Pronunciation: KOR-ee-oh-goe-NAD-oh-TROE-pin AL-fa
Class: Gonadotropin, Ovulation stimulant
- Injection, solution 250 mcg per 0.5 mL
Stimulates late follicular maturation and resumption of oocyte meiosis, and initiates rupture of the preovulatory ovarian follicle.
Bioavailability is 40% after subcutaneous administration; C max of 121 ± 44 units/L is reached in 12 to 24 h.
Vd at steady state is approximately 5.9 L.
Mean terminal half-life is approximately 29 h after subcutaneous administration. One-tenth of the dose is excreted in the urine. Cl is 0.29 L/h.
Special PopulationsRenal Function Impairment
Safety, efficacy, and pharmacokinetics in patients with renal impairment have not been established.Hepatic Function Impairment
Safety, efficacy, and pharmacokinetics in patients with hepatic impairment have not been established.
Indications and Usage
For the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle-stimulating hormones (FSH) as part of an assisted reproductive technology program, such as in vitro fertilization and embryo transfer; induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not caused by primary ovarian failure.
Prior hypersensitivity to human chorionic gonadotropin (hCG) preparations or one of their excipients; primary ovarian failure; uncontrolled thyroid or adrenal dysfunction; an uncontrolled organic intracranial lesion, such as a pituitary tumor; abnormal uterine bleeding of undetermined origin; ovarian cyst or enlargement of undetermined origin; sex hormone–dependent tumors of the reproductive tract and accessory organs; pregnancy.
Dosage and AdministrationAssisted Reproductive Technology/Ovulation Induction
Subcutaneous 250 mcg 1 day after the last dose of follicle-stimulating agent.
- For subcutaneous use only.
- Do not administer until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. Withhold in situations where there is an excessive ovarian response.
Store between 36° and 46°F prior to dispensing. May be stored by the patient at 77°F for up to 30 days. Protect from light. Discard any unused material.
None well documented.
Laboratory Test Interactions
Administration of choriogonadotropin alfa may interfere with the interpretation of pregnancy tests.
Cardiac arrhythmia, heart murmur (less than 2%); thromboembolic events (postmarketing).
Dizziness, emotional lability, headache, insomnia, malaise, paresthesias (less than 2%).
Pruritus, rash (less than 2%).
GI system disorders (9%); abdominal pain (4%); nausea, vomiting (3%); abdominal enlargement, diarrhea, flatulence (less than 2%).
Reproductive disorders (7%); ovarian cyst, ovarian hyperstimulation (3%); albuminuria, breast pain, cervical carcinoma, cervical lesion, dysuria, ectopic pregnancy, genital herpes, genital moniliasis, intermenstrual bleeding, leukorrhea, urinary incontinence, uterine disorders, UTI, vaginal discomfort, vaginal hemorrhage, vaginitis (less than 2%).
Injection-site disorders (16%); injection-site pain (8%); injection-site bruising (5%); injection-site reaction (3%); injection-site inflammation (2%).
Cough, pharyngitis, upper respiratory tract infection (less than 2%).
Postoperative pain (5%); back pain, body pain, fever, hiccup, hot flashes, hyperglycemia, leukocytosis (less than 2%); allergic reactions (postmarketing).
Monitor women for signs of ovary overstimulation (eg, abdominal pain, bloating, severe pelvic pain). Monitor ovarian response with serum estradiol and transvaginal ultrasound on a regular basis during ovulation induction.
Category X . Contraindicated in pregnancy.
Safety and efficacy not established.
Safety and efficacy not established.
Only health care providers experienced with fertility problems should use choriogonadotropin alfa.
Mild to moderate uncomplicated ovarian enlargement that may be accompanied by abdominal distention or abdominal pain may occur in patients treated with FSH and hCG, and generally regresses without treatment within 2 or 3 wk.
Ovarian hyperstimulation syndrome
May occur and progress rapidly (within 24 h to several days) to become a serious medical event.
No information available.
- Review the treatment regimen, including duration and monitoring, that will be required.
- If patient will be administering at home, teach patient how to store, prepare, administer the dose, and dispose of used equipment and supplies.
- Advise women that close monitoring for overstimulation of the ovary is required and to report any of the following immediately to their health care provider: difficulty breathing, severe pelvic pain, nausea, vomiting, weight gain, stomach pain or bloating, diarrhea, or infrequent urination.
- Discuss the risks of possible multiple births to women receiving choriogonadotropin alfa.
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