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Acromegaly Support Resources for You and Your Patients

Watch MYCAPSSA Patient Stories
Jim
Jim
Listen as Jim talks about life with MYCAPSSA, and the support he's received along the way. Watch as he encourages acromegaly patients to advocate for themselves.
Becky
Becky
Watch Becky as she talks about transitioning to treatment with MYCAPSSA, and how she's made it fit into her daily routine.
Bonnie
Bonnie
Watch as Bonnie discusses her experience with acromegaly symptoms, and why she decided to change her treatment to MYCAPSSA.

Downloadable Resources for You and Your Patients

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DOWNLOAD PRESCRIPTION FORM
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DOWNLOAD PATIENT CONSENT FORM
Patient-Brochure
DOWNLOAD Patient Brochure: English
Frequently Asked Questions About MYCAPSSA
About MYCAPSSA

MYCAPSSA is the only oral octreotide.1,2 MYCAPSSA is an oral somatostatin analog approved for the long-term maintenance treatment of acromegaly in people who have responded to and tolerated treatment with octreotide or lanreotide.1

Patients who respond to and tolerate octreotide or lanreotide may be eligible to take MYCAPSSA instead of receiving injections.3

If your patient’s current SSA treatment is effective and tolerable, they may be eligible to take oral MYCAPSSA capsules instead of receiving monthly injections.1,3

MYCAPSSA has an established safety profile consistent with octreotide, without injection-related reactions.4

The most common side effects of MYCAPSSA are headache, joint pain, nausea, weakness, diarrhea, and excessive sweating. GI-related adverse events (AEs) were mostly transient and resolved in less than 2 weeks. Across 2 phase 3 trials, GI-related AEs were reported in 57% and 68% of patients. GI-related AEs were mostly mild to moderate and occurred during the initial 3 months of treatment.1 Learn more about possible side effects in our Safety Profile.

MYCAPSSA is an oral octreotide formulation. MYCAPSSA uses Transient Permeability Enhancer (TPE®), a cutting-edge technology that allows octreotide to be given as an oral treatment.1,5 Watch a short video to learn more about TPE and how MYCAPSSA works here.

MYCAPSSA is an oral form of octreotide, taken twice a day.1

Somavert® (pegvisomant for injection) is a subcutaneous injection, self-administered once daily after a physician-supervised initial loading dose.6 Somatuline® Depot (lanreotide) is for deep subcutaneous injection only, initially administered every 4 weeks by a healthcare professional.7 Sandostatin® LAR Depot (octreotide acetate) and Signifor® LAR (pasireotide) are intramuscular injections, administered monthly by a healthcare professional.8,9

Patients who respond to and tolerate octreotide or lanreotide may be eligible to take MYCAPSSA.
Treating Acromegaly With MYCAPSSA

Yes, MYCAPSSA was proven to effectively maintain normal IGF-I and GH levels in the majority of patients.1,10 Learn more about consistent control and the proven benefits of MYCAPSSA here.

GH, growth hormone; IGF-I, insulin-like growth factor 1.

For patients whose IGF-I is not well controlled or for those experiencing symptoms, a dose adjustment may be appropriate. Titrate the MYCAPSSA dosage, based on IGF-I levels and the patient’s signs and symptoms. Increase the dosage in increments of 20 mg.1 See the recommended titration schedule here.

Once MYCAPSSA has been started, evaluate IGF-I, signs, and symptoms, and titrate MYCAPSSA as needed. The starting dose of MYCAPSSA is 40 mg per day (20 mg bid). The majority of patients in clinical trials titrated up to a 60 mg–dose or higher.1,4,10,11 Once the maintenance dosage of MYCAPSSA is achieved, monitor IGF-I levels and acromegaly signs and symptoms monthly.1 Encourage patients to keep an open dialogue about how they feel and any potential symptoms they may experience.
MYCAPSSA Dosing and Administration

No, MYCAPSSA offers a flexible dosing schedule. First and second doses do not need to be taken 12 hours apart or at the same time each day. See dosing information here.

MYCAPSSA should be taken twice daily. MYCAPSSA should be taken on an empty stomach (1 hour before or 2 hours after a meal) with a glass of water.1 See the recommended titration schedule here.

If a patient forgets to take their dose of MYCAPSSA, they should not take the missed dose at a later time.12 Advise the patient to take the next dose at the scheduled time.12 Encourage patients to be open and honest about any difficulties they experience in taking regular doses.
Access, Support, and Delivery

MYCAPSSA will be delivered monthly to your patient’s home or designated location. The Chiesi Total CareSM team will work with your patient to deliver MYCAPSSA when and where it’s most convenient for them. Your patient should receive a call from the pharmacy (Acaria Specialty Pharmacy) to confirm the shipment every month. Learn more about Chiesi Total CareSM.

The Chiesi Total CareSM team is here to help assess your patient’s insurance eligibility. The team is ready to assist your office with patients with commercial insurance, government insurance, or no insurance, and is available to help navigate prior authorization and appeals. For more information and for help understanding how MYCAPSSA works with your patient’s insurance plan, call 1-833-346-2277, Monday–Friday, 7:00 AM-7:00 PM CT. Learn more about Chiesi Total CareSM.

Chiesi Total CareSM is a comprehensive support program that provides services for you and your patients. The Chiesi Total CareSM team will be there every step of the way to help make accessing, starting, and staying on MYCAPSSA treatment as easy as possible. They will help facilitate communication between your office, your patient, their specialty pharmacy, and their insurance company to make the transition to MYCAPSSA as seamless as possible. Learn more about Chiesi Total CareSM.

Yes! Acaria Specialty Pharmacy will help them stay on track with their refills of MYCAPSSA. The pharmacy will reach out each month to coordinate a convenient delivery time for each refill. If any questions or issues arise, your office or your patient can always contact the Chiesi Total CareSM team for further assistance.
Storing MYCAPSSA

Opened MYCAPSSA wallets can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to one month. Before first use, unopened wallets of MYCAPSSA should be stored in a refrigerator. Be sure not to freeze MYCAPSSA. Care should be taken to keep MYCAPSSA in a safe place and always out of the reach of children.1

Before first use, store unopened wallets of MYCAPSSA in a refrigerator. Be sure not to freeze MYCAPSSA. After the first use for each wallet, opened wallets can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to one month. Care should be taken to keep MYCAPSSA in a safe place and always out of the reach of children.1
*Somavert® is a registered trademark of Pfizer Inc.
†Somatuline Depot is a registered trademark of Ipsen Pharma S.A.S.
‡Sandostatin® is a registered trademark of Novartis Pharmaceuticals Corporation.
§Signifor® is a licensed trademark of Recordati Rare Diseases Inc.
||Please refer to the full Prescribing Information for each product for full Dosage and Administration information.
Chiesi Global Rare Diseases: Our Commitment
Chiesi Global Rare Diseases is committed to helping address wellness within the rare disease community
We strive to provide comprehensive support in the lives of people living with rare diseases. We work in close partnership with caregivers, patient communities, healthcare professionals, government authorities, and other stakeholders to help make an impact in the rare disease community. We relentlessly pursue sustainable development goals with passion, courage, teamwork, and innovation. We believe—from timely and accurate diagnoses to receiving treatments and finding supportive communities—that no one should feel alone.
Learn more about Chiesi Global Rare Diseases
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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. MYCAPSSA [package insert]. Chiesi USA, Inc. 2024. 2. Approved Drug Products With Therapeutic Equivalence Evaluations. 43rd ed. U.S. Department of Health and Human Services, Food and Drug Administration; 2023. 3. Fleseriu M, et al. Pituitary. 2021;24:1-13. 4. Samson SL, et al. J Clin Endocrinol Metab. 2020;105(10):1-13. 5. Tuvia S, et al. Pharm Res. 2014;31(8):2010-2021. 6. Somavert [package insert]. Pfizer Inc; 2023. 7. Somatuline Depot [package insert]. Ipsen Biopharmaceuticals Inc; 2019. 8. Sandostatin LAR Depot [package insert]. Novartis Pharmaceuticals Corp; 2024. 9. Signifor LAR for injectable suspension, for intramuscular use [package insert]. Recordati Rare Diseases Inc; 2024. 10. Melmed S, et al. J Clin Endocrinol Metab. 2015;100(4):1699-1708. 11. Fleseriu M, et al. Lancet Diabetes Endocrinol. 2022;10(2):102-111. 12. Octreotide. MedlinePlus. Updated September 14, 2020. Accessed July 24, 2024.

https://medlineplus.gov/druginfo/meds/a620051.html