PERGOVERIS SOLUTION FOR INJECTION IN PRE-FILLED PEN (300 IU + 150 IU)/0.48 ML [SIN15711P]

Product Info

PERGOVERIS SOLUTION FOR INJECTION IN PRE-FILLED PEN (300 IU + 150 IU)/0.48 ML

[SIN15711P]

4.1 Therapeutic indications

Pergoveris is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

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

Posology

In LH and FSH deficient women, the objective of Pergoveris therapy is to promote follicular development followed by final maturation after the administration of human chorionic gonadotropin (hCG). Pergoveris should be given as a course of daily injections. If the patient is amenorrhoeic and has low endogenous oestrogen secretion, treatment can commence at any time.

A treatment regimen commences with the recommended dose of Pergoveris containing 150 international units r-hFSH/75 international units r-hLH daily. If less than the recommended dose daily is used, the follicular response may be unsatisfactory because the amount of lutropin alfa may be insufficient (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Treatment should be tailored to the individual patient’s response as assessed by measuring follicle size by ultrasound and oestrogen response.

If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7 to 14 day intervals and preferably by 37.5 to 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 250 micrograms of r-hCG or 5,000 international units to 10,000 international units hCG should be administered 24 to 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 or another medically assisted reproduction procedure may be performed based on the physician’s judgment of the clinical case.

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 (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations

Elderly
There is no relevant indication for the use of Pergoveris in the elderly population. Safety and efficacy of this medicinal product in elderly patients have not been established.

Renal and hepatic impairment
Safety, efficacy, and pharmacokinetics of this medicinal product in patients with renal or hepatic impairment have not been established.

Paediatric population
There is no relevant use of this medicinal product in the paediatric population.

Method of administration

Pergoveris is intended for subcutaneous administration. The first injection should be performed under direct medical supervision. Self-administration should only be performed by patients who are well motivated, adequately trained and with access to expert advice.

For instructions on the use of this medicinal product, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Pergoveris is contraindicated in patients with:

• hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• tumours of the hypothalamus and pituitary gland

• ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin

• gynaecological haemorrhages of unknown origin

• 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