Description
Zenpep is a pancreatic enzyme replacement therapy (PERT) indicated for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions such as chronic pancreatitis or pancreatectomy. It contains a combination of porcine-derived lipase, amylase, and protease that assist in the digestion of fats, carbohydrates, and proteins, respectively. Zenpep is formulated as delayed-release capsules designed to resist gastric acid degradation, allowing enzymes to be released in the small intestine where they are most effective. The product is available in multiple dosage strengths to allow individualized therapy based on the degree of enzyme deficiency and dietary fat content.
| Fact Table |
| Formula | C122H196N38O36S (for lipase component) |
| License | US FDA |
| Bioavailability | Not systemically absorbed |
| Legal status | Prescription only |
| Chemical Name | Pancrelipase |
| Elimination half-life | Not applicable (acts locally in GI tract) |
| Dosage (Strength) | Varies by capsule: Lipase 3,000–40,000 USP units; Amylase and Protease vary proportionally |
| Pregnancy | Use only if clearly needed |
| Brands | Zenpep, Creon, Pancreaze, Pertzye, Ultresa, Viokace |
| Protein binding | Not applicable |
| PubChem CID | Not available (mixture) |
| MedlinePlus | a601112 |
| ChEBI | CHEBI:8643 (for lipase) |
| ATC code | A09AA02 |
| DrugBank | DB00085 (Pancrelipase) |
| KEGG | D01711 |
| Routes of administration | Oral (delayed-release capsules) |
Directions
Zenpep should be taken orally with every meal and snack. The capsules should be swallowed whole and not crushed or chewed, as this may damage the enteric coating and reduce efficacy or cause irritation. For patients unable to swallow capsules, the contents may be sprinkled onto a small amount of soft, acidic food (pH = 4.5), such as applesauce, and consumed immediately without chewing. Dosing is individualized based on the patient’s weight, clinical symptoms, and dietary fat content. For patients with cystic fibrosis, typical starting doses are based on body weight and are adjusted to achieve adequate nutrient absorption while minimizing the risk of fibrosing colonopathy. Hydration should be maintained during therapy.
Ingredients
Each Zenpep capsule contains pancrelipase, a mixture of porcine-derived enzymes including lipase, amylase, and protease. The exact units vary by strength, ranging from 3,000 to 40,000 USP units of lipase per capsule. Inactive ingredients include hypromellose phthalate, triethyl citrate, and various capsule shell components. The delayed-release formulation is acid-resistant, ensuring targeted enzyme release in the duodenum and jejunum.
Contraindications
Zenpep is contraindicated in patients with known hypersensitivity to porcine proteins or any component of the formulation. It should not be used in patients with acute pancreatitis or during acute exacerbations of chronic pancreatitis unless deemed appropriate by a healthcare provider.
Cautions
Long-term use of high-dose pancreatic enzyme products has been associated with fibrosing colonopathy, particularly in pediatric patients with cystic fibrosis. Doses exceeding 2,500 lipase units/kg/meal should be used with caution, and total daily doses should not exceed 10,000 lipase units/kg/day. Patients should be monitored for signs of gastrointestinal irritation or obstruction. Use with caution in patients with gout, renal impairment, or hyperuricemia, as Zenpep may increase serum uric acid levels. Patients and caregivers should be educated on proper administration techniques and the importance of adherence to prescribed enzyme doses with all meals and snacks.
Side Effects
The most commonly reported side effects of Zenpep include:
- Fibrosing colonopathy (rare, dose-dependent)
- Hypersensitivity reactions, including rash or anaphylaxis (rare)
Any persistent or severe symptoms should prompt medical evaluation and possible dose adjustment.
Frequently Asked Questions about Zenpep
What is Zenpep for?
Zenpep is a pancreatic enzyme replacement therapy (PERT) used to help people who cannot digest food properly due to exocrine pancreatic insufficiency (EPI). This condition is often caused by cystic fibrosis, chronic pancreatitis, pancreatectomy, or other pancreatic disorders.
How does Zenpep work?
Zenpep contains a mix of digestive enzymes (lipase, protease, and amylase) that mimic the enzymes normally produced by the pancreas. These enzymes help break down fats, proteins, and carbohydrates in the small intestine, aiding nutrient absorption.
How often to take Zenpep?
Zenpep should be taken with every meal and snack. Your doctor will prescribe the correct dose based on your weight, diet, and medical condition. Typically, it’s taken immediately before or during a meal.
How long can you take Zenpep?
Zenpep can be taken long-term as needed, especially in chronic conditions like cystic fibrosis or chronic pancreatitis. Many people take it indefinitely, under the supervision of a healthcare provider.
Does Zenpep cause weight gain?
Zenpep itself does not directly cause weight gain, but by improving nutrient absorption, it can lead to weight stabilization or gain in people who were previously underweight due to malabsorption.
Does Zenpep cause hair loss?
Hair loss is not a known side effect of Zenpep. If you’re experiencing hair loss, it may be related to nutritional deficiencies or another underlying condition. Talk to your doctor.
How long does Zenpep stay in your system?
Zenpep works locally in the gut and is not absorbed into the bloodstream. It is active for the duration of digestion and is then excreted in stool. Its action is temporary, tied to the meal it was taken with.
How long does it take for Zenpep to work?
Zenpep begins working as soon as it reaches the small intestine, usually within 30 minutes of taking it with food. Improvements in digestion (like less bloating or greasy stools) may be noticed within a few days.
Can you drink alcohol while taking Zenpep?
There is no direct interaction between Zenpep and alcohol. However, alcohol can irritate the pancreas and worsen digestive issues, especially if you have pancreatic disease. Use caution and consult your doctor.
Does Zenpep help with bloating?
Yes, Zenpep may help reduce bloating caused by poor digestion due to EPI. If bloating is due to another cause (e.g., IBS), its effectiveness may be limited.
Does Zenpep make you tired?
Fatigue is not a common side effect of Zenpep. If you're feeling tired, it may be related to underlying health conditions, malnutrition, or another medication.
IMPORTANT NOTE:
The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.
Product Code : 15324
Prescription Required
