ULTRESA dosage strengths and dosing guidelines

High-dosage strength capsules may allow patients to take fewer capsules to achieve prescribed dose per meal

  • ULTRESA is available in 3 delayed-release capsule strengths containing enteric-coated minitablets1:

Dosage and administration1

  • Therapy should be initiated at the lowest recommended dose and gradually increased
  • The dosage of ULTRESA should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet as described in the Limitations on Dosing section below
  • Dosage

    Limitations on Dosing

  • Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines
  • 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
  • Use of ULTRESA in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended
  • Children Older Than 12 Months and Younger Than 4 Years and Weight 14 kg or Greater

  • Children older than 12 months and younger than 4 years, weighing under 14 kg should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children
  • Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg of body weight per meal (or ≤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 Weight 28 kg or Greater and Adults

  • Children 4 years and older, weighing under 28 kg should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children
  • Enzyme dosing should begin with 500 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg of body weight per meal (or ≤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 ULTRESA dose for an individualized full meal should be given with each snack. The total daily dosage should reflect approximately three meals plus two or three snacks per day
  • Administration

    Children and Adults

  • ULTRESA should be taken during meals or snacks, with sufficient fluid. ULTRESA capsules should be swallowed whole. ULTRESA capsules and capsule contents should not be crushed or chewed
  • For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents sprinkled on a small amount of applesauce, yogurt and other acidic soft food with a pH of 4.5 or less at room temperature. The ULTRESA-soft food mixture should be swallowed immediately without crushing or chewing and followed with water or juice to ensure complete ingestion. Care should be taken to ensure that no drug is retained in the mouth to avoid mucosal irritation
  • Any unused portion of capsule contents should be discarded, and not used for subsequent dosing. The remaining exposed contents may lose potency and become less effective