Do not use Elonva if you
- are allergic (hypersensitive) to corifollitropin alfa or any of the other ingredients of Elonva (for a list of all ingredients, see Section 6)
- have cancer of the ovary, breast, womb, or brain (pituitary gland or hypothalamus)
- have recently had unexpected vaginal bleeding, other than menstrual, without a diagnosed cause
- have ovaries that do not work because of a condition called primary ovarian failure
- have ovarian cysts or enlarged ovaries
- have had ovarian hyperstimulation syndrome (OHSS), see below for further explanation
- have previously had a treatment cycle of controlled stimulation of the ovaries that resulted in the growth of more than 30 eggs with a size of 11 mm or larger
- have a basal antral follicle count (the number of small follicles present in your ovaries at the beginning of a menstrual cycle) higher than 20
- have malformations of the sexual organs which make a normalpregnancy impossible
- have fibroids in the womb which make a normal pregnancy impossible
Take special care with Elonva
Ovarian hyperstimulation syndrome (OHSS)
Treatment with gonadotropic hormones like Elonva may cause ovarian hyperstimulation syndrome (OHSS). This is a condition where the eggs growing in the ovaries become larger than normal. This may be noticed as severe abdominal swelling and pain in the stomach (abdomen), feeling sick or diarrhoea. Therefore, close supervision by your doctor is very important. To check the effects of treatment, ultrasound scans of the ovaries are usually made, and blood or urine samples may be regularly taken (see also Section 4).
You may use Elonva only once during the same treatment cycle, as otherwise the chance of having OHSS may increase.
Before starting to use this medicine, it is important to inform your doctor if you:
- ever had ovarian hyperstimulation syndrome (OHSS)
- have polycystic ovarian syndrome (PCOS)
- have kidney disease.
Treatment with gonadotropic hormones like Elonva may (just as pregnancy) increase the chance of having a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, which occurs most often in the legs or the lungs.
Please discuss this with your doctor, before starting treatment, especially if:
- you know you already have an increased chance of having a thrombosis
- you, or anyone in your immediate family, have ever had a thrombosis
- you are severely overweight.
Multiple births or birth defects
There is an increased chance of having twins or even more than two babies if more than one embryo is transferred back into the womb. Multiple pregnancies carry an increased health risk for both the mother and her babies. Multiple pregnancies and specific characteristics of couples with fertility problems (e.g. age) may also be associated with an increased chance of birth defects.
If treatment with Elonva results in pregnancy, there is a higher chance of pregnancy outside the womb (an ectopic pregnancy) in women with damaged fallopian tubes (the tubes which carry the egg from the ovary to the womb). Therefore, your doctor should perform an early ultrasound examination to exclude the possibility of pregnancy outside the womb.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
You should not use Elonva if you are already pregnant, or suspect that you might be pregnant, or if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Elonva may cause dizziness. If you feel dizzy, you should not drive or use machines.
Important information about some of the ingredients of Elonva
This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ?sodium-free?.