Janssen’s unbranded Infliximab is NOT a biosimilar
Approved based on a full complement of safety and effectiveness data
Produced through biotechnology in a living system (ie, a “cell line”)
The same as the brand-name biologic
Produced using the same cell line as the brand-name biologic
Highly similar to brand-name biologic* with no clinically meaningful differences
Produced using a different cell line
*“Brand-name biologic” refers to the reference biologic.
UNBRANDED Infliximab: An Additional TREATMENT OPTION FOR PATIENTS Prescribed REMICADE®
An unbranded biologic is2:
An approved brand-name biologic being marketed under its approved biologics license† without the brand name
Considered by the FDA to be the same product as the brand‑name biologic under the same biologics license‡
The same in strength, dosage form, route of administration, and presentation as the brand‑name biologic
†Biologics are FDA-approved through a biologics license application (BLA).
‡No difference in strength, dosage form and route of administration, and presentation vs its approved brand-name biologic.
Janssen’s unbranded Infliximab Is REMICADE® Without the Brand Name4-6
Produced from the same cell line and at the same manufacturing sites as REMICADE®
Approved for all the same indications as REMICADE® with the same safety and efficacy profile
Available in the same strength, same dosage form, and same route of administration as REMICADE®
Offering the same affordability and patient support programs as REMICADE®
Janssen’s unbranded Infliximab is priced 59% lower than branded REMICADE®, based on Wholesale Acquisition Cost
Unbranded Infliximab builds upon the 20‑year manufacturing heritage of REMICADE®
PRODUCT TIMELINE
1993
REMICADE® First Studied in Clinical Trials7
1998
Branded REMICADE® Approved for First Indication4
2021
Introduction of Unbranded Infliximab5
More than 3 million patients worldwide have been Prescribed REMICADE®§4
§Cumulative exposure from August 1998 through August 2020 in all approved indications.
References: 1. US Food and Drug Administration. Biosimilar and Interchangeable Products. Accessed July 20, 2021. https://ww.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products#biological 2. US Food and Drug Administration. FAQs – Purple Book. Accessed July 20, 2021. https://purplebooksearch.fda.gov/faqs 3. Declerck P et al. Biosimilarity versus manufacturing change: two distinct concepts. Pharm Res. 2016;33(2):261-268. 4. Data on file. Janssen Biotech, Inc. 5. Infliximab [Prescribing Information]. Horsham, PA; Janssen Biotech, Inc. 6. REMICADE® [Prescribing Information]. Horsham, PA; Janssen Biotech, Inc. 7. Hsia EC, Ruley KM, Rahman MU. Infliximab (Remicade®): from bench to clinical practice. A paradigm shift in rheumatology practice. APLAR J Dermatol. 2006;9:107-118.
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
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.
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
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.