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Choriogonadotropin Alfa (Monograph)

Brand name: Ovidrel
Drug class: Gonadotropins and Antigonadotropins
ATC class: G03GA08
VA class: HS900
Chemical name: Gonadotropin, chorionic (human α-subunit protein moiety reduced), complex with chorionic gonadotropin (human β-subunit protein moiety reduced)
Molecular formula: C437H682N122O134S13
CAS number: 177073-44-8

Introduction

Gonad-stimulating hormone; biosynthetic (recombinant DNA-derived) form of human chorionic gonadotropin (hCG).

Uses for 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.

Choriogonadotropin Alfa Dosage and Administration

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-Q

250 mcg, given 1 day following last dose of follicle-stimulating agent. (See General under Dosage and Administration.)

Ovulation Induction
Sub-Q

250 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-Q

Maximum 500-mcg single dose studied in clinical trials.

Cautions for Choriogonadotropin Alfa

Contraindications

Warnings/Precautions

Warnings

Ovarian Enlargement

Risk 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 Syndrome

Risk 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 Births

Multiple 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.

Thromboembolism

Potential for arterial thromboembolism exists.

Fetal/Neonatal Morbidity and Mortality

May 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 Monitoring

Administer 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

Pregnancy

Category X. (See Fetal/Neonatal Morbidity and Mortality and also Contraindications under Cautions.)

Lactation

Not known whether choriogonadotropin alfa is distributed into milk. Use caution.

Pediatric Use

Safety and efficacy not established.

Geriatric Use

Safety and efficacy not established.

Hepatic Impairment

Safety and efficacy not established.

Renal Impairment

Safety 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.

Drug Interactions

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

Choriogonadotropin Alfa Pharmacokinetics

Absorption

Bioavailability

Following sub-Q administration, absolute bioavailability is 40%. Peak serum concentrations attained in 12–24 hours; detectable in serum for 10 days.

Onset

Following midcycle administration, peak stimulation of luteal-phase progesterone production (as indicated by serum progesterone concentrations) occurs in approximately 5–7 days. (See Actions.)

Duration

Following midcycle administration, stimulation of luteal-phase progesterone production persists for approximately 10 days.

Distribution

Extent

Median apparent volume of distribution is 21.4 L in women undergoing in vitro fertilization.

Elimination

Metabolism

Urinary-derived hCG extensively metabolized, principally in the liver and kidneys, to active metabolites; urinary-derived choriogonadotropin alfa (r-hCG) exhibits similar pharmacokinetics as hCG.

Elimination Route

Excreted in urine principally as metabolites.

Half-life

Biphasic; median terminal half-life is 29.2 hours in women undergoing in vitro fertilization.

Special Populations

Pharmacokinetics not evaluated in patients with renal or hepatic impairment.

Stability

Storage

Parenteral

Injection

2–8°C until dispensed. Once dispensed, refrigerate prefilled syringe at 2–8°C, but may be stored at ≤25°C for ≤30 days; protect from light. Discard unused portion.

Actions

Advice to Patients

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Choriogonadotropin Alfa

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for subcutaneous use only

257.5 mcg/0.515 mL (delivers 250 mcg)

Ovidrel (available as a 0.515-mL, disposable prefilled syringe)

Serono

AHFS DI Essentials™. © Copyright 2024, Selected Revisions June 1, 2008. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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