About MYCAPSSA (octreotide) Capsules
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
- MYCAPSSA maintained normal IGF-I levels in most patients who switched from injectable SSAs2,3
- BID oral dosing leads to consistent biochemical control3
- MYCAPSSA (octreotide) was generally well tolerated in clinical trials3,4
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
- Starting dose: 40 mg (20 mg morning + 20 mg evening)3
- Dose titration was performed during the first 6 months of the study to a dose of 60 mg (40 mg morning + 20 mg evening) and up to a maximum dose of 80 mg daily (40 mg morning + 40 mg evening) based on biochemical results or symptoms3
- Patients then maintained a fixed dose until end of treatment3
Primary Endpoint3
- Proportion of patients who maintain biochemical response
- Response was defined as an average of IGF-I ≤1.0 x ULN at weeks 34 and 36
Secondary Endpoints3
- 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 x or ≥1.3 x ULN for 2 consecutive visits
- Proportion of patients who reverted to prior injectable SSA up to and including week 36
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
- TRIAL A is a double-blind, placebo-controlled study in 56 patients with acromegaly over a 9-month period2
- TRIAL B is a separate open-label, single-arm multicenter study evaluating 151 patients with acromegaly over a 7-month period4
- Gastrointestinal symptoms were the most commonly reported adverse reactions with MYCAPSSA2
- In the pivotal placebo-controlled study, gastrointestinal adverse reactions were reported in 68% of patients treated with MYCAPSSA. These adverse reactions were diarrhea, nausea, vomiting, abdominal discomfort, dyspepsia, large intestinal polyp, abdominal pain, constipation, and flatulence. The adverse reactions were mild to moderate, occurred mostly during the initial 3 months of treatment, and resolved on treatment within a median duration of 8 days2
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
- Start your patients on the 20mg BID oral dose
- Ensure they take MYCAPSSA with a glass of water
- Coach them on finding a routine for taking MYCAPSSA on an empty stomach, either 1 hour before or 2 hours after eating
Monitor their response to MYCAPSSA
- Initiate MYCAPSSA at a dosage of 40 mg daily (20 mg orally twice daily)
- Measure IGF-I levels every 2 weeks during dose titration and talk to your patients about their signs and symptoms of acromegaly
- Adjust dose up or down to attain target IGF-I levels and/or control patient’s signs and symptoms:
- If needed, titrate the MYCAPSSA dosage stepwise to 60mg (40mg in the AM and 20mg in the PM) up to a maximum dose of 80mg (40mg twice daily)
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.
