Mycapssa (octreotide (oral capsules))

The first oral somatostatin analog for acromegaly, a capsule form of octreotide, the same medicine long given by injection. FDA-approved in June 2020 for long-term maintenance in adults who have already responded to and tolerated injectable octreotide or lanreotide, it lets suitable patients control the disease with a pill instead of regular injections.

Because it is the same molecule as injectable octreotide, the side effects are similar. The most common are gastrointestinal, diarrhea, nausea, abdominal discomfort, and headache, which are often most noticeable early and tend to ease over time. Longer-term somatostatin-analog use is associated with gallstones (cholelithiasis), so doctors may monitor the gallbladder. Octreotide can also affect blood sugar (raising or lowering it) and slow the heart rate, so blood sugar and thyroid function are checked from time to time, and doses of heart-rate-lowering drugs such as beta blockers may need adjusting^[5]. The label also warns about fatty, loose stools from poor fat absorption and about changes in vitamin B12 levels, so B12 is checked during treatment.

Taken by mouth as 20 mg capsules on an empty stomach, at least 1 hour before or 2 hours after a meal, twice daily. The typical starting dose is 40 mg per day (20 mg in the morning and 20 mg in the evening), and the dose can be titrated up to a maximum of 80 mg per day based on IGF-1 levels and symptoms, and people with end-stage kidney disease start at 20 mg once a day. Swallow the capsules whole with a glass of water. Heartburn and acid medicines, such as proton pump inhibitors like omeprazole, H2 blockers and antacids, can lower how much Mycapssa you absorb, so a higher dose may be needed. Mycapssa can also make combined birth control pills less effective, so the label advises a non-hormonal or backup method^[5].

Yes, Octreotide (oral capsules) (Mycapssa) is FDA approved (2020) for the treatment of Acromegaly.

Mycapssa is an oral capsule form of octreotide and the first oral somatostatin analog for acromegaly. The FDA approved it on June 26, 2020 for long-term maintenance treatment in adults who have already responded to and tolerated injectable octreotide or lanreotide, letting suitable patients control the disease with a pill instead of regular injections. Mycapssa is now marketed by Chiesi Global Rare Diseases. ^[1][2]

Mycapssa is taken by mouth as 20 mg capsules twice daily on an empty stomach, at least 1 hour before or 2 hours after a meal. The typical starting dose is 40 mg per day (20 mg in the morning and 20 mg in the evening), and the dose can be increased to a maximum of 80 mg per day based on IGF-1 levels and symptoms. Acid medicines can lower absorption, and Mycapssa can make combined birth control pills less effective. ^[5]

Because Mycapssa is the same molecule as injectable octreotide, the side effects are similar: the most common are diarrhea, nausea, abdominal discomfort and headache, which are often most noticeable early and tend to ease over time. Longer-term somatostatin-analog use is associated with gallstones, so doctors may monitor the gallbladder. Octreotide can also raise or lower blood sugar and slow the heart rate, and the label warns about fatty, loose stools from poor fat absorption and about changes in vitamin B12 levels, so B12 is checked during treatment. ^[3]

FDA approval of Mycapssa in June 2020 was based on the Phase 3 CHIASMA OPTIMAL trial, a randomized, double-blind, placebo-controlled study in adults with acromegaly already controlled on injectable somatostatin analogs. Of those switched to the capsules, 58% kept a normal IGF-1, compared with 19% of those switched to placebo. A second Phase 3 study, MPOWERED, compared the capsules against continued injectable therapy and found they maintained biochemical response with a safety profile consistent with the injectable drugs. ^[5][6]