INFLECTRA® (infliximab-dyyb) lyophilized concentrate for injection, for intravenous use Patient information | Pfizer Medical Information - US

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INFLECTRA® Quick Finder

Pfizer enCompass™

Pfizer enCompass™ is a resource available to patients on INFLECTRA therapy. Support includes assistance for eligible uninsured and insured patients who cannot afford their out-of-pocket costs. To learn more, call Pfizer enCompass to talk to an Access Counselor at (844) 722-6672 or visit the Pfizer enCompass website.
Need Information on Pfizer’s Patient Assistance Programs?

Pfizer RxPathways connects eligible patients to a range of assistance programs that offer insurance support, co-pay help, and medicines for free or at a savings. Patients and physicians can contact RxPathways at (866) 706-2400 or visit the website for more information on these programs www.pfizerrxpathways.com.
Have a Question about Pfizer Clinical Trials?

If you are looking for information about Pfizer studies currently recruiting new patients in your area, you can begin your search on our website. For questions about a Pfizer Clinical Trial, call (800) 718-1021 or email [email protected]
Need to report an Adverse Event, Side Effect, or Product Quality Concern?

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch
Resources

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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WARNING: SERIOUS INFECTIONS and MALIGNANCY

SERIOUS INFECTIONS

Patients treated with...

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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 Warnings and Precautions (5.5) and...

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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...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available...

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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...

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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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Resources

Pfizer enCompass™

Pfizer enCompass™ is a resource available to patients on INFLECTRA therapy. Support includes assistance for eligible uninsured and insured patients who cannot afford their out-of-pocket costs. To learn more, call Pfizer enCompass to talk to an Access Counselor at (844) 722-6672 or visit the Pfizer enCompass website.

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Call (800) 438-1985

Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985

Report Adverse Event

Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.