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INFLECTRA®(infliximab-dyyb)
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INFLECTRA® Quick Finder
Highlights
Boxed Warning
WARNING: SERIOUS INFECTIONS and MALIGNANCY
SERIOUS INFECTIONS
Patients treated with infliximab products are at...
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Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
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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Warnings and Precautions
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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Adverse Reactions
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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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available observational...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
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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Clinical Studies
14 CLINICAL STUDIES
14.1 Adult Crohn's Disease
Active Crohn's Disease in Adults
...
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References
15 REFERENCES
- 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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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
INFLECTRA (infliximab-dyyb) for injection is supplied as one single-dose vial...
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Medication Guide
| This Medication Guide has been approved by the U.S. Food and Drug Administration | Revised: March 2022 | |||
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