TM Owner Chiesi
Mycapssa 20mg Capsule
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Indications & Clinical Uses
- Mycapssa 20 mg delayed-release capsules contain octreotide, a somatostatin analogue, and are the first oral formulation of octreotide approved for long-term maintenance treatment of acromegaly in adults who have already responded to and tolerated treatment with injectable octreotide or lanreotide.
- It is not used to start acromegaly treatment; it is a follow-on option for patients whose disease is already controlled on an injectable somatostatin analogue and who wish to switch to an oral medicine.
- Mycapssa is self-administered by mouth, unlike the injectable forms of octreotide and lanreotide, which are given by a healthcare provider.
- The starting dose is usually 40 mg per day in two divided doses, adjusted every four weeks up to a maximum of 80 mg daily based on growth hormone and IGF-1 blood levels and symptom control.
- Mycapssa is manufactured by Chiesi (originally developed by Amryt/Chiesi) and is approved in the United States; it is not the same product as injectable octreotide (Sandostatin) or lanreotide (Somatuline), which remain separate treatment options.
Side Effects
- The most common side effects of Mycapssa, each reported in more than 1 in 10 patients, are headache, nausea, diarrhea, joint pain (arthralgia), weakness and excessive sweating; raised blood glucose is also common.
- Serious reactions to watch for include gallbladder problems, such as sudden pain in the upper right abdomen or shoulder, fever, nausea or yellowing of the skin, which can signal gallstones; symptoms of very high or very low blood sugar, especially in people with diabetes; a slow or irregular heartbeat; and signs of an allergic reaction such as swelling of the face, lips or throat.
- Thyroid function can also be suppressed, sometimes causing tiredness, weight gain or feeling cold.
- Contact a healthcare provider promptly if any of these occur, and take Mycapssa exactly as prescribed, on an empty stomach, to get a consistent effect.
Precautions & Warnings
- Mycapssa must be taken on an empty stomach, at least one hour before or two hours after a meal, and the capsules should be swallowed whole, never crushed, chewed or opened.
- Gallbladder ultrasound monitoring is recommended periodically because octreotide slows gallbladder emptying and increases the risk of gallstones.
- Blood glucose should be monitored, particularly in people with diabetes, as octreotide can cause either high or low blood sugar and diabetes medicines may need dose adjustment.
- Thyroid function should be checked periodically because octreotide can cause hypothyroidism.
- Heart rate and rhythm should be monitored in patients with existing heart conditions, since bradycardia and conduction changes have been reported.
- Vitamin B12 levels should be checked periodically, as octreotide can reduce absorption.
- Safety in pregnancy is not established; use only if clearly needed, and it is not known whether octreotide passes into breast milk.
- Mycapssa is not for use in children; safety and effectiveness have not been established.
Avoid Interactions
- Mycapssa reduces the effectiveness of hormonal contraceptives, including combined oral contraceptives; women of reproductive age should use an additional non-hormonal method of contraception while taking it.
- Proton pump inhibitors, H2-blockers and antacids reduce absorption of oral octreotide and may require a Mycapssa dose adjustment; timing of these medicines relative to Mycapssa should be discussed with a healthcare provider.
- Octreotide can increase blood levels of cyclosporine, so transplant patients on cyclosporine need closer monitoring, and it can also affect levels of digoxin and lisinopril, requiring dose review.
- Because octreotide affects blood glucose, insulin and other diabetes medicines often need dose adjustment, with closer blood sugar monitoring when starting or stopping Mycapssa.
- Tell the prescriber about all other prescription and over-the-counter medicines, vitamins and herbal supplements being taken, especially heart-rhythm medicines, since octreotide can slow the heart rate.
References
Frequently Asked Questions
Mycapssa (octreotide) is an oral capsule for long-term acromegaly treatment in adults already controlled on injectable octreotide or lanreotide. It is not used to start treatment. It is taken to keep growth hormone and IGF-1 levels down after an injectable somatostatin analogue has worked.
Swallow Mycapssa capsules whole on an empty stomach, at least one hour before or two hours after food. The usual starting dose is 40 mg a day split into two doses, adjusted every 4 weeks up to 80 mg a day based on blood test results.
Common effects are headache, nausea, diarrhea, joint pain and sweating. Get urgent help for right-upper abdominal pain with fever or jaundice (possible gallstones), very high or low blood sugar, or a slow or irregular heartbeat, which need prompt medical review.
Mycapssa lowers the effectiveness of hormonal birth control, so use a backup non-hormonal method. Tell your provider about PPIs, antacids, cyclosporine, digoxin and diabetes medicines, since Mycapssa can change how well these work and needs monitoring.
Yes. Expect periodic checks of growth hormone and IGF-1 levels to guide dosing, plus gallbladder ultrasounds, thyroid function tests, blood glucose checks and vitamin B12 levels, since octreotide can affect all of these over time.
Mycapssa is a delayed-release oral capsule form of octreotide, while Sandostatin and Sandostatin LAR are injectable forms given by a healthcare provider. Mycapssa is only used to continue treatment after an injectable somatostatin analogue has already controlled the acromegaly.
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