• 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

Help Your Patients Start and Stay on Infliximab

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Help Your Patients Start and Stay on Infliximab

We understand that you want to get your patients the help they may need while going through treatment. That’s why we’ve put together some support resources that can help them, whether they’re just starting a new medication or they’ve been taking it for years.

Janssen CarePath Patient Account

Your patients and their caregivers can create an online account at MyJanssenCarePath.com where they can learn about their insurance coverage. They can also:

  • Enroll in the Janssen CarePath Savings Program
  • Manage their benefits
  • Sign up for treatment reminders
  • Find support throughout their treatment journey

Care Coordination

Janssen CarePath gives your patients one-on-one support through our Care Coordinators. Our Care Coordinators will work closely with you and your patients to provide the support you direct and additional support that your patients may need.

Specialty Distributors/Pharmacies

Janssen CarePath can connect you with alternative ways to access Infliximab.

Janssen CarePath Care Coordinators can also:

  • Identify pharmacies to allow you to access Infliximab without direct purchase or billing
  • Investigate payers for potential third-party assignment of patients’ insurance benefits options, both pharmacy and major medical
  • Provide a listing of third-party pharmacy providers for shipment and billing of Infliximab

To learn more, please call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728), Monday–Friday, 8:00 AM to 8:00 PM ET. Multilingual phone support is available.

Infusion Site Locator

Utilize the search capabilities of 2infuse.com to help you locate an infusion site 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 sites such as business hours, insurance plans accepted, and medications infused.

Find an infusion center.

Are you an infusion center?

Register to list with 2infuse.com

Janssen Nurse Support

Even after you’ve spoken to your patient about infusion treatment with Infliximab, they may still have questions. Janssen Nurse Support* can help answer their questions about the infusion process and provide more information about how to prepare for their infusion and what they may expect during the infusion process.

Connect your patients with Janssen Nurse Support at 877-CarePath (877-227-3728), available Monday–Friday, 9:00 AM to 8:00 PM ET. At all other times, a nurse will typically return their call in 15 minutes.

*Janssen Nurse Support is limited to education for patients about their Janssen therapy, its administration, and/or their disease. It is intended to supplement a patient's understanding of their therapy, and is not intended to provide medical advice, replace a treatment plan from the patient's doctor or nurse, provide case management services, or serve as a reason to prescribe.

Emergency Outreach Services

In case of a natural disaster in which your office or infusion center is unable to provide treatment, a Janssen CarePath Care Coordinator can help ensure your patients have continued access to treatment. To enroll in this service, patients just need to call Janssen CarePath at 877-CarePath (877-227-3728), Monday–Friday, 8:00 AM to 8:00 PM ET.

Internet Resources for Your Patients

There are many useful resources available online that may help your patients understand and manage their treatment with Infliximab and their diseases. You may find the websites listed here helpful as referrals in educating your patients about their condition.

The links provided here are for informational purposes only. No endorsement or sponsorship is implied.

Infliximab Patient Website

This website contains additional information about treatment with Infliximab.

Arthritis Foundation

The mission of the Arthritis Foundation is to improve lives through leadership in the prevention, control, and cure of arthritis and related diseases. This website includes education and online community resources for people with arthritis and their families.

Arthritis Today

The online home of the Arthritis Foundation’s “Arthritis Today” magazine is a great source of tips and information for people living with arthritis.

CreakyJoints

CreakyJoints provides treatment information, advice from professionals, and public forums for people living with arthritis to share their experiences.

Crohn's & Colitis Foundation of America

The Crohn's & Colitis Foundation of America is a non-profit, volunteer-driven organization dedicated to finding the cure for Crohn's disease and ulcerative colitis. The website contains medical information, news, and events about digestive diseases.

National Psoriasis Foundation

The National Psoriasis Foundation (NPF) is a non-profit organization with a mission to drive efforts to cure psoriatic disease and improve the lives of those affected.

Spondylitis Association of America

The Spondylitis Association of America is the first and largest resource for people affected by spondylitis. The website’s efforts help to advance education, research, and treatment for ankylosing spondylitis (AS) and related diseases. This site includes information and support for patients with AS and their families.

Call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728), Monday−Friday, 8:00 AM to 8:00 PM ET. Multilingual phone support available.

Sign up or log in to the Provider Portal at JanssenCarePathPortal.com where you can request and review benefits investigations, enroll eligible patients in the Janssen CarePath Savings Program, and view their Savings Program transactions.

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.

    cp-253862v1

    INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

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INDICATIONS

IMPORTANT SAFETY INFORMATION