Version May 2024
Assisted reproductive technologies (ART) and ovulation induction in females: 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
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 (Corbett 2014; Fiedler 2012). This syndrome may begin within 24 hours of human chorionic gonadotropin treatment but may become most severe 7 to 10 days after therapy (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 2016; Corbett 2014; Fiedler 2012). Treatment is primarily symptomatic and includes fluid and electrolyte management, analgesics, and prevention of thromboembolic complications (ASRM 2016; 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: These medications should only be used 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.
Injectable, Subcutaneous:
Ovidrel: 250 mcg/0.5 mL (0.5 mL)
No
Injection (Ovidrel Subcutaneous)
250 mcg/0.5 mL (per 0.5 mL): $261.52
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injectable, Subcutaneous:
Ovidrel: 250 mcg/0.5 mL (0.5 mL, 1 ea)
SubQ: For SubQ use only; inject into stomach area.
Hazardous agent (NIOSH 2016 [group 3]).
Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage.
NIOSH recommends double gloving, a protective gown, ventilated engineering controls (a class II biological safety cabinet or a compounding aseptic containment isolator), and closed system transfer devices (CSTDs) for preparation. Double gloves and a protective gown are required during administration (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).
As part of an assisted reproductive technology (ART) program, induces ovulation in infertile females who have been pretreated with follicle stimulating hormones (FSH); induces ovulation and pregnancy in infertile females when the cause of infertility is functional
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
None known.
There are no known significant interactions.
Chorionic gonadotropin (recombinant) is approved to be used as part of an assisted reproductive technology (ART) program; for use only by physicians who are thoroughly familiar with infertility problems and their management. Multiple births may result from use of this medication.
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 excreted in breast milk. The manufacturer recommends that caution be exercised when administering chorionic gonadotropin (recombinant) to nursing women.
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-CFAS 2011)
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)
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