Pertzye (pancrelipase)

What is Pertzye?

Pertzye is a brand-name prescription medication. It’s FDA-approved to treat exocrine pancreatic insufficiency (EPI). The EPI must be caused by a condition called cystic fibrosis or other conditions.

With EPI, your body doesn’t have pancreatic enzymes available like usual to help digest foods. (Pancreatic enzymes are substances made by your pancreas to help break down fats, proteins, and carbohydrates from your diet.) For more information about EPI and its possible causes, see the “Pertzye uses” section below.

Pertzye is approved for use in adults and children of all ages.

Drug details

Pertzye contains the active drug pancrelipase. It’s classified as a pancreatic enzyme replacement.

Pertzye comes as oral capsules. They’re delayed release, which means that the capsules don’t release all the medication until they reach your small intestine.

Pertzye comes in several strengths. For more information, see the “Pertzye dosage” section below.

Effectiveness

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

Pertzye generic or biosimilar

Pertzye contains the active drug pancrelipase, which is available only as a brand-name medication. It’s not currently available in generic or biosimilar form.

A biosimilar medication is a drug that’s similar to a brand-name biologic drug (the parent drug). Pertzye is a biologic medication, which is also called a biologic.

Biologics are made from living cells. It’s not possible to make an exact copy of these medications. A generic, on the other hand, refers to medications made from chemicals. A generic is an exact copy of the active drug in a brand-name medication.

Biosimilars are considered to be just as safe and effective as their parent medication. And like generics, biosimilars usually cost less than brand-name medications.

Pertzye cost

As with all medications, the cost of Pertzye 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 Pertzye. 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 or your insurance company.

It’s important to note that you may have to get Pertzye at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Pertzye, your insurance company may require you to get prior authorization. This means that your doctor and your 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 Pertzye, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Pertzye, or if you need help understanding your insurance coverage, help is available.

Chiesi Farmaceutici, the manufacturer of Pertzye, offers a program called Chiesi CareDirect. This program can provide support if you need help paying for Pertzye. For more information and to find out if you’re eligible for support, call 888-865-1222 or visit the program website.

Pertzye coupon or copay card

Chiesi Farmaceutici also offers a copay card that may help when paying for Pertzye. For information about the copay card and other financial support options, call 888-865-1222 or visit the Chiesi CareDirect website.

Mail-order pharmacies

Pertzye 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 Pertzye, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and 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

Pertzye is a brand-name medication that contains the active drug pancrelipase. It’s not currently available in generic or biosimilar form.

A biosimilar medication is a drug that’s similar to a brand-name biologic drug (the parent drug). Pertzye is a biologic medication, which is also called a biologic.

Biologics are made from living cells. It’s not possible to make an exact copy of these medications. A generic, on the other hand, refers to medications made from chemicals. A generic is an exact copy of the active drug in a brand-name medication.

Biosimilars are considered to be just as safe and effective as their parent medication. And like generics, biosimilars usually cost less than brand-name medications.

Pertzye dosage

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

• your age
• your weight
• how your condition responds to treatment with Pertzye
• side effects that you have from the medication
• how much fat you eat each day

Typically, your doctor will start you on a low dosage. Then, they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

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

Drug forms and strengths

Pertzye comes as oral capsules that are delayed release.

Capsules often release medication once they reach the stomach. But Pertzye needs to get to the intestines to work properly. As a delayed-release capsule, Pertzye doesn’t enter your system until it reaches the intestines. Once there, the drug releases enzymes so that you can digest food. (Enzymes are types of proteins that help speed up certain processes, such as digesting food.)

Here are the three enzymes that Pertzye contains and what they help digest:

• Lipase helps digest fats.
• Amylase helps digest carbohydrates.
• Protease helps digest proteins.

These enzymes are meant to replace the missing enzymes in your pancreas due to your condition. The different strengths of Pertzye contain different amounts of these enzymes, as shown in the table below:

Your doctor will prescribe Pertzye by the number of lipase units.

Dosage for exocrine pancreatic insufficiency

Pertzye is used to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. The Cystic Fibrosis Foundation Consensus Conferences Guidelines for dosages to treat EPI that’s due to CF are listed below.

For adults, the starting dosage is 500 lipase units per kilogram (kg)* of body weight with each full meal.

If needed, your doctor can increase this to a maximum dosage of:

• 2,500 lipase units per kg of body weight with each full meal, or
• fewer than 4,000 lipase units per gram (g) of fat you eat each day

Your total daily dosage of Pertzye should not exceed 10,000 lipase units per kg of body weight.

The usual dose for when you have a snack is half of the dose you take with meals. Your total daily dosage will typically account for three meals and two or three snacks each day.

Talk with your doctor before taking Pertzye. They’ll determine the best dosage to fit your needs.

* One kg is equal to about 2.2 lb.

Children’s dosage

The recommended dosages of Pertzye for children are based on age, as described below. Talk with your doctor if you have any questions about the dosage of Pertzye that’s best for your child.

Dosage for children up to age 12 months

For children up to age 12 months, the dosage is 4,000 lipase units per 120 milliliters (mL) of formula or breast milk. You should not mix the capsules with the formula or breast milk.

Dosage for children ages 12 months to younger than 4 years

For children ages 12 months to younger than 4 years, the recommended starting dosage of Pertzye is:

• 1,000 lipase units per kg* of body weight each meal

If needed, your child’s doctor can increase this dosage up to a maximum of:

• 2,500 lipase units per kg of body weight with each meal, or
• fewer than 4,000 lipase units per g of fat they eat each day

In this age group, the total daily dosage of Pertzye should not exceed 10,000 lipase units per kg of body weight.

* One kg is equal to about 2.2 lb.

Dosage for children ages 4 years and older

The Pertzye dosage for children ages 4 years and older is the same as for adults. See the “Dosage for exocrine pancreatic insufficiency” section above.

What if I miss a dose?

Pertzye must be taken with meals or snacks. If you miss a dose, skip that dose and take your next dose with your next meal or snack. Do not take two doses at one time.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

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

Alternatives to Pertzye

Other drugs are available that can treat exocrine pancreatic insufficiency (EPI). Some may be a better fit for you than others. If you’re interested in finding an alternative to Pertzye, talk with your doctor. They can tell you about other medications that may work well for you.

Alternatives for exocrine pancreatic insufficiency

Examples of other drugs that may be used to treat EPI include:

• pancrelipase delayed-release capsules (Creon, Pancreaze, Zenpep)
• pancrelipase tablets (Viokace)

Note: Although these drugs contain pancrelipase, they each contain different amounts of enzymes and cannot be substituted for one another.

Common questions about Pertzye

Here are answers to some frequently asked questions about Pertzye.

Does the risk of side effects from Pertzye increase if I take the 24,000-unit capsule instead of the 16,000-unit capsule?

Clinical trials of Pertzye didn’t compare side effects in people taking the 24,000-unit capsule with people taking the 16,000-unit capsule. It’s possible that the risk of side effects may increase with a higher dose. But if you take Pertzye as your doctor prescribes, it’s unlikely that your risk of side effects will increase.

For more about side effects of the drug, see the “Pertzye side effects” section below. To see a complete list of side effects reported in these trials, you can view Pertzye’s prescribing information. You can also talk with your doctor or pharmacist.

Is Pertzye safe?

Yes. In clinical trials, Pertzye was shown to be safe and effective for treating exocrine pancreatic insufficiency in children and adults.

To learn more about side effects reported by people taking Pertzye, see the “Pertzye side effects” section below. You can also view Pertzye’s prescribing information or talk with your doctor or pharmacist.

Are there any reviews available from people who’ve used Pertzye?

The manufacturer of Pertzye hasn’t provided any reviews about the medication.

If you’d like to learn more about how people rate their treatment with Pertzye, talk with your doctor or pharmacist.

Pertzye side effects

Pertzye can cause mild or serious side effects. Side effects are sometimes referred to as adverse effects. The following lists contain some of the key side effects that may occur while taking Pertzye. These lists do not include all possible side effects.

For more information about the possible side effects of Pertzye, 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: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Pertzye, you can do so through MedWatch.

Mild side effects

Mild side effects* of Pertzye can include:

• diarrhea
• indigestion (upset stomach)
• cough

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 Pertzye. To learn about other mild side effects, talk with your doctor or pharmacist or view Pertzye’s medication guide.

Serious side effects

Serious side effects from Pertzye 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 symptoms can include:

• Mouth irritation, if Pertzye capsules aren’t swallowed completely or mixed with foods that aren’t recommended.* Symptoms can include:
  • burning or stinging in your mouth
  • sores or ulcers in your mouth or on your tongue
• High uric acid level in the blood. Symptoms can include:
  • kidney stones
  • joint inflammation
  • pain, redness, or swelling in your big toe
• Fibrosing colonopathy (scarring or narrowing in your colon).†
• Allergic reaction.†

* For more information on how to take Pertzye, see the “How to take Pertzye” section below.
† 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

Drugs that are used to replace pancreas enzymes, such as Pertzye, can cause fibrosing colonopathy. Although this is rare, fibrosing colonopathy is a serious condition.

With fibrosing colonopathy, tissue in your colon (large intestine) becomes damaged and scarred. The condition may require surgery and treatment in a hospital. Fibrosing colonopathy was rare in clinical studies of Pertzye.

Symptoms of fibrosing colonopathy can include unusual or severe:

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

Certain people have a higher risk than usual of developing fibrosing colonopathy. This includes children with cystic fibrosis who are younger than age 12 years and take high doses of Pertzye. An increased risk of fibrosing colonopathy can also occur in both children and adults who take Pertzye for a long period of time.

The best way to avoid fibrosing colonopathy is to take Pertzye exactly as your doctor prescribes. Be sure that you do not take a higher dosage or more doses than your doctor recommends. It’s important that you do not change your Pertzye dosage on your own.

If you experience any symptoms of fibrosing colonopathy, you should talk with your doctor right away. They’ll likely want to evaluate your symptoms further.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Pertzye. Allergic reactions with Pertzye were rare in clinical studies.

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 Pertzye, 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.

Pertzye uses

The Food and Drug Administration (FDA) approves prescription drugs such as Pertzye to treat certain conditions.

Pertzye for exocrine pancreatic insufficiency

Pertzye is prescribed to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. Pertzye is approved for use in adults and children of all ages.

Your pancreas is responsible for making enzymes (types of proteins) that your body uses to break down food after a meal. With EPI, your body doesn’t have enough enzymes in your pancreas to digest food. Or, the enzymes aren’t working properly.

EPI may be caused by:

• CF (a genetic condition that causes thick, sticky mucus in your lungs, pancreas, and other body parts)
• chronic pancreatitis (long-lasting inflammation in your pancreas)
• pancreatectomy (surgery to remove all or part of your pancreas)
• diabetes

Symptoms of EPI can include:

• abdomen (belly) pain
• bloating or feeling gassy
• bulky, frequent, or loose stools
• oil or mucus in your stools
• vomiting
• weight loss

Pertzye works by replacing natural digestive enzymes in your small intestine. This helps your body digest food properly.

Effectiveness for exocrine pancreatic insufficiency

Clinical studies showed Pertzye to be effective for treating EPI due to CF or other conditions. To see how the medication performed in these studies, see Pertzye’s prescribing information.

Guidelines by the American Gastroenterological Association recommend using pancreatic enzyme replacement therapy, such as Pertzye, to treat EPI due to CF or other conditions.

Pertzye and children

Pertzye is approved to treat EPI due to CF or other conditions in children of any age. For more information, see “Pertzye for exocrine pancreatic insufficiency” above.

Pertzye and alcohol

There’s no known interaction between drinking alcohol and taking Pertzye. But alcohol can damage your pancreas, which could worsen symptoms of exocrine pancreatic insufficiency (EPI). This may cause Pertzye to not work as well as usual or not work at all to treat your symptoms.

It may be best to avoid alcohol if you have EPI. If you drink alcohol, be sure to talk with your doctor before taking Pertzye.

Pertzye interactions

It’s possible that Pertzye may interact with other medications, herbs, or supplements. But no such interactions have been reported.

To be safe, you should still talk with your doctor and pharmacist before taking Pertzye. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use.

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

How to take Pertzye

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

Pertzye comes as oral capsules that you swallow.

When to take

Be sure to take Pertzye with a meal or a snack, preferably just before you start eating or with the first bites.

Talk with your doctor about the correct dose of Pertzye that you should take with extra snacks or extra meals. Having a plan ahead of time will help you be prepared for any changes in your diet or daily routine.

Try to keep a supply of Pertzye with you at all times to help make sure you don’t miss a dose with a meal or a snack. It’s important to make sure that the capsules stay cool and dry.

To help make sure that you don’t miss a dose, try using a medication reminder based around the time you usually eat. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Pertzye with food

Pertzye must be taken with food. The drug is meant to help your body digest food after eating. Pertzye doesn’t work unless you take it with food. You should also drink plenty of fluids, such as a full glass of water, when you take a dose of Pertzye.

Can Pertzye be crushed, split, or chewed?

No, you should not crush, split, or chew Pertzye capsules. But you can open the capsules and mix the contents with an acidic food, such as applesauce. Your doctor can tell you about other acidic foods that you may be able to take Pertzye with.

If you have trouble swallowing the capsules, talk with your doctor before taking Pertzye. They may be able to recommend a different treatment that’s easier for you to take.

Can I take Pertzye capsules through a gastrostomy tube?

Yes, you can take Pertzye capsules through a gastrostomy tube. To view step-by-step instructions on how to do so, you can refer to the medication’s instructions for use. You can also visit the drug manufacturer’s site for an administration video.

How can I give a dose of Pertzye to my infant?

You can put Pertzye capsules directly into your infant’s mouth. You can also open the capsules and mix the contents with an acidic food, such as applesauce.

There are specific instructions for each method that you should follow exactly. You can refer to Pertzye’s instructions for use or visit the manufacturer’s website.

How Pertzye works

Pertzye is approved to treat exocrine pancreatic insufficiency (EPI) that’s caused by cystic fibrosis (CF) or other conditions.

Your pancreas makes enzymes that your body uses to digest food. (Enzymes are types of proteins that help speed up certain processes in your body.) Conditions such as CF stop your pancreas from making these enzymes or prevent them from working as they should. This is known as EPI.

Here are the three enzymes that Pertzye contains and what they help digest:

• Lipase helps digest fats.
• Amylase helps digest carbohydrates.
• Protease helps digest proteins.

These enzymes are meant to replace and support ones in your pancreas. When you take Pertzye with food, the drug capsule releases these enzymes in your intestines. There, the enzymes are able to break down food. This allows your body to digest nutrients as usual.

How long does it take to work?

Pertzye begins working soon after you take a dose. The drug helps your body digest food once the drug reaches your intestines. This is why you should take a dose of Pertzye right before you eat.

Pertzye and pregnancy

Pertzye may be safe to use while pregnant, but this isn’t known for sure.

Pertzye hasn’t been studied in pregnant people. But reports from pregnant people who have used the drug haven’t found a risk of complications or pregnancy loss. This is likely because most of a Pertzye dose stays in your intestine and isn’t absorbed into the rest of your body.

If you’re pregnant or planning to become pregnant, talk with your doctor before you start taking Pertzye. They can advise you on the pros and cons of taking the medication.

Pertzye and birth control

Pertzye may be safe to use while pregnant, but this isn’t known for sure. 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 Pertzye.

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

Pertzye and breastfeeding

It isn’t known if Pertzye passes into human breast milk. But if it does, it isn’t expected to appear in amounts that could harm a breastfed child. This is because your body doesn’t absorb much Pertzye after you take a dose. Instead, most (or all) of the medication is used to help digest the food you eat.

If you’re breastfeeding or thinking about doing so, talk with your doctor before you start taking Pertzye. They can review the risks and benefits as well as feeding options for your child.

Pertzye precautions

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

• Allergy to pork. The enzymes in Pertzye are made from the pancreases of pigs. You should not take Pertzye if you’re allergic to pork. Ask your doctor about other treatments for your condition instead.
• Intestinal blockage or scarring. In rare cases, Pertzye can cause fibrosing colonopathy (narrowing or scarring of the colon). If you have or have ever had an intestinal blockage or scarring, you may be at higher risk of this side effect than usual. Or, your condition may worsen. Your doctor may prescribe a lower dosage of Pertzye than usual or switch you to a different treatment.
• Gout or high blood uric acid level. Pertzye may increase uric acid levels in the blood. This can worsen gout or further increase a high blood uric acid level. Your doctor may monitor you more closely than usual. Or, they may recommend a different treatment for your condition.
• Kidney problems. Pertzye may cause uric acid levels in your blood to rise. If you have kidney problems, such as chronic kidney disease, your risk may be increased. This is because your body uses your kidneys to get rid of uric acid. Your doctor may monitor you more closely than usual.
• Trouble swallowing. Pertzye capsules must be swallowed whole. If you have trouble swallowing, including swallowing medications, talk with your doctor before you start taking Pertzye. They may suggest a different treatment for your condition.
• Allergic reaction. If you’ve had an allergic reaction to Pertzye or any of its ingredients, you should not take Pertzye. Ask your doctor what other medications are better options for you.
• Pregnancy. Pertzye may be safe to use while pregnant, but this isn’t known for sure. For more information, see the “Pertzye and pregnancy” section above.
• Breastfeeding. It’s not known if Pertzye passes into human breast milk, but it isn’t expected to cause harm if it does. For more information, see the “Pertzye and breastfeeding” section above.

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

Pertzye overdose

Using more than the recommended dosage of Pertzye can lead to serious side effects.

Do not use more Pertzye than your doctor recommends.

Overdose symptoms

Taking too much Pertzye at once isn’t likely to cause symptoms.

But taking doses that are too high over time can lead to serious conditions, including:

• fibrosing colonopathy*
• colonic stricture (narrowing of your large intestine)
• high uric acid levels in the blood, which can cause gout

* For more information about this side effect, see the “Side effect details” section above.

What to do in case of overdose

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.