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Anwendungsgebiete

1. INDICATIONS AND USAGE VIOKACE, in combination with a proton pump inhibitor, is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in adults. VIOKACE, in combination with a proton pump inhibitor, is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in adults. ( 1 )

Warnhinweise und Vorsichtsmaßnahmen

5. WARNINGS AND PRECAUTIONS Fibrosing Colonopathy : Associated with high doses, usually over prolonged use and in pediatric patients with cystic fibrosis. Colonic stricture reported in pediatric patients less than 12 years of age with dosages exceeding 6,000 lipase units/kg/meal. Monitor during treatment for progression of preexisting disease. Do not exceed the recommended dosage, unless clinically indicated. ( 2.1 , 5.1 ) Irritation of the Oral Mucosa : May occur if tablets are crushed or chewed.

( 5.2 ) Hyperuricemia : Reported with high dosages, consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia. ( 5.3 ) Risk of Viral Transmission : The presence of porcine viruses that might infect humans cannot be definitely excluded. ( 5.4 ) Hypersensitivity Reactions : Monitor patients with known reactions to proteins of porcine origin. If symptoms occur, initiate appropriate medical management; consider the risks and benefits of continued treatment.

( 5.5 ) Potential for Exacerbation of Symptoms of Lactose Intolerance : tablets contain lactose monohydrate. Patients who have lactose intolerance may not be able to tolerate VIOKACE. ( 5.6 ) 5.1. Fibrosing Colonopathy Fibrosing colonopathy has been reported following treatment with pancreatic enzyme products. Fibrosing colonopathy is a rare, serious adverse reaction initially described in association with use of high-dose pancreatic enzyme products, usually over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis.

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Warnhinweise und Vorsichtsmaßnahmen

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6. ADVERSE REACTIONS The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Fibrosing Colonopathy [see Warnings and Precautions (5.1) ] Irritation of the Oral Mucosa [see Warnings and Precautions (5.2) ] Hyperuricemia [see Warnings and Precautions (5.3) ] Risk of Viral Transmission [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Potential for Exacerbation of Symptoms of Lactose Intolerance [see Warnings and Precautions (5.6) ] Most common adverse reactions (≥7%) are: anal pruritus and biliary tract stones.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics, Inc at 1-833-AIM2KNO (1-833-246-2566) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to VIOKACE in 30 adult patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in a single, multicenter, randomized, parallel, placebo-controlled, double-blind study [see Clinical Studies (14) ] . Adverse reactions that were reported in at least 2 VIOKACE-treated patients (greater than or equal to 7%) are shown in Table 1. There were no adverse reactions reported in two or more patients in the placebo group (N=20).

Table 1: Adverse Reactions Reported in at least 2 VIOKACE-treated patients (greater than or equal to 7%) and at a higher rate than placebo-treated patients. in a Clinical Trial of Adult Patients with Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or Pancreatectomy Adverse Reaction VIOKACE N = 30 (%) Anal pruritus 2 (7%) Biliary tract stones 2 (7%) The following adverse reactions were reported in one VIOKACE-treated patient each: anemia, abdominal pain, ascites, flatulence, headache, hydocholecystis, peripheral edema, rash, renal cyst, and viral infection. 6.2.

Postmarketing Experience The following adverse reactions have been identified during post-approval use of VIOKACE or other pancreatic enzyme products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Eye Disorders blurred vision Gastrointestinal Disorders fibrosing colonopathy and distal intestinal obstruction syndrome abdominal pain, diarrhea, flatulence, constipation, and nausea Immune System Disorders anaphylaxis, asthma, hives and pruritis Investigations asymptomatic elevations of liver enzymes Musculoskeletal System myalgia, muscle spasm Skin and Subcutaneous Tissue Disorders urticaria and rash

Packung	Code	Status
PANCRELIPASE (AMYLASE 39,150USP UNITS; LIPASE 10,440USP UNITS; PROTEASE) 39,150USP UNITS	BLA022542-001	Prescription
PANCRELIPASE (AMYLASE 78,300USP UNITS; LIPASE 20,880USP UNITS; PROTEASE) 78,300USP UNITS	BLA022542-002	Prescription

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