PERTZYE

PERTZYE- pancrelipase lipase, pancrelipase amylase and pancrelipase protease capsule, delayed release
Digestive Care, Inc.

1 INDICATIONS AND USAGE

PERTZYE^® is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage

PERTZYE is not substitutable with any other pancrelipase products.

PERTZYE is administered orally or via a gastrostomy tube. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of PERTZYE should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet (see Limitations on Dosing below).

PERTZYE is a mixture of enzymes including lipases, proteases, and amylases and dosing is based on lipase units. Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences.^1,2,3 PERTZYE should be administered in a manner consistent with the recommendations of the Conferences provided in the following paragraphs. Patients may be dosed on a fat ingestion-based or actual body weight-based dosing scheme.

Infants (up to 12 months)

Infants may be given 4,000 lipase units (one capsule) per 120 mL of formula or breast-feeding. Do not mix PERTZYE capsule contents directly into formula or breast milk prior to administration [see Dosage and Administration (2.2)].

Children Older than 12 Months and Younger than 4 Years

Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Children 4 Years and Older and Adults

Enzyme dosing should begin with 500 lipase units/kg of body weight per meal for those older than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Usually, half of the prescribed PERTZYE dose for an individualized full meal should be given with each snack. The total daily dose should reflect approximately three meals plus two or three snacks per day.

Enzyme doses expressed as lipase units/kg of body weight per meal should be decreased in older patients because they weigh more but tend to ingest less fat per kilogram of body weight.

Limitations on Dosing

Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.^1,2,3

If symptoms and signs of steatorrhea persist, the dosage may be increased by a healthcare professional. Patients should be instructed not to increase the dosage on their own. There is great inter-individual variation in response to enzymes; thus, a range of doses is recommended. Changes in dosage may require an adjustment period of several days. If doses are to exceed 2,500 lipase units/kg of body weight per meal, further investigation is warranted.

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. Doses greater than 6,000 lipase units/kg of body weight per meal have been associated with colonic strictures, indicative of fibrosing colonopathy, in children with cystic fibrosis less than 12 years of age [see Warnings and Precautions (5.1)]. Patients currently 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.

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 capsule contents (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 (microspheres).
• 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 entire contents (microspheres) on the applesauce.
  4. Mix the capsule contents (microspheres) with the applesauce being careful not to crush the microspheres when mixing.
  5. Consume the entire mixture immediately. Do not chew the capsule contents (microspheres). Do not save the mixture 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 (microspheres) thoroughly with the transferred applesauce to create a uniform suspension. Once mixed, administer the suspension immediately. Care should be taken not to crush the microspheres when mixing. 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

Delayed-release capsules are available in the following strengths:

• 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”