LUVERIS FOR INJECTION 75 IU/VIAL (REVISED FORMULA) [SIN12507P]

Product Info

LUVERIS FOR INJECTION 75 IU/VIAL (REVISED FORMULA)

[SIN12507P]

Therapeutic indications

Luveris® in association with a follicle stimulating hormone (FSH) preparation is Indicated for the stimulation of follicular development in women with severe LH and FSH deficiency. (See clinical efficacy section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Posology and method of administration

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

Self-administration of Luveris® should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.

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

All clinical experience to date with Luveris® in this indication has been gained with concomitant administration of follitropin alfa.

Luveris® is intended for subcutaneous administration. The injection site should be alternated daily. The powder should be reconstituted, immediately prior to use, with the solvent provided.

A recommended regimen commences at 75 international units of lutropin alfa (ie. one vial of Luveris®) daily with 75–150 international units FSH. Treatment should be tailored to the individual patient’s response as assessed by measuring (i) follicle size by ultrasound and (ii) oestrogen response.

In clinical trials, Luveris has been shown to increase ovarian sensitivity to follitropin alfa. If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7 to 14 day intervals and preferably by 37.5 international units to 75 international units increments. 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 to 48 hours after the last Luveris® and FSH injections. The patient is recommended to have coitus on the day of, and on the day following, hCG administration.

Alternatively, intrauterine insemination (IUI) or another medically assisted reproduction procedure may be performed based on the physician’s judgement 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.

Contraindications

Luveris® is contraindicated in patients with:

• hypersensitivity to gonadotrophins or to any of the excipients.

• ovarian, uterine, or mammary carcinoma;

• active, untreated tumours of the hypothalamus and pituitary gland;

• ovarian enlargement or cyst not due to polycystic ovarian disease;

• gynaecological haemorrhages of unknown origin

Luveris must not be used when a condition exists which would make a normal pregnancy impossible, such as:

• primary ovarian failure

• malformations of sexual organs incompatible with pregnancy

• fibroid tumours of the uterus incompatible with pregnancy