Expiration date: 03/2026

The composition and form of issue:

Lyophilisate for preparation of solution for subcutaneous injection. 1 vial contains: lutropin Alfa 75 IU

excipients: sucrose, Polysorbate 20, methionine, sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate, phosphoric acid, sodium hydroxide 

solvent: water for injection 1 ml 

in glass vials of 3 ml (complete with the solvent in vials or ampoules) in a pack a cardboard 1, 3, 10 sets.

Description pharmaceutical form:

Lyophilisate for preparation of solution for p/to the introduction — powder or porous mass of white color.

Feature:

Recombinant LH, is identical to natural human hormone.

Pharmacokinetics:

After p/to the introduction of the drug is rapidly distributed to organs and tissues, the absolute bioavailability is approximately 60%. T1/2 about 12 hours Lutropin alpha has linear pharmacokinetic properties. Almost is not accumulated in the body. In the urine contains less than 5% of the administered dose.

Pharmacokinetics after a single injection is comparable to that after repeated administration of the drug Luveris.

Description pharmacological action:

Gonadotropin is involved in the physiological regulation of reproductive function. Compensates for the lack of LH in the body. Under its influence the stimulation of the formation of estradiol by the follicles. The introduction of LH in the middle of the menstrual cycle starts the process of formation of the corpus luteum and ovulation, introduction to postovulatory period supports the function of the corpus luteum.

Indications:

Treatment of infertility, due to hypothalamic-pituitary disorders that lead to lower levels of LH and FSH in the body.

Contraindications:

• hypersensitivity to the drug
  
• tumors of the hypothalamic-pituitary region
  
• hyperprolactinemia
  
• diseases of the adrenal glands and the thyroid gland
  
• ovarian cysts (not due to polycystic ovary syndrome)
  
• polycystic ovaries
  
• malformations of the reproductive organs (incompatible with normal pregnancy)
  
• fibroids of the uterus
  
• metrorrhagia (unknown etiology)
  
• estrogen tumors (ovarian cancer, uterine cancer, breast cancer)
  
• primary ovarian failure
  
• pregnancy
  
• lactation.
  

Application of pregnancy and breast-feeding:

The drug should not be taken during pregnancy and lactation.

Side effects:

From the digestive system: often — pain in the abdomen, nausea, vomiting.

CNS: frequently — headache, drowsiness.

Part of the reproductive system: often — pain in the breast, ovarian cysts. Treatment with FSH and LH with subsequent administration of human chorionic gonadotropin (hCG) can lead to ovarian hyperstimulation (symptoms of hyperstimulation are pain in the lower abdomen, possibly in combination with nausea, vomiting and weight loss). In rare cases, the use of such drugs was observed thrombosis of the veins, therefore, it is possible and the application of Luveris. Not described cases of torsion of ovarian cyst and bleeding into the abdominal cavity using the drug of Luveris, however, in rare cases, such violations occurred after treatment of human menopausal gonadotropin (hMG), extracted from the urine and containing LH. There is a possibility of ectopic pregnancy (especially in the primary lesion of fallopian tubes history).

Local reactions: possible pain, redness, itching, swelling, bruising.

Drug interactions:

You should not mix the Luveris with other drugs in the same syringe with the exception of follitropin alpha, because studies have shown that these two drugs can be mixed and enter at the same time without affecting the therapeutic activity.

Method of application and dose:

N/a. the Solution is prepared immediately before injection using solvent attached. Each vial is intended for single use.

The drug is administered every day for 3 weeks simultaneously with injections of FSH.

Usually begin with a dose of 75 IU of drug (1 FL.) along with 75 or 150 ME FSH. Depending on the ovarian response may increase the dose of FSH is approximately 37.5–75 ME every 7-14 days.

In some cases it is necessary to prolong the treatment up to 5 weeks.

Upon reaching the desired result within 24-48 h after the last injection of FSH and held a single injection of human chorionic gonadotropin (hCG) at a dose of 5000-10000 ME (or 250 mcg of recombinant hCG). It is recommended to have intercourse on the day of administration of hCG and the next day.

Alternatively can be used assisted reproductive technology. When excessive/redundant response, stop treatment and cancel the introduction of hCG. Treatment can be resumed over the next cycle with lower dosages of FSH than during the previous cycle.

Overdose:

The symptoms of overdose are unknown. There is a risk of ovarian hyperstimulation syndrome. A single-dose 40000 ME the drug was well tolerated and was not accompanied by severe side effects.

Special instructions:

Before treatment it is necessary to check the fertility patient and her partner. The concentration of LH in the blood was considered low if levels of endogenous hormone in serum was below 1.2 IU/L. the Drug is used in combination with FSH, to promote the growth and development of follicles containing egg cells. After that the treatment continues once the introduction of hCG, which causes ovulation.

The drug increases the risk of ovarian hyperstimulation syndrome. With careful selection of dose and adherence introduction the ovarian hyperstimulation syndrome rarely occurs. On the background of the drug is rarely a serious form of hyperstimulation, if the final maturation of the follicles is not assigned a drug containing hCG. Thus, it is important not to use hCG if you experience ovarian hyperstimulation syndrome, and to refrain from sexual intercourse or use barrier methods of contraception for at least 4 days.

The patient should be warned about discontinuing administration of the drug and seeking medical attention if you experience severe pain in the abdomen.

Must carefully monitor the response from the ovaries by ultrasound and blood tests before starting treatment and during it. Patients undergoing treatment increases the frequency of multiple pregnancies (mainly twins), the probability of which can be minimized, if you stick to the recommended doses and regimens.

If the patient has marked allergic reactions to similar drugs, should inform your doctor.

In that case, when the patient forgot to enter another dose of the drug Luveris, you cannot enter a double dose, contact the doctor.

Expiration date:

Solvent — 3 g.