Instruction for use: Luveris

ATX Code G03GA07 Lutropin alfa

Active substance: Lutropin alfa

Pharmacological group

Hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists

Nosological classification (ICD-10)

E23.7 Pituitary disease, unspecified

Interstitial-pituitary insufficiency, Infertility due to hypothalamic-pituitary dysfunction, Disruption of the pituitary gland, Insufficiency of the anterior lobe of the pituitary gland, Diagnosis of disorders of gonadotropic pituitary gland function, Cerebrohypophyseal disease

N97 Female infertility

Female infertility in anovulation, Hyperprolactinemic infertility, Hyperprolactinaemia with infertility, Endocrine infertility, Infertility due to hypothalamic-pituitary dysfunction, Infertility infertility, Infertility, Infertility on the background of hyperprolactinaemia, Functional infertility, Marriage is infertile, Infertility of ovarian genesis, Stimulation of the growth of a single follicle

Composition

Lyophilizate for the preparation of a solution for subcutaneous administration 75 IU 1 fl.

active substance:

Lutropin alfa 75 IU (3.4 μg)

Auxiliary substances: polysorbate 20 - 0.05 mg; Methionine 0.1 mg; Sodium hydrogen phosphate dihydrate - 0.825 mg; Sodium dihydrogen phosphate monohydrate - 0.052 mg; Sucrose 47.75 mg; Phosphoric acid - q.s .; Sodium hydroxide - q.s.

1 fl. With solvent contains: water for injection - 1 ml

Description of dosage form

Lyophilizate: lyophilized powder or porous mass of white color.

Solvent: clear, colorless liquid.

pharmachologic effect

Pharmacological action - estrogenic, luteinizing, follicle-stimulating.

Pharmacodynamics

Luveris® (lutropin alfa), recombinant LH (p-hLH), identical to human natural hormone, was created using biotechnological methods. He belongs to a family of hormones called gonadotropins, which are involved in the physiological regulation of reproductive function.

Luveris® compensates for the lack of LH in the body. Under the influence of Luveris ® stimulation of the formation of estradiol follicles occurs. Introduction Louversa in the middle of the cycle triggers the formation of the yellow body and ovulation. Introduction Luverisa ® in the postovulyatorny period supports the functioning of the yellow body.

Pharmacokinetics

After sc administration, the drug is quickly distributed to organs and tissues, the absolute bioavailability is approximately 60%; T1 / 2 for about 12 hours. Lutropin alfa has linear pharmacokinetic properties. The preparation practically does not accumulate in the body. The urine contains less than 5% of the administered dose. The pharmacokinetics of lutropin alfa after a single administration is comparable to that after repeated administration of the Luveris® preparation.

Indications

Treatment of infertility, caused by hypothalamic-pituitary disorders, leading to a decrease in the level of luteinizing and follicle-stimulating hormones in the body.

Contraindications

Increased sensitivity to lutropin alpha and to excipients,

Tumors of the hypothalamic-pituitary region;

Hyperprolactinemia;

Adrenal and thyroid gland diseases;

Persistent enlargement of the ovaries;

Ovarian cyst (not due to the presence of polycystic ovary syndrome);

Polycystic ovary;

Anomalies of development of genital organs (incompatible with the normal course of pregnancy);

Uterine fibroids;

Metrorrhagia (of unknown etiology);

Estrogen-dependent tumors (ovarian cancer, uterine cancer, breast cancer);

Primary failure of the ovaries;

pregnancy;

Lactation period.

pregnancy and lactation

The drug should not be taken during pregnancy and lactation.

Side effects

The most common side effects described are headache, abdominal pain, mammary glands, nausea, vomiting, drowsiness, and ovarian cysts.

In a number of cases, local manifestations were observed at the injection site (pain, redness, itching, swelling, and bruising). Treatment with FSH and LH with subsequent administration of hCG can lead to ovarian hyperstimulation. Symptoms of hyperstimulation are pain in the lower abdomen, possibly in combination with nausea, vomiting and weight loss. If a patient has severe abdominal pain in combination with the listed symptoms, no more injections should be done and the doctor should be consulted as soon as possible.

In rare cases, with the use of such drugs, vein thrombosis was observed, hence, it is possible with Luverisa®.

There have been no cases of torsion of the ovarian cyst and bleeding in the abdominal cavity with Luverisa®, but in rare cases such disorders occurred after treatment with human menopausal gonadotropin (hMG) isolated from urine and containing LH. Ectopic pregnancy may develop, especially in women with a history of primary tubal lesions. If the patient finds any side effects not mentioned above, she should consult a doctor.

Interaction

The patient should inform the doctor about all drugs (including OTC drugs) that she is currently or recently taking. Do not mix Luveris® with other medicinal substances in the same syringe, except foliotropin alfa. Studies have shown that these two drugs can be mixed and administered simultaneously, this does not affect their therapeutic activity.

Dosing and Administration

PC. The solution is prepared immediately before injection using the supplied solvent.

Each vial is for single use only. Usually Luveris® is administered every day for 3 weeks along with FSH injections. Typically, start with a dose of 75 IU Luveris® (1 fl.) Along with 75 IU or 150 IU of FSH. Depending on the response of the ovaries, an increase in the FSH dose of approximately 37.5-75 IU every 7-14 days is possible. In some cases it may be necessary to extend the treatment to 5 weeks.

When the desired result is achieved 24-48 hours after the last injection of Luveris® and FSH, a single injection of human HG (hCG) in a dose of 5000-10000 IU is carried out. It is recommended to have sexual contact on the day of administration of hCG and the next day. Alternatively, assisted reproductive technologies may be used.

If the answer is excessive / excessive, stop treatment and cancel the administration of hCG (see "Side Effects"). Treatment can be resumed during the next cycle using a lower FSH dose than during the previous cycle.

Overdose

Symptoms of an overdose of Luveris® are unknown. Single administration of up to 40,000 IU of lyutropin alfa was well tolerated and was not accompanied by severe side effects. Nevertheless, with an overdose, there is a possibility of the occurrence of the ovarian hyperstimulation syndrome (OSS).

special instructions

Before starting treatment, it is necessary to check the fertility of the patient and her partner. Concentration of LH in the blood is considered low, if the level of endogenous hormone in the blood serum is below 1.2 IU / L.

The drug is used in combination with FSH to promote the growth and development of follicles containing eggs. After this treatment is continued with a single administration of hCG, which leads to the release of ovules from the follicle (ovulation).

Treatment with this drug increases the risk of a condition called the ovarian hyperstimulation syndrome (see also "Side effects"). However, with careful selection of the dose and the regimen of administration, SHH occurs rarely. Treatment with Luveris® rarely causes a serious form of hyperstimulation unless a drug containing hCG is prescribed for the final maturation of the follicles. Thus, it is important not to take hCG in case of ovarian hyperstimulation syndrome and to abstain from sexual contacts or use contraceptive means of barrier type for at least 4 days. It is necessary to closely monitor the response from the ovaries with ultrasound and blood tests before and during the course of treatment. In patients undergoing treatment, the frequency of multiple pregnancies (mainly twins) and births increases. However, it can be minimized by adhering to the recommended dose and regimen.

If the patient has allergic reactions to similar drugs, she should inform her doctor about this. In the event that the patient forgot to enter the next dose of Luveris ®, you can not enter a double dose, but you should see a doctor.

Do not use the bottle if there are signs of damage to the drug, such as discoloration of the powder or damage to the bottle. The drug should be used immediately after dissolution. Do not inject the solution if it is opaque or contains solid particles.

If the patient enters Luveris® alone, she should carefully read and strictly follow the instructions below for the administration of the drug:

Wash the hands. It is important that the patient's hands and the objects that he uses are as clean as possible.

Prepare a clean surface and lay out everything you need on it:

- a thin needle for subcutaneous injection;

- one bottle of Luveris®;

- one vial with a solvent;

- Two tampons, moistened with alcohol;

- one syringe;

- one needle for dissolving the powder in the solvent;

- container for sharp objects for the safe disposal of glass parts and needles.

Remove the protective cap from the solvent bottle. Connect the mixing needle to the syringe and draw some air into it, pulling the piston to about 1 ml. Then insert the needle into the bottle, drown the piston to release air, and gently fill all the solvent. Carefully put the syringe on the work surface, trying not to touch the needle.

Prepare the injection solution: remove the protective cap of the vial with the preparation, take the syringe, pierce the rubber stopper and slowly introduce the solvent into the vial with the drug. Smoothly shake the bottle without removing the needle. Do not shake it. After the powder has dissolved (which usually occurs immediately), it is necessary to make sure that the resulting solution is transparent and does not contain solid particles.

Turn the vial and gently recruit the solution back into the syringe. You can also mix Louvers® and follitropin alfa as an alternative to the separate administration of each drug. After dissolving the Luveris® preparation, draw the solution back into the syringe and re-insert it into the container with the follitropin alfa preparation. Once the drug dissolves, draw the solution back into the syringe. Examine it for the presence of solid particles as in the previous case and do not use the solution if it is not transparent. In 1 ml of solvent can dissolve up to 3 fl. With the drug. Replace the needle with a thin one and release air bubbles: if air bubbles are visible in the syringe, point the needle up with a needle and gently knock on it until all the air accumulates at the top. Gently push the plunger to remove air. Introduce the solution immediately. The attending physician or nurse will advise where to inject (for example, in the forearm, the front surface of the thigh). Wipe the selected area with a swab dampened with alcohol. Collect the skin in a crease and insert the needle at an angle of 45-90 ° with a rapid movement. Administer the preparation under the skin. Do not enter the contents directly into the vein. Insert the solution by gently pressing the piston. Use as long as necessary to introduce the entire solution. Immediately after this, remove the needle and in a circular motion, wipe the skin with a swab dampened with alcohol.

Discard all used items: as soon as the drug is finished, immediately place all needles and empty glass containers in a container for sharp objects. Unused solution should be discarded.

Influence on driving and control of other mechanisms. Does not affect.

Form of issue

Lyophilizate for the preparation of a solution for subcutaneous administration of 75 IU. For 75 IU of lutropin alfa in bottles of colorless clear glass type I (Hebrew F.) with a capacity of 3 ml, sealed with a rubber stopper, sealed on top by an aluminum cap with a detachable plastic cap of the type "Flip off".

1 ml of solvent (water for injection) in bottles of colorless clear glass type I (Hebrew F) with a capacity of 2 ml, sealed with a rubber stopper, sealed on top by an aluminum cap with a detachable plastic lid of the type "Flip off".

1, 3 or 10 vials of lyophilizate, complete with a solvent (1, 3 or 10 vials) in a plastic container are placed in a cardboard box.

Terms of leave from pharmacies

On prescription.

Storage conditions

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf Life

2 years. Solvent - 3 g.

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