Drugplain

Viokace 39150 [USP'U]/1

Pancrelipase · TABLET · Aimmune Therapeutics, Inc.

1 Recall on Record
Plain English

Viokace is a tablet containing pancrelipase at 39150 [USP'U]/1, taken oral. Manufactured by Aimmune Therapeutics, Inc..

Key Facts

Brand Name
Viokace
Generic Name
Pancrelipase
NDC Code (Product)
73562-104
Manufacturer
Aimmune Therapeutics, Inc.
Strength
39150 [USP'U]/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
BLA022542
Marketing Start
03/01/2021

Recall History

1 Recall on Record
Class II12/04/2017

ALLERGAN

Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea241 reports
nausea152 reports
dyspnoea128 reports
off label use128 reports
fatigue125 reports
vomiting120 reports
abdominal pain115 reports
asthenia111 reports
pyrexia111 reports
weight decreased105 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 )

Dosage & Administration

2. DOSAGE AND ADMINISTRATION Important Dosing Information ( 2.1 ) VIOKACE is a mixture of enzymes including lipases, proteases, and amylases and dosing is based on lipase units. Dosing scheme based on actual body weight or fat ingestion. Individualize the dosage based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Do not exceed 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day without further investigation. ( 5.1 ) The total daily dosage should reflect approximately three meals plus two or three snacks per day. With each snack, administer approximately half the prescribed dose for a meal. Do not substitute other pancreatic enzyme products for VIOKACE. When switching from another pancreatic enzyme product to VIOKACE, monitor patients for clinical symptoms of exocrine pancreatic insufficiency and titrate the dosage as needed. Recommended Dosage Adult Patients : The recommended initial starting dosage is 500 lipase units/kg/meal. Titrate the dosage to 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day. Higher dosages may be administered if documented …

Contraindications

4. CONTRAINDICATIONS None. None. ( 4 )

Adverse Reactions

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…

Frequently Asked Questions

What is Viokace used for?

Viokace contains Pancrelipase. It is a tablet taken oral. Consult your doctor for specific uses.

Is Viokace a controlled substance?

Viokace is not classified as a controlled substance by the DEA.

What is the generic name for Viokace?

The generic name for Viokace is Pancrelipase. There are 11 other brand versions of Pancrelipase.

What is the NDC code for Viokace 39150 [USP'U]/1?

The NDC (National Drug Code) for Viokace 39150 [USP'U]/1 is 73562-104, listed by Aimmune Therapeutics, Inc..

Product NDC

73562-104

Package NDC

73562-104-10

Other Viokace Dosages

Other Pancrelipase Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)