Choriogonadotropin Alfa

Pronunciation: KOR-ee-oh-goe-NAD-oh-TROE-pin AL-fa
Class: Gonadotropin, Ovulation stimulant

Trade Names

Ovidrel
- Injection, solution 250 mcg per 0.5 mL

Pharmacology

Stimulates late follicular maturation and resumption of oocyte meiosis, and initiates rupture of the preovulatory ovarian follicle.

Slideshow: 2013 Drug News Round-Up - Top 20 Stories

Pharmacokinetics

Absorption

Bioavailability is 40% after subcutaneous administration; C max of 121 ± 44 units/L is reached in 12 to 24 h.

Distribution

Vd at steady state is approximately 5.9 L.

Elimination

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 Populations

Renal 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.

Contraindications

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 Administration

Assisted Reproductive Technology/Ovulation Induction
Adults

Subcutaneous 250 mcg 1 day after the last dose of follicle-stimulating agent.

General Advice

  • 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.

Storage/Stability

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.

Drug Interactions

None well documented.

Laboratory Test Interactions

Administration of choriogonadotropin alfa may interfere with the interpretation of pregnancy tests.

Adverse Reactions

Cardiovascular

Cardiac arrhythmia, heart murmur (less than 2%); thromboembolic events (postmarketing).

CNS

Dizziness, emotional lability, headache, insomnia, malaise, paresthesias (less than 2%).

Dermatologic

Pruritus, rash (less than 2%).

GI

GI system disorders (9%); abdominal pain (4%); nausea, vomiting (3%); abdominal enlargement, diarrhea, flatulence (less than 2%).

Genitourinary

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%).

Local

Injection-site disorders (16%); injection-site pain (8%); injection-site bruising (5%); injection-site reaction (3%); injection-site inflammation (2%).

Respiratory

Cough, pharyngitis, upper respiratory tract infection (less than 2%).

Miscellaneous

Postoperative pain (5%); back pain, body pain, fever, hiccup, hot flashes, hyperglycemia, leukocytosis (less than 2%); allergic reactions (postmarketing).

Precautions

Monitor

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.


Pregnancy

Category X . Contraindicated in pregnancy.

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Safety and efficacy not established.

Administration

Only health care providers experienced with fertility problems should use choriogonadotropin alfa.

Arterial thromboembolism

May occur.

Multiple births

May occur.

Ovarian enlargement

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.

Overdosage

Symptoms

No information available.

Patient Information

  • 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.

Copyright © 2009 Wolters Kluwer Health.

Hide
(web2)