Lutropyn alpha | Luveris bottle, 75 IU

Release form

Lyophilisate for solution preparation

Pharmacological action

Luveris (lutropin alfa), a recombinant LH (r-hLH) identical to the natural human hormone, was created using biotechnological methods. It 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 Louveris, the formation of estradiol by the follicles is stimulated. The introduction of Luveris in the middle of the cycle starts the process of yellow body formation and ovulation. The introduction of Luveris in the post-ovulatory period supports the functioning of the corpus luteum.

Indications

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

Contraindications

Tumors of the hypothalamic-pituitary region.

Hyperprolactinemia.

Diseases of the adrenal gland and thyroid gland.

Ovarian cyst (not caused by polycystic ovary syndrome).

Polycystic ovary.

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

Uterine Fibromyoma.

Metrorrhagia (unexplained etiology).

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

Primary ovarian failure.

Pregnancy.

Lactation.

Hypersensitivity to the drug.

Use during pregnancy and lactation

The drug should not be taken during pregnancy and lactation.

Composition

1 vial contains:

Active ingredient: lutropin alfa 75 IU (3.4 μg)

Excipients: 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 - qs sodium hydroxide - qs

Solvent: water d / i - 1 ml.

Dosage and administration

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

Each vial is for single use only. Typically, Luveris® is administered every day for 3 weeks in parallel with FSH injections. As a rule, they start with a dose of 75 IU of the drug Luveris® (1 vial) together with 75 IU or 150 IU FSH. Depending on the response of the ovaries, an increase in FSH dose of approximately 37.5–75 IU is possible every 7–14 days. 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 CG (hCG) is carried out at a dose of 5000–10000 IU. It is recommended that you have sex on the day of hCG administration and the next day. As an alternative, assisted reproductive technologies can be used.

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

Side effects of

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

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

In rare cases, with the use of such drugs, vein thrombosis was observed, therefore, this is possible with Luveris®.

There are no cases of torsion of the ovarian cyst and bleeding into the abdominal cavity when using Luveris®, however, in rare cases, such violations occurred after treatment with human menopausal gonadotropin (hMG), isolated from urine and containing LH. An ectopic pregnancy may develop, especially in women with a history of primary damage to the fallopian tubes. If the patient finds any side effects not mentioned above, she should consult a doctor.

Drug Interaction

The patient should be informed by the physician of any medication (including over-the-counter) that she is currently taking or has recently taken. Do not mix Louveris® with other medicines in one syringe except follitropin alfa. Studies have shown that these two drugs can be mixed and administered at the same time, this does not affect their therapeutic activity.

overdose

The symptoms of an overdose of the drug Louveris® are unknown. Single administration of up to 40,000 IU lytropin alfa was well tolerated and was not accompanied by severe side effects. However, overdose is likely to cause ovarian hyperstimulation syndrome (CSF).

Storage conditions

In the dark place at a temperature of no higher than 25 РC, in the original packaging.

Keep out of the reach of children.

Shelf suitability

3 Year

Terms of sale of

pharmacies Prescription

dosage form

Dosage form

solution for injections

Merck Serono, Switzerland