Solvay Pharmaceuticals, Inc. Announces Commercial Availability of CREON(R) (Pancrelipase) Delayed-Release Capsules
The new formulation of CREON(R) has new Prescribing Information, a new dosing schedule, and a Medication Guide to provide important dosing and safety information to patients. CREON(R) also has new dosage strengths and — effective immediately — requires new prescriptions for all patients who have previously been prescribed CREON(R).
CREON(R) is available in three prescription strengths dosed by lipase units. As of today, the new FDA-approved dosage strengths are CREON(R) 6,000 lipase units, CREON(R) 12,000 lipase units, and CREON(R) 24,000 lipase units. Patients already taking CREON can be transitioned to the FDA-approved CREON(R) dosage strengths on a capsule-to-capsule basis as follows.
Former Dosage Strength FDA-approved Dosage Strength CREON(R) 5 Creon(R) 6,000 units 19,000 units 30,000 units Lipase Protease Amylase CREON(R) 10 Creon(R) 12,000 units 38,000 units 60,000 units Lipase Protease Amylase CREON(R) 20 Creon(R) 24,000 units 76,000 units 120,000 units Lipase Protease Amylase
The FDA-approved formulation of CREON(R) includes several changes of which prescribers and pharmacists should take note. CREON(R) is the first “zero-overfill” pancreatic enzyme product, meaning that the capsules target 100% of the lipase amount indicated on the product labeling. Mineral oil has also been removed from the product, which may lead to increased absorption of fat-soluble vitamins. Additionally, the product has new trade dress and capsule imprints to distinguish the former dosage strength capsules from this new FDA-approved formulation.
To ensure that patient access to CREON(R) is not disrupted, the former dosage strengths of CREON(R) will continue to be commercially available during a brief transitional period while Solvay Pharmaceuticals educates healthcare professionals, patients and caregivers about the transition to FDA-approved CREON(R). Effective
“We are proud that CREON(R) is the first and only pancreatic enzyme product to receive FDA approval and to meet the FDA’s standards of quality, safety, effectiveness and labeling,” said
Solvay Pharmaceuticals offers a Patient Assistance Program through which certain patients can obtain CREON(R) at no cost if they meet financial eligibility criteria. Solvay Pharmaceuticals also offers a CF-specific support program, SolvayCARES(SM), which provides nutritional, educational and financial resources to those touched by CF. For more information about SolvayCARES(SM), contact your local CF healthcare provider or visit www.SolvayCARES.com.
About Exocrine Pancreatic Insufficiency and Pancreatic Enzyme Products
Exocrine Pancreatic Insufficiency (EPI) is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food. For patients with EPI, pancreatic enzymes are essential to ensure adequate nutrition and health. Pancreatic enzyme products work in patients with EPI by delivering pancreatic enzymes to the small intestine to help break down fats, proteins and carbohydrates in food, thereby acting as a replacement for digestive enzymes physiologically secreted by the pancreas. EPI can occur as a complication of a variety of diseases or conditions, including CF, pancreatic cancer, gastrointestinal surgery and chronic pancreatitis. Statistics show that more than 80% of CF patients have EPI, which usually develops during the first year of life.
The original products in the pancreatic enzyme drug class pre-date modern FDA regulatory requirements. Over the past two decades, products in this class have been allowed to be marketed as prescription drugs without formal NDA approval. In 2004, the FDA required manufacturers to submit NDAs for all pancreatic enzyme products in order to remain on the market. By
Important Safety Information about FDA-Approved CREON(R)
In the clinical study used to demonstrate the efficacy and safety of FDA-approved CREON(R), the incidence of adverse events (regardless of causality) was higher during placebo treatment (71%) than during CREON(R) treatment (50%). Treatment-emergent adverse events occurring in at least two patients (greater than or equal to 6%) receiving CREON(R) or placebo were abdominal pain, abdominal pain upper, abnormal feces, cough, dizziness, flatulence, headache, and weight decreased.
Warnings and precautions include fibrosing colonopathy, a rare, serious adverse reaction that has been described in association with high-dose use of pancreatic enzyme replacement therapy in the treatment of cystic fibrosis patients. Caution should be exercised when doses of CREON(R) exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day). Care should be taken to ensure that CREON(R) is not chewed or retained in the mouth to avoid irritation of oral mucosa. Caution should be exercised when prescribing CREON(R) to patients with gout, renal impairment, or hyperuricemia. There is theoretical risk of viral transmission with all pancreatic enzyme products, including CREON(R). Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.
CREON(R) has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh its risks. As part of the REMS, a Medication Guide with important dosing and safety information applicable to this class of products, including CREON(R), is provided for patients and caregivers, with an emphasis on understanding the risk of fibrosing colonopathy as well as the importance of not over- or under-dosing. The FDA requires that the Medication Guide be handed out with every prescription for the drug dispensed.
For full safety and Prescribing Information about the FDA-approved formulation of CREON(R), visit www.CREON.com.
Solvay Pharmaceuticals, Inc., of
Solvay Pharmaceuticals is a research driven group of companies that constitutes the global pharmaceutical business of the Solvay Group. These companies seek to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology and men’s and women’s health. Its 2008 sales were
Solvay is an international Chemicals and Pharmaceuticals Group with headquarters in
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