LUVERIS Powder and solvent for solution for injection Ref.[8845] Active ingredients: Lutropin alfa

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

Posology

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

Luveris should be administered concomitantly with follitropin alfa.

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 at 75 IU of lutropin alfa (ie. one vial of Luveris) daily with 75-150 IU FSH.

In clinical trials, Luveris has been shown to increase the ovarian sensitivity to follitropin alfa. If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5 IU-75 IU 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 250 microgramsof r-hCG or 5,000 IU to 10,000 IU hCG should be administered 24-48 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) 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.

Special populations

Older people

There is no relevant indication for the use of Luveris in the elderly population. Safety and effectiveness of Luveris in elderly patients have not been established.

Renal and hepatic impairment

Safety, efficacy, and pharmacokinetics of Luveris in patients with renal or hepatic impairment have not been established.

Paediatric population

There is no relevant indication for the use of Luveris in the paediatric population.

Method of administration

Luveris is intended for subcutaneous use. The first injection of Luveris should be performed under direct medical supervision. The powder should be reconstituted immediately prior to use with the solvent provided. Self-administration of this medicinal product should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

The effects of an overdose of Luveris are unknown. Nevertheless there is a possibility that OHSS may
occur, which is further described in section 4.4.

Single doses of up to 40,000 IU of lutropin alfa have been administered to healthy female volunteers
without serious adverse reactions and were well tolerated.

Management

Treatment is directed to symptoms.

3 years.

Do not store above 25°C.

Store in the original package in order to protect from light.

The powder is packaged in 3 ml neutral colourless glass (type I) vials. The vials are sealed with bromobutyl stoppers protected by aluminium seal rings and flip-off caps. The solvent is packaged either in 2 or 3 ml neutral colourless glass (type I) vials with a Teflon-coated rubber stopper or in 2 ml neutral colourless glass (type I) ampoules.

Packs of 1, 3 or 10 vials with the corresponding number of solvent vials or ampoules. Not all pack sizes may be marketed.

For immediate and single use following first opening and reconstitution.

The powder must be reconstituted with the solvent before use by gentle swirling. The reconstituted solution should not be administered if it contains particles or is not clear.

Luveris may be mixed with follitropin alfa and co-administered as a single injection.

In this case Luveris should be reconstituted first and then used to reconstitute the follitropin alfa powder.

In order to avoid the injection of large volumes, one vial of Luveris can be reconstituted together with one or two ampoule(s)/vial(s) of follitropin alfa, 37.5 IU, 75 IU or 150 IU, in 1 ml of solvent.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.