Patients weighing ≥160 to 315 lbs:
DR. SHAHAB MEHDIZADEH, MD: With CREON, finding an appropriate dose for every patient with Exocrine Pancreatic Insufficiency is important. It can help with digestion and improve fat absorption.
INTERVIEWER: Dr. Mehdizadeh, what types of conditions do you see in your practice?
DR. SHAHAB MEHDIZADEH, MD: I practice general gastroenterology, so I see a variety of conditions that affect the gastrointestinal tract. These may include a lot of, for example, bloating or irritable bowel syndrome, and I also see patients with various pancreatic conditions such as pancreatitis or Exocrine Pancreatic Insufficiency.
INTERVIEWER: When it comes to EPI, is there a pancreatic enzyme replacement therapy, or PERT, that you prefer?
DR. SHAHAB MEHDIZADEH, MD: I typically use CREON. It has a long track record. It was the first enzyme that was approved by the FDA, and the dosing provides me flexible options. I use CREON in patients with chronic pancreatitis, pancreatectomy, as well as other pancreatic conditions that could affect their digestion.
INTERVIEWER: Let’s talk a bit about your approach to CREON dosing. How do you determine the CREON starting dose using patient weight?
DR. SHAHAB MEHDIZADEH, MD: First, it’s important to remember that the dose of CREON should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Dosing based on patient weight should begin with 500 to a maximum of 2,500 lipase units per kilogram of body weight per meal, and I usually prescribe half of the per-meal dose for snacks. Oftentimes, I find that two 36K lipase unit capsules per meal and one 36K lipase unit capsule per snack is a good starting dose for my patients who are 160 to 315 pounds. Sometimes if patients fall outside this range, I manually calculate their dose. I like to know about the patient’s snacking habits, so I ask them about how many times per day they snack. I also ask them about what type of snacks they like to consume during the day.
INTERVIEWER: You mentioned two 36K capsules per meal, that's 72,000 lipase units. How do you explain 72,000 lipase units to a patient or referring physician who may think that sounds like a lot?
DR. SHAHAB MEHDIZADEH, MD: It sounds like a lot because it’s different than any other medication, it’s a larger number. Under normal physiologic circumstances, the pancreas produces about 480,000 to 960,000 lipase units per meal. Clinically significant fat maldigestion typically occurs when this lipase output drops below 10%.
SAFETY VOICE OVER: Fibrosing colonopathy has been reported following treatment with pancreatic enzyme products. Do not exceed the recommended dosage of 2,500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation.
INTERVIEWER: Do you typically prescribe the CREON 36K dosing strength to your patients with EPI?
DR. SHAHAB MEHDIZADEH, MD: When it’s appropriate based on patient weight, I am usually comfortable prescribing the 36,000 dosing strength to my EPI patients, because it allows them to take fewer capsules.
SAFETY VOICE OVER: CREON should always be taken with food. CREON should not be crushed or chewed. If a CREON dose is missed, the next dose should be taken with the next meal. Doses should not be doubled.
INTERVIEWER: Before we move on, do you have any additional reminders for physicians who are determining a starting dose?
DR. SHAHAB MEHDIZADEH, MD: It’s important to keep in mind that when it comes to PERTs, many patients, including those on CREON, might be underdosed.
INTERVIEWER: After you have determined the starting dose, how do you instruct your patients to take CREON?
DR. SHAHAB MEHDIZADEH, MD: I instruct my patients to take CREON with a meal, not 30 minutes before or not hours afterward, because we want the enzymes to mix with the food and aid with the digestion. Also, after I start a patient on CREON, I tell them to monitor their symptoms and diet.
INTERVIEWER: How exactly do you determine if a patient is on an appropriate dose?
DR. SHAHAB MEHDIZADEH, MD: I like to follow up with patients and have a frank discussion with them about 2 to 4 weeks after I prescribe CREON. When I follow up with patients, I ask them specific questions, such as, “Are you still experiencing any greasy loose stools or diarrhea?”; “Have you modified your diet in any way?”; “Do you ever forget to take your CREON dose with your meal?”. Based on their symptoms, the degree of steatorrhea, and the fat content of their diet, I may adjust their dose.
INTERVIEWER: Um-hum, makes sense. Is there anything else you would like to share?
DR. SHAHAB MEHDIZADEH, MD: Well, I would also recommend that physicians inform their CREON patients about the educational materials and potential prescription savings available through CREON’s patient support program.
INTERVIEWER: That's great. Thanks for your time, Dr. Mehdizadeh.
SAFETY VOICE OVER:
Indication
CREON® (pancrelipase) delayed-release capsules are indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
Important Safety Information
- Fibrosing colonopathy has been reported following treatment with pancreatic enzyme products. Do not exceed the recommended dosage of 2,500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation.
- To avoid irritation of oral mucosa, care should be taken to ensure that CREON is not crushed, chewed, or retained in the mouth. CREON should always be taken with food.
- Pancreatic enzyme products contain purines that may increase blood uric acid levels. High dosages have been associated with hyperuricosuria and hyperuricemia. Consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia during treatment with CREON.
- There is theoretical risk of viral transmission with all pancreatic enzyme products, including CREON.
- Severe hypersensitivity reactions including anaphylaxis, asthma, hives, and pruritus have been reported with pancreatic enzyme products. Monitor patients with a known hypersensitivity reaction to proteins of porcine origin for hypersensitivity reactions during treatment with CREON.
- Adverse reactions that occurred in at least 2 cystic fibrosis patients (greater than or equal to 4%) receiving CREON were vomiting, dizziness, and cough.
- Adverse reactions that occurred in at least 1 chronic pancreatitis or pancreatectomy patient (greater than or equal to 4%) receiving CREON were hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, and nasopharyngitis.
Please see the accompanying full Prescribing Information, including Medication Guide or visit https://www.rxabbvie.com/pdf/creon_pi.pdf