ELONVA SOLUTION FOR INJECTION 100MCG/0.5ML [SIN13939P]

Product Info

ELONVA SOLUTION FOR INJECTION 100MCG/0.5ML

[SIN13939P]

4.1 Therapeutic indications

Controlled Ovarian Stimulation (COS) in combination with a 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.

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 also sections 4.1, 4.4, and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 Gonadotropin Releasing Hormone (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 estradiol levels may also be useful. The GnRH antagonist is used to prevent premature Luteinizing Hormone (LH) surges.

Stimulation day 8:

Seven days after the injection with Elonva on stimulation day 1, 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, which should be monitored by regular ultrasonographic assessments from stimulation day 5 or 6 onwards. In normal responders a daily dose of 150 international units (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 international units urinary 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) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric population

The use of Elonva in the pediatric population is not relevant within the approved indication.

Method of administration

Subcutaneous injection of Elonva may be carried out by the woman herself or her partner, provided the 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.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients.

• Tumors of the ovary, breast, uterus, pituitary or hypothalamus.

• Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.

• Primary ovarian failure.

• Ovarian cysts or enlarged ovaries.

• Fibroid tumors of the uterus incompatible with pregnancy.

• Malformations of the reproductive organs incompatible with pregnancy.

• Pregnancy (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Risk factors of OHSS

  • A history of Ovarian Hyperstimulation Syndrome (OHSS).

  • A previous COS cycle that resulted in more than 30 follicles ≥ 11 mm measured by ultrasound examination.

  • A basal antral follicle count > 20.

  • Polycystic ovarian syndrome (PCOS).