Proven efficacy and safety profile
What Is MYCAPSSA?
Take control with daily oral MYCAPSSA for your acromegaly diagnosis.
MYCAPSSA combines the proven efficacy of octreotide with the convenience of a twice-daily capsule. It’s the control over your acromegaly treatment that you have been waiting for.
Twice-daily oral capsule
MYCAPSSA is for people in whom treatment with octreotide or lanreotide has been effective and tolerated.
Ask your doctor if making the transition to MYCAPSSA is right for you.
Extensively studied oral treatment for acromegaly
The safety and efficacy of MYCAPSSA was studied in:
3 clinical trials
329 people living with acromegaly
who previously responded to and tolerated injectable SSA treatment with octreotide or lanreotide.
The 2 main studies were:
Study name | Study length | Treatments compared | Outcome |
---|---|---|---|
OPTIMAL | 9 months | MYCAPSSA vs placebo |
|
MPOWERED | 9 months | MYCAPSSA vs Injectable SSA |
|
Study name | |
---|---|
OPTIMAL | MPOWERED |
Study length | |
9 months | 9 months |
Treatments compared | |
MYCAPSSA vs placebo | MYCAPSSA vs Injectable SSA |
Outcome | |
|
|
*Primary endpoint of noninferiority assessment of the proportion of patients maintaining biochemical response (IGF-I <1.3 x ULN using time-weighted average) throughout the randomized controlled treatment phase.
OPTIMAL study results
In the pivotal phase 3 trial, a majority of MYCAPSSA-treated patients maintained IGF-I control.
56 patients with acromegaly participated in the main clinical study, which focused on safety and how MYCAPSSA works in patients. The following outcomes were reported at 9 months:
Nearly 60% maintained control of their IGF-I levels
with MYCAPSSA at the end of the study, at 9 months.
92% who responded to MYCAPSSA at 6 months, with
IGF-I levels in the normal range, continued to respond at 9 months.
90% who completed the study on MYCAPSSA chose to
continue to manage their acromegaly with
MYCAPSSA.
MPOWERED study results
Phase 3 trial further demonstrated that MYCAPSSA maintained biochemical control.
92 patients who responded to MYCAPSSA† after 26 weeks were randomized to a 9-month controlled phase with continued treatment on MYCAPSSA or on their prior injectable therapy. The following outcomes were reported:
IGF-I levels
Demonstrated consistent control of hormone levels, as in other phase 3 studies
Acromegaly symptoms
Consistent control of several common symptoms
Breakthrough‡ symptoms
Patients treated with MYCAPSSA reported fewer breakthrough symptoms:
- Before MYCAPSSA: 25% of patients experienced breakthrough symptoms
- After 26 weeks on MYCAPSSA treatment: only 7% of patients experienced breakthrough symptoms
‡Breakthrough symptoms defined as worsened at the end of treatment cycle.
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
- excessive sweating
Stomach and gut issues were mostly mild to moderate and resolved on treatment.
- Occurred mostly during the first 3 months of treatment
- Typically resolved in less than 2 weeks
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.
Do not stop taking MYCAPSSA before speaking with your doctor or pharmacist.
Ask your doctor if making the transition to MYCAPSSA is right for you.
Sign up to receive more information about MYCAPSSA.
Important Safety Information
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.
Please contact Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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).
Please see full Prescribing Information, including Medication Guide.Indication
MYCAPSSA is an oral prescription medicine used in the long-term maintenance treatment of acromegaly in people for whom 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.
Important Safety Information
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.
Please contact Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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).
Please see full Prescribing Information, including Medication Guide.Indication
MYCAPSSA is an oral prescription medicine used in the long-term maintenance treatment of acromegaly in people for whom 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.