Elonva 100 and 150 micrograms solution for injection.
1. Name of the medicinal product
Elonva 100 micrograms solution for injection
Elonva 150 micrograms solution for injection
2. Qualitative and quantitative composition
Elonva 100 micrograms solution for injection
Each pre-filled syringe contains 100 micrograms of corifollitropin alfa* in 0.5 mL solution for injection.
Elonva 150 micrograms solution for injection
Each pre-filled syringe contains 150 micrograms of corifollitropin alfa* in 0.5 mL solution for injection.
*corifollitropin alfa is a glycoprotein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Excipient(s) with known effect:
This medicinal product contains less than 1 mmol (23 mg) sodium per injection, i.e., essentially 'sodium-free'.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection (injection).
Clear and colourless aqueous solution.
4. Clinical particulars
4.1 Therapeutic indications
Elonva is indicated for Controlled Ovarian Stimulation (COS) in combination with a Gonadotropin Releasing Hormone (GnRH) antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program.
4.2 Posology and method of administration
Treatment with Elonva should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Posology
In the treatment of women of reproductive age, the dose of Elonva is based on weight and age.
- A single 100-microgram dose is recommended in women who weigh less than or equal to 60 kilograms and who are 36 years of age or younger.
- A single 150-microgram dose is recommended in women:
- who weigh more than 60 kilograms, regardless of age.
- who weigh 50 kilograms or more and who are older than 36 years of age.
Women older than 36 years of age who weighed less than 50 kilograms were not studied.
Body Weight
Less than 50 kg
50 – 60 kg
More than 60 kg
Age
36 years or younger
100 micrograms
100 micrograms
150 micrograms
Older than 36 years
Not studied.
150 micrograms
150 micrograms
The recommended doses of Elonva have only been established in a treatment cycle with a GnRH antagonist that was administered from stimulation day 5 or day 6 onwards (see also sections 4.1, 4.4, and 5.1).
Stimulation day 1:
Elonva should be administered as a single subcutaneous injection, preferably in the abdominal wall, during the early follicular phase of the menstrual cycle.
Stimulation day 5 or 6:
Treatment with a GnRH antagonist should be started on stimulation day 5 or day 6 depending on the ovarian response, i.e. the number and size of growing follicles. The concurrent determination of serum oestradiol levels may also be useful. The GnRH antagonist is used to prevent premature Luteinising Hormone (LH) surges.
Stimulation day 8:
Seven days after the injection with Elonva on stimulation day 1, COS treatment may be continued with daily injections of (recombinant) Follicle Stimulating Hormone [(rec)FSH] until the criterion for triggering final oocyte maturation (3 follicles ≥ 17 mm) has been reached. The daily dose of (rec)FSH may depend on the ovarian response. In normal responders a daily dose of 150 IU (rec)FSH is advised. Administration of (rec)FSH on the day of human Chorionic Gonadotropin (hCG) administration can be omitted, de