Zenpep 15,000 IU Capsules
It is used to help break down food when the pancreas is not working the right way.
Drug Class
Pancreatic enzyme replacement therapy (PERT)
Pharmacologic Class
Digestive enzymes
Pregnancy Category
Category C
FDA Approved
Jan 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Zenpep is a medicine that helps your body digest food, especially fats, proteins, and carbohydrates. It contains natural enzymes similar to those your pancreas makes. People who have conditions where their pancreas doesn't make enough of these enzymes, like cystic fibrosis or chronic pancreatitis, need to take this medicine to properly absorb nutrients from their food.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Take your medication with meals and snacks to help minimize potential side effects.
Swallow the medication whole. Do not chew, crush, or hold the medication in your mouth, as this can cause mouth irritation or affect how the medication works. If you have any concerns, talk to your doctor.
Drink plenty of fluids with each dose to help you swallow the medication completely.
Special Instructions
If you have trouble swallowing the medication, you can sprinkle the contents of the capsule onto applesauce. However, do not chew the mixture. Swallow it immediately and follow with a glass of water or juice.
After mixing the medication with food, take the dose right away. Do not store the mixture for later use.
Some medications can be mixed with foods other than applesauce. Be sure to check with your doctor or pharmacist to see what options are available for your specific medication.
Certain brands of this medication can be given through a feeding tube, while others cannot. Check with your pharmacist to determine if your medication can be administered via a feeding tube.
Instructions for Infants (Up to 12 Months Old)
Give your infant this medication at every feeding.
Sprinkle the contents of the capsule into your infant's mouth or onto a small amount of applesauce. Some products can also be mixed with other baby foods, such as bananas or pears. However, do not mix the medication with baby formula or breast milk.
Give the mixture to your infant right away. Do not store it for later use.
After giving the medication, offer your infant baby formula or breast milk as usual.
Check your infant's mouth after feeding to ensure they have swallowed the medication.
Storing and Disposing of Your Medication
Store your medication at room temperature with the lid tightly closed.
Keep the medication in its original container. If the bottle contains a desiccant packet to keep the medication dry, leave the packet in the bottle. Do not eat or swallow the desiccant packet.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time.
* Do not take two doses at the same time or take extra doses to make up for the missed dose.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Take your medication with meals and snacks to help minimize potential side effects.
Swallow the medication whole. Do not chew, crush, or hold the medication in your mouth, as this can cause mouth irritation or affect how the medication works. If you have any concerns, talk to your doctor.
Drink plenty of fluids with each dose to help you swallow the medication completely.
Special Instructions
If you have trouble swallowing the medication, you can sprinkle the contents of the capsule onto applesauce. However, do not chew the mixture. Swallow it immediately and follow with a glass of water or juice.
After mixing the medication with food, take the dose right away. Do not store the mixture for later use.
Some medications can be mixed with foods other than applesauce. Be sure to check with your doctor or pharmacist to see what options are available for your specific medication.
Certain brands of this medication can be given through a feeding tube, while others cannot. Check with your pharmacist to determine if your medication can be administered via a feeding tube.
Instructions for Infants (Up to 12 Months Old)
Give your infant this medication at every feeding.
Sprinkle the contents of the capsule into your infant's mouth or onto a small amount of applesauce. Some products can also be mixed with other baby foods, such as bananas or pears. However, do not mix the medication with baby formula or breast milk.
Give the mixture to your infant right away. Do not store it for later use.
After giving the medication, offer your infant baby formula or breast milk as usual.
Check your infant's mouth after feeding to ensure they have swallowed the medication.
Storing and Disposing of Your Medication
Store your medication at room temperature with the lid tightly closed.
Keep the medication in its original container. If the bottle contains a desiccant packet to keep the medication dry, leave the packet in the bottle. Do not eat or swallow the desiccant packet.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time.
* Do not take two doses at the same time or take extra doses to make up for the missed dose.
Lifestyle & Tips
- Always take Zenpep with every meal and snack that contains fat, protein, or carbohydrates.
- Swallow capsules whole. Do NOT crush, chew, or hold the capsules in your mouth, as this can irritate your mouth and destroy the protective coating.
- If you have trouble swallowing capsules, you may open the capsule and sprinkle the contents on a small amount of soft, acidic food (e.g., applesauce, pureed banana) and swallow immediately without chewing. Follow with water or juice.
- Drink plenty of fluids throughout the day to help prevent constipation.
- Store at room temperature, away from moisture and heat. Do not refrigerate.
- Do not exceed the maximum recommended dose, as very high doses have been associated with a rare but serious bowel condition (fibrosing colonopathy).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose individualized based on fat intake, typically 500 lipase units/kg/meal. Zenpep 15,000 IU capsule contains 15,000 lipase units. For a 70kg adult, this would be approximately 2-3 capsules per meal.
Dose Range:
15000 - 45000 mg
Condition-Specific Dosing:
cysticFibrosis:
Initial: 500 lipase units/kg/meal. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day or 4,000 lipase units/gram of fat ingested.
chronicPancreatitisOtherExocrinePancreaticInsufficiency:
Initial: 500-2,500 lipase units/kg/meal or 30,000-50,000 lipase units per meal. Adjust based on clinical symptoms and stool fat content.
Pediatric Dosing
Neonatal:
Not established for neonates. Use in infants and children is based on weight and fat intake.
Infant:
Initial: 500 lipase units/kg/meal for children <4 years of age. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day or 4,000 lipase units/gram of fat ingested.
Child:
Initial: 500 lipase units/kg/meal for children >=4 years of age. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day or 4,000 lipase units/gram of fat ingested.
Adolescent:
Initial: 500 lipase units/kg/meal. Max: 2,500 lipase units/kg/meal or 10,000 lipase units/kg/day or 4,000 lipase units/gram of fat ingested.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required as pancrelipase is not systemically absorbed.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required.
Dialysis:
No specific considerations as pancrelipase is not systemically absorbed or renally cleared.
Hepatic Impairment:
Mild:
No specific dose adjustment required as pancrelipase is not systemically absorbed or hepatically metabolized.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required.
Pharmacology
Mechanism of Action
Pancrelipase is a pancreatic enzyme product (PEP) containing lipase, amylase, and protease. It acts locally in the gastrointestinal tract to hydrolyze fats into glycerol and fatty acids, starches into dextrins and sugars, and proteins into peptides and amino acids. These products are then absorbed by the intestine.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal to none (acts locally in GI tract)
Tmax:
Not applicable (no systemic absorption)
FoodEffect:
Must be taken with food to be effective; enteric coating protects enzymes from gastric acid until release in the duodenum.
Distribution:
Vd:
Not applicable (no systemic distribution)
ProteinBinding:
Not applicable (no systemic distribution)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (no systemic half-life)
Clearance:
Not applicable (no systemic clearance)
ExcretionRoute:
Fecal excretion of inactive components
Unchanged:
Not applicable (enzymes are digested)
Pharmacodynamics
OnsetOfAction:
Rapid (with food ingestion)
PeakEffect:
During digestion of the meal
DurationOfAction:
Duration of the meal's digestion
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of gallstones, including:
+ Sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
Joint pain, stiffness, redness, or swelling
Mouth or tongue irritation
Swollen gland
Abnormal or severe stomach pain, bloating, trouble passing stools, upset stomach, vomiting, or diarrhea, which could be signs of a rare bowel problem called fibrosing colonopathy
Signs of high or low blood sugar, such as:
+ Breath that smells like fruit
+ Dizziness
+ Fast breathing
+ Fast heartbeat
+ Feeling confused, sleepy, or weak
+ Flushing
+ Headache
+ Unusual thirst or hunger
+ Passing urine more often
+ Shaking or sweating
Other Possible Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following side effects and they bother you or do not go away, contact your doctor or seek medical attention:
Dizziness or headache
Constipation, diarrhea, stomach pain, or upset stomach
Heartburn
Gas
Cough
Sore throat
Anal irritation
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of gallstones, including:
+ Sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
Joint pain, stiffness, redness, or swelling
Mouth or tongue irritation
Swollen gland
Abnormal or severe stomach pain, bloating, trouble passing stools, upset stomach, vomiting, or diarrhea, which could be signs of a rare bowel problem called fibrosing colonopathy
Signs of high or low blood sugar, such as:
+ Breath that smells like fruit
+ Dizziness
+ Fast breathing
+ Fast heartbeat
+ Feeling confused, sleepy, or weak
+ Flushing
+ Headache
+ Unusual thirst or hunger
+ Passing urine more often
+ Shaking or sweating
Other Possible Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following side effects and they bother you or do not go away, contact your doctor or seek medical attention:
Dizziness or headache
Constipation, diarrhea, stomach pain, or upset stomach
Heartburn
Gas
Cough
Sore throat
Anal irritation
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or unusual abdominal pain
- Bloody or black, tarry stools
- Changes in bowel habits (e.g., new or worsening constipation or diarrhea)
- Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regularly undergo blood tests and other laboratory examinations as instructed by your doctor. Adhere to the dietary plan recommended by your doctor. If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels. Be aware of the potential for gout attacks.
This medication is derived from pork (pig) pancreas tissue, which carries a minimal risk of transmitting a viral disease. Although no cases have been reported, discuss this risk with your doctor. If you continue to experience symptoms of pancreas problems while taking this medication, such as stomach pain, bloating, fatty stools, or weight loss, contact your doctor, as your dosage may need to be adjusted.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
This medication is derived from pork (pig) pancreas tissue, which carries a minimal risk of transmitting a viral disease. Although no cases have been reported, discuss this risk with your doctor. If you continue to experience symptoms of pancreas problems while taking this medication, such as stomach pain, bloating, fatty stools, or weight loss, contact your doctor, as your dosage may need to be adjusted.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe abdominal pain
- Nausea
- Vomiting
- Diarrhea
- Hyperuricemia (high uric acid levels, rare)
- Fibrosing colonopathy (rare, serious condition with high doses, especially in CF patients, presenting as severe abdominal pain, distention, vomiting, and constipation)
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Discontinue the medication if fibrosing colonopathy is suspected.
Drug Interactions
Moderate Interactions
- Antacids (e.g., calcium carbonate, magnesium hydroxide): May theoretically reduce the effectiveness of enteric-coated pancrelipase by altering gastric pH and potentially dissolving the coating prematurely, though clinical significance is often low with modern formulations.
- Iron supplements: Some older formulations of pancreatic enzymes were thought to interfere with iron absorption, but this is less clear with modern enteric-coated products.
Monitoring
Baseline Monitoring
Nutritional status (weight, height, BMI)
Rationale: To assess baseline pancreatic insufficiency and monitor treatment efficacy.
Timing: Prior to initiation of therapy
Stool fat content (e.g., 72-hour fecal fat excretion)
Rationale: To objectively quantify malabsorption and guide initial dosing, though often not routinely performed.
Timing: Prior to initiation of therapy (if clinically indicated)
Fat-soluble vitamin levels (A, D, E, K)
Rationale: Patients with EPI are at risk for deficiencies due to malabsorption.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical symptoms of malabsorption (e.g., steatorrhea, abdominal pain, bloating, flatulence)
Frequency: Regularly (e.g., at each clinic visit)
Target: Resolution or significant improvement of symptoms
Action Threshold: Persistent or worsening symptoms despite adequate dosing may indicate need for dose adjustment or re-evaluation of diagnosis.
Weight and growth (especially in pediatric patients)
Frequency: Regularly (e.g., monthly to quarterly)
Target: Appropriate weight gain and growth for age
Action Threshold: Failure to thrive or weight loss may indicate inadequate enzyme replacement.
Nutritional markers (e.g., albumin, prealbumin, fat-soluble vitamins)
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: Within normal limits
Action Threshold: Deficiencies require supplementation and/or enzyme dose adjustment.
Bowel habits and stool characteristics
Frequency: Daily patient self-monitoring
Target: Formed, non-greasy stools
Action Threshold: Persistent greasy, foul-smelling, or loose stools indicate inadequate enzyme activity.
Symptom Monitoring
- Steatorrhea (greasy, foul-smelling stools)
- Abdominal pain or cramping
- Bloating
- Flatulence
- Weight loss or failure to gain weight
- Diarrhea
- Constipation (rare, but can occur with very high doses)
Special Patient Groups
Pregnancy
Zenpep (pancrelipase) is generally considered safe for use during pregnancy as it is not systemically absorbed. However, adequate and well-controlled studies in pregnant women are lacking. Use only if the potential benefit justifies the potential risk to the fetus. Maintaining adequate nutrition is crucial during pregnancy, and enzyme replacement therapy helps achieve this in patients with EPI.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption. Focus on maintaining maternal nutritional status.
Second Trimester:
Low risk. Continue monitoring maternal nutritional status.
Third Trimester:
Low risk. Continue monitoring maternal nutritional status.
Lactation
Pancrelipase is minimally absorbed systemically, making it unlikely to be excreted in breast milk in clinically significant amounts. Therefore, it is generally considered compatible with breastfeeding. The benefits of breastfeeding should be weighed against the mother's clinical need for Zenpep.
Infant Risk:
Low risk to the breastfed infant.
Pediatric Use
Zenpep is approved for use in pediatric patients. Dosing is individualized based on age, weight, and fat intake. Close monitoring of growth, weight gain, and symptoms of malabsorption is crucial. Caution should be exercised to avoid excessive dosing, especially in cystic fibrosis patients, due to the rare risk of fibrosing colonopathy.
Geriatric Use
No specific dose adjustments are required for geriatric patients. Dosing should be individualized based on clinical response and fat intake, similar to younger adults. Elderly patients may have comorbidities or be on multiple medications, so potential drug interactions should be considered, though few are significant with pancrelipase.
Clinical Information
Clinical Pearls
- Always take Zenpep immediately before or with the first bite of every meal and snack to ensure enzymes are present when food enters the duodenum.
- Do not crush or chew the capsules or their contents, as this will inactivate the enzymes and irritate the oral mucosa.
- If a dose is missed, do not double the next dose. Take the next dose with the next meal or snack.
- Monitor for signs of enzyme efficacy, such as improved stool consistency (less greasy, less frequent), reduced abdominal pain/bloating, and weight gain.
- Ensure adequate hydration, especially when taking high doses, to prevent constipation.
- Patients with cystic fibrosis should be monitored for symptoms of fibrosing colonopathy, particularly if on high doses (e.g., >10,000 lipase units/kg/day).
Alternative Therapies
- Dietary modifications (e.g., low-fat diet, though often not sufficient for severe EPI)
- Nutritional supplements (e.g., medium-chain triglycerides, fat-soluble vitamins)
Cost & Coverage
Average Cost:
$800 - $1500+ per 100 capsules (15,000 IU)
Insurance Coverage:
Tier 2 or Tier 3 (Specialty drug, often requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.