Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Self-injections of FOSTIMON should be performed only by motivated, trained and well informed patients. Prior to self-injections, the patient must be shown how to perform a subcutaneous injection, showing her where the injection can be given and how to prepare the solution to be injected. The first injection of FOSTIMON should be performed under direct medical supervision.

Particularly, in patients with known hypersensitivity to gonadotropins anaphylactic reactions might occur. In these patients, the first injection of FOSTIMON should be performed by a physician in settings with facilities for cardio-pulmonary resuscitation.

Before starting the treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, for which appropriate specific treatments are given.
Multiple Pregnancies
In patients undergoing ART procedures the risk of multiple pregnancies is related mainly to the number of replaced embryos. In patients undergoing a treatment for ovulation induction the incidence of multiple pregnancies and births is increased as compared to natural conception. The majority of multiple conceptions are twins. To minimize the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.

Unwanted ovarian hyperstimulation
In the treatment of female patients, ultrasonographic assessment of follicular development, and determination of oestradiol levels should be performed prior to treatment and at regular intervals during treatment. Apart from the development of a high number of follicles, oestradiol levels may rise very rapidly, e.g. more than a daily doubling for two or three consecutive days, and possibly reaching excessively high values. The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound examination. If this unwanted ovarian hyperstimulation occurs (i.e. not as part of controlled ovarian hyperstimulation in medically assisted reproduction programs), the administration of FOSTIMON should be discontinued. In that case pregnancy should be avoided and hCG must be withheld, because it may induce, in addition to multiple ovulation, the ovarian hyperstimulation syndrome (OHSS). Clinical symptoms and signs of mild ovarian hyperstimulation syndrome are abdominal pain, nausea, diarrhoea, and mild to moderate enlargement of ovaries and ovarian cysts. In rare cases severe ovarian hyperstimulation syndrome occurs, which may be life- threatening. This is characterised by large ovarian cysts (prone to rupture), ascites, often hydrothorax and weight gain. In rare instances, venous or arterial thromboembolism may occur in association with OHSS (see section 4.8).

Pregnancy wastage
The incidence of spontaneous miscarriage is higher in patients treated with FSH than in the general population, but it is comparable to the incidence found in women with other fertility disorders.

Ectopic pregnancy
Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.

Reproductive system neoplasms
There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment. It is not yet established if treatment with gonadotropins increases the baseline risk of these tumors in infertile women.

Congenital malformation
The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions. This is thought to be due to differences in parental characteristics (e.g.
maternal age, sperm characteristics) and multiple pregnancies.

Thromboembolic events
Women with generally recognised risk factors for thromboembolic events, such as personal or family history, severe obesity (Body Mass Index > 30 kg/m2) or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins. In these women, the benefits of gonadotropin administration need to be weighed against the risks (see section 4.8).
Infectious diseases
When medicinal products prepared from human urine are administered, the possibility of transmitting infective agents cannot be totally excluded.
This also applies to unknown or emerging viruses and other pathogens.
However, this risk is limited by the extraction/purification process, which includes viral inactivation/removal steps. These steps have been validated using model viruses, and particularly HIV, Herpes virus and Papillomavirus.
Up to now there is reassuring clinical experience with follitropin products regarding the lack of virus transmission associated with the administration of gonadotropins extracted from human urine.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

Effects on Driving

4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
However, FOSTIMON is unlikely to have influence on the patient’s performance to drive and use machines.