Open-Label Study¶
MPOWERED Study#
MYCAPSSA Is the Only Octreotide That’s Taken Orally
Proven safe and effective
Oral medication taken twice a day
MYCAPSSA is the oral version of octreotide, a medication you may already be familiar with.
Bonnie, MYCAPSSA patient
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.
MYCAPSSA Has Been Extensively Studied
The safety and effectiveness of MYCAPSSA were evaluated in 3 clinical studies.
329 people living with acromegaly, who responded to and were able to tolerate injectable somatostatin analog (SSA) treatment with octreotide or lanreotide, participated in the studies.
|
Study name
|
Study length |
Number of participants
|
What was studied |
 OPTIMAL Study
|
9 months
|
56†
|
|
 MPOWERED Study*
|
15 months
|
146‡
|
|
 Open-Label Study
|
13 months
|
155
|
|
| Study name |
|
OPTIMAL Study
|
| Study length |
|
9 months
|
|
Number of participants
|
|
56†
|
| What was studied |
|
| Study name |
|
MPOWERED Study*
|
| Study length |
|
15 months
|
|
Number of participants
|
|
146‡
|
| What was studied |
|
| Study name |
|
Open-Label Study
|
| Study length |
|
13 months
|
|
Number of participants
|
|
155
|
| What was studied |
|
*The MPOWERED study was not powered to report noninferiority or superiority between arms for symptoms and patient-reported outcomes. Patients who enrolled did so with the understanding that they may receive MYCAPSSA. The enrolled population may have been enriched for those who were unsatisfied with injectable therapy.
The 3 trials above studied MYCAPSSA, the oral version of octreotide. Octreotide therapy has been used for decades in thousands of people.
FDA, US Food and Drug Administration.
†28 patients were randomized to receive MYCAPSSA.
‡146 patients total, of which 92 entered the randomized controlled phase.
†28 patients were randomized to receive MYCAPSSA.
‡146 patients total, of which 92 entered the randomized controlled phase.
The IGF-I Control You Expect of Octreotide
Most Patients Treated With MYCAPSSA Kept IGF-I Under Control§
In the OPTIMAL Study:
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.
In the MPOWERED Study:
Almost all patients on MYCAPSSA maintained control of IGF-I,|| similar to those treated with an injectable somatostatin analog.
Patients who completed the MPOWERED study were invited to participate in a long-term study extension. Participants achieved durable control of their acromegaly with MYCAPSSA for up to an additional 3.5 years in the study.
Watch Bonnie as she talks about her experience with breakthrough symptoms.
IGF-I, insulin-like growth factor 1; ULN, upper limit of normal.
§In the OPTIMAL trial, IGF-I response was defined as an average of weeks 34 and 36 IGF-I ≤1.0 × ULN; 58% of patients on MYCAPSSA maintained IGF-I response vs 19% of patients on placebo (P =.008).
||Data are representative of patients responding to both iSSAs and MYCAPSSA. Hormone control was defined as IGF-I <1.3 × ULN using time-weighted average.
§In the OPTIMAL trial, IGF-I response was defined as an average of weeks 34 and 36 IGF-I ≤1.0 × ULN; 58% of patients on MYCAPSSA maintained IGF-I response vs 19% of patients on placebo (P =.008).
||Data are representative of patients responding to both iSSAs and MYCAPSSA. Hormone control was defined as IGF-I <1.3 × ULN using time-weighted average.
MYCAPSSA Controls Symptoms
Fewer Patients Have Reported Breakthrough Symptoms on MYCAPSSA
Breakthrough symptoms are any acromegaly symptoms that get worse near the end of a treatment cycle.
In the MPOWERED Study:
Fewer patients treated with MYCAPSSA reported breakthrough symptoms.
Reported Breakthrough Symptoms
Before taking MYCAPSSA: 25% of patients experienced breakthrough symptoms
After 26 weeks on MYCAPSSA: Only 7% of patients experienced breakthrough symptoms
Across Multiple Studies, MYCAPSSA-Treated Patients Demonstrated Consistent Symptom Control
¶Proportion of patients with active individual symptoms from baseline to end of treatment. Fixed-dose population (n=110). For patients not completing the core treatment period, the last assessment during the core treatment period was used. For patients not completing the extension treatment period, the last assessment during the extension treatment period was used.
#Proportion of patients with active individual symptoms at indicated timepoint during run-in phase.
#Proportion of patients with active individual symptoms at indicated timepoint during run-in phase.
In the MPOWERED study extension, patients achieved long-term symptom control for up to an additional 3.5 years.
MYCAPSSA Is 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. MYCAPSSA may cause your body to have issues with absorbing dietary fats.
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.
Sign up more information and updates about MYCAPSSA.
This program is intended for US residents only.
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Important Safety Information
WHAT IS THE MOST IMPORTANT SAFETY INFORMATION I SHOULD KNOW?
Who should not use MYCAPSSA?
What are the possible side effects of MYCAPSSA?
How should I take MYCAPSSA?
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.
MYCAPSSA may cause your body to have issues with absorbing dietary fats. Tell your healthcare provider if you have any new or worsening symptoms including fatty stools or stools with an oily appearance, changes in the color of your stools, loose stools, stomach (abdominal) bloating or weight loss.
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.
You are encouraged to report negative side effects to 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, and talk to your doctor.
Indication
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.
Important Safety Information
WHAT IS THE MOST IMPORTANT SAFETY INFORMATION I SHOULD KNOW?
Who should not use MYCAPSSA?
What are the possible side effects of MYCAPSSA?
How should I take MYCAPSSA?
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.
MYCAPSSA may cause your body to have issues with absorbing dietary fats. Tell your healthcare provider if you have any new or worsening symptoms including fatty stools or stools with an oily appearance, changes in the color of your stools, loose stools, stomach (abdominal) bloating or weight loss.
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.
You are encouraged to report negative side effects to 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, and talk to your doctor.
Indication
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.
