pending 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
There is no relevant use of Elonva within the approved indication in the paediatric population.
Method of administration
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.
4.3 Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Tumours 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.
• 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.
• Fibroid tumours of the uterus incompatible with pregnancy.
• Malformations of the reproductive organs incompatible with pregnancy.
• Polycystic ovarian syndrome (PCOS).
4.4 Special warnings and precautions for use
Infertility eva luation before starting treatment
Before starting treatment, the couple's infertility should be assessed as appropriate. In particular, women should be eva luated for hypothyroidism, adrenocortical insufficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given. Medical conditions that contraindicate pregnancy should also be eva luated before starting treatment with Elonva.
Dosing during the stimulation cycle
Elonva is intended for single subcutaneous injection only. Additional injections of Elonva should not be given within the same treatment cycle. (See also section 4.2.)
After administration of Elonva, no additional FSH-containing product should be administered prior to stimulation day 8 (see also section 4.2).
Renal insufficiency
In patients with mild, moderate or severe renal insufficiency the rate of elimination of corifollitropin alfa may be reduced (see sections 4.2 and 5.2). Therefore, the use of Elonva in these women is not recommended.
Not recommended with a GnRH agonist protocol
There are limited data on the use of Elonva in combination with a GnRH agonist. Results of a |
