Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Amryt Pharmaceuticals DAC, 45 Mespil Road, Dublin 4, Ireland
Mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.
Treatment may be initiated anytime following the last somatostatin analog injection and before the next injection would have been administered. The injectable somatostatin analogue should be discontinued. Treatment should be initiated at 40 mg daily, administered as 20 mg twice daily. During dose titration, insulin-like growth factor 1 (IGF-1) levels and the patient’s signs and symptoms should be monitored every 2 weeks or as per clinician discretion, based on which dose adjustments should be considered. The dose should be increased in increments of 20 mg daily to obtain adequate control. Doses of 60 mg daily should be administered as 40 mg in the morning and 20 mg in the evening. Doses of 80 mg daily should be administered as 40 mg in the morning and 40 mg in the evening. The maximum recommended dose is 80 mg daily.
For patients receiving a stable dose of Mycapssa, monitoring of IGF-1 and assessment of symptoms should be made periodically per clinician discretion.
Discontinuation of Mycapssa and switching patients to another somatostatin analogue should be considered if IGF-1 levels are not maintained after treatment with the maximum recommended dose of 80 mg daily or the patient cannot tolerate treatment with Mycapssa.
If a dose of Mycapssa is missed the dose should be taken as soon as possible and at least 6 hours prior to the next scheduled dose, otherwise the missed dose should not be taken.
There is no evidence of reduced tolerability or altered dose requirements in elderly patients treated with octreotide.
No dose adjustment is necessary in patients with Child Pugh A or B. Patients with Child Pugh C have not been studied; careful monitoring of these patients when initiating treatment with Mycapssa is recommended. In patients with liver cirrhosis, the half-life of the medicinal product may be increased, necessitating adjustment of the maintenance dose.
No dose adjustment is necessary in patients with mild, moderate, or severe renal impairment. There is a significant increase in octreotide exposure in patients with end stage renal disease (ESRD). Patients with ESRD should start taking Mycapssa 20 mg daily. The maintenance dose should be adjusted based on IGF-1 levels, patient’s signs and symptoms, and tolerability.
The safety and efficacy of Mycapssa in children aged below 18 years have not been established. No data are available.
Oral use.
Mycapssa capsules should be swallowed whole with a glass of water, at least 1 hour before or at least 2 hours after eating any food. To minimise variability in the individual patient it is recommended to have a routine intake of Mycapssa capsules in relation to food every day (for example, Mycapssa should be routinely taken at least 1 hour before breakfast and at least 2 hours after dinner) (see section 5.2).
A limited number of accidental overdoses of octreotide injections in adults and children have been reported. In adults, the doses ranged from 2,400-6,000 micrograms/day administered by continuous infusion (100-250 micrograms/hour) or subcutaneously (1,500 micrograms three times a day). The adverse events reported were arrhythmia, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatic steatosis, diarrhoea, weakness, lethargy, weight loss, hepatomegaly, and lactic acidosis.
In children, the doses ranged from 50-3,000 micrograms/day administered by continuous infusion (2.1-500 micrograms/hour) or subcutaneously (50-100 micrograms). The only adverse event reported was mild hyperglycaemia.
No unexpected adverse events have been reported in cancer patients receiving subcutaneous octreotide at doses of 3,000-30,000 micrograms/day in divided doses.
The management of overdose is symptomatic.
3 years.
Store in a refrigerator (2°C–8°C). Do not freeze.
Mycapssa may be kept out of refrigeration for up to 1 month, at a temperature not above 25℃, after which the medicinal product must be discarded.
Polychlorotrifluoroethylene [PCTFE]/polyethylene [PE]/polyvinylchloride [PVC]-aluminium blisters.
Pack size of 28 gastro-resistant hard capsules.
Patients should be instructed to gently remove capsules from the blister. Patients should press gently on top or bottom of a capsule; not press in the middle of a capsule as this could damage it. If a capsule is cracked or broken, patients should be advised to throw it away and remove a new capsule.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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