SOMATULINE AUTOGEL Solution for injection Ref.[8589] Active ingredients: Lanreotide

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 a reduction in GH and/or IGF-1 levels).

For patients in whom clinical symptoms and biochemical parameters are not adequately controlled (GH concentrations still above 2.5 ng/ml (approximately 5 mU/L) or IGF-1 greater than (age matched) normal), the dose of Somatuline Autogel may be increased to a maximum of 120 mg at 28 day intervals.

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 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 symptoms associated with neuroendocrine tumours

The recommended starting dose is 60 to 120 mg administered every 28 days.

The dose should be adjusted according to the degree of symptomatic relief obtained.

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.

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 a healthcare professional.

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

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

If overdose occurs, symptomatic management is indicated.

2 years.

After opening the protective laminated pack, the product should be administered immediately.

Store in a refrigerator between 2°C-8°C. Store in the original package in order to protect from light.

Once removed from the refrigerator, product left in its sealed pouch may be returned to the refrigerator (the number of temperature excursions must not exceed three times) for continued storage and later use, provided it has been stored for no longer than a total of 24 hours at below 40°C.

Somatuline Autogel is supplied in a pre-filled syringe (polypropylene) fitted with an automatic safety system with a plunger stopper (bromobutyl rubber) and a needle (stainless steel) covered by a plastic cap.

Each ready to use pre-filled syringe is placed into a plastic tray and packed in a laminated pouch and a cardboard box.

Box of one 0.5 ml pre-filled syringe with one needle (1.2 mm x 20 mm).

The solution for injection in a pre-filled syringe is ready for use.

For immediate and single use following first opening.

It is important that the injection of the product is performed exactly according to the instructions in the package leaflet.

Do not use if the laminated pouch is damaged or opened.

The used injection device should be disposed of in a designated sharps container.