Posology : מינונים

4.2 Posology and method of administration
Posology

Acromegaly
The recommended starting dose is 60 mg to 120 mg administered every 28 days. The dose should be individualised according to the response of the patient (as judged by a reduction in symptoms and/or reduction in GH and/or IGF-1 levels).

It is recommended:
-   to reduce the dose when the concentrations are normalised (GH < 1 ng/ml and normalised IGF-1 and/or disappearance of clinical symptoms),
-   to maintain the dose when the concentrations of 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 alternatively be treated with Somatuline Autogel 120 mg every 42 - 56 days (6 to 8 weeks).

Long term monitoring of symptoms, GH and IGF-1 levels should be routinely carried out in all patients.

Treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumours (GEP-NETs) 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 with Somatuline Autogel should be continued for as long as needed for tumour control.

Treatment of clinical symptoms associated with Carcinoid tumours
The recommended starting dose is 90 mg every 28 days (4 weeks) during 2 months.
In case of an insufficient response judged by clinical symptoms (flushes and soft stools), the dose may be increased to 120 mg every 28 days (4 weeks).
In case of a sufficient response judged by clinical symptoms (flushes and soft stools), the dose may be decreased to 60 mg every 28 days (4 weeks).

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 (see section 5.2).

Elderly patients
In elderly patients, no dosage adjustment is necessary due to the wide therapeutic window of lanreotide (see section 5.2).

Paediatric population
The safety and efficacy of Somatuline Autogel in children and adolescents has not been established.

Method of administration
Somatuline Autogel is administered by deep subcutaneous injection in the superior external quadrant of the buttock or in the upper outer thigh.


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For patients who receive a stable dose of Somatuline Autogel, and after appropriate training, the product may be administered either by the patient or by a trained person. In case of self-injection the injection should be given in the upper outer thigh.

The decision regarding administration by the patient or a trained person should be taken by healthcare professional.

Regardless of the injection site, the skin should not be folded and the needle should be inserted rapidly to its full length, perpendicularly to the skin.

Inject the drug slowly using a constant pressure on the plunger and without moving the needle. Typically 20 seconds are needed. Inject the full dose until the plunger cannot be depressed any further. At this point, you will hear or feel a “click”. Once you hear or feel the “click”, maintain pressure on the plunger with your thumb to avoid activation of the automatic safety system until the needle has been fully withdrawn from the patient.

The injection site should alternate between the right and left side.