INFLECTRA® Highlights

(infliximab-dyyb)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use INFLECTRA safely and effectively. See full prescribing information for INFLECTRA.

INFLECTRA (infliximab-dyyb) for injection, for intravenous use
Initial U.S. Approval: 2016
INFLECTRA (infliximab-dyyb) is biosimilar* to REMICADE (infliximab)

WARNING: SERIOUS INFECTIONS and MALIGNANCY

See full prescribing information for complete boxed warning

•
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. (5.1)
•
Discontinue INFLECTRA if a patient develops a serious infection.
•
Perform test for latent TB; if positive, start treatment for TB prior to starting INFLECTRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1)
•
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. (5.2)
•
Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers, including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. (5.2)

INDICATIONS AND USAGE

INFLECTRA is a tumor necrosis factor (TNF) blocker indicated for:

Crohn's Disease (1.1):

•
reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease 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 disease.

Pediatric Crohn's Disease (1.2):

•
reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy.

Ulcerative Colitis (1.3):

•
reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Pediatric Ulcerative Colitis (1.4):

•
reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy.

Rheumatoid Arthritis (1.5) in combination with methotrexate:

•
reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease.

Ankylosing Spondylitis (1.6):

•
reducing signs and symptoms in adult patients with active disease.

Psoriatic Arthritis (1.7):

•
reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients.

Plaque Psoriasis (1.8):

•
treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

DOSAGE AND ADMINISTRATION

Prior to treatment, ensure appropriate personnel and medication are available to treat reactions (e.g., hypersensitivity) that occur during infusion and shortly after infusion (2.11)

INFLECTRA is administered by intravenous infusion for at least 2 hours with an in-line filter (2.11)

Crohn's Disease (2.1)

•
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg every 8 weeks if they later lose their response.

Pediatric Crohn's Disease (≥ 6 years old) (2.2)

•
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Ulcerative Colitis (2.3)

•
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Pediatric Ulcerative Colitis (≥ 6 years old) (2.4)

•
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Rheumatoid Arthritis (2.5)

•
In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks.

Ankylosing Spondylitis (2.6)

•
5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.

Psoriatic Arthritis (2.7) and Plaque Psoriasis (2.8)

•
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

DOSAGE FORMS AND STRENGTHS

For injection: 100 mg of infliximab-dyyb as a lyophilized powder in a single-dose vial for reconstitution and dilution. (2.11, 3)

CONTRAINDICATIONS

•
INFLECTRA doses >5 mg/kg in moderate or severe heart failure. (4)
•
Previous severe hypersensitivity reaction to infliximab products or any inactive ingredients of INFLECTRA or to any murine proteins. (4)

WARNINGS AND PRECAUTIONS

•
Serious infections – do not give INFLECTRA during an active infection. If an infection develops, monitor carefully and stop INFLECTRA if infection becomes serious. (5.1)
•
Invasive fungal infections – for patients who develop a systemic illness on INFLECTRA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. (5.1)
•
Malignancies – the incidence of malignancies, including invasive cervical cancer and lymphoma, was greater in infliximab-treated patients than in controls. Due to the risk of HSTCL carefully assess the risk/benefit especially if the patient has Crohn's disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment. (5.2)
•
Hepatitis B virus (HBV) reactivation – test for HBV infection before starting INFLECTRA. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop INFLECTRA and begin anti-viral therapy. (5.3)
•
Hepatotoxicity – severe hepatic reactions, some fatal or necessitating liver transplantation. Stop INFLECTRA in cases of jaundice and/or marked liver enzyme elevations. (5.4)
•
Heart failure –new onset or worsening symptoms may occur. (4, 5.5)
•
Cytopenias – advise patients to seek immediate medical attention if signs and symptoms develop, and consider stopping INFLECTRA. (5.6)
•
Hypersensitivity – serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur. (5.7)
•
Cardiovascular and Cerebrovascular Reactions – Cerebrovascular accidents, myocardial infarctions (some fatal), and arrhythmias have been reported during and within 24 hours of initiation of infliximab product infusion. Monitor patients during INFLECTRA infusion and if serious reaction occurs, discontinue infusion. (5.8)
•
Demyelinating disease –exacerbation or new onset may occur. (5.9)
•
Lupus-like syndrome –stop INFLECTRA if syndrome develops. (5.12)
•
Vaccinations and Use of Live vaccines/therapeutic infectious agents – Prior to initiating INFLECTRA bring pediatric and adult patients up to date with all vaccinations. Live vaccines or therapeutic infectious agents should not be given with INFLECTRA. At least a six month waiting period following birth is recommended before the administration of live vaccines to infants exposed in utero to infliximab products. (5.13)

ADVERSE REACTIONS

Most common adverse reactions (>10%) – infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION, Inc. at 1-800-383-7504 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Other Biological Products– increased risk of serious infections (7.1)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.


*
Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of INFLECTRA has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

Revised: 4/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use INFLECTRA safely and effectively. See full prescribing information for INFLECTRA.

INFLECTRA (infliximab-dyyb) for injection, for intravenous use
Initial U.S. Approval: 2016
INFLECTRA (infliximab-dyyb) is biosimilar* to REMICADE (infliximab)

WARNING: SERIOUS INFECTIONS and MALIGNANCY

See full prescribing information for complete boxed warning

•
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. (5.1)
•
Discontinue INFLECTRA if a patient develops a serious infection.
•
Perform test for latent TB; if positive, start treatment for TB prior to starting INFLECTRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1)
•
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. (5.2)
•
Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers, including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. (5.2)

INDICATIONS AND USAGE

INFLECTRA is a tumor necrosis factor (TNF) blocker indicated for:

Crohn's Disease (1.1):

•
reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease 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 disease.

Pediatric Crohn's Disease (1.2):

•
reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy.

Ulcerative Colitis (1.3):

•
reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Pediatric Ulcerative Colitis (1.4):

•
reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy.

Rheumatoid Arthritis (1.5) in combination with methotrexate:

•
reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease.

Ankylosing Spondylitis (1.6):

•
reducing signs and symptoms in adult patients with active disease.

Psoriatic Arthritis (1.7):

•
reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients.

Plaque Psoriasis (1.8):

•
treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

DOSAGE AND ADMINISTRATION

Prior to treatment, ensure appropriate personnel and medication are available to treat reactions (e.g., hypersensitivity) that occur during infusion and shortly after infusion (2.11)

INFLECTRA is administered by intravenous infusion for at least 2 hours with an in-line filter (2.11)

Crohn's Disease (2.1)

•
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg every 8 weeks if they later lose their response.

Pediatric Crohn's Disease (≥ 6 years old) (2.2)

•
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Ulcerative Colitis (2.3)

•
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Pediatric Ulcerative Colitis (≥ 6 years old) (2.4)

•
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Rheumatoid Arthritis (2.5)

•
In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks.

Ankylosing Spondylitis (2.6)

•
5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.

Psoriatic Arthritis (2.7) and Plaque Psoriasis (2.8)

•
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

DOSAGE FORMS AND STRENGTHS

For injection: 100 mg of infliximab-dyyb as a lyophilized powder in a single-dose vial for reconstitution and dilution. (2.11, 3)

CONTRAINDICATIONS

•
INFLECTRA doses >5 mg/kg in moderate or severe heart failure. (4)
•
Previous severe hypersensitivity reaction to infliximab products or any inactive ingredients of INFLECTRA or to any murine proteins. (4)

WARNINGS AND PRECAUTIONS

•
Serious infections – do not give INFLECTRA during an active infection. If an infection develops, monitor carefully and stop INFLECTRA if infection becomes serious. (5.1)
•
Invasive fungal infections – for patients who develop a systemic illness on INFLECTRA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. (5.1)
•
Malignancies – the incidence of malignancies, including invasive cervical cancer and lymphoma, was greater in infliximab-treated patients than in controls. Due to the risk of HSTCL carefully assess the risk/benefit especially if the patient has Crohn's disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment. (5.2)
•
Hepatitis B virus (HBV) reactivation – test for HBV infection before starting INFLECTRA. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop INFLECTRA and begin anti-viral therapy. (5.3)
•
Hepatotoxicity – severe hepatic reactions, some fatal or necessitating liver transplantation. Stop INFLECTRA in cases of jaundice and/or marked liver enzyme elevations. (5.4)
•
Heart failure –new onset or worsening symptoms may occur. (4, 5.5)
•
Cytopenias – advise patients to seek immediate medical attention if signs and symptoms develop, and consider stopping INFLECTRA. (5.6)
•
Hypersensitivity – serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur. (5.7)
•
Cardiovascular and Cerebrovascular Reactions – Cerebrovascular accidents, myocardial infarctions (some fatal), and arrhythmias have been reported during and within 24 hours of initiation of infliximab product infusion. Monitor patients during INFLECTRA infusion and if serious reaction occurs, discontinue infusion. (5.8)
•
Demyelinating disease –exacerbation or new onset may occur. (5.9)
•
Lupus-like syndrome –stop INFLECTRA if syndrome develops. (5.12)
•
Vaccinations and Use of Live vaccines/therapeutic infectious agents – Prior to initiating INFLECTRA bring pediatric and adult patients up to date with all vaccinations. Live vaccines or therapeutic infectious agents should not be given with INFLECTRA. At least a six month waiting period following birth is recommended before the administration of live vaccines to infants exposed in utero to infliximab products. (5.13)

ADVERSE REACTIONS

Most common adverse reactions (>10%) – infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION, Inc. at 1-800-383-7504 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Other Biological Products– increased risk of serious infections (7.1)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.


*
Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of INFLECTRA has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

Revised: 4/2023
Medication Guide

Health Professional Information

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