PERGOVERIS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 150IU/75IU [SIN13990P]

Product Info

PERGOVERIS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 150IU/75IU

[SIN13990P]

Indication

Therapeutic indications
Pergoveris is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency.

In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 international units/l.

Dosing

Posology and method of administration
Treatment with Pergoveris should be initiated under the supervision of a physician experienced in the treatment of fertility problems.

Pergoveris is intended for subcutaneous administration. The powder should be reconstituted immediately prior to use with the solvent provided.

In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of Pergoveris therapy is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG). Pergoveris should be given as a course of daily injections. Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.

Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response. A recommended regimen commences with one vial of Pergoveris daily.
If less than one vial of Pergoveris daily is used, the follicular response may be unsatisfactory because the amount of lutropin alfa may be insufficient (see section on pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7–14 day intervals and preferably by 37.5–75 international units increments using a licensed follitropin alfa preparation. It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.

When an optimal response is obtained, a single injection of 5,000 international units to 10,000 international units hCG should be administered 24–48 hours after the last Pergoveris injection. The patient is recommended to have coitus on the day of, and on the day following, hCG administration. Alternatively, intrauterine insemination (IUI) may be performed.

Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.

If an excessive response is obtained, treatment should be stopped and hCG withheld. Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.

In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level <1.2 international units/l as measured in a central laboratory. However, it should be taken into account that there are variations between LH measurements performed in different laboratories. In these trials the ovulation rate per cycle was 70–75%.

Contraindications

Contraindications
Pergoveris is contraindicated in patients with:

• hypersensitivity to the active substances follitropin alfa and lutropin alfa or to any of the excipients

• case of tumours of the hypothalamus and pituitary gland

• ovarian enlargement or cyst not due to polycystic ovarian disease

• gynaecological haemorrhages of unknown aetiology

• ovarian, uterine or mammary carcinoma

Pergoveris must not be used when an effective response cannot be obtained, such as:

• primary ovarian failure

• malformations of sexual organs incompatible with pregnancy

• fibroid tumours of the uterus incompatible with pregnancy