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INFLECTRA®(infliximab-dyyb)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

INFLECTRA® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: SERIOUS INFECTIONS and MALIGNANCY

SERIOUS INFECTIONS

Patients treated with infliximab products are at...

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1 INDICATIONS AND USAGE

1.1 Crohn's Disease

INFLECTRA is indicated for:

  • reducing signs and symptoms and inducing and maintaining clinical...
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2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adult Crohn's Disease

The recommended dosage of INFLECTRA is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6...

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3 DOSAGE FORMS AND STRENGTHS

For injection: 100 mg of infliximab-dyyb as a white lyophilized powder in a single-dose vial for reconstitution and dilution.

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4 CONTRAINDICATIONS

The use of INFLECTRA at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure [see...

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5 WARNINGS AND PRECAUTIONS

5.1 Serious Infections

Patients treated with infliximab products are at increased risk for developing serious infections involving various...

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6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...

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7 DRUG INTERACTIONS

7.1 Other Biological Products

The combination of INFLECTRA with other biological products used to treat the same conditions as INFLECTRA is not...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available observational...

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10 OVERDOSAGE

Single doses up to 20 mg/kg have been administered without any direct toxic effect. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or...

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11 DESCRIPTION

Infliximab-dyyb, a tumor necrosis factor (TNF) blocker, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions). It has a molecular weight of approximately 149.1...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Infliximab products neutralize the biological activity of TNFα by binding with high affinity to the soluble and...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

A 6-month study in CD-1 mice was conducted to assess the tumorigenic potential of...

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14 CLINICAL STUDIES

14.1 Adult Crohn's Disease

Active Crohn's Disease in Adults

...

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15 REFERENCES

  1. Turner D, Otley AR, Mack D, et al. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: A prospective multicenter study. Gastroenterology...
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16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

INFLECTRA (infliximab-dyyb) for injection is supplied as one single-dose vial...

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...
This Medication Guide has been approved by the U.S. Food and Drug AdministrationRevised: June 2021
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Manufactured by:
CELLTRION, Inc.
23, Academy-ro,
Yeonsu-gu, Incheon
22014, Republic of Korea
U.S. License No. 1996

...

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