Instruction for use: Lutropin alfa (Lutropinum alfa)

Pharmacological group

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

Code CAS15923-57-4

Pharmacotherapy

Recombinant LH, has a gonadotropic effect: it stimulates ovulation in women with suppressed endogenous secretion of gonadotropin, stimulates growth and maturation of ovarian follicles, replenishes the deficit of LH. Application in the middle of the cycle contributes to the formation of the yellow body and ovulation, in the period after ovulation - supports the functioning of the yellow body.

Pharmacokinetics

Bioavailability with n / k introduction - 60%, quickly distributed to organs and tissues. Pharmacokinetic parameters are linear in nature, do not change with repeated administration. It is excreted by the kidneys, less than 5% unchanged. T1 / 2 - 12 hours. Does not cumulate.

Indication

Infertility in women due to hypothalamic-pituitary dysfunctions (decreased levels of LH and FSH).

Contraindications

Hypersensitivity, hypothalamic-pituitary tumors, hyperprolactinemia, decompensated thyroid and adrenal gland pathology, persistent enlargement of the ovaries and / or ovarian cyst (not caused by the presence of polycystic ovary syndrome), polycystic ovary syndrome, abnormalities of genital organs (incompatible with normal pregnancy), fibromyoma Uterine, uterine bleeding of unclear etiology, estrogen-dependent tumors (ovarian cancer, uterine cancer, breast cancer), primary failure ovarian cancer, pregnancy, lactation.

Dosing

S / w, the solution is prepared immediately before injection using the supplied solvent. Each vial is for single use only. Enter daily for 3 weeks (in some cases up to 5 weeks) together with FSH injections.

Initial doses are 75 IU of lutropin alfa (1 vial) and 75 IU or 150 IU of FSH. Depending on the changes in the state, it is possible to increase the FSH dose by 37.5-75 IU every 7-14 days.

When the desired result is achieved 24-48 hours after the last injection of lutropin alfa and FSH, a single injection of human HG in a dose of 5-10 thousand ME is carried out. The patient is recommended to have sexual contact on the day of administration of HC and the next day. The auxiliary reproduction methods may be used alternatively.

If the effect of hyperstimulation occurs, treatment should be discontinued and HG injection should be stopped. Treatment can be resumed during the next cycle using a lower FSH dose than during the previous cycle.

Side effect

Often: headache; abdominal pain in the breast; Nausea, vomiting, drowsiness, ovarian cyst; Rarely - ovarian hyperstimulation syndrome (abdominal pain, nausea, vomiting, weight loss), vein thrombosis, ovarian cyst torsion and abdominal cavity bleeding, ectopic pregnancy (in women with a history of fallopian tube disease); At the injection site - pain, redness, itching, swelling and bruising.

Overdose

Symptoms: the development of the ovarian hyperstimulation syndrome is possible.

Interaction

Pharmaceutically it is not compatible with other drugs, except for foliotropin alfa.

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. With the appointment of HG, the probability of the occurrence of a syndrome of ovarian hyperstimulation increases, therefore, when an excessive estrogenic reaction occurs, HC is not prescribed, patients are advised to abstain from coition or use contraceptive means of barrier type for at least 4 days. With careful selection of the dose and the regimen of administration, the ovarian hyperstimulation syndrome occurs rarely.

Before and during the course of treatment, careful monitoring of the ovarian response with ultrasound and blood tests is necessary. In patients undergoing treatment, the frequency of multiple pregnancy (mainly twins) and childbirth increases.

If you miss the introduction of a regular dose of the drug, you can not enter a double dose.

Do not use the vial when changing the color of the powder or damage to the vial. The drug should be used immediately after dissolution. Do not inject the solution if it is opaque or contains solid particles.