Viokace (pancrelipase)

What is Viokace?

Viokace is a brand-name prescription medication. It’s FDA-approved for use in adults with exocrine pancreatic insufficiency (EPI) that’s caused by:

• chronic pancreatitis, which is long-term inflammation (swelling) in your pancreas
• pancreatectomy, which is a surgery that removes all or part of your pancreas

To treat EPI, Viokace is taken with another type of medication called a proton pump inhibitor. (For more information, see the “Viokace use with other drugs” section below.)

Typically, the pancreas makes pancreatic enzymes (a type of protein). They help digest fats, proteins, and carbohydrates (“carbs,” or sugars) from the foods you eat. But with EPI, your body isn’t able to make pancreatic enzymes. This prevents you from digesting food correctly.

Drug details

Viokace contains the active drug pancrelipase. This drug is a mixture of three different enzymes:

• lipase enzymes to digest fats
• protease enzymes to digest proteins
• amylase enzymes to digest carbohydrates

Note: These enzymes come from the tissues of pigs. Talk with your doctor to learn more.

Viokace belongs to a drug class called pancreatic enzyme replacement therapy (PERT). (A drug class is a group of medications that work in a similar way.) PERT replaces enzymes that are usually made by the human pancreas.

Viokace comes as tablets that you take by mouth with each meal and snack you have. Viokace is available in two strengths:

• 10,440 units of lipase/39,150 units of protease/39,150 units of amylase
• 20,880 units of lipase/78,300 units of protease/78,300 units of amylase

Effectiveness

For information about the effectiveness of Viokace, see the “Viokace uses” section below.

Viokace generic or biosimilar

Viokace contains the active ingredient pancrelipase. It’s a biologic drug that only comes as a brand-name medication. Viokace is not available in a biosimilar form.

A biologic drug is made up of living cells, while other drugs are created with chemicals. Chemical drugs made can be available as generics, which are exact copies of the active drug in the brand-name medication.

Biologic medications, however, can’t be copied exactly. So biologics have biosimilars rather than generics. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe.

Like generics, biosimilars are often less expensive compared with brand-name medications.

Viokace dosage

The Viokace dosage your doctor prescribes will depend on several factors. These include:

• the severity of your exocrine pancreatic insufficiency (EPI) symptoms
• your age
• your body weight
• the fat content of the foods in your diet

The following information describes dosages that are commonly used or recommended. But be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug form and strengths

Viokace comes as tablets that you’ll take by mouth. The drug is available in two strengths:

• 10,440 units of lipase/39,150 units of protease/39,150 units of amylase
• 20,880 units of lipase/78,300 units of protease/78,300 units of amylase

Dosage for EPI

Your doctor will prescribe a dose of Viokace that you’ll take with each meal and snack you have.

Your doctor will prescribe a dosage of Viokace that’s specific for you. It will be based on your body weight or your daily fat intake (how much fat is in the foods you eat each day).

Typically, your doctor will prescribe a low dose of Viokace at the beginning of treatment. The recommended starting dosage of Viokace is either:

• 500 to 2,500 units of lipase per kilogram (kg)* of body weight per meal
• fewer than 4,000 units of lipase per gram (g) of fat intake per day

Your doctor will determine the dosage that’s right for you.

Typically, the dose you’ll take with each snack is half of your prescribed dose for a full meal. For example, if you take two tablets per meal, you’ll take one tablet per snack.

You shouldn’t take more than the total daily dose of Viokace prescribed by your doctor. So you’ll need to plan your meals and snacks each day according to your total daily dose of Viokace. The maximum dosage of Viokace is 10,000 units of lipase per kg of your body weight per day.

Depending on how well the medication is working to manage your EPI, your doctor may adjust your dose over time. They’ll continue to adjust it until they find the amount that’s right for you.

The label on your bottle of Viokace will explain your dosage as the number of tablets to take with each meal and snack. If you have questions about your dosage, check the label or talk with your doctor or pharmacist.

* 1 kg is about 2.2 pounds (lb).

What if I miss a dose?

If you miss a dose of Viokace, just skip the missed dose and wait to take your next dose with your next meal or snack. You shouldn’t take an extra dose to make up for a missed dose. Doing so could raise your risk of side effects.

Keep in mind that Viokace contains enzymes (a type of protein) that digest food. So it only works when it’s taken with food. If you skip a meal or snack, you should also skip that dose of Viokace.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or downloading a reminder app on your phone. Consider keeping a bottle of Viokace on your kitchen counter or table where you’ll see it as you prepare or eat food.

You should take a supply of Viokace tablets with you wherever you go. This includes when you go to a restaurant or wherever you may eat a meal or snack.

Will I need to take this drug long term?

Viokace is meant to be taken as a long-term treatment. If you and your doctor determine that Viokace is safe and effective for you, you’ll likely take it long term.

Alternatives to Viokace

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Viokace tablets, talk with your doctor. They can tell you about other medications that may work well for you.

Exocrine pancreatic insufficiency (EPI) can be caused by different factors or medical conditions. The following list includes other drugs that also contain pancrelipase (the active drug in Viokace). Although these medications may be used to treat EPI, some may be approved by the Food and Drug Administration (FDA) to treat EPI caused by various conditions.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when an FDA-approved drug is used for a purpose other than what it’s approved for.

An example of a medication that may be used to manage EPI is pancrelipase delayed-release capsules. This medication is available as the following brand-name drugs:

• Creon
• Pancreaze
• Pertzye
• Zenpep

If you’re interested in alternatives to Viokace, talk with your doctor.

Viokace cost

As with all medications, the cost of Viokace can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Viokace. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor, pharmacist, or your insurance company.

Before approving coverage for Viokace, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Viokace, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Viokace, or if you need help understanding your insurance coverage, help may be available.

You can search Medicine Assistance Tool and NeedyMeds to find programs that may help decrease Viokace’s cost. To learn more, visit their websites.

For more information about saving money on prescriptions, check out this article.

Mail-order pharmacies

Viokace may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Viokace, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor, pharmacist, or your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic or biosimilar version

Viokace is a biologic drug that only comes as a brand-name medication. It’s not available in a biosimilar form. Generics tend to cost less than brand-name drugs.

Viokace side effects

Viokace can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Viokace. These lists do not include all possible side effects.

For more information about the possible side effects of Viokace, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you would like to notify the FDA about a side effect you’ve had with Viokace, you can do so through MedWatch.

Mild side effects

Mild side effects* of Viokace can include:

• anal itching†
• flatulence (passing gas)
• edema (buildup of fluid) in your abdomen (belly), arms, or legs
• headache
• skin rash

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Viokace. To learn about other mild side effects, talk with your doctor or pharmacist, or view Viokace’s prescribing information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Viokace aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their possible symptoms include:

• Bile duct stones or gallstones. These are stones that form in your gallbladder or in the tubes that carry bile to your small intestines. Symptoms can include:
  • intense pain in the upper abdomen
  • dark-colored urine
• Viral infection. Symptoms can vary but may include:
  • fever
  • fatigue (low energy)
  • body aches
• Fibrosing colonopathy (scarring or narrowing in your colon).*
• High uric acid levels.*
• Allergic reaction.*

* For more information about this side effect, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause.

Fibrosing colonopathy

Viokace could increase the risk of fibrosing colonopathy as a rare side effect. With this condition, the colon (large intestine) becomes scarred or narrowed. This scarring or narrowing could slow or prevent food from passing through the colon correctly.

Fibrosing colonopathy didn’t occur in people who took Viokace in clinical studies. But it occurred with other drugs in the pancreatic enzyme replacement therapy (PERT) drug class. (Viokace belongs to the PERT drug class.) Most reports of fibrosing colonopathy have been in children ages 12 years and younger who took high doses of PERTs. But keep in mind that Viokace isn’t approved for use in children. It’s only meant to be used in adults.

You may be able to reduce your risk of fibrosing colonopathy by taking your Viokace dosage exactly as prescribed. Viokace should be taken with each meal and snack that you eat. But you shouldn’t take more Viokace tablets each day than prescribed by your doctor. So you’ll need to plan your meals and number of snacks each day according to your total dose of Viokace.

Fibrosing colonopathy is a very serious condition that may need surgery to be treated. Symptoms of fibrosing colonopathy can include any new or worsening:

• abdominal (belly) pain
• bloating
• bloody diarrhea
• nausea or vomiting
• constipation

Contact your doctor right away if you have any of the symptoms listed above. Do not stop Viokace or change your dosage without talking with your doctor.

High uric acid levels

Viokace may cause high uric acid levels in the blood. This can cause or worsen gout (a type of arthritis). But this side effect didn’t occur in people who took Viokace in clinical studies. It occurred with other drugs in the pancreatic enzyme replacement therapy (PERT) drug class. (Viokace belongs to the PERT drug class.) But high uric acid levels are still a potential side effect of Viokace.

High uric acid levels are possible because Viokace is a mixture of enzymes (a type of protein) that contain purines. Purines are natural substances found in many meats, seafoods, and other foods. (The ingredients that are used to make Viokace come from the tissues of pigs.) When purines get digested, uric acid is formed as a result.

Symptoms of high uric acid levels may include:

• pain or swelling in your joints or big toe
• kidney stones

If you develop any of these symptoms, tell your doctor. They’ll likely use a blood test to check your uric acid levels. They may prescribe treatments to manage gout if you have it.

Anal itching

Anal itching is a common side effect of Viokace. “Anal” refers to the anus, which is the opening at the end of the digestive tract where stool leaves the body. In clinical studies, anal itching was one of the more common side effects reported in people who took Viokace.

If you develop anal itching while taking Viokace, here are a few tips that may relieve this side effect:

• Avoid scratching and vigorous scrubbing of the anal area. You shouldn’t use scented soap or astringent wipes, such as those that contain alcohol or witch hazel. These can further irritate the area. Instead, bathe daily using a gentle cleanser and warm water.
• Consider applying an over-the-counter (OTC) barrier ointment that contains zinc oxide and menthol, such as Calmoseptine.
• Anal itching can also be eased by applying a thin layer of an OTC steroid cream, such as hydrocortisone, to the itchy area. But it’s best to limit the use of steroid creams to 2 weeks. Continuing steroid creams longer than this can cause thinning of the skin.

If anal itching doesn’t go away or becomes severe, talk with your doctor. They may suggest other ways to relieve this side effect or recommend a different medication.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Viokace. It isn’t clear if allergic reaction occurred during clinical studies of the drug. But allergic reaction was reported in people who took Viokace after it was approved by the FDA.

Viokace contains lactose and ingredients that come from the tissues of pigs. These ingredients may cause reactions in people who are allergic to them.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Viokace, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Common questions about Viokace

Here are answers to some frequently asked questions about Viokace.

Is Viokace used to treat cystic fibrosis?

Viokace isn’t approved by the Food and Drug Administration (FDA) to treat cystic fibrosis (CF). Viokace is approved for use in adults with exocrine pancreatic insufficiency (EPI) that’s caused by chronic pancreatitis (long-term inflammation in your pancreas) or pancreatectomy (surgical removal of all or part of the pancreas).

EPI can be caused by other medical conditions, including CF. CF is a genetic condition that causes thick mucus in your pancreas, lungs, and other organs. It’s possible that a doctor may prescribe Viokace off-label to treat EPI that’s caused by CF. But it isn’t approved for this specific use. (Off-label use is when a medication is prescribed for a reason other than its FDA-approved uses.)

Why is Viokace taken with a proton pump inhibitor?

Proton pump inhibitors (PPIs) are medications that block proton pumps (a type of protein in the stomach) from releasing acid. Viokace is taken with a PPI so that your stomach produces less acid. This allows the drug to pass through your stomach to the small intestine, where it works. If you took Viokace without a PPI, your stomach acid could break down the drug before it reaches your small intestine. This would prevent Viokace from working.

To learn more about PPIs, see the “Viokace use with other drugs” section below.

Is Viokace a vegetarian or vegan product?

No, Viokace isn’t a vegetarian or vegan product. It contains digestive enzymes that come from the tissues of pigs. The pigs used to source these enzymes are animals that are already being used to make foods, such as pork.

If you have questions about a vegan or vegetarian alternative to Viokace, talk with your doctor.

Viokace uses

The Food and Drug Administration (FDA) approves prescription drugs such as Viokace to treat certain conditions. Viokace may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Viokace for exocrine pancreatic insufficiency

Viokace is FDA-approved for adults with exocrine pancreatic insufficiency (EPI) that’s caused by:

• chronic pancreatitis, which is long-term inflammation (swelling) in your pancreas
• pancreatectomy, which is a surgery that removes all or part of your pancreas

To treat EPI, Viokace is prescribed with another type of medication called a proton pump inhibitor (PPI). (For more information, see the “Viokace use with other drugs” section below.)

Typically, the pancreas makes pancreatic enzymes (a type of protein). They digest the fats, proteins, and carbohydrates (“carbs,” or sugars) from foods you eat. With EPI, your body isn’t able to make pancreatic enzymes. This prevents you from digesting food correctly.

Symptoms of EPI can include:

• frequent or loose bowel movements
• oily stools or stools that contain mucus
• stools that smell more foul than usual
• abdominal (belly) pain
• bloating
• vomiting

Effectiveness for EPI

Viokace has been found to be effective for managing EPI symptoms when taken with a PPI in clinical studies.

For more information on how Viokace performed in clinical studies, see the drug’s prescribing information.

Viokace and children

Viokace isn’t FDA-approved for use in children. It has not been proven to be safe or effective in children.

Viokace use with other drugs

Viokace should be taken along with another type of medication called a proton pump inhibitor (PPI). PPIs are medications that block proton pumps (a type of protein in the stomach) from releasing acid. PPIs are also used to treat acid reflux, stomach ulcers, and other conditions that are worsened by stomach acid.

If you were to take Viokace without PPI treatment, your stomach acid could break down the drug before it reaches your small intestine. This would prevent Viokace from working.

By taking a PPI, your stomach will produce less acid. This allows Viokace to pass through your stomach to the small intestine. Here, it works to digest (break down) the foods you eat into nutrients that your body can absorb and use as energy.

PPIs are typically taken once a day. Your doctor will recommend which PPI is best for you. Some PPIs are available over the counter, and others require a prescription from your doctor.

Some examples of PPIs include:

• dexlansoprazole (Dexilant)
• esomeprazole (Nexium)
• lansoprazole (Prevacid)
• pantoprazole (Protonix)
• omeprazole (Prilosec)
• rabeprazole (Aciphex)

If you have questions about taking other medications with Viokace, talk with your doctor or pharmacist.

Viokace and alcohol

Viokace isn’t known to interact with alcohol.

But alcohol can cause and worsen chronic pancreatitis (long-term inflammation of the pancreas). Viokace is used to treat exocrine pancreatic insufficiency in adults that’s caused by chronic pancreatitis. So you should not drink alcohol if you have chronic pancreatitis.

If you have any questions about alcohol and Viokace, talk with your doctor.

Viokace interactions

There aren’t any medications, herbs, supplements, or foods that have been specifically shown to interact with Viokace.

But before taking Viokace, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

How to take Viokace

You should take Viokace according to the instructions your doctor gives you.

Viokace comes as tablets that you’ll swallow. Be sure to swallow Viokace tablets whole and wash them down with plenty of water or another nonalcoholic beverage.

You shouldn’t keep Viokace tablets in your mouth any longer than necessary. This is because holding Viokace tablets in your mouth can cause mouth irritation, such as pain or swelling in the mouth.

When to take

You should take Viokace with each meal and snack you have.

It’s important not to take more Viokace tablets in a day than your doctor prescribes for you. So you’ll need to plan your meals and number of snacks each day according to your total dose of Viokace.

Be sure to take a supply of Viokace tablets with you wherever you go. This includes when you go to a restaurant or wherever you may eat a meal or snack.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or downloading a reminder app on your phone. Consider keeping a bottle of Viokace on your kitchen counter or table where you’ll see it as you prepare or eat food.

Taking Viokace with food

You should take Viokace with each meal and snack you have.

Keep in mind that Viokace contains enzymes (a type of protein) that help your body digest food. So it only works when it’s taken with food. If you skip a meal or snack, you should also skip that dose of Viokace.

Can Viokace be crushed, split, or chewed?

No, you should always swallow Viokace tablets whole and wash them down with plenty of water or another nonalcoholic beverage. Crushing, chewing, or holding Viokace tablets in your mouth too long can cause mouth irritation. Also, the tablets may not work as well if they’re not swallowed whole.

How Viokace works

Viokace is approved by the Food and Drug Administration (FDA) for use in adults with exocrine pancreatic insufficiency (EPI) that’s caused by certain conditions. With EPI, your body isn’t able to make pancreatic enzymes (a type of protein). Pancreatic enzymes are important to digest (break down) foods into nutrients that your body can absorb and use as energy.

Viokace helps people with EPI by serving as a pancreatic enzyme replacement to digest food. Viokace contains the active drug pancrelipase. This drug is a mixture of three different enzymes that come from the tissues of pigs. These enzymes include:

• lipase enzymes to digest fats
• protease enzymes to digest proteins
• amylase enzymes to digest carbohydrates (“carbs,” or sugars)

When you take a dose of Viokace with food, pancrelipase (the active drug in Viokace) works in your small intestine. Here, your body uses the replacement enzymes to digest fats, proteins, and carbohydrates. They get broken down into small pieces that your body can absorb and use as energy.

How long does it take to work?

Viokace works right away when you take it with food. From your first dose, Viokace helps to digest the meal or snack that you take it with.

Viokace and pregnancy

It’s not known if Viokace is safe to take during pregnancy. The drug’s use during pregnancy hasn’t been studied. Case reports of people who’ve taken the drug during pregnancy haven’t described any harmful effects or negative outcomes.

When you take Viokace, the active drug (pancrelipase) mostly stays in your digestive system. Very little of the active drug gets absorbed into your bloodstream. So taking Viokace during pregnancy isn’t likely to affect the fetus.

If you’re pregnant or planning to become pregnant, talk with your doctor. They can guide you in choosing the best treatment option for your condition.

Viokace and birth control

It’s unknown if Viokace is safe to take during pregnancy. The drug’s use during pregnancy hasn’t been studied. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re taking Viokace.

For more information about taking Viokace during pregnancy, see the “Viokace and pregnancy” section above.

Viokace and breastfeeding

It’s not known whether Viokace is safe to take while breastfeeding. The drug’s use while breastfeeding hasn’t been studied.

When you take Viokace, the active drug (pancrelipase) mostly stays in your digestive system. Very little of the active drug gets absorbed into your bloodstream. So Viokace shouldn’t pass into breast milk or affect children who are breastfed.

If you’re breastfeeding or planning to breastfeed, talk with your doctor. They can help you decide if you should take Viokace or a different treatment option.

Viokace precautions

Before taking Viokace, talk with your doctor about your health history. Viokace may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Past fibrosing colonopathy or blockage of your intestines. In rare cases, taking Viokace may cause fibrosing colonopathy. If you’ve had this problem or a blockage in your intestines in the past, you may be more likely to develop this serious side effect. Talk with your doctor about other treatment options.
• Gout, kidney disease, or high uric acid level. Viokace may cause increased uric acid levels in the blood. If you already have gout, high uric acid levels can make your symptoms more severe. Also, uric acid levels may be even higher in people with kidney disease. If you have any of these conditions, your doctor may monitor your uric acid levels more carefully while you’re taking Viokace or suggest a different medication.
• Lactose intolerance. Viokace tablets contain lactose. Some people can’t consume lactose products due to lactose intolerance or a lactose allergy. If you can’t consume lactose, talk with your doctor about other treatment options.
• Allergies. If you’ve had an allergic reaction to Viokace or any of its ingredients, including pork or lactose, you shouldn’t take Viokace. Ask your doctor what other medications are better options for you.
• Pregnancy. It isn’t known if Viokace is safe to take during pregnancy. For more information, see the “Viokace and pregnancy” section above.
• Breastfeeding. It’s not known whether Viokace is safe to take while breastfeeding. For more information, see the “Viokace and breastfeeding” section above.

Note: For more information about the potential negative effects of Viokace, see the “Viokace side effects” section above.

Viokace overdose

Do not take more Viokace than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Viokace

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.