Subject: PANCREAZE is now available from VIVUS

 

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PANCREAZE® is now available from VIVUS
 
 
Sign up today at pancreazesupport.com to access helpful resources to support you and your patients’ needs.

 
 
EPI (Exocrine Pancreatic Insufficiency) Requires Targeted Treatment.
  • When it comes to PERT, individualizing treatment for each patient is key.
  • PANCREAZE® offers 5 strengths (2,600 - 21,000 lipase units), so you can titrate treatment based on patient age, weight, and fat content of their meal to achieve control of EPI symptoms.1-3
  • Clinical studies show that PANCREAZE® significantly improved fat digestion  and co-efficient of fat absorption compared to placebo. PANCREAZE® also demonstrated significant improvement in EPI-related symptoms vs. placebo.3
  • “Targeted Dosing” may allow for more tailored treatment in patients with fat malabsorption.4-7
    • Patients can take PANCREAZE® all at once or
    • Splitting the PANCREAZE® dose across a meal may be an optimal strategy in some adult EPI patients as normal pancreatic secretions occur throughout a meal.4

Start

1 or more capsules at the beginning of the meal

To achieve adequate pancreatic enzymes at the same time food is delivered.5-7
 

Continue

1 or more capsules during the meal

Acts on food that enters the duodenum from the stomach during the peak digestive period.1,5
 

Complete 

1 or more capsules at the end of the meal

Continues to aid in digestion which continues ~4 hours after meal intake.5,7
 
 
PANCREAZE® Advantage Program offers comprehensive patient support from co-pay and financial assistance to vitamins and nutritional supplements for all eligible patients.
 
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 (≥ 10%) are: abdominal pain, flatulence, diarrhea, abnormal feces, and fatigue.

 
Additional Important Safety Information
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.
 
Indication
PANCREAZE® is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
 
References:
1. VIVUS, Inc. PANCREAZE®: Highlights of prescribing information. 2010.
2. Van de Vijver E, et al. Treatment of infants and toddlers with cystic fibrosis-related pancreatic insufficiency and fat malabsorption with pancrelipase MT. J Pediatr Gastroenterol Nutr. 2011;53(1):61-64.
3. 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):350-356.
4. Struyvenberg MR, et al. Practical guide to exocrine pancreatic insufficiency - breaking the myths. BMC Med. 2017;15(1):29.
5. Fiekere A, et al. Enzymatic replacement therapy for pancreatic insufficiency: present and future. Clin Exper Gastroenterol. 2011;4:55-73.
6. Ferrone MF, et al. Pancreatic enzyme pharmacotherapy. Pharmacotherapy. 2007;27(6):910-920.
7. Keller J and Layer P. Human pancreatic exocrine response to nutrients in health and disease. Gut. 2005;54(Suppl VI):vi1-vi28.

 
VIVUS, Inc.
900 E. Hamilton Avenue, Suite 550, Campbell, CA 95008 USA
1–888–998–4887 | vivus@druginfo.com | www.vivus.com

500032.03-USP
 
 
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