ELONVA Solution for injection Ref.[7198] Active ingredients: Corifollitropin alfa

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.

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 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, depending on the ovarian response. In general, adequate follicular development is achieved on average by the ninth day of treatment (range 6 to 18 days).

As soon as three follicles ≥17 mm are observed, a single injection of 5,000 up to 10,000 IU hCG is administered the same day or the day thereafter to induce final oocyte maturation. In case of an excessive ovarian response, see the recommendations given in section 4.4 in order to reduce the risk for developing ovarian hyperstimulation syndrome (OHSS).

Special populations

Renal impairment

No clinical studies have been performed in patients with renal insufficiency. Since the rate of elimination of corifollitropin alfa may be reduced in patients with renal insufficiency, the use of Elonva in these women is not recommended (see sections 4.4 and 5.2).

Hepatic impairment

Although data in hepatically impaired patients are not available, hepatic impairment is unlikely to affect the elimination of corifollitropin alfa (see section 5.2).

Paediatric population

In the treatment of adolescent males (14 years and older) with hypogonadotropic hypogonadism, the dose of Elonva is based on body weight.

For adolescent males weighing less than or equal to 60 kg

100 micrograms of Elonva once every two weeks for 12 weeks, followed by concomitant administration of Elonva (once every 2 weeks) with hCG. For patients initiating therapy with 100 micrograms, consider increasing the dose if their body weight increases to greater than 60 kg during the course of treatment.

For adolescent males weighing more than 60 kg

150 micrograms of Elonva once every two weeks for 12 weeks, followed by concomitant administration of Elonva (once every 2 weeks) with hCG.

Combination therapy with hCG twice weekly (500–5000 IU) may be necessary for 52 weeks or longer to achieve adult gonadal development.

There are no data to support safety and efficacy when treatment is used for more than 52 weeks and/or after 17 years of age.

Method of administration

In females

Subcutaneous injection of Elonva may be carried out by the woman herself or her partner, provided that proper instructions are given by the physician. Self administration of Elonva should only be performed by women who are well-motivated, adequately trained and with access to expert advice.

Paediatric population

In adolescent males (14 years and older)

Subcutaneous injection in the abdominal wall may be carried out by the patient or a caregiver, provided they have been appropriately trained. Elonva should be administered once every two weeks, in the morning on the same day of the week in combination with hCG twice weekly (500–5000 IU).

In females

More than one injection of Elonva within one treatment cycle or too high a dose of Elonva and/or (rec)FSH may increase the risk of OHSS (see OHSS in section 4.4).

Paediatric population

The effects of an overdose of Elonva in the adolescent male population are unknown.

3 years.

Store in a refrigerator (2°C-8°C).

Do not freeze.

For convenience, the patient is allowed to store the product at or below 25°C for a period of not more than 1 month.

Keep the syringe in the outer carton in order to protect from light.

Elonva is supplied in pre-filled luerlock syringes of 1 mL (type I hydrolytic glass), closed with a bromobutyl elastomer plunger and a tip cap. The syringe is equipped with an automatic safety system to prevent needle stick injuries after use and is packed together with a sterile injection needle. Each pre-filled syringe contains 0.5 mL solution for injection.

Elonva is available in pack sizes of 1 pre-filled syringe.

Do not use Elonva if the solution is not clear.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.