Pancreatic Enzyme Supplements PDF

Pancreatic Enzyme Supplements Debra Forzese, Pharm. D. Pancreatic Enzyme Supplements Exocrine Pancreatic Insufficiency (EPI) Several conditions can lead to development of EPI – pancreatic and nonpancreatic causes most common causes are cystic fibrosis and chronic pancreatitis Amylase, protease, and...

Pancreatic Enzyme Supplements Debra Forzese, Pharm. D. Pancreatic Enzyme Supplements Exocrine Pancreatic Insufficiency (EPI) Several conditions can lead to development of EPI – pancreatic and nonpancreatic causes most common causes are cystic fibrosis and chronic pancreatitis Amylase, protease, and lipase are digestive enzymes responsible for the breakdown of food EPI results from a reduction in secretion of these pancreatic digestive enzymes, limiting the body’s ability to digest and absorb carbohydrates, fat, protein Clinical symptoms not apparent until lipase levels drop below 10% of normal post prandial levels Exocrine Pancreatic Insufficiency Symptoms of EPI include maldigestion, abdominal pain, flatulence, diarrhea, weight loss, steatorrhea, Malabsorption of fat can lead to deficiency of fat -soluble vitamins (A, E, D, K) and other micronutrients Vitamin deficiencies and reduced levels of lipoproteins can lead to osteoporosis and bone fractures o Vitamin D and calcium supplementation should be considered Pancreatic Enzyme Supplement Formulations ENTERIC COATED NON-ENTERIC COATED Creon Viokase Zenpep Pancreaze Pancreatic Enzyme Supplements Indications Exocrine pancreatic insufficiency o Due to cystic fibrosis, pancreatitis, pancreatectomy Pancreatic Enzyme Supplements Different products not interchangeable, differ by particle size, dosing range, pharmacokinetics Creon, Zenpep, Pancreaze – can open capsules and put in applesauce if patients cannot swallow caps Viokase tablet includes PPI (omeprazole) – not enteric coated so must be combined with PPI Pertzye – delayed release capsule, can be opened, mixed with applesauce Pancreatic Enzyme Supplements Guidelines – Cystic Fibrosis Foundation, Australian Guidelines for Management of Pancreatic Enzyme Insufficiency o Similar dosing recommendations Goal of pancreatic enzyme supplements is to provide at least 10% of estimated pancrelipase to correct steatorrhea and improve digestion Dosing can be challenging – patient response widely variable Varied course of disease and wide variation of symptoms so enzymes must be individually dosed Pancreatic Enzyme Supplements Dosing Estimates for at least 30,000 IU of lipase to the intestine with each meal will help to eliminate steatorrhea (10% of estimated normal pancreatic secretion) and 15-20,000 with snacks Treatment goal is NOT to replace 100% of estimated pancreatic function because steatorrhea only develops in severe disease Symptoms occur when the pancreas loses more than 90% of its ability to produce digestive enzymes. Pancreatic Enzyme Supplements Enzymes should be taken alongside meals and snacks to mick postprandial enzyme output Goal of therapy is to normalize nutritional status and relieve symptoms Pancrelipase is more potent than older products with pancreatin Each brand of PEP has unique active pharmaceutical ingredient source and formulation – not interchangeable Pancreatic Enzyme Supplements Dosing should be individualized to specific patient Need to look at severity of symptoms and response to treatment (stool consistency, oil in stool, weight gain) Check levels of fat -soluble vitamins periodically to ensure adequate levels If no improvement -assess patient compliance to treatment and ensure correct timing of dose in relation to meals Children less than 4 have higher needs for lipase Pancreatic Enzyme Supplements Total pancreatic enzyme dose should reflect 3 meals and 2-3 snacks per day Usually, give ½ dose for snacks Nutrient and fat absorption will depend on appropriate weight- based dosing To ensure accurate dosing it is important to continue to assess patient’s response Pancreatic Enzyme Supplements Inadequate dosing is most common cause of treatment failure After confirming patient compliance, next step is to double the dose Can add PPI or H2 blocker Changing formulation can be helpful Dietary fat should not be restricted Lifestyle interventions – smoking cessation, quit alcohol Pancreatic Enzyme Supplements Patient education needed prior to starting supplement- must be taken with every meal and snack Sporadic doses(w/o food) should be avoided Doses should not be changed or increased without prescriber Dosing of Pancreatic Enzyme Supplements Follow guidelines Main ingredient measured for dosing is lipase – measured by grams fat ingested or weight. Pancreatic Enzyme Supplement Dosing Adult - start at lowest possible dose and then increased to achieve optimal results (follow guidelines) Pediatric- Infants with EPI require lower doses of enzymes Renal impairment – no dose adjustment Hepatic impairment – no dose adjustment Pancreatic Enzyme Supplements Adverse Effects Because all supplements have same active ingredient – pancrelipase – their adverse effects are same Common – headache, neck pain, nasal congestion, abdominal pain. Rare- nausea, blurred vision, constipation, and urticaria Potential for allergic reaction for those allergic to pork Pancreatic Enzyme Supplements No contraindications and no drug interactions Do not administer with alkaline foods such as avocado, onions, tofu – can decrease efficacy Pancreatic Enzyme Supplements Monitoring, Patients should follow up shortly after initiating supplement or changing dose Weight is important monitoring parameter because increase in fat and nutrient absorption can cause patient to gain weight, also monitor for Abdominal symptoms should be monitored to minimize adverse effects In children growth should be monitored to determine drug’s efficacy no systemic absorption Pancreatic Enzyme Supplements Use caution in patients with gout or renal impairment to reduce risk of hyperuricemia - porcine-derived products contain purines which may increase uric acid concentrations. Pancreatic Enzyme Supplements Pregnancy category C – look at risk vs benefit o oral absorption of pancrelipase is low, it should generally be safe for pregnant women o It is not known whether pancrelipase is secreted in breast milk patient's individual risks and benefits of starting the drug should be considered o Considering that the oral absorption of pancrelipase is low, it should generally be safe for breastfeeding women.