choriogonadotropin alfa
Regulatory sources consulted
Approved indications
- Triggering final follicular maturation and luteinization after stimulation of follicular development in assisted reproduction.
- Triggering ovulation and luteinization in women with anovulation or oligo-ovulation after follicular stimulation.
Contraindications
Absolute
- Hypothalamic or pituitary tumor, ovarian, uterine, or breast carcinoma, unexplained gynecologic bleeding, or ovarian enlargement/cyst not due to polycystic ovary disease.
- Active thromboembolism or hypersensitivity; do not use when an effective response cannot be obtained, such as primary ovarian failure or malformations incompatible with pregnancy.
Clinical warnings
- Major warning · Ultrasound and hormonal monitoring are required. Do not administer the trigger if there is excessive risk of ovarian hyperstimulation syndrome. — CIMA/AEMPS, ficha técnica 100165007
- Major warning · It may cause ovarian hyperstimulation, torsion, multiple or ectopic pregnancy, miscarriage, and thromboembolism. — CIMA/AEMPS, ficha técnica 100165007
- Major warning · If there are signs or risk of ovarian hyperstimulation syndrome, withhold hCG and advise sexual abstinence or a barrier method for at least 4 days. Monitor for at least 2 weeks after hCG because the syndrome may develop or progress rapidly. — CIMA/AEMPS, ficha técnica 100165007
Adverse events
Common (≥1%)
Headache · Abdominal pain or distension · Nausea or vomiting · Mild or moderate ovarian hyperstimulation syndrome · Injection-site reaction
Rare but serious
Severe ovarian hyperstimulation syndrome · Thromboembolism · Anaphylaxis
Pregnancy and lactation
Not indicated during pregnancy or breastfeeding.