Corifollitropin alfa


Generic Medicine Info
Indications and Dosage
Subcutaneous
Controlled ovarian stimulation
Adult: 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).
Renal Impairment
Not recommended.
Contraindications
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.
Special Precautions
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.
Adverse Reactions
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).
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
Monitoring Parameters
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.
Lab Interference
May cause a false-positive hCG pregnancy test if given during the ovarian stimulation portion of the ART cycle.
Action
Description: 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).
Storage
Store between 2-8°C. May store at or below 25°C for up to 28 days. Do not freeze. Protect from light.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
G03GA09 - corifollitropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
References
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.

Disclaimer: This information is independently developed by MIMS based on Corifollitropin alfa from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com
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