. 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 7-14 day intervals and preferably by 37.5-75 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 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa and lutropin alfa injections. The patient is recommended to have coitus on the day of, and on the day following, hCG administration. Alternatively, IUI may be performed.
Luteal phase support may be considered since lack of substances with luteotropic 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.
Men with hypogonadotropic hypogonadism
Follitropin alfa should be given at a dose of 150 IU three times a week, concomitantly with hCG, for a minimum of 4 months. If after this period, the patient has not responded, the combination treatment may be continued; current clinical experience indicates that treatment for at least 18 months may be necessary to achieve spermatogenesis.
Special population
Elderly population
There is no relevant use of follitropin alfa in the elderly population. Safety and effectiveness of follitropin alfa in elderly patients have not been established.
Renal or hepatic impairment
Safety, efficacy and pharmacokinetics of follitropin alfa in patients with renal or hepatic impairment have not been established.
Paediatric population
There is no relevant use of follitropin alfa in the paediatric population.
Method of administration
Ovaleap is intended for subcutaneous use. 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 have access to expert advice.
As the multidose cartridge is intended for several injections, clear instructions should be provided to the patients to avoid misuse of the medicine.
The Ovaleap cartridge is designed for use in conjunction with the Ovaleap Pen only, which is separately available. For instructions on the administration with the Ovaleap Pen, see section 6.6.
4.3 Contraindications
• Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed in section 6.1;
• tumours of the hypothalamus or pituitary gland;
• ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome;
• gynaecological haemorrhages of unknown aetiology;
• ovarian, uterine or mammary carcinoma.
Ovaleap 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;
• primary testicular insufficiency.
4.4 Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product should be clearly recorded in the pat |
