• Infliximab

    Crohn’s Disease

    Infliximab is 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

    Infliximab 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 CD who have had an inadequate response to conventional therapy.

    Ulcerative Colitis

    Infliximab is 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

    Infliximab 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 UC who have had an inadequate response to conventional therapy.

    Rheumatoid Arthritis

    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

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

    Psoriatic Arthritis

    Infliximab is 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

    Infliximab is 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. Infliximab should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

    SERIOUS INFECTIONS

    Patients treated with 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 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 Infliximab.1,2 Treatment for latent infection should be initiated prior to treatment with 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 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 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 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 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.

    Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including Infliximab. These cases have had a very aggressive disease course and have been fatal. The majority of reported 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 Infliximab at or prior to diagnosis. Carefully assess the risks and benefits of treatment with 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 Infliximab, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with 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 post-marketing 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 therapy, including 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 Infliximab compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between Infliximab and cervical cancer cannot be excluded. Periodic screening should continue in women treated with Infliximab.

    CONTRAINDICATIONS

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

    HEPATITIS B REACTIVATION

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

    HEPATOTOXICITY

    Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported in patients receiving Infliximab post-marketing. 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, 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 post-marketing reports of new onset and worsening heart failure, with and without identifiable precipitating factors. Patients with moderate or severe heart failure taking 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 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 Infliximab in patients who develop significant hematologic abnormalities.

    HYPERSENSITIVITY

    Infliximab has 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. 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 Infliximab infusion. Cases of transient visual loss have been reported during or within 2 hours of Infliximab infusion. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.

    NEUROLOGIC EVENTS

    TNF blockers, including 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 Infliximab in patients with these disorders and consider discontinuation if these disorders develop.

    CONCURRENT ADMINISTRATION WITH OTHER BIOLOGICS

    Concurrent use of Infliximab with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as 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 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 Infliximab, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with 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 Infliximab.

    ADVERSE REACTIONS

    In clinical trials, the most common adverse reactions occurring in >10% of 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 Infliximab. Provide the Medication Guide 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-253862v1

    INDICATIONS
Click on the left to see the Important Safety Information

INDICATIONS

IMPORTANT SAFETY INFORMATION

  • https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/Infliximab-pi.pdf
    https://www.janssenlabels.com/package-insert/product-patient-information/Infliximab-medication-guide.pdf

Helping Patients Afford Infliximab

Downloadable Forms
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JCP
Hover on a document on the left for a quick document preview
 
 
 

Helping Patients Afford Infliximab

Janssen CarePath can help you find out what affordability assistance may be available for your patients taking Infliximab. Download a summary of affordability options or see a full list of options below.

Select your patient’s coverage status for relevant resources. 

For Patients with Commercial or Private Insurance

Janssen CarePath Savings Program for Infliximab
Eligible patients pay as little as
$5
per infusion
Your eligible patients with commercial or private insurance pay as little as $5 per infusion for their Infliximab medication

There is a limit to savings each year. Program does not cover the cost to give patients their infusion.

Patients may participate without sharing their income information.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners.

If your patients are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please have them contact us at 877-CarePath (877-227-3728).

Expand to calculate program savings.

Enter your patient’s medication out-of-pocket* expense for Infliximab below and click the “Calculate” button to see the savings program benefit that the Janssen CarePath Savings Program may provide.

This calculator is for demonstration purposes only. Actual savings program benefit values will depend on information contained within the patient's explanation of benefits and program business rules.

Please enter a valid number.
Please enter a valid number.
Please enter a valid number.
Please enter a valid percentage.
Please enter a valid percentage.
Calculate
Summary of Cost Breakdown:
 
 
Infliximab Savings Program Benefit in first year
 
 
Patient Responsibility in first year
Drug Cost:
Admin Cost:
Out-of-Pocket Met by Infusion:
Calculate

Click to view the Janssen CarePath Savings Program Overview for additional information.

The Savings Program is for Infliximab medication cost only. It does not cover the cost to administer the patient's infusion.

*Out-of-Pocket = medication co-pay, co-insurance, and/or deductible
Sign your patients up for the Janssen CarePath Savings Program only or create a Provider Portal account.
Janssen CarePath Savings Program Savings Program Only
Janssen CarePath Provider Portal Provider Portal
Sign Patients Up for the Janssen CarePath Savings Program and Get a Savings Card
 
 
Manage Savings Program Transactions
 
 
Requires Business Associate Agreement /Patient Authorizations
 
 
Get Benefits Investigations
 
 
Get Prior Authorization Support
 
 
Create Medical Necessity and Exception Letters
 
 
Request Exceptions and Appeals Information
 
 
View Patient Dashboard
 
 
Get Timely Notifications
 
 
24-hour Online Access to Your Account
 
 
Get Started with the Option That Works Best for You and Your Patients
Sign your patients up for the Janssen CarePath Savings Program only or create a Provider Portal account.
Janssen CarePath Savings Program
  • Sign Patients Up for the Janssen CarePath Savings Program and Get a Savings Card

Sign Up for the Savings Program Only

Janssen CarePath Provider Portal
  • Sign Patients Up for the Janssen CarePath Savings Program and Get a Savings Card
  • Manage Savings Program Transactions
  • Requires Business Associate Agreement /Patient Authorizations
  • Get Benefits Investigations
  • Get Prior Authorization Support
  • Create Medical Necessity and Exception Letters
  • Request Exceptions and Appeals Information
  • View Patient Dashboard
  • Get Timely Notifications
  • 24-hour Online Access to Your Account

Create a Provider Portal Account

In addition to the Janssen CarePath Savings Program, here are some independent programs that may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

For Patients with Government Coverage

Even if your patients have government coverage like Medicare, we can identify programs that may help them afford their medications. Here are some independent programs that may be right for them.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicare Savings Program
Many states have programs that offer support for people with limited income and resources. They may help with Medicare premiums, deductibles, and co-insurance.
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

For Patients with No Insurance Coverage

If your patients need help with drug costs, we can identify programs that may help them afford their medications.

Here are some programs that are not offered by Janssen. Each program has its own eligibility rules.

Take a look and see which ones may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Patients Looking for Coverage?
The Health Insurance Marketplace may have a plan that is right for your patient. Some patients may qualify for savings on premiums.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. Patients may be eligible if they don’t have insurance.

Do you have patients who may need help? They can see if they are eligible and get an application at JJPAF.org or call 800-652-6227 (Monday through Friday, 8:00 AM to 8:00 PM ET).

Janssen CarePath Savings Program for Infliximab
Eligible patients pay as little as
$5
per infusion
Your eligible patients with commercial or private insurance pay as little as $5 per infusion for their Infliximab medication

There is a limit to savings each year. Program does not cover the cost to give patients their infusion.

Patients may participate without sharing their income information.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners.

If your patients are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please have them contact us at 877-CarePath (877-227-3728).

Expand to calculate program savings.

Enter your patient’s medication out-of-pocket* expense for Infliximab below and click the “Calculate” button to see the savings program benefit that the Janssen CarePath Savings Program may provide.

This calculator is for demonstration purposes only. Actual savings program benefit values will depend on information contained within the patient's explanation of benefits and program business rules.

Please enter a valid number.
Please enter a valid number.
Please enter a valid number.
Please enter a valid percentage.
Please enter a valid percentage.
Calculate
Summary of Cost Breakdown:
 
 
Infliximab Savings Program Benefit in first year
 
 
Patient Responsibility in first year
Drug Cost:
Admin Cost:
Out-of-Pocket Met by Infusion:
Calculate

Click to view the Janssen CarePath Savings Program Overview for additional information.

The Savings Program is for Infliximab medication cost only. It does not cover the cost to administer the patient's infusion.

*Out-of-Pocket = medication co-pay, co-insurance, and/or deductible
Sign your patients up for the Janssen CarePath Savings Program only or create a Provider Portal account.
Janssen CarePath Savings Program Savings Program Only
Janssen CarePath Provider Portal Provider Portal
Sign Patients Up for the Janssen CarePath Savings Program and Get a Savings Card
 
 
Manage Savings Program Transactions
 
 
Requires Business Associate Agreement /Patient Authorizations
 
 
Get Benefits Investigations
 
 
Get Prior Authorization Support
 
 
Create Medical Necessity and Exception Letters
 
 
Request Exceptions and Appeals Information
 
 
View Patient Dashboard
 
 
Get Timely Notifications
 
 
24-hour Online Access to Your Account
 
 
Get Started with the Option That Works Best for You and Your Patients
Sign your patients up for the Janssen CarePath Savings Program only or create a Provider Portal account.
Janssen CarePath Savings Program
  • Sign Patients Up for the Janssen CarePath Savings Program and Get a Savings Card

Sign Up for the Savings Program Only

Janssen CarePath Provider Portal
  • Sign Patients Up for the Janssen CarePath Savings Program and Get a Savings Card
  • Manage Savings Program Transactions
  • Requires Business Associate Agreement /Patient Authorizations
  • Get Benefits Investigations
  • Get Prior Authorization Support
  • Create Medical Necessity and Exception Letters
  • Request Exceptions and Appeals Information
  • View Patient Dashboard
  • Get Timely Notifications
  • 24-hour Online Access to Your Account

Create a Provider Portal Account

In addition to the Janssen CarePath Savings Program, here are some independent programs that may be right for your patients.

State-Sponsored Programs
Some states have financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help your patients.
Medicare Savings Program
Many states have programs that offer support for people with limited income and resources. They may help with Medicare premiums, deductibles, and co-insurance.
Medicaid
Some of your patients may qualify for free or low-cost health coverage. Certain states have even expanded their Medicaid programs to cover all people with incomes below a certain level.
Patients Looking for Coverage?
The Health Insurance Marketplace may have a plan that is right for your patient. Some patients may qualify for savings on premiums.
Independent Co-Pay Assistance Foundations
Learn about foundations that may be able to help your patients. We have listed programs that give support to patients with a condition treated by this medication. There may be others that can help that are not listed here. These foundations are independent and have their own rules for eligibility, which are subject to change. We have no control over these foundations. We do not endorse any particular foundation.

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. Patients may be eligible if they don’t have insurance.

Do you have patients who may need help? They can see if they are eligible and get an application at JJPAF.org or call 800-652-6227 (Monday through Friday, 8:00 AM to 8:00 PM ET).

Important Safety Information For

  • Infliximab

    Crohn’s Disease

    Infliximab is 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

    Infliximab 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 CD who have had an inadequate response to conventional therapy.

    Ulcerative Colitis

    Infliximab is 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

    Infliximab 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 UC who have had an inadequate response to conventional therapy.

    Rheumatoid Arthritis

    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

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

    Psoriatic Arthritis

    Infliximab is 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

    Infliximab is 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. Infliximab should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

    SERIOUS INFECTIONS

    Patients treated with 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 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 Infliximab.1,2 Treatment for latent infection should be initiated prior to treatment with 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 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 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 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 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.

    Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including Infliximab. These cases have had a very aggressive disease course and have been fatal. The majority of reported 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 Infliximab at or prior to diagnosis. Carefully assess the risks and benefits of treatment with 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 Infliximab, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with 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 post-marketing 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 therapy, including 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 Infliximab compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between Infliximab and cervical cancer cannot be excluded. Periodic screening should continue in women treated with Infliximab.

    CONTRAINDICATIONS

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

    HEPATITIS B REACTIVATION

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

    HEPATOTOXICITY

    Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported in patients receiving Infliximab post-marketing. 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, 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 post-marketing reports of new onset and worsening heart failure, with and without identifiable precipitating factors. Patients with moderate or severe heart failure taking 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 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 Infliximab in patients who develop significant hematologic abnormalities.

    HYPERSENSITIVITY

    Infliximab has 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. 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 Infliximab infusion. Cases of transient visual loss have been reported during or within 2 hours of Infliximab infusion. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.

    NEUROLOGIC EVENTS

    TNF blockers, including 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 Infliximab in patients with these disorders and consider discontinuation if these disorders develop.

    CONCURRENT ADMINISTRATION WITH OTHER BIOLOGICS

    Concurrent use of Infliximab with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as 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 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 Infliximab, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with 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 Infliximab.

    ADVERSE REACTIONS

    In clinical trials, the most common adverse reactions occurring in >10% of 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 Infliximab. Provide the Medication Guide 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.

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    INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

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INDICATIONS

IMPORTANT SAFETY INFORMATION