Brand Name
Mycapssa
Generic Name
Octreotide
View Brand Information FDA approval date: July 06, 2020
Classification: Somatostatin Analog
Form: Capsule
What is Mycapssa (Octreotide)?
MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide .
Approved To Treat
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Brand Information
Mycapssa (Octreotide)
1INDICATIONS AND USAGE
MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
2DOSAGE FORMS AND STRENGTHS
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.
3CONTRAINDICATIONS
Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide
4ADVERSE REACTIONS
The following important adverse reactions are described below and elsewhere in the labeling:
- Cholelithiasis and Complications of Cholelithiasis
- Hyperglycemia and Hypoglycemia
- Thyroid Function Abnormalities
- Cardiac Function Abnormalities
- Steatorrhea and Malabsorption of Dieatary Fats
- Changes in Vitamin B
4.1Clinical Studies Experience
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
4.2Immunogenicity
As with all therapeutic peptides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other octreotide acetate products may be misleading.
No antibodies to the octreotide peptide from MYCAPSSA were detected in 149 patients assessed in the open label study throughout 13 months of treatment.
4.3Postmarketing Experience
The following adverse reactions have been identified during the post-approval use of octreotide acetate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Blood and lymphatic: pancytopenia, thrombocytopenia
- Cardiac: myocardial infarction, cardiac arrest, atrial fibrillation
- Ear and labyrinth: deafness
- Endocrine: diabetes insipidus, adrenal insufficiency in patients 18 months of age and under, pituitary apoplexy
- Eye: glaucoma, visual field defect, scotoma, retinal vein thrombosis
- Gastrointestinal: intestinal obstruction, peptic/gastric ulcer, abdomen enlarged
- General and administration site: generalized edema, facial edema
- Hepatobiliary: gallbladder polyp, fatty liver, hepatitis
- Immune: anaphylactoid reactions including anaphylactic shock
- Infections and infestations: appendicitis
- Laboratory abnormalities: increased liver enzymes, CK increased, creatinine increased
- Metabolism and nutrition: diabetes mellitus
- Musculoskeletal: arthritis, joint effusion, Raynaud's syndrome
- Nervous System: convulsions, aneurysm, intracranial hemorrhage, hemiparesis, paresis, suicide attempt, paranoia, migraines, Bell's palsy, aphasia
- Renal and urinary: renal failure, renal insufficiency
- Reproductive and breast: gynecomastia, galactorrhea, libido decrease, breast carcinoma
- Respiratory: status asthmaticus, pulmonary hypertension, pulmonary nodule, pneumothorax aggravated
- Skin and subcutaneous tissue: urticaria, cellulitis, petechiae
- Vascular: orthostatic hypotension, hematuria, gastrointestinal hemorrhage, arterial thrombosis of the arm
5OVERDOSAGE
A limited number of accidental overdoses of injectable octreotide acetate in adults has been reported. The doses ranged from 2.4 mg/day to 6 mg/day administered by continuous infusion or subcutaneously 1.5 mg three times a day. Adverse reactions in some patients included arrhythmia, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatic steatosis, hepatomegaly, lactic acidosis, flushing, diarrhea, lethargy, weakness, and weight loss.
If overdose occurs, contact Poison Control (1-800-222-1222) for latest recommendations.
6DESCRIPTION
MYCAPSSA delayed release capsules contain octreotide acetate, a somatostatin analog. Octreotide is known chemically as L-cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)].
The molecular weight of octreotide is 1019.3 (free peptide, C
MYCAPSSA (octreotide) delayed-release capsules are enteric-coated capsules for oral use. Each capsule contains 20 mg of octreotide (provided as octreotide acetate). Octreotide is present as a salt with 1.4 to 2.5 molar equivalents of acetate. The capsules contain the following inactive ingredients: polyvinylpyrrolidone (PVP-12), sodium caprylate, magnesium chloride, polysorbate 80, glyceryl monocaprylate, glyceryl tricaprylate, gelatin, gelatin capsules, and Acryl-EZE
7CLINICAL STUDIES
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.
8HOW SUPPLIED/STORAGE AND HANDLING
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:
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
10INSTRUCTIONS FOR USE MYCAPSSA® [my (as in sky)-cap-sah] (octreotide) delayed-release capsules, for oral use
Read this Instructions for Use before you start taking MYCAPSSA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk to your healthcare provider or pharmacist if you have any questions about how to use MYCAPSSA.
Important information:
- Each MYCAPSSA wallet contains twenty-eight 20-mg capsules. The number of wallets required in a 28-day period depends on your prescribed dose.
How to Use the MYCAPSSA Wallet
- Each MYCAPSSA wallet has a locking mechanism that helps to keep the medicine away from children.
- Become familiar with using the MYCAPSSA wallet so you will know how to use it the right way.
To open the wallet:
Step 1. With your left thumb, gently press the tip of the release button on the left side of the wallet (see Figure A).
Step 2. While holding the release button, grasp the medicine card at the notch on the right side and pull it out (see Figure A).
Step 3. Unfold the medicine card (see Figure A).
Figure A: How to Open the MYCAPSSA Wallet
How to Remove a Capsule from the MYCAPSSA Wallet
Capsules need to be removed carefully, because if they are cracked or broken they may not be as effective. Follow these instructions to easily remove capsules without damaging them.
- Place the tip of a thumb at the edge of a capsule's plastic cavity (see
- Gently push the capsule until it is removed. Collect the removed capsule in your hand.
- Do not use two thumbs to push a capsule as this could damage it.
- Do not press the middle of a capsule. This could also damage it.
- If a capsule is cracked or broken, throw it away (discard it) and remove another capsule.
Figure B: How to Remove a Capsule from the Medicine Card Inside the MYCAPSSA Wallet
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
11PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack
Always take with a glass of water on an empty stomach at least
Mycapssa
20 mg*
2
28 Capsules
*Each capsule contains octreotide 20 mg (provided as octreotide acetate).
12PRINCIPAL DISPLAY PANEL - 20 mg Blister Pack Dose Pack
NDC 10122-550-28
Mycapssa
20 mg*
Rx only
*Each capsule contains octreotide 20 mg (provided
1
PULL OUT HERE
❶
❷
OPENING AND CLOSING INSTRUCTIONS
- Use left thumb to push the button gently
- While holding the button down, pull out the medication card
- Press out to take capsule(s)
- Slide medication card back to lock
28 capsules
Always take with a glass of water on an empty stomach at least
