Dosing & Uses
Dosage Forms & Strengths
lipase/protease/amylase
(KU=1000 units)
capsule, delayed-release (contains enteric-coated microspheres)
- Creon
- 6KU/19KU/30KU
- 12KU/38KU/60KU
- 24KU/76KU/120KU
- 36KU/114KU/180KU
capsule, delayed-release (contains enteric-coated microtablets)
- Pancreaze
- 4.2KU/10KU/17.5KU
- 10.5KU/25KU/43.75KU
- 16.8KU/40KU/70KU
- 21KU/37KU/61KU
capsule, delayed-release (contains enteric-coated minitablets)
- Ultresa
- 13.8KU/27.6KU/27.6KU
- 20.7KU/41.4KU/41.4KU
- 23KU/46KU/46KU
tablet
- Viokace
- 10.44KU/39.15KU/39.15KU
- 20.88KU/78.3KU/78.3KU
capsule, delayed-release (contains enteric-coated microspheres)
- Pertzye
- 8KU/28.75KU/30.25KU
- 16KU/57.5KU/60.5KU
- 24KU/86.25KU/90.75KU
capsule, delayed-release (contains enteric-coated beads)
- Zenpep
- 5KU/17KU/27KU
- 10KU/34KU/55KU
- 15KU/51KU/82KU
- 20KU/68KU/109KU
- 25KU/85KU/136KU
Exocrine Pancreatic Insufficiency
Creon, Ultresa, Pertzye, Zenpep, Pancreaze are indicated for pancreatic insufficiency due to cystic fibrosis, pancreatitis, pancreatectomy, or other conditions
- Cystic fibrosis guidelines: Generally, start 500 lipase units/kg PO per meal; can titrate up to 2500 units/kg/meal based on response; not to exceed 10,000 lipase units/kg/day or <4000 lipase units/g fat ingested per day
- Administer 50% of meal dose with snacks
- High-dose Creon: In 1 clinical trial described in the prescribing information, adults received a dose of 72,000 lipase units/meal while consuming at least 100 g of fat/day for chronic pancreatitis or pancreatectomy; lower starting doses (ie, 500 lipase units/kg/meal) are consistent with Cystic Fibrosis guidelines
Viokace
- Only indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy (and not cystic fibrosis)
- Generally, start 500 lipase units/kg PO per meal; can titrate up to 2500 units/kg/meal based on response; not to exceed 10,000 lipase units/kg/day or <4000 lipase units/g fat ingested per day
- Administer 50% of meal dose with snacks
- Viokace should be administered with a PPI
Dosing Considerations
For patients who are unable to swallow intact capsules, may carefully open capsules and contents mixed with a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce, or administered with applesauce via a gastrostomy tube with a diameter of 14 French or larger (only for the 4,000 USP lipase unit capsule strength); if administered orally, the mixture should be swallowed immediately and followed with water or juice to ensure complete ingestion
Dosage Forms & Strengths
lipase/protease/amylase
(KU=1000 units)
capsule, delayed-release (enteric-coated microspheres)
- Creon
- 3KU/9.5KU/15KU
- 6KU/19KU/30KU
- 12KU/38KU/60KU
- 24KU/76KU/120KU
capsule, delayed-release (enteric-coated microtablets)
- Pancreaze
- 4.2KU/10KU/17.5KU
- 10.5KU/25KU/43.75KU
- 16.8KU/40KU/70KU
- 21KU/37KU/61KU
capsule, delayed-release (contains enteric-coated minitablets)
- Ultresa
- 13.8KU/27.6KU/27.6KU
- 20.7KU/41.4KU/41.4KU
- 23KU/46KU/46KU
tablet
- Viokace
- 10.44KU/39.15KU/39.15KU
- 20.88KU/78.3KU/78.3KU
capsule, delayed-release (contains enteric-coated microspheres)
- Pertzye
- 4KU/14.375KU/15.125KU
- 8KU/28.75KU/30.25KU
- 16KU/57.5KU/60.5KU
- 24KU/86.25KU/90.75KU
capsule, delayed-release (contains enteric-coated beads)
- Zenpep
- 3KU/10KU/16KU
- 5KU/17KU/27KU
- 10KU/34KU/55KU
- 15KU/51KU/82KU
- 20KU/68KU/109KU
- 25KU/85KU/136KU
Exocrine Pancreatic Insufficiency
Creon, Ultresa, Pertzye, Zenpep, Pancreaze are indicated for pancreatic insufficiency due to cystic fibrosis, pancreatitis, pancreatectomy, or other conditions
Creon/Zenpep
- ≤12 months: 3000 lipase units/kg/120 mL of formula or per breastfeeding; administer prior to feeding; capsule contents should not be mixed directly in formula or breast milk
- 1-3 years: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
- ≥4 years: Initiate at 500 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
Pancreaze
- ≤12 months: 2000-4000 lipase units/kg/120 mL of formula or per breastfeeding; administer prior to feeding; capsule contents should not be mixed directly in formula or breast milk
- 1-3 years: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
- ≥4 years: Initiate at 500 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
- Not to exceed 10,000 unit lipase/kg/day or <4,000 lipase unites/g fat ingested daily
Pertzye
- ≤12 months: 4000 lipase units/kg/120 mL of formula or per breastfeeding; administer prior to feeding; capsule contents should not be mixed directly in formula or breast milk
- 1-4 years and weight ≥8 kg: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
- ≥4 years and weight ≥16 kg: Initiate at 500 lipase units/kg per meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
Ultresa
- 1-4 years and weight >14 kg: Initiate at 1000 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
- ≥4 years and weight >28 kg: Initiate at 500 lipase units/kg/meal; not to exceed 2500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or <4000 lipase units/g fat ingested per day
Viokace
- Safety and effectiveness not established
Recommendations from Cystic Fibrosis Foundation Consensus Report
- Infants <2 years is 2000-5000 lipase units/120 mL feeding; as infant grows, adjust dose not to exceed 2500 lipase units/kg/feeding (or 10,000 lipase units/kg/day)
- In general, daily requirements of 500-4000 lipase units/g of fat are required
- J Pediatr 2009;155(6 Suppl):S73-S93
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Abdominal pain/cramping (3-18% )
Headache (3-15% )
1-10%
Dyspepsia (10%)
Cough (4-10%)
Diarrhea (0-10%)
Hyperglycemia (8%)
Pharyngolaryngeal pain (7%)
Epistaxis (7%)
Anal pruritus (7%)
Biliary tract stones (7%)
Vomiting (6%)
Contusion (6%)
Weight loss (6%)
Early satiety (6%)
Flatulence (5-6%)
Dizziness (4%)
Hypoglycemia (4%)
Abnormal Feces (4%)
Frequent bowel movements (4%)
Nasopharyngitis (4%)
Anemia (3%)
Ascites (3%)
Flatulence (3%)
Peripheral edema (3%)
Hydrocholecystis (3%)
Viral infection (3%)
Renal cyst (3%)
Rash (3%)
Postmarketing Reports
Severe allergic reactions including anaphylaxis, asthma and hives
Skin disorders including pruritus, rash and urticaria
Asymptomatic elevations of liver enzymes
Gastrointestinal disorders: Abdominal distension, abdominal pain, diarrhea, flatulence, constipation and nausea; rare reports of fibrosing colonopathy and distal intestinal obstruction syndrome
Endocrine: May affect glycemic control in susceptible individuals
Warnings
Contraindications
Documented hypersensitivity
Cautions
Avoid exceeding maximum dose due to risk of fibrosing colonopathy; ≥6,000 lipase units/kg per meal associated with colonic stricture, indicative of fibrosing colonopathy, particularly in children ≤12 years
Swallow pills as chewing or retaining in mouth may cause oral mucosa irritation; do not chew, crush or mixed in foods having a pH ≥4.5
Monitor uric acid levels in patients with gout, hyperuricemia or renal impairment due to risk of hyperuricemia
Caution in patients with known allergy or porcine proteins
Do not exceed ≥2,500 units/kg per meal (or ≥10,000 lipase units/kg per day or ≥ 4000 lipase units/g fat ingested per day)
Avoid inhalation of powder
Theoretical risk of viral transmission
Pregnancy & Lactation
Pregnancy Category: C
Lactation: unknown
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Product contains a combination of lipase, protease, and amylase that replace endogenous pancreatic enzymes and catalyze the hydrolysis of starches into dextrins and short chain sugars such as maltose and maltotriose, fats to monoglycerides, glycerol and free fatty acids and proteins into peptides and amino acids in the duodenum and proximal small intestine
Pharmacokinetics
Absorption: not absorbed, acts locally in GI tract
Excretion: feces
Administration
Oral Administration
Pancrelipase products are not interchangeable
Initiate therapy at lowest recommended dose and increase gradually
Individualize therapy based on symptoms, degree of steatorrhea, fat content of diet, and patient response
Children and adults
- Usually, 50% of the full meal dose should be administered with snacks; total daily dosage should reflect approximately 3 meals plus 2-3 snacks per day
- Decrease dose in geriatric patients as, on average, they weigh more but tend to ingest less fat per kilogram of body weight
- Capsule should be swallowed whole with sufficient fluid; do not crush, chew, or retain in the mouth, to avoid irritation of the oral mucosa
- Unable to swallow capsule: Capsule contents may be sprinkled on applesauce, yogurt, or acidic soft food with pH <4.5 and consumed without chewing; follow with water or juice to ensure complete ingestion and to ensure nothing is retained in the mouth to avoid mucosal irritation
- Gastrostomy tube administration (Pertzye)
- Contents of one or two 4000-unit lipase capsules can be administered with soft foods via gastrostomy tube (G-tube) with a diameter ≥14 French
- Note: The 4000-unit Pertzye capsules were developed with reduced size microspheres to meet requirements needed to administer via G-tube
- Flush G-tube with 10 mL of water
- Discard any unused portion of pancrelipase-soft food mixture; do not save for later use
- If dose requires >two 4000-unit lipase capsules, repeat process until prescribed dose is reached
Infants aged ≤12 months
- Do not mix capsule contents directly into formula or breast milk (may decrease efficacy)
- Administered to infants immediately prior to each feeding
- Capsule contents may be mixed with ~10 mL of soft acidic food with a pH ≤4.5 (eg, applesauce) or directly to the mouth
- Administration should be followed by breast milk or formula
- Contents of the capsule should not be mixed directly into
- Do not crush, chew, or retain in the mouth, to avoid irritation of the oral mucosa
Images
Patient Handout
Formulary
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