Dosing and
Administration

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Dosing of Infliximab for adults1

Infusions are administered every 8 weeks (or 6 weeks for those with active Ankylosing Spondylitis) after 3 induction doses. Infliximab is administered by intravenous (IV) infusion over a period of not less than 2 hours.

Recommended Dosage and Intervals for Infliximab in Adult Patients1
Indication

Moderately to Severely 
Active Crohn’s Disease*

*Patients who do not respond by Week 14 are unlikely to respond with continued dosing, and consideration should be given to discontinuing Infliximab in these patients.

Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Rheumatoid Arthritis‡

In conjunction with methotrexate.

Active Ankylosing Spondylitis

Active Psoriatic ArthritisII

IICan be used with or without methotrexate.

Chronic Severe Plaque Psoriasis

Induction

5 mg/kg 0, 2, and 6 weeks

5 mg/kg 0, 2, and 6 weeks

3 mg/kg 0, 2, and 6 weeks

5 mg/kg 0, 2, and 6 weeks

5 mg/kg 0, 2, and 6 weeks

5 mg/kg 0, 2, and 6 weeks

Maintenance

5 mg/kg† every 8 weeks

For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg every 8 weeks.

5 mg/kg every 8 weeks

3 mg/kg§ every 8 weeks

§For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses per infusion or more frequent dosing.

5 mg/kg every 6 weeks

5 mg/kg every 8 weeks

5 mg/kg every 8 weeks

Dosing of infliximab for pediatric patients1

Infusions are administered every 8 weeks after 3 induction doses. Infliximab is administered by IV infusion over a period of not less than 2 hours.

Recommended Dosage and Intervals for Infliximab in Pediatric Patients (≥6 Years)1
Indication

Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Ulcerative Colitis

Induction

5 mg/kg 0, 2, and 6 weeks

5 mg/kg 0, 2, and 6 weeks

Maintenance

5 mg/kg every 8 weeks

5 mg/kg every 8 weeks

Administration GUIDE

Before infusing Infliximab, provide patients or their caregivers with the Medication Guide for Infliximab. You can obtain a printable PDF of the full Prescribing Information and the Medication Guide here. Refer to the Preparation and Administration Instructions and important information on what to do in the event your patient experiences an infusion reaction.

RECONSTITUTION, DILUTION,AND ADMINISTRATION INSTRUCTIONS1

Infliximab is intended for use under the guidance and supervision of a healthcare provider. The supplied lyophilized powder must be reconstituted and diluted prior to administration. The infusion solution should be prepared and administered by a trained medical professional using aseptic technique by the following procedure:

Calculate the dose, total volume of reconstituted Infliximab solution required, and the number of Infliximab vials needed. More than 1 vial may be needed for a full dose.

Reconstitute each 100-mg Infliximab vial with 10 mL of Sterile Water for Injection, USP, to obtain a concentration of 10 mg/mL, using a syringe equipped with a 21-gauge or smaller needle as follows:

  • Remove the flip-top from the vial and wipe the top with an alcohol swab
  • Insert the syringe needle into the vial through the center of the rubber stopper and direct the stream of Sterile Water for Injection, USP, to the glass wall of the vial. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder, which has a cake-like appearance. Avoid prolonged or vigorous agitation. DO NOT SHAKE. Foaming of the solution on reconstitution is not unusual
  • Allow the reconstituted solution to stand for 5 minutes. Visually inspect the reconstituted solution for particulate matter and discoloration. The reconstituted solution should be colorless to light yellow and opalescent, and the solution may develop a few translucent particles as infliximab is a protein. Do not use if the lyophilized powder has not fully dissolved or if opaque particles, discoloration, or other foreign particles are present. Do not store unused reconstituted Infliximab solution

Dilute the total volume of the reconstituted Infliximab solution to 250 mL* with sterile 0.9% Sodium Chloride Injection USP (do not dilute with any other diluent) as follows:

  • Withdraw a volume from the 0.9% Sodium Chloride Injection, USP, 250-mL bottle or bag equal to the total volume of reconstituted Infliximab required for a dose. Slowly add the total volume of reconstituted Infliximab solution from the vial(s) to the 250-mL infusion bottle or bag
  • Discard any unused portion of the reconstituted Infliximab solution remaining in the vial(s)
  • Gently invert the bag to mix the solution. The resulting infusion concentration should range between 0.4 mg/mL (minimum recommended concentration) and 4 mg/mL (maximum recommended concentration) of Infliximab

*For volumes greater than 250 mL, either use a larger infusion bag (eg, 500 mL) or multiple 250-mL infusion bags to ensure that the concentration of the infusion solution does not exceed 4 mg/mL.

The Infliximab infusion should begin within 3 hours of reconstitution and dilution. The infusion must be administered intravenously for at least 2 hours with an infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 µm or less).

Given that the vials do not contain antibacterial preservatives, discard any unused portion of the infusion solution (do not store for reuse). No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Infliximab with other agents. Infliximab should not be infused concomitantly in the same intravenous line with other agents.

Infusion reactions1

Infusion reactions may occur with numerous IV medications, including Infliximab. In clinical trials of Infliximab, the majority of infusion reactions were mild to moderate. Most of these reactions were manageable and responded to appropriate treatment steps.

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 infusion of Infliximab. Monitor patients during infusion and if serious reactions occur, discontinue infusion. Further management of reactions should be dictated by signs and symptoms.

Thorough patient assessment and screening for hypersensitivity reactions are key to helping prevent infusion-related events.

Administration Instructions Regarding Infusion Reactions:

Prior to treatment, ensure appropriate personnel and medication are available to treat reactions (eg, hypersensitivity, other reactions) that occur during infusion and shortly after infusion. Prior to infusion with Infliximab, patients may be premedicated with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids.

For mild to moderate reactions during the infusion, consider slowing or stopping the infusion. Upon resolution of these reactions, may reinitiate at a lower infusion rate and/or with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids. Discontinue the infusion if the mild to moderate reactions reoccur.

Discontinue the infusion if severe hypersensitivity reactions occur during the infusion.

Reference: 1. Infliximab [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

IMPORTANT SAFETY INFORMATION
INDICATIONS
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS

Patients treated with either REMICADE® or Infliximab are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue either REMICADE® or Infliximab if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with either REMICADE® or Infliximab.1,2 Treatment for latent infection should be initiated prior to treatment with either REMICADE® or Infliximab.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, and cryptococcosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella, Listeria, and Salmonella.

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

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

MALIGNANCIES

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

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

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

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapies, including either REMICADE® or Infliximab. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

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

CONTRAINDICATIONS

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

HEPATITIS B REACTIVATION

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

HEPATOTOXICITY

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

HEART FAILURE

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

HEMATOLOGIC EVENTS

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

HYPERSENSITIVITY

REMICADE® and Infliximab have been associated with hypersensitivity reactions that differ in their time of onset. Anaphylaxis, acute urticaria, dyspnea, and hypotension have occurred in association with infusions of either REMICADE® or Infliximab. Medications for the treatment of hypersensitivity reactions should be available.

CARDIOVASCULAR AND CEREBROVASCULAR REACTIONS DURING AND AFTER INFUSION

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

NEUROLOGIC EVENTS

TNF blockers, including REMICADE® and Infliximab, have been associated with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering either REMICADE® or Infliximab in patients with these disorders and consider discontinuation if these disorders develop.

CONCURRENT ADMINISTRATION WITH OTHER BIOLOGICS

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

AUTOIMMUNITY

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

VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS

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

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

ADVERSE REACTIONS

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

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

References: 1. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000;161:S221-S247. 2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.

cp-253861v1



INDICATIONS
Crohn’s Disease

REMICADE® and Infliximab are indicated for:

  • reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy.
  • reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD.
Pediatric Crohn’s Disease

REMICADE® and Infliximab are indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy.

Ulcerative Colitis

REMICADE® and Infliximab are indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

Pediatric Ulcerative Colitis

REMICADE® and Infliximab are indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy.

Rheumatoid Arthritis

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

Ankylosing Spondylitis

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

Psoriatic Arthritis

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

Plaque Psoriasis

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




IMPORTANT SAFETY INFORMATION
INDICATIONS
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS

Patients treated with either REMICADE® or Infliximab are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue either REMICADE® or Infliximab if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with either REMICADE® or Infliximab.1,2 Treatment for latent infection should be initiated prior to treatment with either REMICADE® or Infliximab.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, and cryptococcosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella, Listeria, and Salmonella.

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

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

MALIGNANCIES

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

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

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

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapies, including either REMICADE® or Infliximab. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

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

CONTRAINDICATIONS

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

HEPATITIS B REACTIVATION

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

HEPATOTOXICITY

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

HEART FAILURE

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

HEMATOLOGIC EVENTS

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

HYPERSENSITIVITY

REMICADE® and Infliximab have been associated with hypersensitivity reactions that differ in their time of onset. Anaphylaxis, acute urticaria, dyspnea, and hypotension have occurred in association with infusions of either REMICADE® or Infliximab. Medications for the treatment of hypersensitivity reactions should be available.

CARDIOVASCULAR AND CEREBROVASCULAR REACTIONS DURING AND AFTER INFUSION

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

NEUROLOGIC EVENTS

TNF blockers, including REMICADE® and Infliximab, have been associated with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering either REMICADE® or Infliximab in patients with these disorders and consider discontinuation if these disorders develop.

CONCURRENT ADMINISTRATION WITH OTHER BIOLOGICS

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

AUTOIMMUNITY

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

VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS

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

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

ADVERSE REACTIONS

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

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

References: 1. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000;161:S221-S247. 2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.

cp-253861v3



ISI button expand
INDICATIONS
Crohn’s Disease

REMICADE® and Infliximab are indicated for:

  • reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy.
  • reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD.
Pediatric Crohn’s Disease

REMICADE® and Infliximab are indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy.

Ulcerative Colitis

REMICADE® and Infliximab are indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

Pediatric Ulcerative Colitis

REMICADE® and Infliximab are indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy.

Rheumatoid Arthritis

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

Ankylosing Spondylitis

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

Psoriatic Arthritis

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

Plaque Psoriasis

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