Elonva Corifollitropin Alfa 150 mcg/0.5 mL - 1 Prefilled Syringe Injection

Product Overview:

• Elonva (corifollitropin alfa) 150mcg is a hormonal medicine used in women who are undergoing fertility treatment to stimulate the development of more than one mature egg at a time in the ovaries. It is used together with a gonadotrophin-releasing hormone (GnRH) antagonist (another type of medicine used in fertility treatments).


• Elonva combined with another hormonal medicine called human chorionic gonadotropin (hCG) is also used to treat adolescent boys aged 14 years and older who have delayed or absent puberty due to hypogonadotropic hypogonadism. In adolescent males with this condition, production of the hormones that stimulate testicular development is inadequate. Therefore, the testes remain small and produce little or no testosterone. This results in delayed or absent pubertal characteristics, and no sperm production resulting in problems with fertility

Key Features:

• Controlled ovarian stimulation in combination with a gonadotrophin-releasing-hormone antagonist for the development of multiple follicles in women participating in an assisted-reproductive-technology programme.

How it Works:

• The active substance in Elonva, corifollitropin alfa, is similar to follicle stimulating hormone (FSH), a natural hormone in the body. FSH stimulates the production of eggs in the ovaries. In corifollitropin alfa, a peptide (a short chain of amino acids) is attached to the FSH to prolong its activity in the body. As a result a single dose of the medicine can be given to stimulate egg production for seven days, thereby replacing daily injections that would be required with other FSH medicines.


• Corifollitropin alfa is produced by a method known as ‘recombinant DNA technology’. This means that it is made by cells into which a gene (DNA) has been introduced that makes them able to produce corifollitropin alfa.

Benefits:

• Elonva is used in women who are undergoing fertility treatment to stimulate the development of more than one mature egg at a time in the ovaries. It is used together with a gonadotrophin-releasing hormone (GnRH) antagonist (a type of medicine also used in fertility treatments).

Directions for Use:

• Treatment with Elonva should be started under the supervision of a doctor experienced in treating fertility problems.


• Elonva is given once as a single injection under the skin in a dose of 100 or 150 micrograms, depending on age and body weight. The patient or their partner may carry out the injection if they have been properly instructed. For further details, see the package leaflet.


• Four or five days after the Elonva injection, depending on how the ovaries have responded, treatment is started with a GnRH antagonist, which prevents the ovaries from releasing their eggs too early. Seven days after the Elonva injection, if further ovarian stimulation is needed, injections of another medicine similar to Elonva, but suitable for daily injection, may be given. Finally, as soon as three eggs are close to maturation, a single injection of a hormone called human chorionic gonadotropin (hCG) is given to release the mature eggs.


• The eggs are collected using a surgical procedure. They will then be fertilised in a laboratory and the resulting embryo is implanted in the womb.

Active Ingredient:

• Corifollitropin alfa

Side Effects:

Elonva 150 injections may cause some side effects, such as:

• Headache.


• Nausea.


• Pelvic pain.


• Breast tenderness.


• Fatigue.


• Vomiting.


• Injection site pain.

Caution & Warnings:

Elonva injections should not be used in the following cases:

• Hypersensitivity to any of its components.


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


• Abnormal vaginal bleeding without a known cause.


• Primary ovarian failure.


• Ovarian cysts or enlargement of the ovaries.


• Uterine fibroids that are incompatible with pregnancy.


• Malformations of the female reproductive organs incompatible with pregnancy.


• Presence of a risk factor for Ovarian Hyperstimulation Syndrome (OHSS).


• Breastfeeding.

Storage:

• Keep out of reach of children.


• Store in a refrigerator at a temperature between 2°C – 8°C.


• Do not freeze.


• It may be stored outside the refrigerator at a temperature not exceeding 25°C for a maximum period of one month.


• Store in the original package, protected from light.

FAQs:

• Q:Why has Elonva been approved?


• A:The CHMP decided that Elonva’s benefits are greater than its risks and recommended that it be given marketing authorisation.

• Q:What measures are being taken to ensure the safe and effective use of Elonva?


• A:A risk management plan has been developed to ensure that Elonva is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Elonva, including the appropriate precautions to be followed by healthcare professionals and patients.

• Q:What is Elonva?


• A:Elonva is a solution for injection that contains the active substance corifollitropin alfa. It is available as a pre-filled syringe (100 and 150 micrograms).

• Q:What is Elonva used for?


• A;Elonva is used in women who are undergoing fertility treatment to stimulate the development of more than one mature egg at a time in the ovaries. It is used together with a gonadotrophin-releasing hormone (GnRH) antagonist (a type of medicine also used in fertility treatments).

• Q:How is Elonva used?


• A:Treatment with Elonva should be started under the supervision of a doctor experienced in treating fertility problems.Elonva is given once as a single injection under the skin in a dose of 100 or 150 micrograms, depending on age and body weight. The patient or their partner may carry out the injection if they have been properly instructed. For further details, see the package leaflet.