OCTREOTIDE-TEVA POWDER AND SOLVENT FOR PR SUSPENSION FOR INJECTION 20MG/VIAL [SIN17361P]

Product Info

OCTREOTIDE-TEVA POWDER AND SOLVENT FOR PR SUSPENSION FOR INJECTION 20MG/VIAL

[SIN17361P]

Indication

4. INDICATIONS

Treatment of patients with acromegaly:

• who are adequately controlled on s.c. treatment with octreotide.

• in whom surgery or radiotherapy or dopamine agonist treatment is inappropriate or ineffective, or in the interim period until radiotherapy becomes fully effective (see DOSAGE AND ADMINISTRATION).

Treatment of patients with symptoms associated with functional gastro-entero-pancreatic endocrine tumors in whom symptoms are adequately controlled on s.c. treatment with octreotide:

• Carcinoid tumors with features of the carcinoid syndrome

• VIPomas.

• Glucagonomas.

• Gastrinomas/Zollinger-Ellison syndrome.

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

• GRFomas.

Treatment of patients with advanced Neuroendocrine Tumors of the midgut or unknown primary tumor location where non-midgut sites of origin have been excluded.

Dosing

5. DOSAGE REGIMEN AND ADMINISTRATION

Dosage regimen

General target population
Octreotide-Teva may only be administered by deep intragluteal injection. The site of repeat intragluteal injections should be alternated between the left and right gluteal muscle (see INSTRUCTIONS FOR USE AND HANDLING – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Acromegaly
For patients who are adequately controlled with s.c. octreotide, it is recommended to start treatment with the administration of 20 mg Octreotide-Teva prolonged release injection at 4-week intervals for 3 months. Patients on treatment with s.c. octreotide can start treatment with Octreotide-Teva the day after the last dose of s.c. octreotide. Subsequent dosage adjustment should be based on serum growth hormone (GH) and insulin-like growth factor 1/somatomedin C (IGF 1) concentrations and clinical symptoms.

For patients in whom, within this 3 month period, clinical symptoms and biochemical parameters (GH; IGF 1) are not fully controlled (GH concentrations still above 2.5 microgram/L), the dose may be increased to 30 mg every 4 weeks.

For patients whose GH concentrations are consistently below 1 microgram/L, whose IGF 1 serum concentrations normalized, and in whom most reversible signs/symptoms of acromegaly have disappeared after 3 months of treatment with 20 mg, 10 mg Octreotide may be administered every 4 weeks. However, particularly in this group of patients, it is recommended to closely monitor adequate control of serum GH and IGF 1 concentrations, and clinical signs/symptoms at this low dose of Octreotide.

For patients on a stable dose of Octreotide-Teva prolonged release injection, assessment of GH and IGF 1 should be made every 6 months.

Gastro-entero-pancreatic endocrine tumors

Treatment of patients with symptoms associated with functional gastro-entero- pancreatic neuroendocrine tumors
For patients in whom symptoms are adequately controlled with s.c. octreotide, it is recommended to start treatment with the administration of 20 mg Octreotide-Teva prolonged release injection at 4-week intervals. Patients on treatment with s.c. octreotide should continue at the previously effective dosage for 2 weeks after the first injection of Octreotide-Teva prolonged release injection. For patients who were not previously treated with s.c. octreotide, it is recommended to start with the administration of s.c. octreotide at a dosage of 0.1 mg three times daily for a short period (approximately 2 weeks) to assess the response and systemic tolerability of octreotide before initiating the treatment with Octreotide-Teva prolonged release injection as described above.

For patients in whom symptoms and biological markers are well controlled after 3 months of treatment, the dose may be reduced to 10 mg Octreotide every 4 weeks.

For patients in whom symptoms are only partially controlled after 3 months of treatment, the dose may be increased to 30 mg Octreotide-Teva prolonged release injection every 4 weeks.

For days when symptoms associated with gastro-entero-pancreatic tumors may increase during treatment with Octreotide-Teva prolonged release injection, additional administration of s.c. octreotide is recommended at the dose used prior to the Octreotide-Teva prolonged release injection treatment. This may occur mainly in the first 2 months of treatment until therapeutic concentrations of octreotide are reached.

Treatment of patients with advanced Neuroendocrine Tumors of the midgut or unknown primary tumor location

The recommended dose of Octreotide-Teva prolonged release injection is 30 mg administered every 4 weeks (see section PHARMACODYNAMICS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Treatment with Octreotide-Teva prolonged release injection for tumor control should be continued in the absence of tumor progression.

Special populations

Renal impairment
Impaired renal function did not affect the total exposure (AUC) to octreotide when administered s.c. octreotide. Therefore, no dose adjustment of Octreotide-Teva prolonged release injection is necessary.

Hepatic impairment
In a study with octreotide administered s.c. and i.v. it was shown that the elimination capacity may be reduced in patients with liver cirrhosis, but not in patients with fatty liver disease. Due to the wide therapeutic window of octreotide, no dose adjustment of Octreotide-Teva prolonged release injection is necessary in patients with liver cirrhosis.

Geriatric patients (65 years or above)
In a study with octreotide administered s.c., no dose adjustment was necessary in subjects ≥ 65 years of age. Therefore, no dose adjustment is necessary in this group of patients with Octreotide-Teva prolonged release injection.

Pediatric patients (below 18 years)
There is limited experience with the use of octreotide in children.

Contraindications

6. 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).