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Frequently Asked Questions about MYCAPSSA

What is MYCAPSSA® (octreotide) delayed-release oral capsules?

MYCAPSSA is an oral prescription medicine approved for use in the long-term maintenance treatment of acromegaly in people for whom initial treatment with octreotide or lanreotide has been effective and tolerated.

If these treatments are effective and your body is tolerating it, you may be eligible to take MYCAPSSA instead of the injections.


Is MYCAPSSA a replacement for my current somatostatin analog (SSA) injection?

If your current SSA treatment is effective and your body is tolerating it, you may be eligible to take oral MYCAPSSA capsules instead of your monthly injections.


What are the most common side effects of MYCAPSSA?

The most common side effects of MYCAPSSA are headache, joint pain, nausea, weakness, diarrhea, and sweating a lot. Learn more about possible side effects in our Safety Profile.


How do MYCAPSSA capsules work?

The main ingredient of MYCAPSSA is octreotide, a well-known and proven medication.

Once swallowed with water, the coating on the capsule protects the medicine from being released too early or broken down before it gets to where it needs to be. The coating keeps the octreotide intact until it can make it to the right place in your body, your small intestine, to let the medication start to do its job.


Can MYCAPSSA help maintain my IGF-I and GH levels?

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


What can I expect when transitioning to treatment with MYCAPSSA?

Once you’ve started on MYCAPSSA, your doctor may or may not decide to adjust the number of capsules you take each day, depending on your IGF-I hormonal levels and your acromegaly signs and symptoms.

Make sure to have an open dialogue about how you feel, and let your doctor know how MYCAPSSA is working for you. This will help ensure that you are receiving the right amount of medicine to properly manage your acromegaly.


How do I take MYCAPSSA? And can it be taken with food, coffee, or drinks?

MYCAPSSA is a twice daily medication. So, you take it once in the morning and once in the evening. Make sure you take each dose with a glass of water and on an empty stomach. And that means you shouldn’t eat or drink anything, except water, two hours before taking MYCAPSSA and one hour after.


Why is it so important to take my doses of MYCAPSSA on a regular schedule?

It all has to do with how it works, its delayed release delivery, and maintaining consistent control. Taking MYCAPSSA around the same time, in the morning and at night with water and on an empty stomach, delivers your medicine every day — so your acromegaly is consistently controlled.


What happens if I forget to take a dose?

If you forget to take your dose of MYCAPSSA, do not take the missed dose at a later time. Just take the next dose at the scheduled time. Call your doctor right away if you are having trouble regularly taking your doses. Not taking MYCAPSSA consistently may affect how you feel and how well the medicine can work for you.


How will MYCAPSSA be delivered to me?

MYCAPSSA will be delivered monthly to your home. Your Amryt Assist Case Manager will help coordinate with your specialty pharmacy to deliver MYCAPSSA when and where it’s most convenient, and you should receive a call from the pharmacy to confirm the shipment. Learn more about Amryt Assist services.


Is MYCAPSSA covered by insurance?

Commercially insured patients can get MYCAPSSA for as little as $0 out of pocket, based on eligibility. For more information and for help understanding how MYCAPSSA works with your insurance plan, call Amryt Assist at 1-833-346-2277, Monday–Friday, 8:30am-7:00pm EST.


Is there a patient support program for MYCAPSSA?

Dedicated Amryt Assist Case Managers 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 you, your doctors, your specialty pharmacy, and your insurance company to make the transition to MYCAPSSA as seamless as possible. Learn more about Amryt Assist services.


Will I get refill reminders to ensure that I receive my MYCAPSSA each month?

Yes! Your specialty pharmacy will help you stay on track with your refills of MYCAPSSA. Your pharmacy will reach out each month to coordinate a convenient delivery time for your refill. If any questions or issues arise, you can always contact your Amryt Assist Case Manager for further assistance.


How should I store MYCAPSSA?

Before first use, store unopened wallets of MYCAPSSA in a refrigerator. Be sure not to freeze your MYCAPSSA. After the first use for each wallet, you can store opened wallets at room temperature between 68°F to 77°F (20°C to 25°C) for up to one month. Be sure to keep your MYCAPSSA in a safe place and always out of the reach of children.


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INDICATION AND IMPORTANT SAFETY INFORMATION

What is MYCAPSSA (octreotide) for?

MYCAPSSA is an oral prescription medicine used in the long-term maintenance treatment of acromegaly in people for whom initial treatment with octreotide or lanreotide has been effective and tolerated.

If these treatments are effective and your body is tolerating it, you may be eligible to take MYCAPSSA instead of the injections. Ask your doctor if this oral treatment is appropriate for you.

What is the most important safety information I should know?

MYCAPSSA can cause problems with the gallbladder. Tell your healthcare provider if you have any of these symptoms: sudden pain in your upper right stomach (abdomen) or right shoulder or between your shoulder blades; yellowing of your skin or the whites of your eyes; fever with chills; or nausea.

MYCAPSSA may affect your blood sugar, thyroid hormone, or vitamin B12 levels. Tell your healthcare provider if you have any problems or conditions related to these. Your healthcare provider may monitor these levels during your treatment with MYCAPSSA.

Tell your healthcare provider if you have an irregular heartbeat.

Who should not use MYCAPSSA?

MYCAPSSA can cause a serious allergic reaction including anaphylactic shock. Stop taking MYCAPSSA right away and get emergency help if you have any of these symptoms: swelling of your tongue, throat, lips, eyes or face; trouble swallowing or breathing; severe itching of the skin with rash or raised bumps; feeling faint; chest pain; or rapid heartbeat.

Do not use MYCAPSSA if you are allergic to octreotide or any other ingredients in MYCAPSSA. If you need to know the ingredients, ask your healthcare provider or pharmacist.

If you have certain other medical conditions, you should use MYCAPSSA with caution. Tell your healthcare provider about all your medical conditions, especially the following: pregnancy or breastfeeding; liver disease; kidney disease; or difficulty in emptying bladder completely.

Women taking an oral contraceptive should use an alternative non-hormonal method of contraception or a back-up method when taking MYCAPSSA. Tell your healthcare provider about all the medicines you take. MYCAPSSA may affect the way other medicines work, and other medicines may affect how MYCAPSSA works.

What are the possible side effects of MYCAPSSA?

The most common side effects are headache, joint pain, nausea, weakness, diarrhea, and sweating a lot.

Talk to your healthcare provider if you have any side effect that bothers you or that does not go away. You may report side effects to the FDA at 1-800-FDA-1088.

Keep MYCAPSSA and all medicines out of the reach of children.

How should I take MYCAPSSA?

Do not take MYCAPSSA with food. MYCAPSSA should be taken with a glass of water on an empty stomach. Take MYCAPSSA at least 1 hour before a meal or at least 2 hours after a meal (for example, you could take your morning dose 1 hour before breakfast and your evening dose at bedtime).

INDICATION AND IMPORTANT SAFETY INFORMATION

What is MYCAPSSA (octreotide) for?

MYCAPSSA is an oral prescription medicine used in the long-term maintenance treatment of acromegaly in people for whom initial treatment with octreotide or lanreotide has been effective and tolerated.

If these treatments are effective and your body is tolerating it, you may be eligible to take MYCAPSSA instead of the injections. Ask your doctor if this oral treatment is appropriate for you.

What is the most important safety information I should know?

MYCAPSSA can cause problems with the gallbladder. Tell your healthcare provider if you have any of these symptoms: sudden pain in your upper right stomach (abdomen) or right shoulder or between your shoulder blades; yellowing of your skin or the whites of your eyes; fever with chills; or nausea.

MYCAPSSA may affect your blood sugar, thyroid hormone, or vitamin B12 levels. Tell your healthcare provider if you have any problems or conditions related to these. Your healthcare provider may monitor these levels during your treatment with MYCAPSSA.

Tell your healthcare provider if you have an irregular heartbeat.

Who should not use MYCAPSSA?

MYCAPSSA can cause a serious allergic reaction including anaphylactic shock. Stop taking MYCAPSSA right away and get emergency help if you have any of these symptoms: swelling of your tongue, throat, lips, eyes or face; trouble swallowing or breathing; severe itching of the skin with rash or raised bumps; feeling faint; chest pain; or rapid heartbeat.

Do not use MYCAPSSA if you are allergic to octreotide or any other ingredients in MYCAPSSA. If you need to know the ingredients, ask your healthcare provider or pharmacist.

If you have certain other medical conditions, you should use MYCAPSSA with caution. Tell your healthcare provider about all your medical conditions, especially the following: pregnancy or breastfeeding; liver disease; kidney disease; or difficulty in emptying bladder completely.

Women taking an oral contraceptive should use an alternative non-hormonal method of contraception or a back-up method when taking MYCAPSSA. Tell your healthcare provider about all the medicines you take. MYCAPSSA may affect the way other medicines work, and other medicines may affect how MYCAPSSA works.

What are the possible side effects of MYCAPSSA?

The most common side effects are headache, joint pain, nausea, weakness, diarrhea, and sweating a lot.

Talk to your healthcare provider if you have any side effect that bothers you or that does not go away. You may report side effects to the FDA at 1-800-FDA-1088.

Keep MYCAPSSA and all medicines out of the reach of children.

How should I take MYCAPSSA?

Do not take MYCAPSSA with food. MYCAPSSA should be taken with a glass of water on an empty stomach. Take MYCAPSSA at least 1 hour before a meal or at least 2 hours after a meal (for example, you could take your morning dose 1 hour before breakfast and your evening dose at bedtime).

©2022 Amryt Pharmaceuticals, Inc. MYCAPSSA is a registered trademark of the Amryt Pharma Group. All rights reserved. MC/US/450 08/2022