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Viokace

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Viokace

Viokace Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Viokace (pancrelipase) is a compound prescription medicine containing enzymes used with a proton pump inhibitor medicine (PPI) to treat adults with pancreatitis, chronic pancreatitis, or pancreatectomy who cannot digest food normally. Viokace and its components are available in generic forms. Viokace may cause serious side effects, including irritation inside of the mouth if Viokace is not swallowed completely. The use of Viokace may also increase levels of uric acid in the blood. Allergic reactions such as trouble breathing, skin rashes, swollen lips have also been reported. The most common side effects of Viokace include gallstones and anal itching.

Viokase comes in two strengths: 10,440 USP units of lipase; 39,150 USP units of protease and 39,150 USP units of amylase in tablets or as 20,880 USP units of lipase; 78,300 USP units of protease and 78,300 USP units of amylase in tablet form The recommended dose of Viokace is 500 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day. Patients should inform their doctors if they are pregnant or planning to become pregnant. Serious side effects include fibrosing colonopathy, hyperuricemia and allergic reactions. It is not known if Viokace will harm unborn babies. Women should tell their doctors if they are breastfeeding or planning to breastfeed. It is not known is Viokace passes into breast milk. The patient and her doctor should decide whether to take Viokace or breastfeed. Patients should not do both. Although some clinicians have used Viokace in certain pediatric patients, the safety and efficacy of this drug has not been established in the pediatric population. Clinicians suggest that if Viokace is used in a pediatric population, the enteric coated tablets should be used.

Our Viokace Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Viokace in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

  • nausea or vomiting;
  • mild stomach pain or upset;
  • diarrhea or constipation;
  • bloating or gas;
  • greasy stools;
  • rectal irritation;
  • headache, dizziness;
  • cough; or
  • weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Viokace (Pancrelipase) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Viokace FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most serious adverse reactions reported with different pancreatic enzyme products of the same active ingredient (pancrelipase) that are described elsewhere in the label include fibrosing colonopathy, hyperuricemia and allergic reactions [see WARNINGS AND PRECAUTIONS].

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 short-term safety of VIOKACE was assessed in a single, multicenter, randomized, parallel, placebo-controlled, double-blind study of 50 patients, ages 24-70 years, with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis or pancreatectomy. VIOKACE Tablets (20,880 USP units of lipase per tablet) or placebo were administered as 22 tablets per day (6 tablets with 3 meals and 2 tablets with 2 of 3 snacks). Duration of exposure ranged from 6 to 7 days. The majority of the subjects were Caucasian (96%) and male (82%).

The most common adverse reactions (greater than or equal to 7%) were biliary tract stones and anal pruritus. Table 1 enumerates adverse reactions that occurred in at least 1 patient (greater than or equal to 3%) treated with VIOKACE at a higher rate than with placebo. Two adverse reactions reported in greater than one patient were biliary tract stones and anal pruritus.

TABLE 1: Adverse Reactions Occurring in at Least 1 Patient (greater than or equal to 3%) in Chronic Pancreatitis or Pancreatectomy

  Treatment Group
MedDRA Primary System Organ Class/Adverse Reactions VIOKACE
(N=30)
Placebo
(N=20)
Blood And Lymphatic System Disorders
  Anemia 1 ( 3%) 0
Gastrointestinal Disorders
  Anal pruritus 2 ( 7%) 0
  Abdominal pain 1 ( 3%) 0
  Ascites 1 ( 3%) 0
  Flatulence 1 ( 3%) 0
General Disorders and Administration Site Conditions
  Edema peripheral 1 ( 3%) 0
Hepatobiliary Disorders
  Biliary tract stones 2 ( 7%) 0
  Hydrocholecystis 1 ( 3%) 0
Infections and Infestations
  Viral infection 1 ( 3%) 0
Nervous System Disorders
  Headache 1 ( 3%) 0
Renal and Urinary Disorders
  Renal cyst 1 ( 3%) 0
Skin and Subcutaneous Tissue Disorders
  Rash 1 ( 3%) 0

Postmarketing Experience

Post-marketing data for VIOKACE have been available since 2003. The safety data are similar to that described below. 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.

Pancreatic enzyme products (delayed and immediate-release) with different formulations of the same active ingredient (pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis. The long-term safety profile of these products has been described in the medical literature. The most serious adverse events included fibrosing colonopathy, distal intestinal obstruction syndrome (DIOS), recurrence of pre-existing carcinoma, and severe allergic reactions including anaphylaxis, asthma, hives, and pruritus. The most commonly reported adverse events were gastrointestinal disorders, including abdominal pain, diarrhea, flatulence, constipation and nausea, and skin disorders including pruritus, urticaria and rash.

Read the entire FDA prescribing information for Viokace (Pancrelipase) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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