va. The woman and her partner should be advised of the potential risks for the mother (pregnancy and delivery complications) and the neonate (low birth weight) before starting treatment. In women undergoing ART procedures the risk of multiple pregnancy is mainly related to the number of embryos transferred.
Ectopic pregnancy
Infertile women undergoing ART have an increased incidence of ectopic pregnancies. It is important to have early ultrasound confirmation that a pregnancy is intrauterine, and to exclude the possibility of extrauterine pregnancy.
Congenital malformations
The incidence 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 the higher incidence of multiple pregnancies.
Ovarian and other reproductive system neoplasms
There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility treatment. It is not established whether or not treatment with gonadotropins increases the risk of these tumours in infertile women.
Vascular complications
Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotropins, including Elonva. Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities. In women with generally recognized risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia, treatment with gonadotropins may further increase this risk. In these women the benefits of gonadotropin administration need to be weighed against the risks. It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies with Elonva and other medicines have been performed. Since corifollitropin alfa is not a substrate of cytochrome P450 enzymes, no metabolic interactions with other medicinal products are anticipated.
Elonva may cause a false positive hCG pregnancy test if the test is administered during the ovarian stimulation portion of the ART cycle. This may be due to cross-reactivity of some hCG pregnancy tests with the carboxy-terminal peptide of the beta subunit of Elonva.
4.6 Fertility, pregnancy and lactation
Pregnancy
In case of inadvertent exposure to Elonva during pregnancy, clinical data are not sufficient to exclude an adverse outcome of pregnancy. In animal studies reproductive toxicity has been observed (see preclinical safety data in section 5.3). The use of Elonva during pregnancy is not indicated.
Breast-feeding
The use of Elonva during breast-feeding is not indicated.
Fertility
Elonva is indicated for use in infertility (see section 4.1).
4.7 Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed.
Elonva may cause dizziness. Women should be advised that if they feel dizzy, they should not drive or use machines.
4.8 Undesirable effects
Summary of the safety profile
The most frequently reported adverse reactions during treatment with Elonva in clinical trials (N=2,397) are pelvic discomfort (6.0%), OHSS (4.3%, see also |
