Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injectable, Subcutaneous:
Ovidrel: 250 mcg/0.5 mL (0.5 mL)
Pharmacology
Mechanism of Action
Luteinizing hormone analogue produced by recombinant DNA techniques; stimulates late follicular maturation and initiates rupture of the ovarian follicle once follicular development has occurred
Pharmacokinetics/Pharmacodynamics
Distribution
Vd: 21.4L
Excretion
Urine (10% of dose)
Time to Peak
12-24 hours
Half-Life Elimination
Initial: 4 hours; Terminal: 29 hours
Use: Labeled Indications
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
Contraindications
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
Dosage and Administration
Dosing: Adult
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.
Dosing: Geriatric
Safety and efficacy have not been established.
Administration
SubQ: For SubQ use only; inject into stomach area.
Storage
Prefilled syringe: Prior to dispensing, store at 2°C to 8°C (36°F to 46°F). Patient may store at 25°C (77°F) for up to 30 days. Protect from light.
Drug Interactions
There are no known significant interactions.
Test Interactions
May interfere with interpretation of pregnancy tests; may cross-react with radioimmunoassay of luteinizing hormone and other gonadotropins
Adverse Reactions
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
Warnings/Precautions
Concerns related to adverse effects:
- Ovarian enlargement: May be accompanied by abdominal distention or abdominal pain and generally regresses without treatment within 2 to 3 weeks. If ovaries are abnormally enlarged on the last day of treatment, withhold hCG to reduce the risk of ovarian hyperstimulation syndrome (OHSS).
- Ovarian hyperstimulation syndrome: 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 treatment but may become most severe 7 to 10 days after therapy (Corbett 2014). Symptoms of mild/moderate OHSS may include abdominal distention/discomfort, diarrhea, nausea, and/or vomiting. Severe OHSS symptoms may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, or nausea/vomiting (intractable). Decreased creatinine clearance, 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; SOGC-CFAS 2011). Therapy with gonadotropins should be stopped.
- Thromboembolism: In association with and separate from ovarian hyperstimulation syndrome (OHSS), arterial thromboembolic events have been reported.
Special populations:
- Elderly: 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.
Monitoring Parameters
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)
Pregnancy
Pregnancy Considerations
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.
For use only by physicians who are thoroughly familiar with infertility problems and their management. Multiple births may result from use of this medication.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience injection site pain. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), chest pain, coughing up blood, or signs of ovarian hyperstimulation syndrome (severe abdominal pain or bloating; severe nausea, vomiting, or diarrhea; excessive weight gain; shortness of breath; or change in amount of urine passed) (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
