ADVERSE REACTIONS
The most common adverse events (≥6% of patients treated with ZENPEP) are abdominal pain, flatulence, headache, cough, decreased weight, early satiety, and contusion. (6.1)
There is no postmarketing experience with this formulation of Zenpep (6.2)
To report SUSPECTED ADVERSE REACTIONS, contact EURAND Pharmaceuticals, Inc. at 1-800-716-6507 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

 
USE IN SPECIFIC POPULATIONS
Pediatric Patients:

The safety and effectiveness of ZENPEP were assessed in pediatric patients, ages 1 to 17 years. (8.4)
The safety and efficacy of pancreatic enzyme products with different formulations of pancrelipase in pediatric patients have been described in the medical literature and through clinical experience. (8.4)

See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide 

Revised: 05/2010
 

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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 

1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
2.2 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Fibrosing Colonopathy
5.2 Potential for Irritation to Oral Mucosa
5.3 Potential for Risk of Hyperuricemia
5.4 Potential Viral Exposure from the Product Source
5.5 Allergic Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Dosing and Administration
17.2 Fibrosing Colonopathy
17.3 Allergic Reactions
 

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FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE
ZENPEP® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage
ZENPEP is not interchangeable with other pancrelipase products.

ZENPEP is orally administered. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of ZENPEP should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet (see Limitations on Dosing below).

Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences.1, 2, 3 ZENPEP should be administered in a manner consistent with the recommendations of the Conferences provided in the following paragraphs. Patients may be dosed on a fat-ingestion-based or actual body weight-based dosing scheme.

Infants (up to 12 months)
Infants may be given 2,