Luveris^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Merck Serono, S.p.A. (Italy)

Manufactured By

Merck Serono S.A., Succursale d'Aubonne (Switzerland)

ATC Code

G03GA07 (Lutropin alfa)

Active Substance

Lutropin alfa (Rec.INN registered by WHO)

Dosage Form

Luveris®

Lyophilisate for preparation of solution for subcutaneous administration 75 IU: vial 1, 3 or 10 pcs. in set with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for subcutaneous administration in the form of a white powder or porous mass.

Excipients: sucrose, polysorbate 20, methionine, sodium phosphate dibasic dihydrate, sodium phosphate monobasic monohydrate, phosphoric acid, sodium hydroxide.

Solvent: water for injections (1 ml).

Glass vials with a volume of 3 ml (1) in a set with a solvent (amp./vial 1 pc.) – plastic containers (1) – cardboard packs.
Glass vials with a volume of 3 ml (3) in a set with a solvent (amp./vial 3 pcs.) – plastic containers (1) – cardboard packs.
Glass vials with a volume of 3 ml (10) in a set with a solvent (amp./vial 10 pcs.) – plastic containers (1) – cardboard packs.

Clinical-Pharmacological Group

Recombinant human luteinizing hormone

Pharmacotherapeutic Group

Follicle-stimulating agent

Pharmacological Action

Recombinant luteinizing hormone, identical to endogenous LH. It participates in the physiological regulation of reproductive function.

It compensates for the lack of endogenous LH. It stimulates estradiol production by the follicles and the formation of the Graafian follicle.

Administration of lutropin alfa in the middle of the cycle induces the process of corpus luteum formation and ovulation.

Administration of lutropin alfa in the postovulatory period supports the functioning of the corpus luteum.

Pharmacokinetics

After subcutaneous administration, Lutropin alfa is rapidly distributed in organs and tissues. The absolute bioavailability is about 60%.

It practically does not accumulate.

T_1/2 is about 12 hours.

It is excreted in the urine – less than 5% of the dose.

Indications

Treatment of infertility caused by hypothalamic-pituitary disorders leading to decreased levels of LH and FSH in the body.

ICD codes

Dosage Regimen

Administer Luveris^® by subcutaneous injection only.

Reconstitute the 75 IU lyophilisate immediately before use with the supplied 1 ml solvent (Water for Injections).

The initial dose is 75 IU of lutropin alfa per day.

Use this medication in combination with a follicle-stimulating hormone (FSH) preparation.

Adjust the dosage based on the individual ovarian response, as determined by ultrasound examination and estradiol level monitoring.

Do not administer human chorionic gonadotropin (hCG) to trigger final follicular maturation if there is a risk of ovarian hyperstimulation syndrome (OHSS).

The maximum duration of treatment in a single cycle is 5 weeks.

Discontinue treatment if there is no response after the first 2 weeks.

Cease Luveris^® administration when adequate follicular development is achieved, prior to the single injection of hCG.

Adverse Reactions

Frequently: headache, abdominal pain, breast pain, nausea, vomiting, drowsiness, ovarian cysts.

Possible: reactions at the injection site – pain, redness, skin itching, swelling, hematoma; ovarian hyperstimulation (pain in the lower abdomen, sometimes combined with nausea, vomiting, weight loss).

When using drugs containing LH, in rare cases, venous thrombosis, ovarian cyst torsion and bleeding into the abdominal cavity, ectopic pregnancy (especially with a history of primary fallopian tube damage) are possible.

Contraindications

Hypersensitivity to lutropin alfa; tumors of the hypothalamic-pituitary region, hyperprolactinemia, diseases of the adrenal glands and thyroid gland, persistent enlargement of the ovaries, ovarian cyst (not caused by the presence of polycystic ovary syndrome), polycystic ovaries, anomalies in the development of the 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 ovarian failure, pregnancy, lactation period.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during the lactation (breastfeeding) period.

Special Precautions

Before starting treatment, the fertility of the patient and her partner should be checked.

Lutropin alfa is used in combination with FSH to normalize the development of follicles containing eggs. The use of hCG leads to the release of eggs from the follicle (ovulation).

In case of development of ovarian hyperstimulation syndrome, hCG should not be used, and the patient should refrain from sexual intercourse or use barrier-type contraceptives for at least 4 days.

Before starting and during the course of treatment, careful monitoring of the ovarian response is necessary using ultrasound and blood tests.

An increase in the frequency of multiple pregnancy is observed. To minimize the likelihood of its occurrence, the dosing regimen recommended for the drug used should be followed.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.