Pertzye

Name: Pertzye

Pertzye Overview

Pancrelipase is a prescription medication for people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions. Pancrelipase is a mixture of enzymes normally produced by the pancreas that help the body digest foods.

This medication comes in capsule form and is several times a day, with food and plenty of fluids.  Some of the common side effects of pancrelipase include diarrhea, upset stomach, and cough.

Pertzye Precautions

Pancrelipase may increase your chance of having a rare bowel disorder called fibrosing colonopathy. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gave you. 

Call your doctor right away if you have any unusual or severe:

  • stomach area (abdominal) pain
  • bloating
  • trouble passing stool (having bowel movements)
  • nausea, vomiting, or diarrhea

Take pancrelipase exactly as prescribed by your doctor. Do not take more or less pancrelipase than directed by your doctor.

Pertzye and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if pancrelipase passes into your breast milk. You and your doctor should decide if you will take pancrelipase or breastfeed.

Pertzye Dosage

Take pancrelipase exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. 

Children Older than 12 Months and Younger than 4 Years and Weight 8 kg or Greater 
Children older than 12 months and younger than 4 years, weighing less than 8 kg, should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children.

Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Children 4 Years and Older and Weight 16 kg or Greater and Adults 
Children 4 years and older, weighing less than 16 kg, should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children.

Enzyme dosing should begin with 500 lipase units/kg of body weight per meal for those older than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Usually, half of the prescribed pancrelipase dose for an individualized full meal should be given with each snack. The total daily dose should reflect approximately three meals plus two or three snacks per day.

Enzyme doses expressed as lipase units/kg of body weight per meal should be decreased in older patients because they weigh more but tend to ingest less fat per kilogram of body weight.

Limitations on Dosing 
Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines. 

If symptoms and signs of steatorrhea persist, the dosage may be increased by a healthcare professional. Patients should be instructed not to increase the dosage on their own. There is great inter-individual variation in responses to enzymes; thus, a range of doses is recommended. Changes in dosage may require an adjustment period of several days. If doses are to exceed 2,500 lipase units/kg of body weight per meal, further investigation is warranted.

Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Doses greater than 6,000 lipase units/kg of body weight per meal have been associated with colonic strictures, indicative of fibrosing colonopathy, in children with cystic fibrosis less than 12 years of age. Patients currently receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.

Use of pancrelipase in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended.

Pertzye Overdose

If you take too much pancrelipase, call your local Poison Control Center or seek emergency medical attention right away.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Pancrelipase side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • joint pain or swelling; or

  • symptoms of a rare but serious bowel disorder--severe or unusual stomach pain, vomiting, bloating, diarrhea, constipation.

Tell your doctor if your child is not growing at a normal rate while using pancrelipase.

Common side effects may include:

  • stomach pain, gas, upset stomach;

  • diarrhea, frequent or abnormal bowel movements;

  • rectal itching;

  • headache;

  • runny or stuffy nose, sore throat; or

  • changes in your blood sugar.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Drug Interactions

No drug interactions have been identified. No formal interaction studies have been conducted.

Overdosage

In a clinical study, a 10 year-old patient was administered lipase doses over the maximum lipase dose of 2500 lipase units/kg/meal (Dose Stabilization 2799 lipase units/kg/meal; Wash-out/Re-Stabilization 2783 lipase units/kg/meal; and Pertzye 2720 lipase units/kg/meal). Despite the administration of this slightly (10%) higher than recommended dose, no gastrointestinal AEs were reported for this subject.

Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures [see Dosage and Administration ( 2.1) and Warnings and Precautions ( 5.1)] . High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia, and should be used with caution in patients with a history of hyperuricemia, gout, or renal impairment [see Warnings and Precautions ( 5.3)] .

Nonclinical Toxicology


Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, genetic toxicology, and animal fertility studies have not been performed with pancrelipase.

Important information

Pertzye may increase your chance of having a rare bowel disorder called fibrosing colonopathy. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gave you.

Call your doctor right away if you have any unusual or severe:

  • stomach area (abdominal) pain
  • bloating
  • trouble passing stool (having bowel movements)
  • nausea, vomiting, or diarrhea

Take Pertzye exactly as prescribed by your doctor. Do not take more or less Pertzye than directed by your doctor.

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