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.
| F act Table |
| Formula | Mixture (amylase, lipase, protease) |
| License | US FDA |
| Bioavailability | Not systemically absorbed (local GI action) |
| Legal status | Prescription only |
| Chemical Name | Pancrelipase (combination of lipase, protease, amylase) |
| Elimination half-life | Not applicable (enzymatic action in GI tract) |
| Dosage (Strength) | Varying capsule strengths: e.g., 3,000–40,000 USP units of lipase per capsule (plus protease and amylase) |
| Pregnancy | Use only if clearly needed |
| Brands | Zenpep |
| Protein binding | Not applicable |
| PubChem CID | Not applicable (mixture) |
| MedlinePlus | a604038 |
| ChEBI | Not applicable (biological mixture) |
| ATC code | A09AA02 |
| DrugBank | DB00085 |
| KEGG | D01028 |
| 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.
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
