Multifollicular development during assisted reproductive technology (ART) and ovulation induction: SUBQ: 250 mcg given 1 day following the last dose of follicle stimulating agent. Use only after adequate follicular development has been determined. Hold treatment when there is an excessive ovarian response.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
2% to 10%:
Endocrine & metabolic: Ovarian cyst (3%), ovarian hyperstimulation (<2% to 3%)
Gastrointestinal: Abdominal pain (3% to 4%), nausea (3%), vomiting (3%)
Local: Pain at injection site (8%), bruising at injection site (3% to 5%), injection site reaction (<2% to 3%), inflammation at injection site (≤2%)
Miscellaneous: Postoperative pain (5%)
<2%, postmarketing, and/or case reports: Abdominal swelling, albuminuria, back pain, breast pain, cardiac arrhythmia, cervical carcinoma, cervical lesion, cough, diarrhea, dizziness, dysuria, ectopic pregnancy, emotional lability, fever, flatulence, headache, heart murmur, herpes genitalis, hiccups, hot flash, hyperglycemia, hypersensitivity reaction, insomnia, intermenstrual bleeding, leukocytosis, leukorrhea, malaise, mastalgia, paresthesia, pharyngitis, pruritus, skin rash, upper respiratory tract infection, urinary incontinence, urinary tract infection, vaginal discomfort, vaginal hemorrhage, vaginitis, vulvovaginal candidiasis
Hypersensitivity to hCG preparations or any component of the formulation; primary ovarian failure; uncontrolled thyroid or adrenal dysfunction; uncontrolled organic intracranial lesion (ie, pituitary tumor); abnormal uterine bleeding, ovarian cyst or enlargement of undetermined origin; sex hormone dependent tumors; pregnancy.
Canadian labeling: Additional contraindications (not in US labeling): Tumors of the hypothalamus and pituitary gland; ovarian, uterine, or mammary cancer.
Concerns related to adverse effects:
• Ovarian enlargement: The lowest effective dose should be used to decrease the risk of abnormal ovarian enlargement. If ovaries are abnormally enlarged on the last day of follicle stimulating hormone treatment, follow current clinical practice to reduce the risk of ovarian hyperstimulation syndrome (OHSS).
• Ovarian hyperstimulation syndrome: OHSS is a rare, exaggerated response to ovulation induction therapy (Fiedler 2012; SOGC [Corbett 2014]). This syndrome may begin within 24 hours of human chorionic gonadotropin treatment but may become most severe 7 to 10 days after therapy (SOGC [Corbett 2014]). Mild/moderate OHSS signs/symptoms may include abdominal distention/discomfort, diarrhea, nausea, vomiting, and mild/moderate enlargement of ovaries/ovarian cysts. Severe OHSS signs/symptoms may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, hydrothorax, nausea/vomiting (intractable), pleural effusion, rapid weight gain, venous thrombosis, and large ovarian cysts. Decreased CrCl, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM 2024; Fiedler 2012; SOGC [Corbett 2014]). Treatment is primarily symptomatic and includes fluid and electrolyte management, analgesics, and prevention of thromboembolic complications (SOGC [Shmorgun 2017]).
• Thromboembolism: In association with and separate from OHSS, thromboembolic events have been reported. Risk may be increased in patients with a personal or family history of thromboembolic events, severe obesity, or thrombophilia.
Special populations:
• Older adult: Safety and efficacy have not been established in the elderly.
• Pediatric: Safety and efficacy have not been established in children.
Other warnings/precautions:
• Experienced physician: For use by physicians who are thoroughly familiar with infertility problems and their management.
• Multiple births: May result from the use of these medications; advise patients of the potential risk of multiple births before starting the treatment.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous:
Ovidrel: 250 mcg/0.5 mL (0.5 mL)
No
Solution Prefilled Syringe (Ovidrel Subcutaneous)
250 mcg/0.5 mL (per 0.5 mL): $302.21
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Pen-injector, Subcutaneous:
Ovidrel: 250 mcg/0.5 mL (0.5 mL)
Solution Prefilled Syringe, Subcutaneous:
Ovidrel: 250 mcg/0.5 mL (0.5 mL, 1 ea)
SubQ: For SubQ use only; inject into stomach area.
Hazardous agent (NIOSH 2024 [table 2]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).
Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.
Multifollicular development during assisted reproductive technology: For the induction of final follicular maturation and early luteinization in patients who are infertile who have undergone pituitary desensitization and who have been appropriately pretreated with follicle-stimulating hormones as part of an assisted reproductive technology program.
Ovulation induction: For the induction of ovulation and pregnancy in anovulatory patients who are infertile in whom the cause of infertility is functional and not caused by primary ovarian failure.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs (contraindicated in pregnancy) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care Settings).
None known.
There are no known significant interactions.
When needed for ovulation induction, should only be used by providers with expertise in managing infertility; exclude pregnancy prior to use. Multiple births may result from use of this medication; a low dose step-up protocol is recommended to increase the chance of monofollicular development. Gonadotropins are an alternative option for ovulation induction in patients with polycystic ovary syndrome with anovulatory infertility and no other infertility factors (Teede 2023).
Chorionic gonadotropin (recombinant) is approved to be used as part of an assisted reproductive technology (ART) program; use is contraindicated in an established pregnancy.
Ectopic pregnancy, premature labor, postpartum fever, and spontaneous abortion have been reported in clinical trials. Congenital abnormalities have also been observed; however, the incidence is similar during natural conception.
It is not known if chorionic gonadotropin (recombinant) is present in human milk.
The manufacturer recommends that caution be exercised when administering chorionic gonadotropin (recombinant) to lactating patients.
Ultrasound and/or estradiol levels to assess follicle development; ultrasound to assess number and size of follicles; ovulation (basal body temperature, serum progestin level, menstruation, sonography).
OHSS: Monitoring of hospitalized patients should include abdominal circumference, albumin, cardiorespiratory status, electrolytes, fluid balance, hematocrit, hemoglobin, serum creatinine, urine output, urine specific gravity, vital signs, weight (all daily or as necessary) and liver enzymes (weekly) (SOGC [Shmorgun 2017]).
Luteinizing hormone analogue produced by recombinant DNA techniques; stimulates late follicular maturation and initiates rupture of the ovarian follicle once follicular development has occurred
Distribution: Vd: 21.4L
Bioavailability: 40%
Half-life elimination: Initial: 4 hours; Terminal: 29 hours
Time to peak: 12-24 hours
Excretion: Urine (10% of dose)