Oczyesa

Posology The recommended dose is 20 mg octreotide every 4 weeks administered by a single subcutaneous injection. For patients transitioning from octreotide or lanreotide, patients should be instructed to take their first dose of Oczyesa at the end of the daily or monthly dosing interval of the previous treatment.

g. ). Monitoring of insulin-like growth factor-1 (IGF-1) levels and assessment of symptoms should be made periodically as per the clinician’s discretion. Discontinuation of Oczyesa and switching patients to another somatostatin analogue should be considered if IGF‑1 levels are not maintained after treatment with dose of 20 mg monthly or the patient cannot tolerate treatment with Oczyesa.

Missed dose If a dose is missed, the next dose of Oczyesa should be administered as soon as possible. Special populations Elderly No dose adjustment is required for elderly patients. 3 Hepatic impairment In patients with liver cirrhosis, the half-life of the medicinal product may be increased.

2). Renal impairment Oczyesa can be used in patients with mild, moderate, or severe renal impairment. 2). Paediatric population The safety and efficacy of octreotide in children below 18 years of age have not been established. No data are available.

Method of administration Subcutaneous use. Prior to initiation of Oczyesa, patients should be trained on proper injection technique. For complete administration instructions with illustrations, see the instructions for use at the end of the package leaflet.

Oczyesa should be injected subcutaneously in the abdomen, thigh or buttock. Patients should be instructed to rotate the injection site within or between injection areas.

Summary of the safety profile The most frequent adverse reactions reported during octreotide therapy include gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, and metabolism and nutritional disorders. The most commonly reported adverse reactions in clinical studies with other formulations of octreotide were diarrhoea, abdominal pain, nausea, flatulence, headache, cholelithiasis, hyperglycaemia and constipation.

g. decreased thyroid stimulating hormone [TSH], decreased total T4, and decreased free T4), loose stools, impaired glucose tolerance, vomiting, asthenia, and hypoglycaemia. Tabulated list of adverse reactions The following adverse reactions, listed in Table 1, have been accumulated from clinical studies and post- marketing safety experience with octreotide.

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000) very rare (< 1/10 000), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness. g. decreased TSH, decreased total T4, and decreased free T4) a Metabolism and nutrition disorders Hyperglycaemiaa Hypoglycaemiaa Glucose tolerance impaireda Anorexiaa Dehydrationa Nervous system disorders Headachea Dizzinessa Cardiac disorders Bradycardiaa Tachycardiaa 7 System organ class Very common Common Uncommon Frequency not known Respiratory, thoracic and mediastinal disorders Dyspnoeaa Gastrointestinal disorders Abdominal paina Constipationa Flatulencea Nauseaa Diarrhoeaa Abdominal distensiona Dyspepsiaa Vomitinga Steatorrhoeaa Faeces discoloureda Hepatobiliary disorders Cholelithiasisa Cholecystitis Hyperbilirubinaemiaa Pancreatitis acutea Hepatitis acutea Cholestatic hepatitisa, Cholestasisa Jaundicea Skin and subcutaneous tissue disorders Alopeciaa Pruritus Rasha Urticariaa Musculoskeletal and connective tissue disorders Arthralgia General disorders and administration site conditions Injection site reactionsb Asthenia Investigations Transaminases increaseda Increased alkaline phosphatase levelsa, Gamma-glutamyl transferase increased a a The adverse reactions and frequencies were established based on data from other octreotide products.

g. visual field defects), it is essential that all patients be carefully monitored. If evidence of tumour expansion appears, alternative procedures may be advisable. Women of childbearing potential 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 Thyroid function should be monitored in patients receiving prolonged treatment with octreotide. Hepatic function 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 before, and at about 6‑ to 12‑month intervals during octreotide 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. 8). 8). Insulin requirements of patients with Type 1 diabetes mellitus therapy may be reduced by administration of octreotide. In non-diabetics and Type 2 diabetics with partially intact insulin reserves, octreotide administration can result in postprandial increases in glycaemia.

8). 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 Oczyesa in patients who have a history of vitamin B12 deprivation.

1.