Pertzye Generic Name: pancrelipase Brand Name: Pertzye Pertzye (Pancrelipase) side effects drug center Related Drugs Ibuprofen Pulmozyme Tobi Zithromax Zithromax Injection Zmax Health Resources Cystic Fibrosis Amniocentesis Test Chest X-Ray Chorionic Villus Sampling Sweat Chloride Test (Cystic Fibrosis) What Is a Bronchoscopy? PROFESSIONAL CONSUMER SIDE EFFECTS Overview Professional Information Pertzye Side Effects Center What Is Pertzye? Pertzye (lipase, protease and amylase) is a combination of enzymes indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. What Are Side Effects of Pertzye? Common side effects of Pertzye include: irritation of the inside of the mouth increased uric acid levels in the blood diarrhea indigestion upset stomach abdominal pain gas cough, and allergic reactions (trouble breathing, skin rash, itching, or swollen lips) Dosage for Pertzye Pertzye is available in 8,000 and 16,000 lipase units (USP). In children older than 12 months and younger than 4 years and weighing 8 kg or greater, enzyme dosing should begin with 1,000 lipase units/kg of body weight to a maximum of 2,500 lipase units/kg of body weight. In children older than 4 years and older and weighing 16 kg or greater and adults, enzyme dosing should begin with 500 lipase units/kg of body weight to a maximum of 2,500 lipase units/kg of body weight (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. Pertzye should be taken with a meal or a snack. What Drugs, Substances, or Supplements Interact with Pertzye? Pertzye may interact with other drugs. Tell your doctor all medications and supplements you use. Pertzye During Pregnancy and Breastfeeding Tell your doctor all medications and supplements you use. Pertzye should be given to a pregnant woman only if clearly needed. The risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. Adequate caloric intake during pregnancy is important for normal maternal weight gain and fetal growth. Reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes. Because many drugs are excreted in human milk, caution should be exercised when Pertzye is administered to a nursing mother. Additional Information Our Pertzye Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Pertzye Consumer Information 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. Read the entire detailed patient monograph for Pertzye (Pancrelipase) Pertzye Professional Information SIDE EFFECTS The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) include fibrosing colonopathy, hyperuricemia and allergic reactions [see WARNINGS AND PRECAUTIONS] . 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 short-term safety of PERTZYE was assessed in a randomized, double-blind, placebo-controlled, crossover study of 24 patients, ages 8 to 43 years, with exocrine pancreatic insufficiency due to cystic fibrosis. In this study, patients were randomized to receive PERTZYE at individually titrated doses (not to exceed 2,500 lipase units per kilogram per meal) or matching placebo for 6 to 8 days of treatment, followed by crossover to the alternate treatment for an additional 6 to 8 days. The length of exposure to PERTZYE during this study was 20-28 days, including the treatment period of 6 to 8 days, and the open label titration and transition periods of 7 to 10 days. The most common adverse reactions (≥ 10%) were diarrhea, dyspepsia, and cough. Table 1 enumerates adverse reactions that occurred in at least 2 patients (≥ 10%) treated with PERTZYE at a higher rate than with placebo. Table 1. Adverse Reactions Occurring in at Least 2 Patients (≥ 10%) Adverse Reaction PERTZYEn=21 n (%) PLACEBOn=24n (%) Diarrhea 2 (10%) 1 (4%) Dyspepsia 2 (10%) 1 (4%) Cough 2 (10%) 1 (4%) Postmarketing Experience The following adverse reactions have been identified during post approval use of PERTZYE. 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. This formulation of PERTZYE has been marketed since 2004 under the trademark PANCRECARB®. Two product complaints relating to an adverse drug reaction were reported. A mild allergic reaction (itching and red, blotchy rash on face) was reported by a patient with a known history of allergy to another pancrelipase product, and a dull headache was reported by another patient taking concomitant ursodeoxycholic acid. Both events resolved without sequelae after discontinuation of treatment. Delayed- and immediate-release pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis. The long-term safety profile of these products has been described in the medical literature. The most serious adverse events include fibrosing colonopathy, distal intestinal obstruction syndrome (DIOS), recurrence of preexisting carcinoma, and severe allergic reactions including anaphylaxis, asthma, hives, and pruritus. The most commonly reported adverse events were gastrointestinal disorders, including abdominal pain, diarrhea, flatulence, constipation and nausea, and skin disorders, including pruritus, urticaria and rash. Read the entire FDA prescribing information for Pertzye (Pancrelipase) &Copy; Pertzye Patient Information is supplied by Cerner Multum, Inc. and Pertzye Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
