MYCAPSSA is the first and only FDA-approved oral somatostatin analog (SSA) for appropriate patients with acromegaly, providing effective and consistent biochemical control while freeing patients from the burden of injections.1-3
Download the MYCAPSSA Brochure for more information or continue reading below.
MYCAPSSA IS POWERED BY TRANSIENT PERMEABILITY ENHANCER (TPE®) TECHNOLOGY4
Peptides and large molecule drugs are generally administered via injection because these agents can be degraded by digestive enzymes and/or blocked from crossing the intestinal epithelium via transcellular or paracellular routes resulting in low bioavailability and sub-therapeutic levels in the blood.7
THE SAFETY AND EFFICACY OF MYCAPSSA WAS EVALUATED IN A PIVOTAL PHASE 3 CLINICAL TRIAL3
The safety and efficacy of MYCAPSSA was studied in a 9-month, randomized, double-blind, placebo-controlled study in 56 patients with acromegaly and IGF-I ≤1.0 x upper limit of normal (ULN) at screening3
Primary Endpoint3
Secondary Endpoints3
THE PHASE 3 CLINICAL TRIAL MET KEY ENDPOINTS INCLUDING PRIMARY AND SECONDARY3
PRIMARY ENDPOINT
58% of patients receiving MYCAPSSA vs 19% of patients receiving placebo met criteria for maintaining IGF-I response defined as an average of week 34 and 36 IGF-I ≤1.0 x ULN (p=0.0079)2
DESCRIPTIVE ENDPOINT
The mean IGF-I level was maintained within normal range in the group receiving MYCAPSSA at the end of oral treatment3
TESTED IN 183 PATIENTS IN TWO PHASE 3 STUDIES, MYCAPSSA (OCTREOTIDE) WAS GENERALLY WELL TOLERATED2
More than 100 patients from TRIALS A and B have received MYCAPSSA for ≥1 year8
Summary of Most Common (≥5% and >placebo) AEs in TRIAL A by Preferred Term2
SUCCESSFULLY TRANSITIONING PATIENTS TO MYCAPSSA2
Start your patients on MYCAPSSA and titrate for optimal therapeutic benefit:
Work with your patient to identify the day to transition their treatment
Consider the originally planned timing of their next injection to help ease the patient into a new treatment routine and provide a smooth transition onto MYCAPSSA
Educate your patients on how to take MYCAPSSA properly and encourage adherence
Monitor their response to MYCAPSSA
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.
IMPORTANT SAFETY INFORMATION
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 to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.
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.
IMPORTANT SAFETY INFORMATION
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 to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.
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. Colao A, et al. Nat Rev Dis Primers 2019;5(1):20. 2. MYCAPSSA. Prescribing information. Chiasma, Inc.;2020. 3. Samson SL, et al. J Clin Endocrinol Metab. 2020;105(10):dgaa526. 4. Melmed S, et al. J Clin Endocrinol Metab. 2015;100(4):1699-1708. 5. Geer EB, et al. Pituitary. 2020. https://doi.org/10.1007/s11102-019-01013-2 6. Strasburger CJ, et al. Eur J Endocrinol. 2016;174(3):355-362. 7. Karsdal MA, et al. Br J Clin Pharmacol. 2015;79(5):720-732. 8. Data on file. Chiasma, Inc.