Elonva is a solution for injection that contains the active substance Corifollitropin alfa. It is available as a pre filled syringe ( 100 and 150 micrograms ).
Elonva is used in women who are undergoing fertility treatment to stimulate the development of more than one mature egg at time in the ovaries. It is used together with a gonadotrophin releasing hormone ( GnRH ) antagonist ( a type of medicine also used in fertility treatments ).
Elonva is given once as a single injection under the skin in a dose of 100 or 150 micrograms, depending on age and body weight.
The patient or their partner may carry out the injection if they have been properly instructed.
Four or five days after the Elonva injection, depending on how the ovaries have responded, treatment is started with a GnRH antagonist, which prevents the ovaries from releasing their eggs too early.
Seven days after the Elonva injection, if further ovarian stimulation is needed, injections of another medicine similar to Elonva, but suitable for daily injection, may be given.
Finally, as soon as three eggs are close to maturation, a single injection of a hormone called human chorionic gonadotropin ( hCG ) is given to release the mature eggs.
The eggs are collected using a surgical procedure. They will then be fertilised in a laboratory and the resulting embryo is implanted in the womb.
The active substance in Elonva, Corifollitropin alfa, is similar to follicle stimulating hormone ( FSH ), a natural hormone in the body. FSH stimulates the production of eggs in the ovaries.
In Corifollitropin alfa, a peptide is attached to the FSH to prolong its activity in the body.
As a result a single dose of the medicine can be given to stimulate egg production for seven days, thereby replacing daily injections that would be required with other FSH medicines.
Corifollitropin alfa is produced by a method known as recombinant DNA technology. This means that it is made by cell into which a gene ( DNA ) has been introduced that makes them able to produce Corifollitropin alfa.
In three main studies involving 3.29 women who needed to have ovarian stimulation, Elonva treatment was compared with treatment with Follitropin beta ( an FSH medicine also used to stimulate the ovaries ).
One of the studies involved women weighing 60 kg or less who received a 100 microgram dose of Elonva, and a second study involved women weighing above 60 kg who received a 150 microgram dose.
Both these studies involved women aged 18 to 36 years. The main measure of effectiveness for these studies was the average number of eggs collected from each woman after treatment.
The study in women over 60 kg had an additional main effectiveness measure which was the number of women with a successful early pregnancy.
The third study involved women in the age range 35 to 42 years weighing 50 kg or more who were given a 150 microgram dose of Elonva; the main measure of effectiveness in this study was the number of women with a successful early pregnancy.
Treatment with Elonva was as effective as treatment with Follitropin beta.
In the first study in women weighing 60 kg or less, the number of eggs collected from each woman was 13.3 for those treated with Elonva and 10.6 for those treated with Follitropin beta.
In the second study in women weighing above 60 kg, the average number of eggs collected from each woman was 13 in those treated with Elonva compared with 12 in those treated with Follitropin beta. Around 39% of those who received Elonva became pregnant compared with 38% of those treated with follitropin beta. In the third study in women weighing 50 kg or more 24 and 27% of women treated with Elonva and Follitropin beta respectively became pregnant.
The most common side effects with Elonva ( seen in between 1 and 10 patients in 100 ) are headache, nausea, tiredness, pelvic pain and discomfort, breast tenderness and ovarian hyperstimulation syndrome ( OHSS ).
OHSS occurs when the ovaries over respond to treatment, causing abdominal swelling and pain, nausea and diarrhoea.
Elonva must not be used in patients with tumours of the ovary, breast, womb, pituitary ( a gland located at the base of the brain that produces FSH ) or hypothalamus ( a region of the brain ).
It must also not be used in women with abnormal ( not-menstrual ) bleeding from the vagina without a known cause, primary ovarian failure, enlarged ovaries or ovaries with cysts, polycystic ovarian syndrome or in women with a history of OHSS. ( Xagena )
Source: EMA, 2015