SCIOTIDE LAI POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION 30MG/VIAL [SIN17379P]

Product Info

SCIOTIDE LAI POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION 30MG/VIAL

[SIN17379P]

Indication

4.1 Therapeutic indications

Treatment of patients with acromegaly

• who are adequately controlled on subcutaneous 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 section 4.2).

Treatment of patients with symptoms associated with functional gastro-entero-pancreatic endocrine tumours in whom symptoms are adequately controlled on subcutaneous treatment with octreotide:

• carcinoid tumours 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 tumours of the midgut or unknown primary tumour location where non-midgut sites of origin have been excluded.

Dosing

4.2 Posology and method of administration

Posology
General Target Population
SCIOTIDE LAI 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 section 6.7 – 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 SCIOTIDE LAI at 4-week intervals for 3 months. Patients on treatment with s.c. octreotide can start treatment with SCIOTIDE LAI 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 SCIOTIDE LAI 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 SCIOTIDE LAI.

For patients on a stable dose of SCIOTIDE LAI, assessment of GH and IGF-1 should be made every 6 months.

Gastro-entero-pancreatic endocrine tumours

Treatment of patients with symptoms associated with functional gastro-entero-pancreatic neuroendocrine tumours

For patients in whom symptoms are adequately controlled with s.c. octreotide, it is recommended to start treatment with the administration of 20 mg SCIOTIDE LAI 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 SCIOTIDE LAI. 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 SCIOTIDE LAI 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 SCIOTIDE LAI 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 SCIOTIDE LAI every 4 weeks.

For days when symptoms associated with gastro-entero-pancreatic tumours may increase during treatment with SCIOTIDE LAI, additional administration of s.c. octreotide is recommended at the dose used prior to the SCIOTIDE LAI 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 Tumours of the midgut or unknown primary tumour location

The recommended dose of SCIOTIDE LAI is 30 mg administered every 4 weeks (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Treatment with SCIOTIDE LAI for tumour control should be continued in the absence of tumour progression.

Special Populations
Patients with impaired renal function
Impaired renal function did not affect the total exposure (AUC) to octreotide when administered s.c. Therefore, no dose adjustment of SCIOTIDE LAI is necessary.

Patients with impaired hepatic function
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 SCIOTIDE LAI 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 SCIOTIDE LAI.

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

Contraindications

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.