OVIDREL
Clinical safety rating
cautionComprehensive clinical and safety monograph for OVIDREL (OVIDREL).
Comprehensive clinical and safety monograph for OVIDREL (OVIDREL).
Induction of final follicular maturation and early luteinization in infertile women undergoing controlled ovarian hyperstimulation (COH) for assisted reproductive technologies (ART)Induction of ovulation in anovulatory or oligo-ovulatory women who have been pretreated with follicle-stimulating hormone (FSH)
Injection site pain, Headache, Fatigue, Depression, Irritation, Restlessness
OVIDREL (choriogonadotropin alfa) acts as a luteinizing hormone (LH) agonist, binding to the LH/choriogonadotropin receptor on ovarian theca and granulosa cells, triggering ovulation and luteinization by inducing resumption of oocyte meiosis and follicle rupture.
| Metabolism | Primarily metabolized in the kidney and other tissues via proteolytic degradation into amino acids and peptides; not significantly metabolized by cytochrome P450 enzymes. |
| Excretion | Primarily renal, with approximately 10% of the administered dose excreted unchanged in urine within 24 hours. The remainder undergoes metabolic degradation in the kidneys and liver. |
| Half-life | The terminal elimination half-life is approximately 30 hours (range 20-48 hours) in healthy adults. This supports a single-dose regimen for final follicular maturation in assisted reproductive technology. |
| Protein binding | Highly bound to plasma proteins, predominantly albumin, with approximately 80-85% bound. |
| Volume of Distribution | Approximately 6 L (0.1 L/kg in a 60 kg adult), indicating limited distribution primarily to the extracellular space. |
| Bioavailability | Subcutaneous injection: approximately 80% absolute bioavailability. Not administered orally. |
| Onset of Action | Subcutaneous administration: Onset of action is approximately 12 hours, with the peak effect (triggering final follicular maturation and ovulation) occurring at about 36-48 hours post-dose. |
| Duration of Action | The pharmacodynamic effect (induction of ovulation) lasts approximately 48-72 hours after administration. Clinical note: Timing of oocyte retrieval is typically scheduled 34-36 hours after OVIDREL administration. |
| Molecular Weight | 25700 Da (approx. 25.7 kDa) |
| Action Class | Gonadotropins |
| Brand Substitutes | Life 250mcg Injection |
250 mcg subcutaneously once daily for 7 days following recombinant FSH stimulation. Alternatively, a single 250 mcg subcutaneous dose is used to trigger final follicular maturation 24-48 hours after last gonadotropin dose.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment guidelines; use caution in renal impairment. GFR <30 mL/min: consider alternatives due to potential accumulation. |
| Liver impairment | No specific dose adjustment guidelines; use caution in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Not indicated for pediatric use; no established pediatric dosing. |
| Geriatric use | Not indicated for geriatric use; no standard dosing established. |
| 1st trimester | Not indicated for use in pregnancy. Choriogonadotropin alfa is a pregnancy category X drug; there is no indication for use during pregnancy. If used inadvertently, consider potential risk of fetal harm. |
| 2nd trimester | Not indicated for use during pregnancy. Category X. |
| 3rd trimester | Not indicated for use during pregnancy. Category X. |
Clinical note
Comprehensive clinical and safety monograph for OVIDREL (OVIDREL).
| Placental transfer | Likely does not cross the placental barrier in significant amounts due to its high molecular weight and protein structure, but no specific human data. |
| Breastfeeding | Excretion in human milk is unknown. Due to potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. |
| Lactation Rating | L3 (Moderately Safe) - limited data; due to high molecular weight, likely minimal excretion into breast milk but no specific studies. |
| Teratogenic Risk | OVIDREL (choriogonadotropin alfa) is not indicated for use during pregnancy. Based on its mechanism as a luteinizing hormone analog, inadvertent exposure during early pregnancy may theoretically support corpus luteum function, but no increased risk of congenital anomalies has been reported in postmarketing surveillance. First trimester: No known teratogenic risk, but limited data. Second trimester: Not applicable as not used. Third trimester: Not applicable. |
| Fetal Monitoring | During OVIDREL therapy for ovulation induction, monitor ovarian response via ultrasound and estradiol levels to assess risk of ovarian hyperstimulation syndrome (OHSS). In pregnancy cycles, standard prenatal monitoring applies. No specific fetal monitoring required from the drug itself beyond routine obstetric care. |
| Fertility Effects | OVIDREL is used to trigger final follicular maturation and ovulation in assisted reproductive technology (ART) and ovulation induction. It restores fertility in women with anovulatory infertility secondary to hypothalamic-pituitary dysfunction. Use may increase the risk of multiple gestations and OHSS, which can affect reproductive outcomes. |
■ FDA Black Box Warning
None (no FDA black box warning for OVIDREL).
| Serious Effects |
PregnancyUncontrolled thyroid or adrenal dysfunctionKnown hypersensitivity to choriogonadotropin alfa or any componentPresence of a sex-hormone-dependent tumor (e.g., ovarian, testicular, or pituitary tumor)Abnormal uterine bleeding of undetermined origin
| Precautions | Ovarian hyperstimulation syndrome (OHSS): can be severe with pulmonary and vascular complications; monitor closely and discontinue if OHSS develops., Ovarian torsion: risk is increased in patients with enlarged ovaries; evaluate for abdominal pain., Respiratory distress syndrome: associated with severe OHSS., Multiple pregnancy: increased risk; counsel patients on potential outcomes., Congenital malformations: incidence may increase following gonadotropin therapy; no causal link established., Thromboembolic events: increased risk, especially in patients with obesity, thrombophilia, or prior history. |
| Food/Dietary | No known significant food interactions. Grapefruit may affect metabolism of certain hormones; avoid excessive grapefruit intake. |
| Clinical Pearls | OVIDREL (choriogonadotropin alfa) is a recombinant human chorionic gonadotropin (hCG) used to trigger final follicular maturation and ovulation in assisted reproductive technology (ART). Administer subcutaneously exactly 36 hours before oocyte retrieval; timing is critical. Monitor for ovarian hyperstimulation syndrome (OHSS) risk, especially in patients with polycystic ovary syndrome (PCOS). Do not use in patients with primary ovarian failure or uncontrolled thyroid/adrenal dysfunction. |
| Patient Advice | Inject OVIDREL exactly as prescribed, at the same time each day if multiple doses are needed. · Common side effects include injection site reactions, headache, and nausea. · Contact your doctor immediately if you experience severe pelvic pain, nausea, vomiting, or weight gain (signs of OHSS). · OVIDREL may cause false positive pregnancy tests; consult your doctor if you get a positive result. |
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