Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Fibrosing Colonopathy
Additions and/or
revisions underlined:
…
If there is a history of fibrosing colonopathy, monitor patients during treatment with
VIOKACE because some patients may be at risk of progressing to colonic stricture
formation. It is uncertain whether regression of fibrosing colonopathy occurs. Do
not exceed the recommended dosage of either 2,500 lipase units/kg/meal,
10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day without
further investigation. Higher dosages may be administered if
they are documented to be effective by fecal fat measures or an improvement
in signs or symptoms of malabsorption including measures of nutritional status.
Patients receiving dosages higher than 6,000 lipase units/kg/meal
should frequently monitored for symptoms of fibrosing colonopathy and
the dosage decreased or titrated downward to a lower range if clinically
appropriate [see Dosage and Administration (2.1)].
5.2 Irritation of the Oral Mucosa
Additions and/or
revisions underlined:
Crushing or chewing VIOKACE tablets can result in irritation of the oral mucosa, and/or loss of enzyme activity. Instruct
the patient to swallow tablets whole. Do not crush or chew VIOKACE tablets.
Consume sufficient liquids immediately following administration of VIOKACE to
ensure complete swallowing [see Dosage and Administration (2.3)].
5.3 Hyperuricemia
Additions and/or
revisions underlined:
Pancreatic enzyme products contain purines that may
increase blood uric acid levels. High dosages have been associated with
hyperuricosuria and hyperuricemia [see Overdosage (10)].
Consider
monitoring blood uric acid levels in patients with gout, renal
impairment, or hyperuricemia during treatment with VIOKACE.
5.5 Hypersensitivity Reactions
Additions
and/or revisions underlined:
Severe
hypersensitivity
reactions including anaphylaxis, asthma, hives, and pruritus have been reported
with pancreatic enzyme products [see
Adverse Reactions (6.2)]. If symptoms occur, initiate appropriate
medical management.
Monitor patients with a
known hypersensitivity reaction to proteins of porcine origin for
hypersensitivity reactions during treatment with VIOKACE. The risks and
benefits of continued VIOKACE treatment in patients with severe hypersensitivity
reactions should be taken into consideration with the overall clinical
needs of the patient.
6
Adverse Reactions
Additions and/or
revisions underlined:
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)]
6.1 Clinical Trials Experience
Additions and/or
revisions underlined:
…
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).
Please refer to
label to view Table 1.
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
Additions
and/or revisions underlined:
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
8
Use in Specific Populations
8.4 Pediatric Use
Additions
and/or revisions underlined:
The
safety and effectiveness of VIOKACE in pediatric patients have not been
established.
Use
of VIOKACE in pediatric patients may increase the risk of inadequate treatment
of pancreatic insufficiency and result in suboptimal weight gain, malnutrition
and/or need for larger doses of pancreatic enzyme replacement due to tablet
degradation in the gastric environment of the stomach.
High
dosages of pancreatic enzyme products have been associated with fibrosing
colonopathy and colonic strictures in pediatric patients less than 12 years of
age [see Warnings and Precautions (5.1)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or revisions underlined:
…
Fibrosing Colonopathy
Advise patients that if signs and symptoms
of colon stricture formation occur (e.g., stomach area (abdominal) pain,
bloating, trouble passing stool (constipation), nausea, vomiting, diarrhea) to
immediately contact their healthcare provider [see Warnings and Precautions (5.1)].
Hyperuricemia
Advise the patient that hyperuricemia may occur
in patients with gout or renal impairment and to contact the
healthcare provider if they experience pain, stiffness,
redness or swelling of their joints [see
Warnings and Precautions (5.3)].
Hypersensitivity Reactions+
Inform the patient that
severe hypersensitivity
reactions, including anaphylaxis asthma, hives, and pruritus, have been reported
with use of pancreatic enzyme products. Seek medical attention if signs or
symptoms of a hypersensitivity reaction develop [see Warnings and
Precautions (5.5)].
Dosage
Advise the patient to
increase take VIOKACE as prescribed, and to contact the healthcare provider
if signs and symptoms of malabsorption persist [see Dosage and
Administration (2.1)].
Administration
Instruct the patient to:
Take VIOKACE with meals
or snacks.
Swallow tablets whole. Do
not crush or chew VIOKACE tablets.
Consume sufficient
liquids (water) to ensure complete swallowing of VIOKACE tablets.
Storage
Instruct
the patient or caregiver as follows:
Keep VIOKACE in a dry place and protect from moisture
and heat.
After opening, keep the container tightly closed between
uses to protect from moisture.
Keep VIOKACE in the original bottle.
The desiccant packet should not be eaten or thrown
away.
MEDICATION GUIDE
Extensive additions and/or revisions, please refer
to label for complete information.
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