Elonva

Elonva

corifollitropin alfa

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Corifollitropin α
Indications/Uses
Controlled ovarian stimulation (COS) in combination w/ GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program.
Dosage/Direction for Use
Women ≤60 kg, ≤36 yr 100 mcg as single dose, ≥50 kg, >36 yr or >60 kg (regardless of age) 150 mcg as single dose. Stimulation day 1: Administer as single SC inj during early follicular phase. Day 5 or 6: Initiate GnRH antagonist depending on ovarian response. Day 8: Continue COS treatment w/ recombinant FSH daily inj until criterion for triggering final oocyte maturation (3 follicles ≥17 mm) has been reached. Then, administer urinary hCG 5,000-10,000 IU single inj the same day or day thereafter to induce final oocyte maturation.
Contraindications
Hypersensitivity. Ovarian, breast, uterine, pituitary or hypothalamic tumours; abnormal vag bleeding w/o known/diagnosed cause; primary ovarian failure; ovarian cysts or enlarged ovaries; uterine fibroid tumors & reproductive organ malformations 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, polycystic ovarian syndrome. Pregnancy.
Special Precautions
Increased risk of ectopic pregnancy & congenital malformations. Closely monitor patients & perform ultrasonographic assessments of follicular development prior to & at regular intervals during treatment for risk of OHSS development. Ovarian torsion; multi-fetal gestation & birth; benign & malignant ovarian & other reproductive system neoplasms. Personal or family history of thromboembolic events, severe obesity or thrombophilia. Assess couple's infertility & women's hypothyroidism, adrenocortical insufficiency, hyperprolactinemia, pituitary or hypothalamic tumors & medical conditions contraindicating pregnancy prior to treatment. Additional inj should not be given w/in same treatment cycle; after administration, no additional FSH-containing product should be given prior to stimulation day 8. Not recommended in combination w/ GnRH agonist. May affect ability to drive & use machines. Not recommended in renal insufficiency. Not to be used during pregnancy. Not indicated during lactation.
Adverse Reactions
Headache; nausea; OHSS, pelvic pain & discomfort, breast tenderness; fatigue.
Drug Interactions
May cause false positive hCG pregnancy test.
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 150 mcg/0.5 mL
Packing/Price
1's
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