SOMATULINE AUTOGEL PROLONGED RELEASE SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 120 MG [SIN14289P]

Product Info

SOMATULINE AUTOGEL PROLONGED RELEASE SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 120 MG

[SIN14289P]

4.1 Therapeutic Indications
For the long-term treatment of individuals with acromegaly when the circulating levels of Growth Hormone (GH) and/or Insulin-like Growth Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy or in patients who require medical treatment. The goal of treatment in acromegaly is to reduce GH and IGF-1 levels and where possible to normalize these values.
For the relief of symptoms associated with acromegaly.
For the reduction of the symptoms associated with carcinoid syndrome.
For the 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.

4.2 Posology and Method of Administration

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;

Carcinoid tumours
The recommended starting dose is 60 mg to 120 mg administered every 28 days.
The dose should be adjusted according to the degree of symptomatic relief obtained.

Gastroenteropancreatic Neuroendocrine Tumours
The recommended dose is one injection of Somatuline® Autogel® 120 mg administered every 28 days. The treatment with Somatuline® Autogel® 120 mg should be continued for as long as needed for tumour control.

Adaptation of treatment

The treatment should be adjusted for each patient in a specialised unit.
The dose should be individualised 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 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 be treated with Somatuline® Autogel® 120 mg every 42 or 56 days.

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

Carcinoid tumours
In case of an insufficient response judged by clinical symptom (reduction in episodes of flushing or diarrhoea), the dose may be increased to 120 mg every 28 days (4 weeks). In case of a sufficient response judged by clinical symptom (reduction in episodes of flushing or diarrhoea), 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.

Elderly patients
In elderly patients, no dosage adjustment is necessary.

Paediatric population
Somatuline® Autogel® is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.

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. The injection is made by healthcare professional. However, for patients who receive a 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 made in the upper outer thigh.
The decision of administration by the patient or another trained person should be taken 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.

4.3 Contraindications
Hypersensitivity to the active substance, somatostatin or related peptides or to any of the excipients listed in the excipients list – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.