Elonva

Elonva

corifollitropin alfa

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Corifollitropin alfa
Indications/Uses
Controlled ovarian stimulation (COS) in combination w/ a gonadotropin releasing hormone (GnRH) antagonist for the 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. Women ≤36 yr weighing ≥60 kg 150 mcg, weighing 50-60 kg or <50 kg 100 mcg. Stimulation Day 1: Administer in the abdominal wall during the early follicular phase of the 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 injections of (recombinant) FSH until the criterion for triggering final oocyte maturation (3 follicles ≥17 mm) has been reached. As soon as 3 follicles ≥17 mm has been observed, a single injection of 5,000-10,000 IU urinary hCG is administered the same day or the day thereafter, to induce final oocyte maturation.
Contraindications
Hypersensitivity. Ovarian, breast, uterus, pituitary or hypothalamic tumours; abnormal (not menstrual) vag bleeding w/o known/diagnosed cause; primary ovarian failure; ovarian cysts or enlarged ovaries; history of ovarian hyperstimulation syndrome (OHSS); previous COS cycle that resulted in >30 follicles ≥11 mm measured by ultrasound exam; basal antral follicle count >20; fibroid tumours of the uterus & malformations of reproductive organs incompatible w/ pregnancy; polycystic ovarian syndrome (PCOS). Pregnancy.
Special Precautions
Do not give additional Elonva inj w/in the same treatment cycle; do not administer additional FSH-containing drugs after administration of Elonva prior to stimulation day 8. Not recommended for women w/ renal insufficiency; concomitant use w/ a GnRH agonist. Assess couple's infertility. Evaluate & correct hypothyroidism, adrenocortical insufficiency, hyperprolactinemia & pituitary or hypothalamic tumours in particular to women prior to treatment. Adhere to the recommended dose & treatment regimen, & carefully monitor ovarian response to reduce risk of OHSS. Assess ultrasonographically follicular development prior to therapy & at regular intervals during treatment. Increased risk of multiple & ectopic pregnancy, congenital malformations. Ovarian & other reproductive neoplasms (benign & malignant). Personal or family history of thromboembolic events, severe obesity or thrombophilia. May affect ability to drive or operate machinery. Lactation is not indicated during therapy. False +ve hCG pregnancy result if administered during ovarian stimulation portion of the ART cycle.
Adverse Reactions
Headache; nausea; OHSS, pelvic pain, pelvic 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 pre-filled syringe 100 mcg/0.5 mL
Packing/Price
1's
Form
Elonva pre-filled syringe 150 mcg/0.5 mL
Packing/Price
1's
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