUPPORT: INFUSION CENTER LOCATOR

Utilize the search capabilities of 2infuse.com to help you locate an infusion center convenient to your patient’s home or office. Searchable by city or ZIP code, this helpful site provides detailed search results organized by driving distance. This website also includes valuable information about the infusion center such as business hours, insurance plans accepted, and medications infused.

FIND AN INFUSION CENTER
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2 Infuse

Resources for Your Office

The following resources are available for use within your offices:

REMICADE® (infliximab) and Infliximab Billing & Coding Guide

Download Resource

REMICADE® and Infliximab Dosing and Administration Guide

Download Resource
IMPORTANT SAFETY INFORMATION
INDICATIONS
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS

Patients treated with either REMICADE® or Infliximab 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 either REMICADE® or Infliximab 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 and during treatment with either REMICADE® or Infliximab.1,2 Treatment for latent infection should be initiated prior to treatment with either REMICADE® or Infliximab.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, and cryptococcosis. 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, Listeria, and Salmonella.

The risks and benefits of treatment with either REMICADE® or Infliximab should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with either REMICADE® or Infliximab, 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 either REMICADE® or Infliximab included pneumonia, cellulitis, abscess, and skin ulceration.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including either REMICADE® or Infliximab. 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 either REMICADE® or Infliximab. These cases have had a very aggressive disease course and have been fatal. The majority of reported REMICADE® and Infliximab cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with either REMICADE® or Infliximab at or prior to diagnosis. Carefully assess the risks and benefits of treatment with either REMICADE® or Infliximab, especially in these patient types.

In clinical trials of all TNF blockers, 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 blockers, including either REMICADE® or Infliximab, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with either REMICADE® or Infliximab 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 blockers 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 therapies, including either REMICADE® or Infliximab. 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 either REMICADE® or Infliximab compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between either REMICADE® or Infliximab and cervical cancer cannot be excluded. Periodic screening should continue in women treated with either REMICADE® or Infliximab.

CONTRAINDICATIONS

The use of either REMICADE® or Infliximab at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure. REMICADE® and Infliximab are contraindicated in patients with a previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of REMICADE® and Infliximab or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness).

HEPATITIS B REACTIVATION

TNF blockers, including REMICADE® and Infliximab, 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 either REMICADE® or Infliximab. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing either REMICADE® or Infliximab for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with either REMICADE® or Infliximab. Discontinue either REMICADE® or Infliximab in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of either REMICADE® or Infliximab and monitor patients closely.

HEPATOTOXICITY

Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported in patients receiving either REMICADE® or Infliximab 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, either REMICADE® or Infliximab should be discontinued, and a thorough investigation of the abnormality should be undertaken.

HEART FAILURE

In a randomized, placebo-controlled study in patients with moderate or severe heart failure (NYHA Functional Class III/IV), higher mortality rates and a higher risk of hospitalization were observed at Week 28 at a dose of 10 mg/kg and higher rates of cardiovascular events were observed at both 5 mg/kg and 10 mg/kg. There have been postmarketing reports of new onset and worsening heart failure, with and without identifiable precipitating factors. Patients with moderate or severe heart failure taking either REMICADE® or Infliximab (≤5 mg/kg) or patients with mild heart failure should be closely monitored and treatment should be discontinued if new or worsening symptoms appear.

HEMATOLOGIC EVENTS

Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to REMICADE® and 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 either REMICADE® or Infliximab in patients who develop significant hematologic abnormalities.

HYPERSENSITIVITY

REMICADE® and Infliximab 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 either REMICADE® or Infliximab. Medications for the treatment of hypersensitivity reactions should be available.

CARDIOVASCULAR AND CEREBROVASCULAR REACTIONS DURING AND AFTER INFUSION

Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of either REMICADE® or Infliximab infusions. Cases of transient visual loss have been reported during or within 2 hours of either REMICADE® or Infliximab infusions. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.

NEUROLOGIC EVENTS

TNF blockers, including REMICADE® and Infliximab, have been associated 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 either REMICADE® or Infliximab in patients with these disorders and consider discontinuation if these disorders develop.

CONCURRENT ADMINISTRATION WITH OTHER BIOLOGICS

Concurrent use of either REMICADE® or Infliximab with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as REMICADE® and Infliximab 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.

AUTOIMMUNITY

Treatment with either REMICADE® or Infliximab may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS

Prior to initiating either REMICADE® or Infliximab, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with either REMICADE® or Infliximab due to the possibility of clinical infections, including disseminated infections.

At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to either REMICADE® or Infliximab.

ADVERSE REACTIONS

In clinical trials, the most common adverse reactions occurring in >10% of REMICADE®- and Infliximab-treated patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.

For more information, please see the full Prescribing Information, including Boxed Warning and Medication Guide for REMICADE® and full Prescribing Information, including Boxed Warning and Medication Guide for Infliximab. Provide the Medication Guides to your patients and encourage discussion.

References: 1. 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.

cp-253861v1



INDICATIONS
Crohn’s Disease

REMICADE® and Infliximab are indicated for:

  • 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

REMICADE® and Infliximab are 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 CD who have had an inadequate response to conventional therapy.

Ulcerative Colitis

REMICADE® and Infliximab are indicated for 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 (UC) who have had an inadequate response to conventional therapy.

Pediatric Ulcerative Colitis

REMICADE® and Infliximab are 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 UC who have had an inadequate response to conventional therapy.

Rheumatoid Arthritis

REMICADE® or Infliximab, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA).

Ankylosing Spondylitis

REMICADE® and Infliximab are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS).

Psoriatic Arthritis

REMICADE® and Infliximab are indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA).

Plaque Psoriasis

REMICADE® and Infliximab are indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis (Ps) who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. REMICADE® or Infliximab should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.




IMPORTANT SAFETY INFORMATION
INDICATIONS
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS

Patients treated with either REMICADE® or Infliximab 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 either REMICADE® or Infliximab 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 and during treatment with either REMICADE® or Infliximab.1,2 Treatment for latent infection should be initiated prior to treatment with either REMICADE® or Infliximab.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, and cryptococcosis. 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, Listeria, and Salmonella.

The risks and benefits of treatment with either REMICADE® or Infliximab should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with either REMICADE® or Infliximab, 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 either REMICADE® or Infliximab included pneumonia, cellulitis, abscess, and skin ulceration.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including either REMICADE® or Infliximab. 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 either REMICADE® or Infliximab. These cases have had a very aggressive disease course and have been fatal. The majority of reported REMICADE® and Infliximab cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with either REMICADE® or Infliximab at or prior to diagnosis. Carefully assess the risks and benefits of treatment with either REMICADE® or Infliximab, especially in these patient types.

In clinical trials of all TNF blockers, 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 blockers, including either REMICADE® or Infliximab, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with either REMICADE® or Infliximab 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 blockers 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 therapies, including either REMICADE® or Infliximab. 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 either REMICADE® or Infliximab compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between either REMICADE® or Infliximab and cervical cancer cannot be excluded. Periodic screening should continue in women treated with either REMICADE® or Infliximab.

CONTRAINDICATIONS

The use of either REMICADE® or Infliximab at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure. REMICADE® and Infliximab are contraindicated in patients with a previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of REMICADE® and Infliximab or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness).

HEPATITIS B REACTIVATION

TNF blockers, including REMICADE® and Infliximab, 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 either REMICADE® or Infliximab. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing either REMICADE® or Infliximab for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with either REMICADE® or Infliximab. Discontinue either REMICADE® or Infliximab in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of either REMICADE® or Infliximab and monitor patients closely.

HEPATOTOXICITY

Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported in patients receiving either REMICADE® or Infliximab 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, either REMICADE® or Infliximab should be discontinued, and a thorough investigation of the abnormality should be undertaken.

HEART FAILURE

In a randomized, placebo-controlled study in patients with moderate or severe heart failure (NYHA Functional Class III/IV), higher mortality rates and a higher risk of hospitalization were observed at Week 28 at a dose of 10 mg/kg and higher rates of cardiovascular events were observed at both 5 mg/kg and 10 mg/kg. There have been postmarketing reports of new onset and worsening heart failure, with and without identifiable precipitating factors. Patients with moderate or severe heart failure taking either REMICADE® or Infliximab (≤5 mg/kg) or patients with mild heart failure should be closely monitored and treatment should be discontinued if new or worsening symptoms appear.

HEMATOLOGIC EVENTS

Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to REMICADE® and 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 either REMICADE® or Infliximab in patients who develop significant hematologic abnormalities.

HYPERSENSITIVITY

REMICADE® and Infliximab 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 either REMICADE® or Infliximab. Medications for the treatment of hypersensitivity reactions should be available.

CARDIOVASCULAR AND CEREBROVASCULAR REACTIONS DURING AND AFTER INFUSION

Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of either REMICADE® or Infliximab infusions. Cases of transient visual loss have been reported during or within 2 hours of either REMICADE® or Infliximab infusions. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.

NEUROLOGIC EVENTS

TNF blockers, including REMICADE® and Infliximab, have been associated 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 either REMICADE® or Infliximab in patients with these disorders and consider discontinuation if these disorders develop.

CONCURRENT ADMINISTRATION WITH OTHER BIOLOGICS

Concurrent use of either REMICADE® or Infliximab with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as REMICADE® and Infliximab 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.

AUTOIMMUNITY

Treatment with either REMICADE® or Infliximab may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS

Prior to initiating either REMICADE® or Infliximab, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with either REMICADE® or Infliximab due to the possibility of clinical infections, including disseminated infections.

At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to either REMICADE® or Infliximab.

ADVERSE REACTIONS

In clinical trials, the most common adverse reactions occurring in >10% of REMICADE®- and Infliximab-treated patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.

For more information, please see the full Prescribing Information, including Boxed Warning and Medication Guide for REMICADE® and full Prescribing Information, including Boxed Warning and Medication Guide for Infliximab. Provide the Medication Guides to your patients and encourage discussion.

References: 1. 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.

cp-253861v1



ISI button expand
INDICATIONS
Crohn’s Disease

REMICADE® and Infliximab are indicated for:

  • 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

REMICADE® and Infliximab are 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 CD who have had an inadequate response to conventional therapy.

Ulcerative Colitis

REMICADE® and Infliximab are indicated for 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 (UC) who have had an inadequate response to conventional therapy.

Pediatric Ulcerative Colitis

REMICADE® and Infliximab are 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 UC who have had an inadequate response to conventional therapy.

Rheumatoid Arthritis

REMICADE® or Infliximab, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA).

Ankylosing Spondylitis

REMICADE® and Infliximab are indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS).

Psoriatic Arthritis

REMICADE® and Infliximab are indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA).

Plaque Psoriasis

REMICADE® and Infliximab are indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis (Ps) who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. REMICADE® or Infliximab should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.