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INFLECTRA® (infliximab-dyyb)
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INFLECTRA® Quick Finder
WARNING: SERIOUS INFECTIONS and MALIGNANCY
SERIOUS INFECTIONS
Patients treated with...
1 INDICATIONS AND USAGE
1.1 Crohn's Disease
INFLECTRA is indicated for:
- •
- reducing signs and symptoms and inducing and maintaining clinical...
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...
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.
4 CONTRAINDICATIONS
The use of INFLECTRA at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure [see Warnings and Precautions (5.5) and...
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
Patients treated with infliximab products are at increased risk for developing serious infections involving various...
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...
7 DRUG INTERACTIONS
7.1 Other Biological Products
The combination of INFLECTRA with other biological products used to treat the same...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available...
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...
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...
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...
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...
14 CLINICAL STUDIES
14.1 Adult Crohn's Disease
Active Crohn's Disease in Adults
...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....
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
INFLECTRA (infliximab-dyyb) for injection is supplied as one single-dose vial...
This Medication Guide has been approved by the U.S. Food and Drug... |
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