Studies in laboratory animals have demonstrated no mutagenic potential of octreotide acetate.
No carcinogenicity studies have been conducted with MYCAPSSA. No carcinogenic potential was demonstrated in mice treated subcutaneously with octreotide acetate for 85–99 weeks at doses up to 2000 mcg/kg/day (8 times the clinical dose based on octreotide injection body surface area). In a 116-week subcutaneous study in rats administered octreotide acetate, a 27% and 12% incidence of injection-site sarcomas or squamous cell carcinomas was observed in males and females, respectively, at the highest dose level of 1250 mcg/kg/day (10 times the clinical dose based on octreotide injection body surface area) compared to an incidence of 8% to 10% in the vehicle-control groups. The increased incidence of injection-site tumors was most probably caused by irritation and the high sensitivity of the rat to repeated subcutaneous injections at the same site. There was also a 15% incidence of uterine adenocarcinomas in the 1250 mcg/kg/day females compared to 7% in the saline-control females and 0% in the vehicle-control females. The presence of endometritis coupled with the absence of corpora lutea, the reduction in mammary fibroadenomas, and the presence of uterine dilatation suggest that the uterine tumors were associated with estrogen dominance in the aged female rats, which does not occur in humans.
No fertility studies in animals have been conducted with MYCAPSSA. Injectable octreotide acetate did not impair fertility in rats at doses up to 1000 mcg/kg/day, which represents 7 times the clinical dose based on octreotide injection body surface area.
The efficacy of MYCAPSSA was established in a 9 month, randomized, double-blind, placebo-controlled study (NCT03252353) that enrolled 56 patients with acromegaly.
In the overall study population, 54% were female and the average age of patients was 55 years. 91% of patients were Caucasian, 5% Asian, 2% Black, and 2% Other. The percentage of patients with previous pituitary surgery was 88%. The baseline IGF-1 levels (the average of 2 assessments measured within 2 weeks of randomization) was 0.80 times ULN (range: 0.5–1.1 times ULN) in the patients treated with MYCAPSSA and 0.84 times ULN (range: 0.3–1.1 times ULN) in patients treated with the placebo.
In this study, patients initiated MYCAPSSA treatment twice daily 1 month after their last injection of somatostatin analogs. The starting dose was 40 mg (20 mg in the morning and 20 mg in the evening). Dose increase was allowed during dose titration to 60 mg (40 mg in the morning and 20 mg in the evening) and to a maximal dose of 80 mg daily (40 mg in the morning and 40 mg in the evening) until patients were deemed adequately controlled based on biochemical results and/or clinical judgement. Patients then maintained their target dose until end of treatment.
The primary efficacy endpoint was somatostatin dose-adjusted proportion of patients who maintain their biochemical response, defined as an IGF-1 levels less than or equal to the ULN at the end of 9 months of treatment. 58% of patients treated with MYCAPSSA vs. 19% of patients treated with placebo maintained their biochemical response.
25% of patients treated with MYCAPSSA required discontinuation of MYCAPSSA and treatment with other somatostatin analogs at some point during the 9-month study. Criteria for somatostatin analog rescue were IGF-1 levels ≥ 1.3 times ULN and exacerbation of acromegaly signs and symptoms on two consecutive assessments while treated for at least 2 weeks with 80 mg/day or other reasons such as adverse reactions or patient’s decision.
MYCAPSSA delayed-release 20 mg capsules are white hard gelatin capsules imprinted with “OT” on one half of the capsule and “20” on the other half.
The capsules are supplied as:
|NDC Number||Package Size|
|69880-120-28||Wallet of 28 capsules|
Until first use, store unopened wallets of MYCAPSSA refrigerated at 2° to 8°C (36° to 46°F). Do not freeze.
After first use, opened wallets may be stored at 20° to 25°C (68° to 77°F) for up to 1 month.
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Cholelithiasis and Complications of Cholelithiasis
Advise patients to contact their healthcare provider if they experience signs or symptoms of gallstones (cholelithiasis) or complications of cholelithiasis (e.g., cholecystitis, cholangitis and pancreatitis) [see Warnings and Precautions (5.1)].
Hypoglycemia and Hyperglycemia
Advise patients to contact their healthcare provider if they have problems with blood sugar levels, either hyperglycemia or hypoglycemia [see Warnings and Precautions (5.2)].
Thyroid Function Abnormalities
Inform patients that their thyroid function will be assessed periodically during treatment [see Warnings and Precautions (5.3)].
Cardiac Function Abnormalities
Inform patients to contact the health care provider in case they notice irregular heartbeat [see Warnings and Precautions (5.4)].
Decreased Vitamin B12 Levels and Abnormal Schilling’s Tests
Inform patients that Vitamin B12 levels may be monitored during the treatment [see Warnings and Precautions (5.5)].
Females and Males of Reproductive Potential
Inform female patients that treatment with MYCAPSSA may result in unintended pregnancy [see Use in Specific Populations (8.3)].
Manufactured by MW Encap Ltd., Scotland, UK.
©2022 Amryt Pharmaceuticals, Inc. Mycapssa is a registered trademark of the Amryt Pharma Group. All rights reserved
|Patient Information MYCAPSSA® [my (as in sky)-cap-sah] (octreotide) delayed-release capsules, for oral use|
|This Patient Information has been approved by the U.S. Food and Drug Administration.||Approved: 06/2020|
|What is MYCAPSSA?|
|Do not take MYCAPSSA if you:|
| || |
|See the end of this leaflet for a complete list of ingredients in MYCAPSSA.|
|Before you take MYCAPSSA, tell your healthcare provider about all of your medical conditions, including if you:|
|Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.|
|MYCAPSSA may affect the way other medicines work, and other medicines may affect how MYCAPSSA works.|
|Especially tell your healthcare provider if you take oral contraceptives. Use an alternative non-hormonal method of contraception or a back-up method while taking MYCAPSSA.|
|Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.|
|How should I take MYCAPSSA?|
|Swallow the capsules whole. Do not crush or chew the capsules before swallowing.|
|What are the possible side effects of MYCAPSSA?|
|The most common side effects of MYCAPSSA include:|
| || |
|These are not all the possible side effects of MYCAPSSA. For more information, ask your healthcare provider or pharmacist.|
|Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
|How should I store MYCAPSSA?|
|Keep MYCAPSSA and all medicines out of the reach of children.|
|General information about the safe and effective use of MYCAPSSA.|
|Medicines are sometimes prescribed for purposes other than those listed in a Patient Information. Do not use MYCAPSSA for a condition for which it was not prescribed. Do not give MYCAPSSA to other people, even if they have the same symptoms you have. It may harm them.|
|You can ask your pharmacist or healthcare provider for information about MYCAPSSA that is written for health professionals.|
|What are the ingredients in MYCAPSSA?|
|Active ingredient: octreotide acetate|
|Inactive ingredients: polyvinylpyrrolidone (PVP-12), sodium caprylate, magnesium chloride, polysorbate 80, glyceryl monocaprylate, glyceryl tricaprylate, gelatin, gelatin capsules, and Acryl-EZE® (methacrylate).|
|Amryt Pharmaceuticals DAC.Dublin, Ireland|
|For more information about MYCAPSSA call the medical information department at 1-855-303-2347 or firstname.lastname@example.org or go to www.MYCAPSSA.com and select patient information.|
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.