SubcutaneousControlled ovarian stimulationAdult: In combination with gonadotropin-releasing hormone (GnRH) antagonist for the development of multiple follicles as part of assisted reproductive technology (ART) programme: ≤36 years weighing ≤60 kg: 100 mcg as a single dose; >36 years weighing ≥50 kg: 150 mcg as a single dose; >60 kg, regardless of age: 150 mcg as a single dose. Initiate treatment during the early follicular phase of the menstrual cycle. Depending on the ovarian response, may give GnRH antagonist on stimulation day 5 or 6. Treatment may be continued with a recombinant FSH on day 8 until the criterion for triggering a final oocyte maturation (3 follicles ≥17 mm) is achieved. Generally, adequate follicular development is attained on average by 9th day of treatment (range: 6-18 days). When adequate follicular development is evident, give hCG on the same or next day to induce final oocyte maturation. In case of an excessive ovarian response, may consider therapy modification (refer to specific product guidelines).
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Tumours of the ovary, breast, uterus, pituitary or hypothalamus; abnormal vaginal bleeding with unknown or undiagnosed cause; primary ovarian failure; ovarian cysts or enlarged ovaries; fibroid tumours of the uterus incompatible with pregnancy; malformations of the reproductive organs incompatible with pregnancy; history of ovarian hyperstimulation syndrome (OHSS); previous controlled ovarian stimulation cycle that resulted in >30 follicles ≥11 mm measured by ultrasound examination; basal antral follicle count >20; polycystic ovarian syndrome (PCOS). Pregnancy and lactation.
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Patient with risk factors for thromboembolic events (e.g. personal or family history, severe obesity, thrombophilia). Intended for single inj only; additional inj should not be given within the same treatment cycle. No additional FSH-containing product should be given prior to stimulation day 8. Not recommended for use with GnRH agonists and in renal impairment.
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Significant: Ovarian torsion, multiple pregnancies and births, ectopic pregnancies, congenital malformations, ovarian and other reproductive system neoplasms (benign and malignant), thromboembolic events.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, abdominal distention.
General disorders and administration site conditions: Fatigue, inj site pain or haematoma, irritability.
Immune system disorders: Hypersensitivity reactions (local and generalised), including rash.
Injury, poisoning and procedural complications: Procedural pain.
Investigations: Increased ALT or AST.
Musculoskeletal and connective tissue disorders: Back pain.
Nervous system disorders: Headache, dizziness.
Pregnancy, puerperium and perinatal conditions: Spontaneous abortion.
Psychiatric disorders: Mood swings.
Reproductive system and breast disorders: Pelvic pain or discomfort, breast pain or tenderness, adnexa uteri pain, premature ovulation.
Vascular disorders: Hot flush.
Potentially Fatal: Ovarian hyperstimulation syndrome (OHSS).
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This drug may cause dizziness, if affected, do not drive or operate machinery.
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Prior to starting treatment: Assess the couple’s infertility; women should be evaluated for hypothyroidism, adrenocortical insufficiency, hyperprolactinaemia, pituitary or hypothalamic tumours, and other medical conditions that contraindicate pregnancy. Monitor follicular growth by transvaginal ultrasound and measurement of serum estradiol levels to determine adequate ovarian response and hCG timing. Evaluate for signs and symptoms of OHSS for at least 2 weeks after hCG administration.
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May cause a false-positive hCG pregnancy test if given during the ovarian stimulation portion of the ART cycle.
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Description:
Mechanism of Action: Corifollitropin alfa is a modified recombinant human FSH with a prolonged duration of activity. Its follicle stimulating activity can be sustained due to the addition of a carboxy-terminal peptide of the β-subunit of hCG to the β-chain of human FSH.
Duration: 7 days (sustained multiple follicular development activity).
Pharmacokinetics:
Absorption: Bioavailability: 58% (range: 48-70%). Time to peak plasma concentration: 44 hours (range: 34-57 hours).
Distribution: Primarily distributed to ovaries and kidneys.
Excretion: Elimination half-life: 69 hours (range: 59-79 hours).
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Store between 2-8°C. May store at or below 25°C for up to 28 days. Do not freeze. Protect from light.
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G03GA09 - corifollitropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
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Anon. Corifollitropin Alfa. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 29/04/2022. Buckingham R (ed). Corifollitropin Alfa. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/04/2022. Elonva 150 mcg Solution for Injection (Organon Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 29/04/2022. Elonva 150 mcg Solution for Injection (Organon Pharma [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 29/04/2022. Organon (New Zealand) Limited. Elonva 100 mcg, 150 mcg Solution for Injection data sheet 16 August 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 29/04/2022.
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