PANCREAZE is a combination of porcine-derived lipases, proteases, amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

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Dosing and administration

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PANCREAZE comes in 5 strengths, including the lowest lipase dose on the market1-6

You can individually dose and titrate treatment — right from the start

At lower doses, PANCREAZE has smaller increments than any other PERT available, for more individualized dosing options.1-6 PANCREAZE dosing is consistent with Cystic Fibrosis Foundation Recommendations.1

PANCREAZE Capsule Sizes and Contents

Objects are shown at relative size

Lipase (USP units) 2,600 4,200 10,500 16,800 21,000
Protease (USP units) 6,200 14,200 35,500 56,800 54,700
Amylase (USP units) 10,850 24,600 61,500 98,400 83,900

Objects are shown at relative size

Lipase
(USP units)		 Protease
(USP units)		 Amylase
(USP units)
2,600 6,200 10,850
4,200 14,200 24,600
10,500 35,500 61,500
16,800 56,800 98,400
21,000 54,700 83,900
  • PANCREAZE recommended starting dose is 500 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg per meal1
  • Usually half the prescribed PANCREAZE dose for a full meal should be given with each snack1
  • Dose should be individualized based on age, weight, clinical symptoms, degree of steatorrhea and fat content of diet1
  • Exercise caution when doses of PANCREAZE exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day)1
  • PANCREAZE should be initiated at the lowest recommended dose and gradually increased1
  • PANCREAZE is dosed by lipase units and is not interchangeable with any other pancrelipase product1
  • 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 age1

Targeted Dosing — effective dosing strategies will vary by patient

Patients can take PANCREAZE all at once or divide the dose throughout their meal. Splitting the PANCREAZE dose may be an optimal strategy in some adult EPI patients as normal pancreatic secretions occur throughout a meal.9

1. Start

  • 1 or more capsules at the beginning of the meal
  • To achieve adequate pancreatic enzymes at the same time food is delivered10-12

2. Continue

  • 1 or more capsules during the meal
  • Acts on food that enters the duodenum from the stomach during this peak digestive period1,10

3. Complete

  • 1 or more capsules at the end of the meal
  • Continues to aid in digestion, which continues until ~4 hours after meal intake10,12

Pancreatic Enzyme Replacement Therapy (PERT) is reported to be effective for 30 minutes after consumption. For slow eaters or meals extended over a longer duration the total dose required may be split and half given at the commencement of a meal and half during or towards the end.13

How to administer PANCREAZE1

  • Swallow capsules whole with sufficient fluid
  • Do not crush, chew or retain in the mouth to avoid irritation of the oral mucosa

For Infants

  • Administer immediately prior to each feeding
  • Do not mix directly with formula or breast milk as this may diminish efficacy

For patients unable to swallow the capsules, contents of the capsule may be sprinkled on small amounts of acidic soft food with a pH <4.5 and consumed within 15 minutes.

  • Applesauce (3.10-3.60 pH)
  • Crushed blueberries (3.12-3.33 pH)
  • Orange or grapefruit juice(3.00-4.19 pH)
  • Apricot nectar (3.78 pH)

Patients should drink water or juice immediately after to ensure complete ingestion.
Care should be taken to ensure no drug is retained in the mouth.

 

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Indication

PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Important Safety Information

Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PANCREAZE (pancrelipase) exceed 2,500 lipase units/kg body weight per meal (or greater than 10,000 lipase units/kg body weight per day).

Hyperuricemia may develop. Consider monitoring uric acid levels in patients with hyperuricemia, gout, or renal impairment.

To avoid irritation of oral mucosa, do not chew PANCREAZE or retain in the mouth.

There is theoretical risk of viral transmission with all pancreatic enzyme products including PANCREAZE.

Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

Most common adverse reactions are: abdominal pain, flatulence, diarrhea, abnormal feces, and fatigue.

PANCREAZE is not interchangeable with any other pancrelipase products.

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

Please read the PANCREAZE Medication Guide and PANCREAZE Product Information.

References: 1. PANCREAZE Full Prescribing Information. Campbell, CA: VIVUS, Inc; 2020. 2. CREON® Full Prescribing Information. Chicago, IL: Abvie, Inc; 2015. 3. PERTZYE® Full Prescribing Information. Bethlehem, PA: Digestive Care, Inc; 2017. 4. ULTRESA® Full Prescribing Information. Bridgewater, NJ: Aptalis Pharma US, Inc; 2011. 5. VIOKACE™ Full Prescribing Information. Birmingham, AL: Allergan USA, Inc; 2012. 6. ZENPEP® Full Prescribing Information. Irvine, CA: Allergan USA, Inc; 2017. 7. Trapnell BC, et al. Efficacy and safety of PANCREAZE® for treatment of exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2011;10(5):350-35 6. 8. The National Pancreas Foundation (n.d.). Exocrine Pancreatic Insufficiency (EPI), Retrieved from https://pancreasfoundation.org/patient-information/ailments-pancreas/exocrine-pancreatic-insufficiency-epi/ 9. Struyvenberg MR, et al. Practical guide to exocrine pancreatic insufficiency - breaking the myths. BMC Med. 2017;15(1):2 9. 10. Fiekere A, et al. Enzymatic replacement therapy for pancreatic insufficiency: present and future. Clin Exper Gastroenterol. 2011;4:55- 73. 11. Ferrone MF, et al. Pancreatic enzyme pharmacotherapy. Pharmacotherapy. 2007;27(6):910-9 20. 12. Keller J and Layer P. Human pancreatic exocrine response to nutrients in health and disease. Gut. 2005;54(Suppl VI):v i1-vi 28. 13. Van der Haak N, Kench A. Chapter 10: pancreatic enzyme replacement therapy. In: Saxby N, King S, Kench A. Nutrition Guidelines for Cystic Fibrosis in Australia and New Zealand Administration Report. 2018.

Important Safety Information

Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PANCREAZE (pancrelipase) exceed 2,500 lipase units/kg body weight per meal (or greater than 10,000 lipase units/kg body weight per day).

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