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MYCAPSSA Is Powered by Octreotide

MYCAPSSA is an oral SSA, a subclass of SRL therapies.

SSAs represent a standard-of-care therapy within the SRL class, with decades of clinical experience in acromegaly management.1-3
As an analog, MYCAPSSA (octreotide) mimics the effect of naturally occurring somatostatin, decreasing the production of growth hormone (GH).2,3
  • MYCAPSSA uses TPE® technology, which enables oral delivery of octreotide. An enteric coating prevents capsules from degrading in the stomach.4
  • TPE induces the expansion of tight junctions between intestinal epithelial cells in the small intestine to help promote absorption of octreotide.4
  • The MYCAPSSA fasting requirements allow for better absorption of octreotide.5
Suitable for patients who have demonstrated biochemical response to and tolerated octreotide or lanreotide.5
SRL, somatostatin receptor ligand; SSA, somatostatin analog; TPE, Transient Permeability Enhancer.

Watch the video below to see how it works.

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Important Safety Information

Contraindications

Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.


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.

New onset of steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur with MYCAPSSA and other somatostatin analogs. If new occurrence or worsening of these symptoms are reported, evaluate for potential pancreatic exocrine insufficiency and manage accordingly.


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 taking an oral contraceptive to use an alternative non-hormonal method of contraception or a back-up method when taking MYCAPSSA.

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.

Please report adverse events to Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including Medication Guide.

Indication

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.

Important Safety Information

Contraindications

Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.


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.

New onset of steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur with MYCAPSSA and other somatostatin analogs. If new occurrence or worsening of these symptoms are reported, evaluate for potential pancreatic exocrine insufficiency and manage accordingly.


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 taking an oral contraceptive to use an alternative non-hormonal method of contraception or a back-up method when taking MYCAPSSA.

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.

Please report adverse events to Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including Medication Guide.

Indication

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.

REFERENCES: 1. Paragliola RM, et al. Front Endocrinol (Lausanne). 2018;9:78. 2. Gadelha MR, et al. J Clin Endocrinol Metab. 2022;107(2):297-308. 3. Gomes-Porras M, et al. Int J Mol Sci. 2020;21(5):1682. 4. Tuvia S, et al. Pharm Res. 2014;31(8):2010-2021. 5. MYCAPSSA [package insert]. Chiesi USA, Inc. 2024.