Medicinal Products

ELONVA 100 micrograms

Generic drug of the therapeutic class: Endocrinology
active ingredients: Corifollitropin alpha
laboratory: Msd Limited

SC Injection Solution
Box of 1 pre-filled syringe (+ 1 needle) 0.5 mL
All forms

Indication

Controlled ovarian stimulation (SOC) in combination with a GnRH antagonist to induce the development of multiple follicles in women treated as part of a program of medical assistance to procreation (MPA).

Dosage ELONVA 100 micrograms Solution for injection SC Box of 1 pre-filled syringe (+ 1 needle) 0.5 mL

Treatment with Elonva should be initiated by a physician experienced in treating fertility problems.

Dosage

In women with a body weight ≤ 60 kilograms, the recommended single dose is 100 micrograms.

In women with body weight> 60 kilograms, the recommended single dose is 150 micrograms.

Stimulation the 1st day:

Elonva should be administered as a single subcutaneous injection, preferably in the abdomen, at the beginning of the follicular phase of the menstrual cycle.

The recommended doses of Elonva have only been determined in a treatment protocol using a GnRH antagonist (see also the sections Therapeutic indications and Warnings and precautions for use ).

Stimulation at 5 th and 6 th day:

Treatment with Gonadotrophin Releasing Hormone (GnRH) antagonist should be started on the 5th or 6th day of stimulation depending on the ovarian response, ie the number and size of follicles growing and / or circulating estradiol level. The GnRH antagonist is used to prevent premature Luteinizing Hormone (LH) peaks.

Stimulation on the 8th day:

Seven days after the Elonva injection, treatment may be continued by daily injections of follicle-stimulating hormone (recombinant) (FSH (rec)) until the criterion for triggering the final oocyte maturation (3) follicles ≥ 17 mm) is reached. The daily dose of FSH (rec) will be adjusted according to the ovarian response. In women who respond normally to treatment, a daily dose of 150 IU FSH (rec) is recommended. Depending on the ovarian response, FSH (rec) may not be given on the day of administration of Human Chorionic Gonadotropin (hCG). In general, an adequate follicular development is obtained on average around the 9th day of treatment (6 to 18 days of treatment are usually sufficient).

As soon as 3 follicles ≥ 17 mm are observed, a single injection of 5000 to 10 000 IU hCG is administered the same day or the following day to induce the final follicular maturation. In the case of excessive ovarian response, refer to the recommendations given in section 4.4 to minimize the risk of developing ovarian hyperstimulation syndrome (OHSS).

Special populations

Renal Insufficiency: No clinical studies have been performed in patients with renal impairment. Since the elimination of corifollitropin alfa can be decreased in patients with renal impairment, the use of Elonva in these women is not recommended (see Warnings and Precautions and Pharmacokinetic Properties ).

Hepatic impairment: Although there are no data in patients with hepatic impairment, hepatic failure is unlikely to affect the clearance of corifollitropin (see section 5.2).

Pediatric population

There is no justified use of Elonva in the pediatric population in the approved indication.

Administration mode

The subcutaneous injection of Elonva can be done by the woman herself or her partner, provided that the doctor has provided appropriate instructions. Elonva self-injection should only be performed by motivated, properly trained and informed patients.

Against indications

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

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

• Abnormal vaginal bleeding (outside menstruation) of undetermined or unknown cause.

• Primary ovarian failure.

• Ovarian cysts or ovarian hypertrophy.

• History of ovarian hyperstimulation syndrome (OHSS).

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

• A count of antral follicles> 20.

• Uterine myomas incompatible with pregnancy.

• Malformations of genitals incompatible with pregnancy.

Elonva side effects

The most commonly reported adverse events in clinical trials with Elonva are OHSS (5.2%, see also Warnings and Precautions ), pain (4.1%), and discomfort sensations. pelvic (5.5%), headache (3.2%), nausea (1.7%), fatigue (1.4%) and breast symptoms (such as breast tenderness) (1.2%) .

The table below lists the main adverse reactions in Elonva-treated women based on clinical trial experience according to the organ-organ system and frequency: frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100). Within each frequency group, adverse effects are presented in order of decreasing severity.

Class-organ system

Frequency

Side effects

Nervous system disorders

Frequent

Headache

Rare

Dizziness

Gastrointestinal disorders

Frequent

nausea

Rare

Abdominal pain, vomiting, diarrhea, constipation and bloating

Disorders of reproductive organs and breast

Frequent

Rare

SHSO, pelvic pain and discomfort, breast symptoms.

Ovarian torsion

General disorders and administration site abnormalities

Frequent

Tired

In addition, ectopic pregnancies, miscarriages and multiple pregnancies have been reported. They are considered to be related to the MPA technique or the subsequent pregnancy.

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