Instruction for use: Somatuline Autogel

ATX Code H01CB03 Lanreotide

Active substance: Lanreotide

Pharmacological group

Somatostatin, a synthetic analogue [Hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists]

Nosological classification (ICD-10)

C26 Malignant neoplasm of other and inaccurately indicated digestive organs

Bowel cancer, Gastrointestinal cancer, Carcinoid GI tract, Adenocarcinoma of the intestine, Cancer of other parts of the large intestine, Argentaffinoma, Carcinoid, Enterochromaffinoma, Cancer of the colon, Colon cancer

E22.0 Acromegaly and pituitary gigantism

Pituitary gigantism, Acromegaly, Dysfunction of growth hormone secretion

Composition

Gel for hypodermic administration of prolonged action 60 mg 1 syringe

Content (mg / syringe):

Lanreotide acetate 79.8 mg

(In terms of lanreotide - 65.4 mg) *

Excipients: water for injection - 186.2 mg

Total weight - 266 mg

Weight administered by injection - 244 mg

Injected dose of lanreotide *** - 60 mg

Gel for hypodermic administration of prolonged action 90 mg 1 syringe

Content (mg / syringe):

Lanreotide acetate 116.4 mg

(In terms of lanreotide - 95.4 mg) *

Excipients: water for injection - 271.6 mg

Total weight 388 mg

Mass administered by injection ** - 366 mg

Administered dose of lanreotide *** - 90 mg

Gel for hypodermic administration of prolonged action 120 mg 1 syringe

Content (mg / syringe):

Lanreotide acetate 155.5 mg

(In terms of lanreotide - 127.5 mg) *

Excipients: water for injection - 363 mg

Total weight 518.5 mg

Mass administered by injection ** - 488 mg

Administered dose of lanreotide *** - 120 mg

* The average content of base lantheotide in lanreotide acetate is 82%, the concentration of base lanreotide in the supersaturated solution is 24.6% (w / w)

** weight loss in the syringe is 22 mg for dosages of 60 mg and 90 mg and 30.5 mg for 120 mg

*** the amount delivered by injection of lanreotide

In a disposable syringe for 266 mg (for 60 mg), for 388 mg (for 90 mg) and 518.5 mg (for 120 mg); In a package (complete with a silanized needle); In a pack of cardboard 1 syringe.

pharmachologic effect

The pharmacological action is somatostatin-like.

Dosing and Administration

PC.

Acromegaly

The recommended initial dose is 60-120 mg every 28 days.

In patients who received somatulin® lyophilizate to prepare a suspension for IV administration of a prolonged action at a dose of 30 mg every 14 days, the initial dose of Somatulina® Autogel®, a gel for long-acting sequential administration, should be 60 mg every 28 days. In patients who received somatulin® at a dose of 30 mg every 10 days, the initial dose of Somatulina® Autogel® is 90 mg every 28 days. In patients who received somatulin® at a dose of 30 mg every 7 days, the initial dose of Somatulina® Autogel® is 120 mg every 28 days.

In the future, on average, after 3 injections with an interval of 28 days, the dose should be selected individually depending on the patient's response (which is evaluated on the basis of symptoms and / or a decrease in the level of growth hormone (GH) and / or insulin-like growth factor-1 IGF-1):

- The dose should be increased to 120 mg every 28 days, with a GH level above 2.5 ng / ml, maintaining a high level of IGF-1 and / or in the absence of control over clinical symptoms;

- Keep the dose unchanged, if the level of GH is 1-2.5 ng / ml, the level of IGF-1 is normal and control over clinical symptoms is achieved;

- should reduce the dose of the drug to 60 mg every 28 days, when the level of GH is below 1 ng / ml, the normalization of IGF-1 and the control of clinical symptoms.

Patients who have achieved effective control of the disease against somatostatin analogues can be assigned Somatulin® Autologel® at a dose of 120 mg with an increased interval every 42-56 days. These patients need to monitor regularly and in the long term clinical symptoms and the level of GH and IGF-1.

All patients are shown regular monitoring of clinical symptoms, GH level and IGF-1.

Carcinoid tumors

The recommended initial dose is 60-120 mg every 28 days.

In the future, the dose should be selected depending on the attained symptom reduction.

Patients who have achieved effective control of the disease against somatostatin analogues can be assigned Somatulin® Autologel® at a dose of 120 mg with an increased interval every 42-56 days.

Rules for the administration of the drug

Gel for the long-acting administration of a prolonged action in a pre-filled syringe is ready for use.

The drug should be injected deep immediately after opening the package.

1 syringe with the drug is intended for single administration only.

The drug is injected by medical personnel into the upper lateral quadrant of the buttock.

If the patient receives a stable dose of injections, they can be carried out at home by the patient or his relatives after preliminary appropriate training with the doctor. If the patient carries out the injection himself, the drug should be injected into the upper part of the thigh.

When administering the drug, the following information should be observed:

1. Remove Somatulin® Autologel® from the refrigerator 30 minutes before use.

2. Make sure there is a clean place for the preparations and wash your hands.

3. Before opening, check the integrity of the package in which the syringe containing the drug is placed. Then remove the syringe.

4. Remove the piston retainer and save it for safe concealment of the needle after injection.

5. Disinfect the site of the proposed injection (upper thigh or upper lateral quadrant of the buttock), avoiding rubbing the skin. The injection is done every time alternately, then in the left, then in the right buttock or thigh.

6. Remove the cap from the needle.

7. Insert the needle into the upper part of the thigh or the upper lateral quadrant of the buttock without grasping the skin fold. The needle should be inserted quickly, the entire length, perpendicular to the skin surface (deep SC injection).

8. Slowly introduce the entire preparation, applying constant even pressure to the piston, while leaving the needle stationary.

9. Do not rub and massage the injection site after injection.

10. After use, do not attempt to re-attach the protective cap to the needle, but it is necessary to hide it with the piston retainer.

11. Dispose of the syringe properly.

Do not use the drug if the syringe package was damaged or opened!

Storage conditions

At a temperature of 2-8 ° C (do not freeze). In a refrigerator.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiry date printed on the package.