New Oral Medication Approved For Acromegaly

 

Chiasma Logo RGB FinalOn June 26, 2020, the U.S. Food and Drug Administration (FDA) approved MYCAPSSA® (octreotide)
delayed-release oral capsules, the first and only oral somatostatin analog (SSA) capsule for the management
of appropriate patients with acromegaly. MYCAPSSA may provide the opportunity to comfortably and
conveniently manage acromegaly treatment at home, or wherever patients are.
MYCAPSSA can cause problems with the gallbladder. The most common side effects are headache, joint
pain, nausea, weakness, diarrhea, and sweating a lot.


Chiasma, a commercial stage biopharmaceutical company, is excited to bring this new treatment option to
people living with acromegaly. Chiasma hopes this new option will offer people living with acromegaly
freedom from the burden of injections and empower them to live their lives without planning around
potentially painful treatment.


Chiasma offers a patient assistance program, Chiasma Access & Patient Support (CAPS), that
offers dedicated and personalized support to help patients with acromegaly get started on
MYCAPSSA and guide them throughout their treatment. Learn more about MYCAPSSA
and CAPS at www.MYCAPSSA.com.

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.
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).

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