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Mycapssa is a brand name for Octreotide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.
Verbatim from this product's EMA label. Tap a section to expand.
Posology 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.
Missed dose 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. Special populations Elderly There is no evidence of reduced tolerability or altered dose requirements in elderly patients treated with octreotide.
Medicinal product no longer authorised 3 Hepatic impairment 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. Renal impairment 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.
Summary of the safety profile The most frequent adverse reactions reported during treatment with Mycapssa are mostly mild to moderate gastrointestinal disorders, with abdominal pain, diarrhoea, and nausea reported most frequently. The overall frequency of gastrointestinal adverse reactions is known to decrease over time with continued treatment.
Tabulated list of adverse reactions The adverse drug reactions (ADRs) listed below have been accumulated from clinical studies and post-marketing safety experience with octreotide. Medicinal product no longer authorised 7 Adverse drug reactions are listed by System Organ Class according to the following classification: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); and not known (cannot be estimated from the available data).
g. decreased thyroid stimulating hormone, decreased total T4, and decreased free T4)* Metabolism and nutrition disorders Hyper- glycaemia** Hypo- glycaemia**, impaired fasting glucose**, anorexia* Decreased appetite, diabetes mellitus, hypertriglyceridaemia, dehydration* Psychiatric disorders Agitation, anxiety, depression, disorientation, auditory hallucination, visual hallucination, insomnia, mood altered, mood swings Medicinal product no longer authorised 8 System organ class Very common Common Uncommon Post- marketing safety experience (frequency not known) Nervous system disorders Headache** Dizziness Burning sensation, carpal tunnel syndrome, disturbance in attention, dysgeusia, hypoaesthesia, memory impairment, paraesthesia, presyncope, sinus headache, somnolence, tremor Eye disorders Lacrimation increased Ear and labyrinth disorders Vertigo Cardiac disorders Bradycardia** Nodal arrhythmia, tachycardia* Cardiac disorder, arrhythmias* Vascular disorders Flushing, hypotension Respiratory, thoracic and mediastinal disorders Dyspnoea* Nasal mucosal disorder, throat irritation Gastrointestinal disorders Abdominal pain, diarrhoea nausea, constipation** , flatulence** Dyspepsia, vomiting, abdominal bloating*, steatorrhoea*, faeces soft**, faeces discoloured**, abdominal discomfort, abdominal distension, gastritis, gastro- oesophageal reflux disease Acute pancreatitis, change of bowel habit, dry mouth, faecal incontinence, faecal volume increased, frequent bowel movements, gastrointestinal disorder, gastrointestinal motility disorder, haemorrhoidal haemorrhage, odynophagia, oesophageal achalasia, parotid gland enlargement, rectal tenesmus Hepatobiliary disorders Chole- lithiasis** Cholecystitis* *, biliary sludge*, hyperbili- rubinaemia* Bile duct obstruction, jaundice, post cholecystectomy syndrome, biliary colic, gallbladder disorder, hepatic steatosis Acute hepatitis without cholestasis*, cholestatic hepatitis*, cholestasis*, cholestatic jaundice* Skin and subcutaneous tissue disorders Pruritus**, rash**, alopecia* Allergic dermatitis, hyperhidrosis, hypertrichosis Urticaria* Medicinal product no longer authorised 9 System organ class Very common Common Uncommon Post- marketing safety experience (frequency not known) Musculoskeletal and connective tissue disorders Arthralgia Back pain, bone pain, flank pain, groin pain, joint swelling, muscle spasms, musculoskeletal discomfort, musculoskeletal pain, myalgia, pain in extremity, soft tissue swelling General disorders and administration site conditions 1 Asthenia, fatigue, peripheral swelling Feeling abnormal, feeling of body temperature change, malaise, pain, tenderness, thirst Investigations Elevated liver function tests2 Blood creatine phosphokinase increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, cardiac murmur, heart rate irregular, insulin- like growth factor increased, lipase increased, thyroxine increased, weight decreased, weight increased Blood growth hormone increased * These adverse reactions were not observed with Mycapssa.
g. visual field defects), it is essential that all patients be carefully monitored. If evidence of tumour expansion appears, alternative procedures may be advisable. The therapeutic benefits of a reduction in GH levels and normalisation of IGF-1 concentration in female acromegalic patients could potentially restore fertility.
6). Thyroid function should be monitored in patients receiving prolonged treatment with octreotide. Hepatic function should be monitored during octreotide therapy. 8). 5). 8). Additionally, cases of cholangitis have been reported as a complication of cholelithiasis in patients receiving octreotide injections in the post-marketing setting.
Ultrasonic examination of the gallbladder at about 6- to 12-month intervals during Mycapssa therapy is recommended. Glucose metabolism Because of its inhibitory action on GH, glucagon, and insulin, octreotide may affect glucose regulation.
Post-prandial glucose tolerance may be impaired. As reported for patients treated with subcutaneous octreotide, in some instances, the state of persistent hyperglycaemia may be induced as a result of chronic administration. Hypoglycaemia has also been reported.
Insulin requirements of patients with type I diabetes mellitus therapy may be reduced by administration of octreotide. In non-diabetics and type II diabetics with partially intact insulin reserves, octreotide administration can result in postprandial increases in glycaemia.
It is therefore recommended to monitor glucose tolerance and antidiabetic treatment. Nutrition Octreotide may alter absorption of dietary fats in some patients. Depressed vitamin B12 levels and abnormal Schilling's tests have been observed in some patients receiving octreotide therapy.
Monitoring of vitamin B12 levels is recommended during therapy with Mycapssa in patients who have a history of vitamin B12 deprivation. Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially sodium-free.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Octreotide in European Union.
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Paediatric population The safety and efficacy of Mycapssa in children aged below 18 years have not been established. No data are available. Method of administration 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.
2).
Their frequencies were established based on data from injectable octreotide ** Very common or common adverse reactions reported more frequently for injectable octreotide versus Mycapssa 1 Injection site reactions were reported as very common ADR for injectable octreotide.
Since Mycapssa is for oral administration only, this ADR is not included in the table 2 For injectable octreotide, elevated transaminase levels were reported as common ADR, and increased alkaline phosphatase levels and gamma glutamyl transferase levels were reported post-marketing (frequency not known) Description of selected adverse reactions Gallbladder and related reactions Somatostatin analogues have been shown to inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder abnormalities or sludge.
If gallstones do occur, they are usually asymptomatic; symptomatic stones should be treated either by dissolution therapy with bile acids or by surgery. Cardiac disorders Bradycardia is an adverse reaction with somatostatin analogues.
ECG changes observed with octreotide include QT prolongation, axis shifts, early repolarisation, low voltage, R/S transition, early R wave progression, and non-specific ST-T wave changes. 4). Medicinal product no longer authorised 10 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is […]