MYRELEZ Solution for injection Ref.[50169] Active ingredients: Lanreotide

Posology

Acromegaly

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

The dose may be varied according to the patient’s response (judged by symptomatology and/or biochemical effect) or by the patient’s possible experience with somatostatin analogues.

For example, in patients previously treated with lanreotide 30 mg with a dose every 14 days, the initial dose of Myrelez should be 60 mg every 28 days, and in patients previously treated with lanreotide 30 mg with a dose every 10 days, the initial dose of Myrelez should be 90 mg 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, the dose of Myrelez may be increased to a maximum of 120 mg at 28-day intervals.

If complete control is obtained (based on GH levels under 1 ng/ml, normalised IGF1 levels and/or disappearance of symptoms), the dose may be decreased.

Patients well controlled on a somatostatin analogue can alternatively be treated with Myrelez 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 Myrelez 120 mg administered every 28 days. The treatment with Myrelez 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

Myrelez is not recommended for use in children and adolescents due to lack of data on safety and efficacy.

Method of administration

Myrelez 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 Myrelez, 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 aluminum pouch, the product should be administered immediately.

Store in a refrigerator (2°C–8°C) in the original package in order to protect from light.

The product can, provided it has been stored in the sealed pouch at a maximum temperature of 40°C for up to a total of 24 hours, be returned to the refrigerator (the number of temperature fluctuations must not exceed three) for continued storage and later use.

Myrelez is supplied in a pre-filled syringe (polypropylene with thermoplastic elastomer rubber plunger stopper sealed with polypropylene cap) placed in a plastic tray and sealed inside an aluminum pouch and a separately packed automatic single use needle-safe device. Both are packaged inside a cardboard box.

Box of one 0.5 mL syringe with one co-packaged safety needle (1.2 mm x 20 mm).

Multipack with 3 boxes, each containing one 0.5 mL syringe with one co-packaged safety needle (1.2 mm x 20 mm).

Not all pack sizes may be marketed.

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

For immediate and single use following first opening. Do not use if the pouch is damaged or opened. It is important that the injection of the product is performed exactly according to the instructions in the package leaflet.

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

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.