Choriogonadotropin Alfa
Brand names: Ovidrel
Drug class:
Antineoplastic Agents
Usage of Choriogonadotropin Alfa
Female Infertility
Used in conjunction with other infertility agents (e.g., gonadotropin-releasing hormone agonist, FSH) for induction of final follicular maturation and early luteinization in ovulatory, infertile women during assisted reproductive technology (ART) programs.
Use in patients with tubal obstruction only if participating in ART programs.
Choriogonadotropin alfa (r-hCG) is equivalent to urinary-derived hCG with regard to number of oocytes recovered, fertilized oocytes or embryos, and live births.
Used in conjunction with follicle-stimulating agent to induce ovulation in anovulatory, infertile women in whom anovulation is functional and not due to primary ovarian failure.
Choriogonadotropin alfa (r-hCG) is similar to urinary-derived hCG with regard to ovulation rates.
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How to use Choriogonadotropin Alfa
General
Administration
Sub-Q Administration
Administer by sub-Q injection, generally into abdomen using commercially available prefilled syringe; may be self-administered by patient.
Dosage
Adults
Female Infertility ART Sub-Q250 mcg, given 1 day following last dose of follicle-stimulating agent. (See General under Dosage and Administration.)
Ovulation Induction Sub-Q250 mcg, given 1 day following last dose of follicle-stimulating agent. (See General under Dosage and Administration.)
If stimulation of ovulation is unsuccessful, adjust dosage of follicle-stimulating agent administered in subsequent cycles based on woman’s response in preceding cycle.
Prescribing Limits
Adults
Female Infertility Sub-QMaximum 500-mcg single dose studied in clinical trials.
Warnings
Contraindications
Warnings/Precautions
Warnings
Ovarian EnlargementRisk of mild to moderate uncomplicated ovarian enlargement; may be accompanied by abdominal distention and/or pain, but generally regresses without treatment within 2–3 weeks. Careful monitoring of ovarian response recommended.
If ovaries are abnormally enlarged during controlled ovarian stimulation, withhold choriogonadotropin alfa during current course of therapy to minimize risk of OHSS. (See Ovarian Hyperstimulation Syndrome under Cautions.)
Ovarian Hyperstimulation SyndromeRisk of potentially severe OHSS, characterized by apparent dramatic increase in vascular permeability that may result in rapid accumulation of fluid in peritoneal cavity, thorax, and potentially, pericardium.
May progress rapidly (within 24 hours to several days). Initial manifestations include severe pelvic pain, nausea, vomiting, and weight gain. Other symptoms include abdominal pain/distention, diarrhea, severe ovarian enlargement, dyspnea, and oliguria. Hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events may occur.
Transient liver function test abnormalities, which may be accompanied by morphologic changes (as detected by liver biopsy), reported.
Occurs most often after completion of gonadotropin therapy, reaching maximum severity after 7–10 days; usually resolves spontaneously with onset of menses. Monitor patients for ≥2 weeks after hCG administration. OHSS may be more severe and protracted if pregnancy occurs.
If severe OHSS develops, discontinue therapy, hospitalize patient, and consult clinician experienced in management of OHSS or fluid and electrolyte imbalances.
Multiple BirthsMultiple ovulations resulting in multiple gestations reported in 30.9 or 13.3% of women during ART programs or ovulation induction, respectively.
Risk of multiple births correlates with number of embryos transferred.
ThromboembolismPotential for arterial thromboembolism exists.
Fetal/Neonatal Morbidity and MortalityMay cause fetal harm; exclude pregnancy before initiating treatment.
Animal studies indicate adverse effects on pregnancy outcomes and/or labor. (See Contraindications under Cautions.)
General Precautions
Adequate Patient Evaluation and MonitoringAdminister only under supervision of qualified clinicians experienced in fertility disorders and interpretation of indices of ovulation.
Monitor follicular development (e.g., using transvaginal ultrasound, serum estradiol concentrations) to correctly identify follicular maturation, determine timing of choriogonadotropin alfa administration, detect ovarian enlargement, and minimize risks of OHSS and multiple gestation.
Obtain clinical confirmation of ovulation from direct and indirect indices of progesterone production, including rise in basal body temperature, an increase in serum progesterone concentrations, and menstruation following shift in basal body temperature. Sonographic evidence of ovulation includes findings of fluid in cul-de-sac, ovarian stigmata, collapsed follicle, and secretory endometrium.
Specific Populations
PregnancyCategory X. (See Fetal/Neonatal Morbidity and Mortality and also Contraindications under Cautions.)
LactationNot known whether choriogonadotropin alfa is distributed into milk. Use caution.
Pediatric UseSafety and efficacy not established.
Geriatric UseSafety and efficacy not established.
Hepatic ImpairmentSafety and efficacy not established.
Renal ImpairmentSafety and efficacy not established.
Common Adverse Effects
ART: Injection site reactions (i.e., pain, bruising), abdominal pain, nausea, vomiting, postoperative pain.
Ovulation induction: Injection site reactions (i.e., pain, inflammation, bruising, other injection site reaction), ovarian cysts, ovarian hyperstimulation, abdominal pain.
What other drugs will affect Choriogonadotropin Alfa
No formal drug interaction studies to date.
Laboratory Tests
Test
Interaction
Comments
Radioimmunoassays for gonadotropins
Possible cross-reaction with radioimmunoassays for gonadotropins, particularly LH
Individual laboratories should establish degree of cross-reactivity with their gonadotropin assay
When requesting gonadotropin concentration determinations, inform laboratory of choriogonadotropin alfa therapy
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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