*IGF-I response was defined as an average of weeks 34 and 36 IGF-I ≤1.0 x upper limit of normal (ULN) (P=0.0079)1,2
The Pivotal Phase 3 Trial was a 9-month, randomized, double-blind, placebo-controlled study in 56 patients with acromegaly and IGF-I ≤ 1 x upper limit of normal (ULN) at screening.
Starting dose: 40 mg (20 mg AM + 20 mg PM)
Dose titration was performed during the first 6 months of the study to a dose of 60 mg (40 mg AM + 20 mg PM) and up to a maximum dose of 80 mg daily (40 mg AM + 40 mg PM) based on biochemical results or symptoms.
Patients then maintained a fixed dose until end of treatment.
Proportion of patients who maintained biochemical response. Response was defined as an average IGF-I≤1.0 x upper limit of normal (ULN) based on average of weeks 34 and 36.
Proportion of patients who maintained GH response at week 36 (average GH <2.5 ng/mL).
Time to loss of IGF-I response defined as either IGF-I >1.0 or ≥ 1.3 x ULN for 2 consecutive visits.
Proportion of patients who reverted to prior iSSA up to and including week 36 measurements.
aIncludes blood glucose increased, hyperglycemia, and glycosylated hemoglobin increased.
GI AEs were reported in up to 68% of MYCAPSSA patients.1
AEs occurred mostly during the initial 3 months of treatment and resolved on treatment within a median duration of less than 2 weeks after onset.1
AEs, adverse events; GI, gastrointestinal.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE
MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
CONTRAINDICATIONS
Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.
WARNINGS AND PRECAUTIONS
MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.
Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.
Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.
ADVERSE REACTIONS
The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.
DRUG INTERACTIONS
The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women taking an oral contraceptive to use an alternative non-hormonal method of contraception or a back-up method when taking MYCAPSSA.
Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.
PREGNANCY
Advise premenopausal females of the potential for an unintended pregnancy.
To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE
MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
CONTRAINDICATIONS
Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.
WARNINGS AND PRECAUTIONS
MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.
Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.
Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.
ADVERSE REACTIONS
The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.
DRUG INTERACTIONS
The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women taking an oral contraceptive to use an alternative non-hormonal method of contraception or a back-up method when taking MYCAPSSA.
Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.
PREGNANCY
Advise premenopausal females of the potential for an unintended pregnancy.
To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
REFERENCES
1. MYCAPSSA [package insert]. Amryt Pharmaceuticals;2022. 2. Samson SL, et al. J Clin Endocrinol Metab. 2020;105(10):dgaa526. 3. Samson SL, et al. J Endocr Soc.. 2021;5(suppl 1):A515-516.