Elonva

Elonva

corifollitropin alfa

Manufacturer:

MSD

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 positive 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.
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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