Zenpep
Generic: PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE
Basic Information
Manufacturer
Aimmune Therapeutics, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
7f16f2d4-8df6-4bd7-ac10-56994fa257b0
Indications & Usage
1 INDICATIONS AND USAGE ZENPEP ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
ZENPEP ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
( 1 )
ZENPEP ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Fibrosing Colonopathy [see Warnings and Precautions (5.1) ] Irritation of the Oral Mucosa [see Warnings and Precautions (5.2) ] Hyperuricemia [see Warnings and Precautions (5.3) ] Risk of Viral Transmission [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥6%) are: headache, contusion, cough, and early satiety.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics, Inc at 1-833-AIM2KNO (1-833-246-2566) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure to ZENPEP in 53 adult and pediatric patients with exocrine pancreatic insufficiency due to cystic fibrosis in two clinical trials conducted [see Clinical Studies (14) ] .
In both trials, ZENPEP was administered at dosages of approximately 5,000 lipase units/kg/day for 19 to 42 days.
Study 1 was a randomized, double-blind, placebo-controlled, crossover study of 34 adult and pediatric patients, aged 7 to 23 years.
Adverse reactions that were reported in at least 2 ZENPEP-treated patients (greater than or equal to 6%) and at a higher rate than in placebo-treated patients in Study 1 are shown in Table 1.
Table 1: Adverse Reactions Reported in at least 2 ZENPEP-treated patients (greater than or equal to 6%) and at a higher rate than placebo-treated patients.
in a Clinical Trial of Adult and Pediatric Patients 7 Years of Age and Older with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis (Study 1) Adverse Reaction ZENPEP N=34 n (%) Placebo N=32 n (%) Headache 5 (15%) 0 Contusion 2 (6%) 0 Cough 2 (6%) 0 Early Satiety 2 (6%) 0 Study 2 was an open-label, uncontrolled study of ZENPEP in 19 pediatric patients aged 1 to 6 years.
The most commonly reported adverse reactions were gastrointestinal, including abdominal pain and steatorrhea.
The type and incidence of adverse reactions in Studies 1 and 2 were similar between pediatric patients and adults.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ZENPEP or other pancreatic enzyme products.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye Disorders blurred vision Gastrointestinal Disorders fibrosing colonopathy and distal intestinal obstruction syndrome abdominal distension, abdominal pain, diarrhea, flatulence, constipation, and nausea Immune System Disorders anaphylaxis, asthma, hives and pruritis Investigations asymptomatic elevations of liver enzymes Musculoskeletal System myalgia, muscle spasm Skin and Subcutaneous Tissue Disorders urticaria and rash
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics, Inc at 1-833-AIM2KNO (1-833-246-2566) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure to ZENPEP in 53 adult and pediatric patients with exocrine pancreatic insufficiency due to cystic fibrosis in two clinical trials conducted [see Clinical Studies (14) ] .
In both trials, ZENPEP was administered at dosages of approximately 5,000 lipase units/kg/day for 19 to 42 days.
Study 1 was a randomized, double-blind, placebo-controlled, crossover study of 34 adult and pediatric patients, aged 7 to 23 years.
Adverse reactions that were reported in at least 2 ZENPEP-treated patients (greater than or equal to 6%) and at a higher rate than in placebo-treated patients in Study 1 are shown in Table 1.
Table 1: Adverse Reactions Reported in at least 2 ZENPEP-treated patients (greater than or equal to 6%) and at a higher rate than placebo-treated patients.
in a Clinical Trial of Adult and Pediatric Patients 7 Years of Age and Older with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis (Study 1) Adverse Reaction ZENPEP N=34 n (%) Placebo N=32 n (%) Headache 5 (15%) 0 Contusion 2 (6%) 0 Cough 2 (6%) 0 Early Satiety 2 (6%) 0 Study 2 was an open-label, uncontrolled study of ZENPEP in 19 pediatric patients aged 1 to 6 years.
The most commonly reported adverse reactions were gastrointestinal, including abdominal pain and steatorrhea.
The type and incidence of adverse reactions in Studies 1 and 2 were similar between pediatric patients and adults.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ZENPEP or other pancreatic enzyme products.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye Disorders blurred vision Gastrointestinal Disorders fibrosing colonopathy and distal intestinal obstruction syndrome abdominal distension, abdominal pain, diarrhea, flatulence, constipation, and nausea Immune System Disorders anaphylaxis, asthma, hives and pruritis Investigations asymptomatic elevations of liver enzymes Musculoskeletal System myalgia, muscle spasm Skin and Subcutaneous Tissue Disorders urticaria and rash