MYCAPSSA- octreotide capsule, delayed release
MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
- 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.
- 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.
- 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.
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)].
2.5 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)].
Delayed-release capsules: 20 mg. White hard gelatin capsules imprinted with “OT” on one half of the capsule and “20” on the other half. Each capsule contains 20 mg octreotide, provided as octreotide acetate.
Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide [see Adverse Reactions (6.3)].
MYCAPSSA may inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder abnormalities or sludge. Gallbladder-related adverse reactions have been reported in clinical trials in patients receiving MYCAPSSA. There have been postmarketing reports of cholelithiasis (gallstones) in patients taking somatostatin analogs resulting in complications, including cholecystitis, cholangitis, pancreatitis and requiring cholecystectomy [see Adverse Reactions (6)]. Monitor patients periodically. If complications of cholelithiasis are suspected, discontinue MYCAPSSA and treat appropriately.
MYCAPSSA alters the balance between the counter-regulatory hormones, insulin, glucagon, and growth hormone, which may result in hypoglycemia, or hyperglycemia, or diabetes mellitus. In clinical trials with MYCAPSSA, the following adverse reactions were reported: increased blood glucose (7%), hypoglycemia (4%), and diabetes mellitus (1%) [see Adverse Reactions (6.1)]. Blood glucose levels should be monitored when MYCAPSSA treatment is initiated, or when the dose is altered. Adjust antidiabetic treatment accordingly.
MYCAPSSA suppresses the secretion of thyroid-stimulating hormone, which may result in hypothyroidism. In clinical trials with MYCAPSSA, the following adverse reactions were reported: hypothyroidism (1%), increased TSH (1%), or decreased free T4 (1%) [see Adverse Reactions (6.1)]. Assess thyroid function periodically during treatment with MYCAPSSA.
Cardiac conduction abnormalities and other ECG changes including QT prolongation, axis shifts, early repolarization, low voltage, R/S transition, and early R wave progression, have occurred during treatment with octreotide. In MYCAPSSA clinical trials the following adverse reactions were reported: bradycardia (2%), conduction abnormalities (1%), and arrhythmias/tachycardia (2%) [see Adverse Reactions (6)]. These ECG changes may occur in patients with acromegaly. Dosage adjustments of concomitantly used drugs that have bradycardia effects (i.e. beta-blockers) may be necessary [see Drug Interactions (7.2)].
MYCAPSSA may alter absorption of dietary fats in some patients. Decreased vitamin B12 levels and abnormal Schilling’s tests have been observed in some patients receiving octreotide. Monitor vitamin B12 levels during treatment with MYCAPSSA.
The following important adverse reactions are described below and elsewhere in the labeling:
- Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.1)]
- Hyperglycemia and Hypoglycemia [see Warnings and Precautions (5.2)]
- Thyroid Function Abnormalities [see Warnings and Precautions (5.3)]
- Cardiac Function Abnormalities [see Warnings and Precautions (5.4)]
- Decreased Vitamin B12 Levels and Abnormal Schilling’s Tests [see Warnings and Precautions (5.5)]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
MYCAPSSA has been evaluated in patients with acromegaly in a placebo-controlled study [see Clinical Studies (14)] and an open-label baseline-controlled study. The data reflect exposure of 183 patients to MYCAPSSA for a mean duration of 29 weeks. In the overall study population, 56% were female and the average age of patients was 54.3 years. Adverse reactions occurring ≥ 5% and greater than placebo for the placebo-controlled study are presented in Table 1 and adverse reactions occurring ≥ 5% in the open-label study are presented in Table 2.
|MYCAPSSA % (N=28)||PLACEBO % (N=28)|
|Blood glucose increased *||14||7|
|Urinary tract infection||7||4|
|Large intestine polyp||7||0|
|MYCAPSSA % (N=155)|
|Abdominal pain upper||8|
|Blood glucose increased *||6|
|Upper respiratory tract infection||5|
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