Pergoveris 150/75 IU/IU

Trade Name

Pergoveris®

International Nonproprietary Name

None

Dosage Form

Lyophilized powder for solution for injection supplied with solvent

Composition

One vial contains

active substances: follitropin alfa 150 IU (equivalent to 11 mcg), lutropin alfa 75 IU (equivalent to 3 mcg),

excipients: sucrose, polysorbate 20, methionine, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dihydrate, concentrated phosphoric acid, sodium hydroxide.

Solvent – water for injection.

Description

White or almost white lyophilized cake.

Pharmacotherapeutic Group

Sex hormones and modulators of the genital system. Gonadotropins and other ovulation stimulants. Gonadotropins.

ATC code G03GA

Pharmacological Properties

Pharmacokinetics

When administered in combination, no pharmacokinetic interaction between follitropin alfa and lutropin alfa is observed, and the pharmacokinetic parameters of the individual substances remain unchanged.

Follitropin alfa

Following subcutaneous administration, the absolute bioavailability of follitropin alfa is approximately 70%. Following repeated administration, follitropin alfa accumulates and steady state is reached within 3–4 days. One eighth of the administered dose of follitropin alfa is excreted in the urine.

In women with suppressed endogenous gonadotropin secretion, follitropin alfa effectively stimulates follicular development and steroidogenesis despite immeasurably low levels of luteinizing hormone.

Lutropin alfa

Following subcutaneous administration, the absolute bioavailability of lutropin alfa is approximately 60%, and the mean terminal half-life is approximately 18 hours. The pharmacokinetic parameters of lutropin alfa following single and repeated administration are comparable, and the degree of accumulation of lutropin alfa is minimal.

Pharmacodynamics

Pergoveris® is a medicinal product containing follicle-stimulating hormone (follitropin alfa, recombinant FSH) and luteinizing hormone (lutropin alfa, recombinant LH), produced using recombinant DNA technology.

The primary action of FSH is to induce folliculogenesis and is mediated through its effect on the granulosa cells of the developing ovarian follicle, whereas LH is involved in increasing estradiol production by mature follicles, inducing ovulation, and promoting the formation and function of the corpus luteum, thereby supporting early pregnancy.

During stimulation of follicular growth in women with anovulation and LH and FSH deficiency, the primary effect of lutropin alfa administration is an increase in estradiol secretion by follicles whose growth is stimulated by follitropin alfa.

Indications for Use

— stimulation of follicular development in women with severe luteinizing hormone and follicle-stimulating hormone deficiency (hypogonadotropic hypogonadism)

Method of Administration and Dosage

Treatment with Pergoveris® should be initiated under the supervision of a physician experienced in the treatment of infertility.

The medicinal product is intended for subcutaneous administration. The powder should be dissolved in the solvent supplied in the package immediately before administration.

Pergoveris® is administered as a course of daily injections. Treatment is recommended to begin with the contents of 1 vial per day (150 IU of follitropin alfa and 75 IU of lutropin alfa). Since the medicinal product is used to treat patients with amenorrhea and low endogenous estrogen secretion, treatment may be started at any time.

Treatment should be adjusted according to the individual patient’s response, which is assessed by ultrasound examination of follicular size and measurement of blood estradiol levels.

If an increase in the FSH dose is required, the dose should preferably be increased at 7–14-day intervals by 37.5 IU–75 IU using an approved follitropin alfa medicinal product. Within any single treatment cycle, the duration of stimulation may be extended up to 5 weeks.

Once an optimal ovarian response has been achieved, a single dose of 5,000–10,000 IU of human chorionic gonadotropin (hCG) or 250 mcg of recombinant hCG should be administered 24–48 hours after the last Pergoveris® injection. The patient is advised to have sexual intercourse on the day of hCG administration and on the following day. Alternatively, intrauterine insemination may be performed.

Luteal phase support may be required during treatment, since a deficiency of substances with luteotropic activity (LH/hCG) after ovulation may lead to premature corpus luteum insufficiency.

If an excessive response is observed, treatment should be discontinued and hCG administration should be withheld. In the following cycle, treatment should be initiated with a lower FSH dose than in the previous cycle.

If the patient administers Pergoveris herself, she should carefully read and strictly follow the instructions below:

• Wash your hands. It is important that your hands and all items to be used are as clean as possible.
• Prepare a clean surface and place the following items on it: one vial of Pergoveris, one vial of solvent, one syringe, one needle for preparing the solution, one fine needle for subcutaneous administration, two alcohol swabs, and a container for used glassware and needles.