ELONVA

What it is

ELONVA is a solution for injection containing corifollitropin alfa, available in strengths of 100 micrograms per 0.5 mL or 150 micrograms per 0.5 mL in pre-filled syringes. Corifollitropin alfa is produced in Chinese Hamster Ovary cells by recombinant DNA technology, using a chemically defined cell culture medium without the addition of antibiotics, human- or animal-derived proteins or any other components of human or animal origin. ELONVA is presented as a sterile, ready for use, clear and colourless aqueous solution for subcutaneous administration.

Approved indications

— Controlled ovarian stimulation for the development of multiple follicles and pregnancy in women undergoing in-vitro fertilisation techniques.

Dosing overview

In 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, or who weigh 50 kilograms or more and who are older than 36 years of age. ELONVA should be administered as a single subcutaneous injection, preferably in the abdominal wall, during the early follicular phase of the menstrual cycle. Seven days after the injection with ELONVA, controlled ovarian stimulation treatment may be continued with daily injections of recombinant follicle-stimulating hormone until the criterion for triggering final oocyte maturation has been reached, with a daily dose of 150 IU recombinant follicle-stimulating hormone advised in normal responders.

Key safety warnings

Ovarian hyperstimulation syndrome is a medical event distinct from uncomplicated ovarian enlargement. Clinical signs and symptoms of mild and moderate ovarian hyperstimulation syndrome are abdominal pain, nausea, diarrhoea, mild to moderate enlargement of ovaries and ovarian cysts. Severe ovarian hyperstimulation syndrome may be life-threatening, with clinical signs and symptoms including large ovarian cysts, acute abdominal pain, ascites, pleural effusion, hydrothorax, dyspnoea, oliguria, haematological abnormalities and weight gain. In rare instances, venous or arterial thromboembolism may occur in association with ovarian hyperstimulation syndrome. Because of the risk of developing ovarian hyperstimulation syndrome, patients should be monitored for at least two weeks after human Chorionic Gonadotrophin administration. Ovarian torsion has been reported after treatment with gonadotrophins, including ELONVA. Multiple pregnancies and births have been reported for all gonadotrophin treatments, including ELONVA. The woman and her partner should be advised of the potential risks for the mother (pregnancy and delivery complications) and the neonate (low birth weight) before starting treatment. Thromboembolic events, both in association with and separate from ovarian hyperstimulation syndrome, have been reported following treatment with gonadotrophins, including ELONVA. Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities. In women with generally recognised risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia, treatment with gonadotrophins, including ELONVA may further increase this risk.

Contraindications

ELONVA is contraindicated in tumours of the ovary, breast, uterus, pituitary or hypothalamus; abnormal (not menstrual) vaginal bleeding without a known or diagnosed cause; primary ovarian failure; and ovarian cysts or enlarged ovaries. Contraindications include factors associated with risk of ovarian hyperstimulation syndrome including a history of ovarian hyperstimulation syndrome, a previous controlled ovarian stimulation cycle that resulted in more than 30 follicles of 11 mm or more measured by ultrasound examination, a basal antral follicle count greater than 20, and polycystic ovarian syndrome. ELONVA is also contraindicated in fibroid tumours of the uterus incompatible with pregnancy and malformations of the reproductive organs incompatible with pregnancy. ELONVA is contraindicated in pregnancy and lactation. ELONVA is contraindicated in hypersensitivity to the active substance or to any of the excipients.

PBS listing

ELONVA 150 micrograms in 0.5 mL single dose pre-filled syringe is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$607.84. ELONVA 100 micrograms in 0.5 mL single dose pre-filled syringe is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$370.15.

Regulatory history

ELONVA corifollitropin alfa 100 micrograms per 0.5 mL solution for injection pre-filled syringe (ARTG 160646) and 150 micrograms per 0.5 mL solution for injection pre-filled syringe (ARTG 160645) were first listed on the Australian Register of Therapeutic Goods on 30 July 2010.