Important Administration Instructions

• Take MYCAPSSA orally with a glass of water on an empty stomach, at least 1 hour before a meal or at least 2 hours after a meal.
• Swallow MYCAPSSA capsules whole. Do not crush or chew the capsules.

Recommended Dosage, Titration, and Monitoring

• Initiate MYCAPSSA at a dosage of 40 mg daily, administered as 20 mg orally twice daily.
• Monitor insulin-like growth factor 1 (IGF-1) levels and patient's signs and symptoms every two weeks during the dose titration or as indicated.
• Titrate the MYCAPSSA dosage based on IGF-1 levels and patient's signs and symptoms. Increase the dosage in increments of 20 mg daily.
• For MYCAPSSA dosages of 60 mg daily, administer as 40 mg in the morning and 20 mg in the evening.
• For MYCAPSSA dosages of 80 mg daily, administer as 40 mg twice daily.
• The maximum recommended dosage of MYCAPSSA is 80 mg daily.
• Once the maintenance dosage of MYCAPSSA is achieved, monitor IGF-1 levels and patient's signs and symptoms monthly or as indicated.

Dosage Interruptions and Modifications

• If IGF-1 levels remain above the upper normal limit after treatment with the maximum recommended dosage of 80 mg daily or the patient cannot tolerate treatment with MYCAPSSA, consider discontinuing MYCAPSSA and switching patient to another somatostatin analog.
• Withdraw MYCAPSSA therapy periodically to assess disease activity. If IGF-1 levels increase and signs and symptoms recur, resume MYCAPSSA therapy.

Recommended Dosage in Patients with End Stage Renal Disease

For patients with end-stage renal disease, initiate MYCAPSSA at a dosage of 20 mg orally once daily. Titrate and adjust the maintenance dosage of MYCAPSSA based on IGF-1 levels, patient's signs and symptoms and tolerability [see Dosage and Administration (‎2.2, ‎2.3), Use in Specific Populations (‎8.6)].

Dosage Modifications with Concomitant Use of Proton Pump Inhibitors, H2-receptor Antagonists, or Antacids

Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA [see Drug Interactions (‎7.1)].