OCTRA SOLUTION FOR INJECTION 0.1 MG/ML [SIN17549P]

Product Info

OCTRA SOLUTION FOR INJECTION 0.1 MG/ML

[SIN17549P]

Indication

INDICATIONS

Symptomatic control and reduction of growth hormone (GH) and IGF-1 plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy.

Octreotide acetate treatment is also indicated for acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.

Relief of symptoms associated with functional gastro-entero-pancreatic (GEP) endocrine tumors:

• Carcinoid tumours with features of the carcinoid syndrome.

• VIPomas.

• Glucagonomas.

• Gastrinomas/Zollinger-Ellison syndrome, usually in conjunction with proton pump inhibitors, or H2-antagonist therapy.

• Insulinomas, for pre-operative control of hypoglycaemia and for maintenance therapy.

• GRFomas.

Octreotide acetate is not an anti-tumour therapy and is not curative in these patients.

Control of refractory diarrhoea associated with AIDS.

Prevention of complications following pancreatic surgery.

Emergency management to stop bleeding and to protect from re-bleeding owing to gastroesophageal varices in patients with cirrhosis. Octreotide acetate is to be used in association with specific treatment such as endoscopic sclerotherapy.

Dosing

DOSAGE REGIMEN AND ADMINISTRATION

Dosage Regimen

General target population

Acromegaly

Initially 0.05 to 0.1 mg by s.c. injection every 8 or 12 hours. Dosage adjustment should be based on monthly assessment of GH and IGF-1 levels (target: GH < 2.5 ng/mL; IGF-1 within normal range) and clinical symptoms, and on tolerability. In most patients, the optimal daily dose will be 0.3 mg. A maximum dose of 1.5 mg per day should not be exceeded. For patients on a stable dose of Octreotide acetate, assessment of IGF-1 and/or GH should be made every 6 months.

If no relevant reduction in IGF-1 and/or GH levels and no improvement in clinical symptoms have been achieved within 3 months of starting treatment with Octreotide acetate, therapy should be discontinued.

Gastro-entero-pancreatic endocrine tumours

Initially 0.05 mg once or twice daily by s.c. injection. Depending on clinical response, effect on levels of tumour-produced hormones (in cases of carcinoid tumours, on the urinary excretion of 5-hydroxyindole acetic acid), and on tolerability, dosage can be gradually increased to 0.1 to 0.2 mg 3 times daily. Under exceptional circumstances, higher doses may be required. Maintenance doses have to be adjusted individually.

In carcinoid tumors, if there is no beneficial response within 1 week of treatment with Octreotide acetate at the maximum tolerated dose, therapy should not be continued.

AIDS-related refractory diarrhoea

The data suggest that 0.1 mg 3 times per day by s.c. injection is the optimal starting dose. If diarrhoea is not controlled after 1 week of treatment, the dose should be titrated on an individual basis up to 0.25 mg 3 times per day. Dose adjustment should be based on assessment of stool output and on tolerability.

If within 1 week of treatment with Octreotide acetate at a dose of 0.25 mg 3 times per day no improvement is achieved, therapy should be discontinued.

Complications following pancreatic surgery

0.1 mg 3 times daily by s.c. injection for 7 consecutive days, starting on the day of operation at least 1 hour before laparotomy.

Bleeding gastro-oesophageal varices

25 microgram/hour for 5 days by continuous i.v. infusion. Octreotide acetate can be used in dilution with physiological saline.

In cirrhotic patients with bleeding gastro-oesophageal varices, Octreotide acetate has been well tolerated at continuous i.v. doses of up to 50 microgram/hour for 5 days (see section OVERDOSAGE – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations

Hepatic impairment

In patients with liver cirrhosis, the half-life of the drug may be increased, necessitating adjustment of the maintenance dosage.

Renal impairment

Impaired renal function did not affect the total exposure (AUC) to octreotide administered as s.c. injection, therefore no dose adjustment of Octreotide acetate is necessary.

Paediatric Patients (below 18 years)

Experience with Octreotide acetate in children is limited.

Geriatric Patients (65 years of age or above)

There is no evidence of reduced tolerability or altered dosage requirements in elderly patients treated with Octreotide acetate.

Contraindications

CONTRAINDICATIONS

Known hypersensitivity to octreotide or to any of the excipients, (see section DESCRIPTION AND COMPOSITION – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).