Learn about MYCAPSSA® (octreotide) capsules

About MYCAPSSA

The same acromegaly medicine. In a new form.

It’s been years since the last major advancement in acromegaly. But finally, you may be able to make the burden of painful SSA injections a thing of the past with MYCAPSSA.

MYCAPSSA is the first and only oral somatostatin analog (SSA) for the treatment of appropriate patients living with acromegaly.

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    It is an alternative to SSA injections that can eliminate the need for a painful administration

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    In clinical trials, MYCAPSSA was shown to be generally well tolerated

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    Also, it was proven to effectively maintain normal IGF-I and GH levels in the majority of patients

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    Twice daily oral dosing of MYCAPSSA offers consistent hormonal control

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    MYCAPSSA capsules provide the opportunity to comfortably and conveniently manage your acromegaly treatment at home, or wherever you are

Ask your doctor about MYCAPSSA to see if it could be right for you. You can prepare for your appointment by downloading our Doctor Discussion Guide to make sure you’re asking all the right questions.

HOW MYCAPSSA CAN MAKE A DIFFERENCE

The safety and efficacy of MYCAPSSA was studied in two clinical trials with 183 patients living with acromegaly who previously responded to or tolerated SSA injectable treatment with octreotide or lanreotide.

56 patients with acromegaly participated in the main clinical study, which focused on safety and how MYCAPSSA works in patients. The following outcome was reported at 9 months:

NEARLY 60% OF PATIENTS

responded and maintained their response to MYCAPSSA at the end of the study, at 9 months.

Additionally, the following results were observed in other analyses:

92% OF THE PATIENTS

who responded to MYCAPSSA at 6 months, with IGF-I levels in the normal range, continued to respond at 9 months.

90% OF THE PATIENTS

who completed the study on MYCAPSSA chose to continue managing their acromegaly with MYCAPSSA.

During the clinical trial, my levels were under control and I wasn’t having to work up the courage to hurt myself with a needle every 28 days. The way MYCAPSSA worked for me, in the convenience of an oral option, was what I had been waiting for.

– Jim, Living With Acromegaly
Jim participated in a clinical trial for MYCAPSSA

How safe is MYCAPSSA?

In clinical studies, MYCAPSSA was shown
TO BE GENERALLY WELL TOLERATED
AND IT CAN HELP AVOID
INJECTION-RELATED
SIDE EFFECTS.

MYCAPSSA can cause problems with the gallbladder (especially in those with a history of gallstones). The most common side effects of MYCAPSSA are:

  • Headache
  • Weakness
  • Joint pain
  • Diarrhea
  • Nausea
  • Sweating a lot
  • With twice daily MYCAPSSA, you can manage your acromegaly treatment comfortably and conveniently from home or wherever you are.

    I finally had the opportunity to experience control of my IGF-I and GH levels without the pain and inconvenience of my injections. And the freedom to travel without sticking to that regimen of monthly injections has made a big difference for me.

    – Shannon, Living With Acromegaly
    Shannon participated in a clinical trial for MYCAPSSA

    HOW DOES MYCAPSSA WORK?

    • The main ingredient of MYCAPSSA is octreotide, a well-known and proven medication.
    • MYCAPSSA capsules work by using a unique technology called Transient Permeability Enhancer or TPE®.
    • Powered by TPE Technology, MYCAPSSA capsules allow octreotide to be absorbed more easily by the body.

    1

    MYCAPSSA capsules, engineered with TPE, have a special coating on each capsule that protects the octreotide medication inside.

    2

    Once swallowed with water, this coating protects the medicine from being released too early or broken down in 
the stomach.

    3

    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.

    4

    Taking MYCAPSSA twice daily as directed by your doctor can help ensure your body gets consistent levels of octreotide each day.

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    INDICATION AND IMPORTANT SAFETY INFORMATION

    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. Tell your healthcare provider if you have an irregular heartbeat. 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.

    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.

    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).

    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.

    READ MORE  

    INDICATION AND IMPORTANT SAFETY INFORMATION

    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. Tell your healthcare provider if you have an irregular heartbeat. 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.

    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.

    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).

    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.