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 mini tablets1

Adverse reactions occurring in at least 2 patients (≥7%) treated with ULTRESA1

Dosage and administration1

Dosage

  • 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
  • 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 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 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 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 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 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