Somatulin® (Somatuline®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceLanreotideLanreotide
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  • Somatulin®
    lyophilizate w / m 
    IPSEN PHARMA     France
  • Somatulin® Autologel®
    gel PC 
    IPSEN PHARMA     France
    • Dosage form: & nbsplyophilizate for the preparation of a suspension for intramuscular administration of prolonged action
    Composition:

    1 bottle contains:

    Active ingredient: lanreotide - 0.030 * g.

    Auxiliary components: copolymers (lactide-glycolide and lactide-glycol), mannitol, sodium carboxymethylcellulose, polysorbate 80.

    The composition of the solvent in the ampoule: mannitol, water for injection.

    * taking into account the characteristics of the dosage form, each bottle contains 0.040 g of lanreotide acetate corresponding to 0.030 g of lanreotide.

    Description:

    White or white lyophilizate with a creamy shade of color, dispersed in the applied solvent to form a white or white suspension with a creamy shade of color.

    Pharmacotherapeutic group:Somatostatin (synthetic analog)
    ATX: & nbsp

    H.01.C.B   Hormones that slow growth

    H.01.C.B.03   Lanreotide

    Pharmacodynamics:

    Somatulin is a synthetic peptide, an analogue of somatostatin (a natural hormone).

    Similar to natural somatostatin, lanreotide inhibits a number of endocrine, exocrine and paracrine mechanisms, has a more pronounced tropism to the peripheral somatostatin receptors (pituitary and pancreatic) than to the central ones.This is due to the selectivity of the action with respect to the secretion of growth hormone, glands of the intestine and pancreas. The drug inhibits the pathologically increased secretion of growth hormone, as well as the secretion of the glands of the intestine and pancreas.

    Pharmacokinetics:

    Absorption of lanreotide is characterized by the first phase of rapid release of the peptide located on the surface of the microspheres, which is replaced by a slow second release phase.

    The peak of the first phase (Cm1: 6.8 ± 3.8 μg / l) was recorded after 1.4 ± 0.8 hours and the peak of the second phase (Cm2: 2.5 ± 0.9 μg / L) after 1.9 ± 1.8 days. Absolute bioavailability is 46.1 ± 16.7%. The average retention time is 8 ± 1 days and the elimination half-life is 5.2 ± 2.5 days. These indicators confirm prolonged release of the drug.

    In patients with acromegaly, and in healthy individuals, pharmacokinetics is similar. In this case, the concentrations of growth hormone and insulin-like growth factor (IGF-1) decrease for at least 14 days after a single administration of the drug.

    With continuous administration of the drug for several months, cumulation is not noted. The study of binding of lanreotide with blood components showed that such an interaction is unlikely at this level.

    Indications:

    - Acromegaly;

    - carcinoid tumors (symptomatic therapy);

    - treatment of the fistula of the organs of the digestive tract, which arose as a result of surgical intervention.

    Contraindications:

    1. pregnancy;

    2. the period of breastfeeding;

    3. hypersensitivity to the components of the drug.

    Dosing and Administration:

    The drug is administered only intramuscularly (in / m) in specialized institutions and in strict accordance with this instruction.

    Treatment begins with a trial injection (in the case of its ineffectiveness, further therapy is impractical) and evaluate the response (dynamics of growth hormone growth, symptoms associated with a carcinoid tumor).

    Dosing regimen and duration of therapy are set individually for each patient.

    Begin 30 mg of the drug in / m 1 time in 14 days. If there is insufficient effectiveness, you can increase the frequency of the drug to 1 injection every 10 days.

    Treatment of organ fistulae the digestive tract

    Treatment is started with a trial intramuscular injection to evaluate the response. If the volume of discharge from the fistula is reduced by more than 50% within 72 hours after the injection, the drug is applied once every ten days, until the fistula is healed. Maximum number of additional injections - 3.In 50% of patients complete closure of the fistula is observed after 14 days.

    INSTRUCTION FOR PREPARATION AND INTRODUCTION OF THE PREPARATION

    Mixing of the lyophilizate with the applied solvent should be performed immediately before the injection by shaking the contents of the vial with smooth movements, rotating the bottle 20 or 30 times between the fingers until a homogeneous suspension of white or white with a creamy hue is obtained.

    Suspension should not be mixed with other drugs.

    1. Remove the cap from the needle with a pink nozzle and attach it to the syringe.

    2. Type all the solvent from the ampoule into the syringe.

    3. Remove the lid from the vial with lyophilizate, removing the blue plastic cover.

    4. Insert the needle through a stopper of chlorobutyl rubber and transfer the solvent into the bottle.

    5. Gently shake the contents by rotating the bottle 20 or 30 times between the fingers until a uniform suspension is obtained. Do not pump it back and forth.

    6. Do not flip the vial, put the entire suspension into the syringe.

    7. Remove the needle from the syringe. Push the syringe piston so that all air is out.

    8. Attach another needle with a pink nozzle. Injection should always be performed intramuscularly

    9. INJECTION SHOULD BE IMMEDIATELY


    Side effects:

    Local: itching, burning, moderate transient pain at the injection site, sometimes accompanied by hyperemia.

    On the part of the digestive system: diarrhea or mild stool, steatorrhoea, abdominal pain, flatulence, nausea, vomiting. With prolonged use of the drug, the formation of stones in the gallbladder (asymptomatic cholelithiasis).

    From the side of metabolism: in rare cases, there was an increase in glucose concentration, a change in glucose tolerance.

    Overdose:

    Symptoms: side effects from the gastrointestinal tract, electrolyte disturbances. Treatment: symptomatic.

    Interaction:

    With a simultaneous appointment with insulin, its hypoglycemic effect is enhanced, and therefore, the dose of insulin must be adjusted.

    With simultaneous administration with cyclosporine (oral), it is necessary to correct the dose of cyclosporine.

    Special instructions:

    When appointing somatulin to patients with diabetes mellitus (both type 1 and type 2), regular monitoring of blood glucose level should be carried out and, if necessary, correct dose of hypoglycemic drugs.

    In carcinoid tumors of the gastrointestinal tract, somatulin treatment is prescribed after removal of the existing intestinal obstruction by the tumor.

    In the treatment of acromegaly, careful monitoring of the pituitary gland is necessary.

    With prolonged treatment every 6 months, it is necessary to perform an ultrasound examination of the gallbladder.

    If there is a violation of the liver or kidneys, you need to adjust the dose of the drug.

    It is necessary to warn patients who are being treated with Somatulin about a possible violation of reproductive function, as well as about the advisability of using contraceptives during treatment with Somatulin and within 3 months after the end of treatment.

    Form release / dosage:Liofilizate for the preparation of a suspension for intramuscular administration of prolonged action of 30 mg.
    Packaging:

    30 mg lanreotide per bottle of slightly darkened hydrolytic glass type I (Hebrew F), sealed with a chlorobutyl rubber stopper under aluminum with a needle hole in the center and covered with a protective plastic cover of the first opening.

    2 ml of solvent in an ampoule of colorless hydrolytic glass type II (Hebrew F.).

    One empty sterile disposable polypropylene syringe with a capacity of 3 ml and two sterile disposable needles with tips (needle size 1.20 x 40 mm) in a blister pack of PVC and laminated paper.

    One vial of lanreotide, one ampoule of solvent, one blister pack with a syringe and two needles is placed in a cardboard box along with the instructions for use.

    Storage conditions:

    Store at temperatures between + 2 ° and + 8 ° C (in the refrigerator), out of the reach of children.

    List B.

    Shelf life:

    2 years. Do not use after the expiration date printed on the package.

    Shelf life of the preparation after mixing with the solvent and ready for use is 6 hours when stored under normal conditions (room temperature).

    Terms of leave from pharmacies:On prescription
    Registration number:П N010212 / 01
    Date of registration:31.05.2010
    The owner of the registration certificate:IPSEN PHARMA IPSEN PHARMA France
    Representation: & nbspIPSEN PHARMA IPSEN PHARMA France
    Information update date: & nbsp27.09.2015
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