Mycapssa

Acromegaly, Flushing, Gastroenteritis + 4 more

Treatment

6 FDA approvals

17 Active Studies for Mycapssa

What is Mycapssa

Octreotide

The Generic name of this drug

Treatment Summary

Acromegaly is a rare disorder caused by too much growth hormone in the body, leading to abnormal growth of the feet, hands, and face. It also causes organ enlargement and difficulty using insulin. Octreotide is a drug that works like somatostatin, a natural hormone, to reduce growth hormone levels. It has been used to treat acromegaly and other tumors in the past, but now there is a new delayed-release oral medication called Mycapssa that has been approved by the FDA to treat this condition.

Octreotide Acetate

is the brand name

Mycapssa Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Octreotide Acetate

Octreotide

1988

89

Approved as Treatment by the FDA

Octreotide, otherwise known as Octreotide Acetate, is approved by the FDA for 6 uses such as metastatic Carcinoid Tumors and Gastroenteritis .

metastatic Carcinoid Tumors

Gastroenteritis

Diarrhea

Carcinoid Tumor

Acromegaly

Helps manage Acromegaly

Flushing

Effectiveness

How Mycapssa Affects Patients

Octreotide works like the hormone somatostatin and helps reduce growth hormones and the effects of too much insulin in the body. It also helps with flushing and diarrhea caused by tumors by reducing blood flow in the digestive system and decreasing hormones that lead to diarrhea. Taking octreotide may reduce gallbladder contractility, bile secretion, and the release of TSH, so it is important to monitor vitamin B12 levels in patients taking octreotide.

How Mycapssa works in the body

Octreotide binds to receptors in the blood vessels and causes them to constrict. This reduces the production of growth hormone, which is used to treat conditions caused by too much growth hormone. Octreotide also helps to reduce symptoms of tumors like carcinoid by reducing luteinizing hormone, splanchnic blood flow, and a range of hormones associated with digestion.

When to interrupt dosage

The suggested dosage of Mycapssa is contingent upon the diagnosed condition, including Acromegaly, Vasoactive Intestinal Peptide Tumors and metastatic Carcinoid Tumors. The measure of dosage shifts as indicated by the administration technique (e.g. Injection - Intravenous; Subcutaneous or Capsule, delayed release) featured in the table beneath.

Condition

Dosage

Administration

Flushing

, 1.0 mg/mL, 0.2 mg/mL, 0.05 mg/mL, 0.1 mg/mL, 0.5 mg/mL, 10.0 mg, 20.0 mg, 30.0 mg, 3.33 mg/mL, 5.0 mg/mL, 1.667 mg/mL, 2.5 mg/mL

Injection, solution, Intravenous; Subcutaneous, Injection, solution - Intravenous; Subcutaneous, , Injection, Injection - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Intramuscular, Kit, Injection - Intravenous, Intravenous, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Injection - Subcutaneous, Subcutaneous, Capsule, delayed release, Oral, Capsule, delayed release - Oral, Injection, powder, for suspension, extended release; Kit - Intramuscular, Injection, powder, for suspension, extended release; Kit, Kit - Intramuscular

Carcinoid Tumor

, 1.0 mg/mL, 0.2 mg/mL, 0.05 mg/mL, 0.1 mg/mL, 0.5 mg/mL, 10.0 mg, 20.0 mg, 30.0 mg, 3.33 mg/mL, 5.0 mg/mL, 1.667 mg/mL, 2.5 mg/mL

Injection, solution, Intravenous; Subcutaneous, Injection, solution - Intravenous; Subcutaneous, , Injection, Injection - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Intramuscular, Kit, Injection - Intravenous, Intravenous, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Injection - Subcutaneous, Subcutaneous, Capsule, delayed release, Oral, Capsule, delayed release - Oral, Injection, powder, for suspension, extended release; Kit - Intramuscular, Injection, powder, for suspension, extended release; Kit, Kit - Intramuscular

octreotide

, 1.0 mg/mL, 0.2 mg/mL, 0.05 mg/mL, 0.1 mg/mL, 0.5 mg/mL, 10.0 mg, 20.0 mg, 30.0 mg, 3.33 mg/mL, 5.0 mg/mL, 1.667 mg/mL, 2.5 mg/mL

Injection, solution, Intravenous; Subcutaneous, Injection, solution - Intravenous; Subcutaneous, , Injection, Injection - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Intramuscular, Kit, Injection - Intravenous, Intravenous, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Injection - Subcutaneous, Subcutaneous, Capsule, delayed release, Oral, Capsule, delayed release - Oral, Injection, powder, for suspension, extended release; Kit - Intramuscular, Injection, powder, for suspension, extended release; Kit, Kit - Intramuscular

Acromegaly

, 1.0 mg/mL, 0.2 mg/mL, 0.05 mg/mL, 0.1 mg/mL, 0.5 mg/mL, 10.0 mg, 20.0 mg, 30.0 mg, 3.33 mg/mL, 5.0 mg/mL, 1.667 mg/mL, 2.5 mg/mL

Injection, solution, Intravenous; Subcutaneous, Injection, solution - Intravenous; Subcutaneous, , Injection, Injection - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Intramuscular, Kit, Injection - Intravenous, Intravenous, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Injection - Subcutaneous, Subcutaneous, Capsule, delayed release, Oral, Capsule, delayed release - Oral, Injection, powder, for suspension, extended release; Kit - Intramuscular, Injection, powder, for suspension, extended release; Kit, Kit - Intramuscular

Gastroenteritis

, 1.0 mg/mL, 0.2 mg/mL, 0.05 mg/mL, 0.1 mg/mL, 0.5 mg/mL, 10.0 mg, 20.0 mg, 30.0 mg, 3.33 mg/mL, 5.0 mg/mL, 1.667 mg/mL, 2.5 mg/mL

Injection, solution, Intravenous; Subcutaneous, Injection, solution - Intravenous; Subcutaneous, , Injection, Injection - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Intramuscular, Kit, Injection - Intravenous, Intravenous, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Injection - Subcutaneous, Subcutaneous, Capsule, delayed release, Oral, Capsule, delayed release - Oral, Injection, powder, for suspension, extended release; Kit - Intramuscular, Injection, powder, for suspension, extended release; Kit, Kit - Intramuscular

Vasoactive Intestinal Peptide Tumors

, 1.0 mg/mL, 0.2 mg/mL, 0.05 mg/mL, 0.1 mg/mL, 0.5 mg/mL, 10.0 mg, 20.0 mg, 30.0 mg, 3.33 mg/mL, 5.0 mg/mL, 1.667 mg/mL, 2.5 mg/mL

Injection, solution, Intravenous; Subcutaneous, Injection, solution - Intravenous; Subcutaneous, , Injection, Injection - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Intramuscular, Kit, Injection - Intravenous, Intravenous, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Injection - Subcutaneous, Subcutaneous, Capsule, delayed release, Oral, Capsule, delayed release - Oral, Injection, powder, for suspension, extended release; Kit - Intramuscular, Injection, powder, for suspension, extended release; Kit, Kit - Intramuscular

long-term maintenance therapy

, 1.0 mg/mL, 0.2 mg/mL, 0.05 mg/mL, 0.1 mg/mL, 0.5 mg/mL, 10.0 mg, 20.0 mg, 30.0 mg, 3.33 mg/mL, 5.0 mg/mL, 1.667 mg/mL, 2.5 mg/mL

Injection, solution, Intravenous; Subcutaneous, Injection, solution - Intravenous; Subcutaneous, , Injection, Injection - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Intramuscular, Kit, Injection - Intravenous, Intravenous, Injection, powder, for suspension, extended release, Injection, powder, for suspension, extended release - Intramuscular, Injection - Subcutaneous, Subcutaneous, Capsule, delayed release, Oral, Capsule, delayed release - Oral, Injection, powder, for suspension, extended release; Kit - Intramuscular, Injection, powder, for suspension, extended release; Kit, Kit - Intramuscular

Warnings

Mycapssa Contraindications

Condition

Risk Level

Notes

known hypersensitivity to the drug or any of the ingredients

Do Not Combine

There are 20 known major drug interactions with Mycapssa.

Common Mycapssa Drug Interactions

Drug Name

Risk Level

Description

Dotatate gallium Ga-68

Major

Octreotide may decrease effectiveness of Dotatate gallium Ga-68 as a diagnostic agent.

Eliglustat

Major

The metabolism of Eliglustat can be decreased when combined with Octreotide.

Fentanyl

Major

The metabolism of Fentanyl can be decreased when combined with Octreotide.

Hydroxyzine

Major

The risk or severity of QTc prolongation can be increased when Octreotide is combined with Hydroxyzine.

Lutetium Lu 177 dotatate

Major

The therapeutic efficacy of Lutetium Lu 177 dotatate can be decreased when used in combination with Octreotide.

Mycapssa Toxicity & Overdose Risk

There have been a few cases of octreotide overdose, which may cause low blood pressure, lack of oxygen to the brain, abnormal heart rhythm, heart stoppage, excess lactic acid in the body, inflammation of the pancreas, enlarged liver, diarrhea, redness in the face, fatigue, and weakness.

Mycapssa Novel Uses: Which Conditions Have a Clinical Trial Featuring Mycapssa?

41 active clinical trials are currently examining the potential of Mycapssa to provide metastatic Carcinoid Tumor, long-term maintenance therapy, and Flushing relief.

Condition

Clinical Trials

Trial Phases

Acromegaly

6 Actively Recruiting

Phase 2, Phase 3, Phase 1

Flushing

0 Actively Recruiting

Gastroenteritis

12 Actively Recruiting

Phase 1, Phase 2, Not Applicable, Early Phase 1

Vasoactive Intestinal Peptide Tumors

0 Actively Recruiting

Carcinoid Tumor

1 Actively Recruiting

Early Phase 1

long-term maintenance therapy

0 Actively Recruiting

octreotide

0 Actively Recruiting

Patient Q&A Section about mycapssa

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an oral form of octreotide?

"Octreotide is a drug that is available as an injection, and the new capsule formulation is taken orally."

Answered by AI

What is Mycapssa used for?

"Mycapssa (octreotide) is a oral medication used to treat acromegaly. It is a convenient option for those who have responded well to lanreotide or other forms of octreotide in the past."

Answered by AI

Clinical Trials for Mycapssa

Image of Stanford Digestive Health Clinic in Redwood City, United States.

MITI-001 for Irritable Bowel Syndrome

18 - 65
All Sexes
Redwood City, CA

While the pathophysiology of diarrhea-predominant irritable bowel syndrome (IBS-D) is complex and heterogeneous, dysbiosis of the gut microbiome is frequently observed, suggesting that a substantial subset of patients with irritable bowel syndrome (IBS) have symptoms that are initiated and/or perpetuated by a microbiome dysfunction. Successful randomized controlled trials (RCT) for IBS-D (Ford 2018; Black 2022) leveraging microbiome-targeted therapies (antibiotics or low microbiome fermentation diets) suggest the gut microbiome is at least partially involved in IBS symptoms. Furthermore, fecal microbiota transplantation (FMT) for patients with IBS-D has demonstrated promising results (El-Salhy 2020), supporting the possibility that altering the microbiome composition could ameliorate IBS-D symptoms. MITI-001 is a transplantable gut bacterial community composed of 157 live bacterial strains, encompassing 79 genera of commensal bacteria, that have been isolated from healthy donor stool, purified, and banked. The hypothesis of the proposed research is that MITI-001 can target the pathophysiologic lesion in a subset of IBS-D patients, restore the altered microbial metabolic process, and thus alleviate IBS-D symptoms.

Phase < 1
Waitlist Available

Stanford Digestive Health Clinic (+1 Sites)

Sean P Spencer, MD, PhD

Have you considered Mycapssa clinical trials?

We made a collection of clinical trials featuring Mycapssa, we think they might fit your search criteria.
Go to Trials

Have you considered Mycapssa clinical trials?

We made a collection of clinical trials featuring Mycapssa, we think they might fit your search criteria.
Go to Trials

Have you considered Mycapssa clinical trials?

We made a collection of clinical trials featuring Mycapssa, we think they might fit your search criteria.
Go to Trials