Somatuline Autogel Dosage/Direction for Use

Initiation of treatment: Acromegaly: The recommended starting dose is 60 mg to 120 mg administered every 28 days.
For example: In patients previously treated with SOMATULINE P.R. 30 mg powder and solvent for prolonged-release suspension for injection (I.M.) every 14 days, the initial dose of Somatuline Autogel should be 60 mg every 28 days.
In patients previously treated with SOMATULINE P.R. 30 mg powder and solvent for prolonged-release suspension for injection (I.M.) every 10 days, the initial dose of Somatuline Autogel should be 90 mg every 28 days.
In patients previously treated with SOMATULINE P.R. 30 mg powder and solvent for prolonged-release suspension for injection (I.M.) every 7 days, the initial dose of Somatuline Autogel should be 120 mg every 28 days.
Neuroendocrine tumors: The recommended dose is 60 mg to 120 mg administered every 28 days. The dose should be adjusted according to the degree of symptomatic relief obtained.
Adaptation of treatment: The treatment should be adjusted for each patient in a specialized unit.
The dose should be individualized according to the response which is evaluated by monitoring plasma GH and IGF-1 levels and by assessing changes in symptoms.
Acromegaly: It is recommended: To reduce the dose when the concentrations are normalized GH <1 ng/ml and normalized IGF-1 and/or disappearance of clinical symptoms; To maintain the dose when the concentrations of the GH are between 2.5 ng/ml and 1 ng/ml; To increase the dose when the concentrations of GH are higher than 2.5 ng/ml.
Patients well controlled on a somatostatin analogue can be treated with Somatuline Autogel 120 mg every 42 or 56 days.
Treatment of clinical symptoms associated with carcinoid tumours: In case of insufficient response judged by clinical symptom (flushes and soft stools), the dose may be increased to 120 mg every 28 days (4 weeks).
In case of sufficient response judged by clinical symptom (flushes and soft stools), the dose may be decreased to 60 mg every 28 days (4 weeks).
Treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumours of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease: The recommended dose is one injection of Somatuline Autogel 120 mg administered every 28 days. The treatment should be continued for as long as needed for tumour control.
Renal and/or hepatic impairment: In patients with impaired renal or hepatic function, no dosage adjustment is necessary due to the wide therapeutic window of lanreotide.
Elderly patients: In elderly patients, no dosage adjustment is necessary.
Paediatric population: The safety and efficacy of Somatuline Autogel in children and adolescents has not been established.
Method of administration: The solution should be injected via the deep subcutaneous route in the superior external quadrant of the buttock.
The injection is made by healthcare professional. However, for patients receiving stable dose of Somatuline Autogel the product may be administered either by the patient or by a person around him after appropriate training by a healthcare professional. In case of self-injection, the injection should be given in the upper outer thigh.
The decision to allow administration by the patient or a trained person should be made by the healthcare professional.
Regardless of the site of injection, the skin should not be folded and the needle should be inserted rapidly to its full length, perpendicularly to the skin. The injection site should alternate between the right and left side.