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CLINICAL PHARMACOLOGY The natural digestive enzymes in VIOKASE® (pancrelipase tablets, powder) hydrolyze fats into fatty acids and glycerol, split protein into amino acids, and convert carbohydrates to dextrins and short chain sugars. Under conditions of the USP test method (in vitro) VIOKASE® (pancrelipase tablets, powder) has the following total digestive capacity: VIOKASE® 8 Tablet VIOKASE® 16 Tablet VIOKASE® Powder Each 0.7 g (1/4 Teaspoonful) Dietary fat, grams 28 56 59 Dietary protein, grams 30 60 70 Dietary starch, grams 30 60 70 VIOKASE® (pancrelipase tablets, powder) 8 Tablets are 468 mg immediate release tablets and are not enteric-coated. VIOKASE® (pancrelipase tablets, powder) 16 Tablets are 935 mg immediate release tablets and are not enteric-coated. The digestive capacity of a pancreatic enzyme concentrate depends on the amount that passes through the stomach unchanged and is available at the site of action in the small intestine.

VIOKASE® (pancrelipase, USP) Tablets, Powder DESCRIPTION VIOKASE® (pancrelipase, USP) is a pancreatic enzyme concentrate of porcine origin containing standardized lipase, protease, and amylase as well as other pancreatic enzymes. VIOKASE® (pancrelipase tablets, powder) is available in tablet and powder dosage form for oral administration. The enzyme potencies of the tablets and powder are: VIOKASE® 8 Tablet VIOKASE® 16 Tablet VIOKASE® Powder Each 0.7 g (1/4 Teaspoonful) Lipase, USP units 8,000 16,000 16,800 Protease, USP units 30,000 60,000 70,000 Amylase, USP units 30,000 60,000 70,000 Inactive Ingredients: VIOKASE® (pancrelipase tablets, powder) 8 and VIOKASE® (pancrelipase tablets, powder) 16 Tablets: Lactose, croscarmellose sodium, microcrystalline cellulose, silicon dioxide, stearic acid, talc. VIOKASE® (pancrelipase tablets, powder) Powder: Lactose, sodium chloride.

INDICATIONS VIOKASE® (pancrelipase, USP) is indicated in the treatment of exocrine pancreatic insufficiency as associated with but not limited to cystic fibrosis, chronic pancreatitis, pancreatectomy, or obstruction of the pancreas ducts. DOSAGE AND ADMINISTRATION Powder: Dosage for patients with cystic fibrosis: 1/4 teaspoonful (0.7 g) with meals. Tablets: Dosage range for patients with c®ystic fibrosis or chronic pancreatitis is from 8,000 to 32,000 Lipase USP Units taken with meals, i.e., one to four VIOKASE 8 tablets or one to two VIOKASE® (pancrelipase tablets, powder) 16 tablets with meals or as directed by a physician. In patients with pancreatectomy or obstruction of pancreatic ducts: one to two VIOKASE® (pancrelipase tablets, powder) 8 tablets or one VIOKASE® (pancrelipase tablets, powder) 16 tablet taken at 2-hour intervals or as directed by a physician. HOW SUPPLIED VIOKASE® (pancrelipase tablets, powder) 8 Tablets: Tan, round, compressed tablets engraved VIOKASE (pancrelipase tablets, powder) on one side and 9111 on the other side in bottles of 100 (NDC 58914-111-10) and 500 (NDC 58914-111-50). VIOKASE® (pancrelipase tablets, powder) 16 Tablets: Tan, oval, biconvex tablets engraved V16 on one side and 9116 on the other side in bottles of 100 (NDC 58914-116-10). Powder: Tan powder in bottles of 8 oz (227 g) (NDC 58914-115-08). Store in tightly closed container in a dry place at a temperature not exceeding 25°C (77°F). Dispense tablets and powder in tight container, preferably with a desiccant. For product information please call 1-800-742-6706. References: 1. Regan PT, Malagelada J-R, DiMagno EP, Gianzman SL, Go VLW. Comparative effects of antacids, cimetidine and enteric coating on the therapeutic response to oral enzymes in severe pancreatic insufficiency. N Engl J Med 1977;297:854-8. 2. Graham DY. Enzyme replacement therapy of exocrine pancreatic insufficiency in man. N Eng J Med 1977;296:1314-7. REV. June 2008. Manufactured in Canada for: AXCAN PHARMA US, INC., 22 Inverness Center Parkway Birmingham, AL 35242 USA. www.axcan.com. FDA rev date: n/a

PATIENT INFORMATION VIOKASE® (pancrelipase tablets, powder) should not be held in the mouth as the proteolytic action may cause irritation of the mucosa. Avoid inhalation of the powder when administering VIOKASE® (pancrelipase tablets, powder) . Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

OVERDOSE Acute toxicity determinations in animals have not been possible since the maximum dose that could be given orally produced no toxic reaction. In chronic feeding tests rats developed swollen salivary glands. This is believed due to the proteolytic activity and the mucosal irritation caused by tissue digestion. No acute toxic reactions have been reported. CONTRAINDICATIONS Should not be used in patients hypersensitive to pork protein.

SIDE EFFECTS The dust or finely powdered pancreatic enzyme concentrate is irritating to the nasal mucosa and the respiratory tract. It has been documented that inhalation of the airborne powder can precipitate an asthma attack. The literature also contains several references to asthma due to inhalation in patients sensitized to pancreatic enzyme concentrates. Extremely high doses of exogenous pancreatic enzymes have been associated with hyperuricemia and hyperuricosuria. Overdosage of pancreatic enzyme concentrate may cause diarrhea or transient intestinal upset. DRUG INTERACTIONS No information provided.

WARNINGS No information provided. PRECAUTIONS General Individuals previously sensitized to trypsin, pancreatin or pancrelipase may have allergic manifestations. Carcinogenesis, Mutagenesis Long-term studies in animals have not been performed to evaluate the carcinogenic potential. Pregnancy Category C: Animal reproduction studies have not been conducted with VIOKASE® (pancrelipase tablets, powder) . It is also not known whether VIOKASE® (pancrelipase tablets, powder) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VIOKASE® (pancrelipase tablets, powder) should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pancrelipase is administered to a nursing mother.