About - Mycapssa

BENEFITS OF MYCAPSSA CONSIDERING MYCAPSSA SAFETY PROFILE TALK TO YOUR DOCTOR

Take control with daily oral MYCAPSSA.

MYCAPSSA combines the proven efficacy of octreotide with the convenience of a twice-daily capsule. It’s the control over your treatment that you have been waiting for.

First and only oral somatostatin analog (SSA)

Consistent, proven control of your IGF-I levels

In the Pivotal Phase 3 Trial, 58% of MYCAPSSA patients demonstrated biochemical control vs 19% on placebo.

Generally well-tolerated

MYCAPSSA can cause problems with the gallbladder. Blood sugar, thyroid levels, and vitamin B₁₂ levels may be impacted.

Backed by personalized and helpful support from Amryt Assist

MYCAPSSA is for people in whom initial treatment with octreotide or lanreotide has been effective and tolerated.

Ask your doctor if making the transition to MYCAPSSA is right for you.

Thinking about making the move to MYCAPSSA?

Daily control may be closer than you think.

The safety and efficacy of MYCAPSSA was studied in two clinical studies with 183 patients living with acromegaly.

All had previously responded to and tolerated SSA injectable treatment with octreotide or lanreotide.

56 patients with acromegaly participated in the main clinical study. This study focused on safety and how MYCAPSSA works. Here are the results at 9 months:

Nearly 60% maintained control of their IGF-I levels with MYCAPSSA at the end of the study, at 9 months.

Nearly 80% maintained their growth hormone levels with MYCAPSSA at 9 months.

Additionally, the following results were observed in other analyses:*

90% who completed the study on MYCAPSSA chose to continue to manage their acromegaly with MYCAPSSA.

92% who responded to MYCAPSSA at 6 months, with IGF-I levels in the normal range, continued to respond at 9 months.

*Samson SL, et al. J Clin Endocrinol Metab. 2020;105(10):e3785-e3797.

IGF-I: insulin-like growth factor 1

Safety Profile of MYCAPSSA

In clinical studies, MYCAPSSA was shown to be generally well-tolerated.

MYCAPSSA can cause problems with the gallbladder (especially in those with a history of gallstones). MYCAPSSA may affect your blood sugar, thyroid hormone, and vitamin B₁₂ levels.

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

Please note: Stomach issues were mostly mild to moderate, occurring during the first 3 months of treatment and resolved on treatment, on average in less than 2 weeks after starting MYCAPSSA.

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.

Ask your doctor if making the transition to MYCAPSSA is right for you.

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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).