Elonva

Elonva

corifollitropin alfa

Manufacturer:

Organon

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Corifollitropin α
Indications/Uses
Controlled ovarian stimulation (COS) in combination w/ a gonadotropin-releasing hormone (GnRH) antagonist for development of multiple follicles in women on assisted reproductive technology (ART) program.
Dosage/Direction for Use
Administer Elonva on stimulation day 1. Stimulation day 5 or 6: Start treatment w/ GnRH antagonist depending on ovarian response. Stimulation day 8: COS treatment may be continued w/ daily inj of recombinant FSH until criterion for triggering final oocyte maturation is reached. SC Women >36 yr weighing 50-60 kg 150 mcg single dose, ≤36 yr weighing ≤60 kg 100 mcg single dose, weighing >60 kg regardless of age 150 mcg single dose.
Contraindications
Hypersensitivity. Tumors of the ovary, breast, uterus, pituitary or hypothalamus. Abnormal (not menstrual) vag bleeding w/o known or diagnosed cause. Primary ovarian failure. Ovarian cysts or enlarged ovaries. Risk factors for ovarian hyperstimulation syndrome (OHSS): History of OHSS; previous COS cycle that resulted in >30 follicles ≥11 mm; basal antral follicle count >20; PCOS. Fibroid tumors of uterus or malformations of reproductive organs incompatible w/ pregnancy. Pregnancy.
Special Precautions
Assess couple's infertility as appropriate prior to treatment initiation. Evaluate women & give appropriate specific treatment for hypothyroidism, adrenocortical insufficiency, hyperprolactinemia & pituitary or hypothalamic tumours before starting therapy. Intended for single SC inj only. After treatment administration, no additional FSH-containing product should be given prior to stimulation day 8. Monitor ovarian response to reduce risk of OHSS. Risk of ovarian torsion; multiple pregnancies & birth; ectopic pregnancy; thromboembolic events. Incidence of congenital malformations after ART may be slightly higher than after spontaneous conceptions. Reports of ovarian & other reproductive system neoplasms in women who have undergone multiple treatment regimens for infertility treatment. Combination w/ GnRH agonist is not recommended. May cause false +ve HCG pregnancy test if the test is administered during the ovarian stimulation portion of the ART cycle. May cause dizziness that may affect ability to drive & use machines. Not recommended in women w/ renal insufficiency. Not indicated during breast-feeding.
Adverse Reactions
Headache; nausea; OHSS, pelvic pain or discomfort, breast tenderness; fatigue.
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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