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Elonva

Elonva

corifollitropin alfa

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Corifollitropin alfa
Indications/Uses
Controlled ovarian stimulation (COS) in combination w/ gonadotropin releasing hormone (GnRH) antagonist for development of multiple follicles in women participating in an assisted reproductive technology (ART) program.
Dosage/Direction for Use
SC Women >36 yr weighing 50-60 kg &/or >60 kg 150 mcg, ≤36 yr weighing >60 kg 150 mcg, 50-60 kg or <50 kg 100 mcg. Stimulation day 1: Administer as single inj in abdominal wall during early follicular phase of menstrual cycle. Stimulation day 5 or 6: Start GnRH antagonist on stimulation day 5 or 6 depending on ovarian response. Stimulation day 8: Continue COS treatment w/ daily inj of (recombinant) FSH until final oocyte maturation (3 follicles ≥17 mm) has been reached & administer single inj of urinary hCG 5,000-10,000 IU on the same day or day thereafter.
Contraindications
Hypersensitivity. Ovarian, breast, uterus, pituitary or hypothalamic tumors; abnormal (not menstrual) vag bleeding w/o known/diagnosed cause; primary ovarian failure; ovarian cysts or enlarged ovaries; fibroid tumours of uterus & malformations of reproductive organs incompatible w/ pregnancy. History of ovarian hyperstimulation syndrome (OHSS); previous COS cycle resulting in >30 follicles ≥11 mm measured by ultrasound exam; basal antral follicle count >20; PCOS. Pregnancy.
Special Precautions
Not to give additional inj w/in the same treatment cycle. Not to administer additional FSH-containing product after administration of treatment prior to stimulation day 8. OHSS; ovarian torsion; multiple pregnancies & birth; increased incidence of ectopic pregnancy in infertile women; higher incidence of congenital malformations; benign & malignant ovarian & other reproductive system neoplasm in women who have undergone multiple treatment regimens for infertility; thromboembolic events. Venous or arterial thromboembolism. Transient LFT abnormalities in association w/ OHSS. Women w/ known risk factors for high ovarian response; personal or family history of thromboembolic events, severe obesity or thrombophilia, gonadotropin treatment. Previous abdominal surgery, history of ovarian torsion, previous or current ovarian cysts. Assess couple's infertility prior to treatment. Evaluate patient for hypothyroidism, adrenocortical insufficiency, hyperprolactinemia & pituitary or hypothalamic tumours. Monitor patients for at least 2 wk after hCG administration. Closely observe for early signs & symptoms of OHSS in women having their 1st cycle of ovarian stimulation. Perform ultrasonographic assessments of follicular development to monitor risk for OHSS prior to & at regular intervals during treatment; early ultrasound confirmation to exclude possibility of extrauterine pregnancy. Not recommended to use in combination w/ GnRH agonist. May affect ability to drive & use machines. Not recommended in patients w/ renal insufficiency. Not indicated during lactation.
Adverse Reactions
Headache; nausea; OHSS, pelvic pain & discomfort, breast tenderness; fatigue.
Drug Interactions
May cause false +ve hCG pregnancy test if administered during ovarian stimulation portion of assisted reproductive technology (ART) cycle.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
G03GA09 - corifollitropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Presentation/Packing
Form
Elonva soln for inj 100 mcg/0.5 mL
Packing/Price
1's
Form
Elonva soln for inj 150 mcg/0.5 mL
Packing/Price
1's
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