PERTZYE (Page 2 of 6)

2.2 Administration

PERTZYE should always be taken as prescribed by a healthcare professional.

​Infants (up to 12 months)

PERTZYE should be administered to infants immediately prior to each feeding, using a dosage of 4,000 lipase units (one capsule) per 120 mL of formula or per breast-feeding. Contents of the capsule may be mixed with approximately 10 mL of soft acidic food with a pH of 4.5 or less, (e.g., applesauce). Contents of the capsule may also be administered directly to the mouth. Administration should be followed by breast milk or formula. Do not mix contents of the capsule directly into formula or breast milk as this may diminish efficacy. Care should be taken to ensure that the PERTZYE microspheres are not crushed or chewed or retained in the mouth, to avoid irritation of the oral mucosa [see Warnings and Precautions (5.2)].

Children and Adults

  • Administer PERTZYE during meals or snacks, with sufficient fluid.
  • Swallow PERTZYE capsules whole.
  • If a dose is missed, take the next dose with the next meal or snack as directed. Do not take two doses at one time.
  • Do not crush or chew the capsules or the capsule contents.
  • For patients who are unable to swallow intact capsules, follow the instructions below for oral administration with soft foods with a pH of 4.5 or less (e.g., applesauce):
  1. Place a small amount (approximately 10 mL) of applesauce into a clean container.
  2. Carefully open the capsule(s).
  3. Sprinkle the intact microspheres on the applesauce.
  4. Mix the microspheres with the applesauce being careful not to crush the microspheres when mixing.
  5. Consume the entire contents immediately. Do not chew the microspheres. Do not save the applesauce and microspheres for later use.
  6. Follow with water or juice to ensure complete ingestion and to ensure nothing is retained in the mouth to avoid mucosal irritation [see Warnings and Precautions (5.2)].

Alternatively, the contents of one or two 4,000 USP lipase unit capsules can be administered with soft foods with a pH of 4.0 or less (e.g., applesauce) via a gastrostomy tube with a diameter of 14 French or larger.

Gastrostomy Tube Administration Instructions (14 French Gastrostomy Tube or Larger)

Only perform gastrostomy tube administration with the contents of the 4,000 USP lipase unit capsule of PERTZYE. The contents of no more than two capsules may be administered at a time.

  1. Transfer a minimum of 10 mL of applesauce into a small bowl or medicine cup.
  2. Carefully open one or two Pertzye 4,000 lipase unit capsules.
  3. Mix the capsule contents thoroughly with the transferred applesauce to create a uniform suspension. Once mixed, administer the suspension immediately. Care should be taken not to crush the enzyme microspheres. Discard the empty capsules.
  4. Remove the plunger from a 35 mL slip tip syringe. Cover the tip of the syringe with your finger. Transfer the PERTZYE-applesauce mixture into the syringe. Replace the plunger partially back into the syringe.
  5. Shake or tap the syringe lightly with the syringe tip facing upward so that the PERTZYE-applesauce mixture will move towards the plunger. Carefully push the plunger slowly until the residual air is removed from the syringe tip.
  6. Once the residual air is removed, connect the syringe directly into the gastrostomy tube feeding port.
  7. Push the syringe contents into the gastrostomy tube feeding port using steady pressure until empty.
  8. Draw up approximately 10 mL of water with the slip tip syringe and flush the gastrostomy tube feeding port with the water.
  9. Discard any unused portion of the PERTZYE-applesauce mixture. Do not save for later use.
  10. If dose requires more than two capsules, repeat steps 1-9 until prescribed dose is reached.

3 DOSAGE FORMS AND STRENGTHS

The active ingredient in PERTZYE evaluated in clinical trials is lipase. PERTZYE is dosed by lipase units.

PERTZYE is available in 3 color coded capsule strengths. Each PERTZYE delayed-release capsule strength contains the specified amounts of lipase, protease and amylase as follows:

  • 4,000 USP units of lipase; 14,375 USP units of protease; 15,125 USP units of amylase. Delayed-release capsules have a clear body printed in green with “4” and a clear cap printed with a green circular stripe and “DCI”
  • 8,000 USP units of lipase; 28,750 USP units of protease; 30,250 USP units of amylase. Delayed-release capsules have a clear body printed in blue with “8” and a clear cap printed with a blue circular stripe and “DCI”
  • 16,000 USP units of lipase; 57,500 USP units of protease; 60,500 USP units of amylase. Delayed-release capsules have a clear body printed in red with “16” and a clear cap printed with a red circular stripe and “DCI”
  • 24,000 USP units of lipase; 86,250 USP units of protease; 90,750 USP units of amylase. Delayed-release capsules have a clear body printed in purple with “24” and a clear cap printed with a purple circular stripe and “DCI”

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Fibrosing Colonopathy

Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products. 4,5 Fibrosing colonopathy is a rare serious adverse reaction initially described in association with high-dose pancreatic enzyme use, usually with use over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. The underlying mechanism of fibrosing colonopathy remains unknown. Doses of pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with colonic strictures in children less than 12 years of age.1 Patients with fibrosing colonopathy should be closely monitored because some patients may be at risk of progressing to stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs.1 It is generally recommended, unless clinically indicated, that enzyme doses should be less than 2,500 lipase units/kg of body weight per meal (or less than 10,000 lipase units/kg of body weight per day) or less than 4,000 lipase units/g fat ingested per day [ see Dosage and Administration ( 2.1)].

Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Patients receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.

5.2 Potential for Irritation to Oral Mucosa

Care should be taken to ensure that no drug is retained in the mouth. PERTZYE should not be crushed or chewed or mixed in foods having a pH greater than 4.5. These actions can disrupt the protective enteric coating resulting in early release of enzymes, irritation of oral mucosa, and/or loss of enzyme activity [ see Dosage and Administration ( 2.2)]. For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents mixed with a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce, or administered with applesauce via a gastrostomy tube with a diameter of 14 French or larger (only for the 4,000 USP lipase unit capsule strength) [ see Dosage and Administration ( 2.2)]. If administered orally, the PERTZYE-soft food mixture should be swallowed immediately and followed with water or juice to ensure complete ingestion.

5.3 Potential for Risk of Hyperuricemia

Porcine-derived pancreatic enzyme products contain purines that may increase blood uric acid levels. Consider monitoring serum uric acid levels in patients with hyperuricemia, gout, or renal impairment.

5.4 Potential Viral Exposure from the Product Source

PERTZYE is sourced from pancreatic tissue from swine used for food consumption. Although the risk that PERTZYE will transmit an infectious agent to humans has been reduced by testing for certain viruses during manufacturing and by inactivating certain viruses during manufacturing, there is a theoretical risk for transmission of viral disease, including diseases caused by novel or unidentified viruses. Thus, the presence of porcine viruses that might infect humans cannot be definitely excluded. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.

5.5 Allergic Reactions

Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin. Rarely, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus, have been reported with other pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase). The risks and benefits of continued PERTZYE treatment in patients with severe allergy should be taken into consideration with the overall clinical needs of the patient.

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