Kutrase Side Effects

Generic name: pancrelipase

Note: This document contains side effect information about pancrelipase. Some of the dosage forms listed on this page may not apply to the brand name Kutrase.

Some side effects of Kutrase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to pancrelipase: oral delayed release capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking pancrelipase (the active ingredient contained in Kutrase) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects of pancrelipase may include:

• nausea or vomiting;

• mild stomach pain or upset;

• diarrhea or constipation;

• bloating or gas;

• greasy stools;

• rectal irritation;

• headache, dizziness;

• cough; or

• weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to pancrelipase: oral capsule, oral capsule extended release, oral delayed release capsule, oral powder for reconstitution, oral tablet, oral tablet extended release

General

In general, pancreatic enzymes are well tolerated at recommended therapeutic doses. Gastrointestinal symptoms appear to be the primary, and most common adverse effect.

Gastrointestinal

Fibrosing colonopathy should be suspected in patients who present with obstruction, bloody diarrhea, chylous ascites, or a combination of abdominal pain with chronic diarrhea, inadequate weight gain, or both. Patients with fibrosing colonopathy should have their enzyme dosage reduced to the recommended range of 500 to 2500 units/kg per meal. Surgical intervention is often needed in patients who cannot maintain their nutritional status.

Gastrointestinal side effects have included cramping, nausea, abnormal feces, flatulence abdominal pain, upper abdominal pain, and diarrhea, particularly with high doses. Fibrosing colonopathy has been reported. Animal studies suggest that the fibrosing colonopathy seen in some patients receiving high doses of pancreatic enzymes may be due to a plasticizer (methacrylic acid copolymer) found in some of the enteric coatings.

Metabolic

Krasinger and colleagues suggest that it may be reasonable to add allopurinol to the pancreatic enzyme treatment regimen in CF patients that have a urine pH of less than 6 and also excrete large amounts of uric acid. The addition of allopurinol may help to protect the renal tubules from long-term damage due to uric acid crystallization.

Metabolic side effects reported with high doses of pancreatic enzymes have included hyperuricosuria and hyperuricemia. It appears that both the enzyme product and some undefined aspect of the disease may lead to increased uric acid levels. Postmarketing reports of inadequate control of diabetes melitius have been reported.

Hypersensitivity

Hypersensitivity side effects have included reversible bronchial asthma and nasal rhinitis due to exposure to pancreatic enzyme powder.

Local

Local side effects have included ulcerations and stomatitis after a prolonged retention of pancreatic enzyme formulations in the mouth.

Nervous system

Nervous system side effects have included several case reports of elevation in intracranial pressure (leading to a bulging cranial fontanelle) in cystic fibrosis children receiving pancreatic enzymes. The adverse effect has been self-limiting without interruption of cystic fibrosis therapy in most cases.

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