Drug intelligence / Profile preview

Pancreaze

Development stage
Approved
Lead developer
Johnson & Johnson
Modality
Replacement Enzymes → Therapeutic Enzymes → Recombinant Proteins and Enzymes
Administration
Oral
01

Overview

Pancreaze is a prescription medication containing pancrelipase, which is a mixture of digestive enzymes (lipases, proteases, and amylases) used to treat exocrine pancreatic insufficiency (EPI). This condition occurs when the pancreas doesn't produce enough digestive enzymes to properly break down food. Description Pancreaze is a pancreatic enzyme product (PEP) approved by the FDA on April 12, 2010. It contains a mixture of digestive enzymes including lipases, proteases, and amylases that help in the digestion of fats, proteins, and starches in the duodenum and proximal small intestine. These enzymes act like the digestive enzymes physiologically secreted by the pancreas. The medication is specifically indicated for patients who cannot digest food normally due to pancreatic enzyme deficiency, which may result from conditions such as cystic fibrosis, chronic pancreatitis, pancreatic tumors, or partial/complete removal of the pancreas. Dosage and Administration Pancreaze comes as delayed-release capsules in various strengths. Dosing is based on lipase units and should be individualized according to: - Patient's weight - Fat content of diet - Severity of symptoms - Degree of steatorrhea (fatty stool) For adults and children 4 years and older, the typical starting dose is 500 lipase units per kilogram of body weight per meal. For children 12 months to under 4 years, the dose is usually 1000 lipase units per kg per meal. For infants up to 12 months, the recommended dose is 2600 lipase units per 120 mL of formula or per breastfeeding. The medication should be taken with every meal or snack, usually 5-6 times per day, with plenty of water. The capsules should be swallowed whole, though they can be opened and the contents mixed with soft, acidic food like applesauce if swallowing is difficult. Side Effects Common side effects of Pancreaze include: - Abdominal pain - Gas - Nausea and vomiting - Diarrhea More serious side effects, though rare, may include: - Irritation of the mouth if not swallowed completely - Increased blood uric acid levels, which may worsen gout - Allergic reactions including breathing difficulties, skin rashes, or swollen lips - Fibrosing colonopathy (narrowing of the large intestine) with high doses used over long periods Important Considerations Pancreaze and other pancreatic enzyme products are derived from pig pancreas, which theoretically carries a risk of viral transmission, though this has never been reported. The medication should not exceed certain dosage limits (2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day) without further investigation due to the risk of serious side effects. Pancreaze is one of several FDA-approved pancreatic enzyme products, with others including Creon, Zenpep, Pertzye, and Viokace.

Brand names
Pancreaze
Other names
pancreatin
02

Targets

FAS-I (Mycobacterial fatty acid synthase I complex)

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