Chorionic Gonadotropin (Recombinant)

Pronunciation

(kor ee ON ik goe NAD oh troe pin ree KOM be nant)

U.S. Brand Names

Ovidrel®

Synonyms

Choriogonadotropin Alfa; r-hCG

Generic Available

No

Use

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

Pregnancy Risk Factor

X

Pregnancy Implications

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.

Lactation

Excretion in breast milk unknown/use caution

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

Warnings/Precautions

For use by infertility specialists; may cause ovarian hyperstimulation syndrome (OHSS); if severe, treatment should be discontinued and patient should be hospitalized. OHSS results in a rapid (<24 hours to 7 days) accumulation of fluid in the peritoneal cavity, thorax, and possibly the pericardium, which may become more severe if pregnancy occurs; monitor for ovarian enlargement; use may lead to multiple births; risk of arterial thromboembolism with hCG products; safety and efficacy in pediatric and geriatric patients have not been established.

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: Injection site: Pain (8%), bruising (3% to 5%), reaction (<2% to 3%), inflammation (<2% to 2%)

Miscellaneous: Postoperative pain (5%)

<2%:

Cardiovascular: Cardiac arrhythmia, heart murmur

Central nervous system: Dizziness, emotional lability, fever, headache, insomnia, malaise

Dermatologic: Pruritus, rash

Endocrine & metabolic: Breast pain, hot flashes, hyperglycemia, intermenstrual bleeding, vaginal hemorrhage

Gastrointestinal: Abdominal enlargement, diarrhea, flatulence

Genitourinary: Cervical carcinoma, cervical lesion, dysuria, genital herpes, genital moniliasis, leukorrhea, urinary incontinence, urinary tract infection, vaginitis

Hematologic: Leukocytosis

Neuromuscular & skeletal: Back pain, paresthesia

Renal: Albuminuria

Respiratory: Cough, pharyngitis, upper respiratory tract infection

Miscellaneous: Ectopic pregnancy, hiccups

In addition, the following have been reported with menotropin therapy: Adnexal torsion, hemoperitoneum, mild to moderate ovarian enlargement, pulmonary and vascular complications. Ovarian neoplasms have also been reported (rare) with multiple drug regimens used for ovarian induction (relationship not established).

Drug Interactions

Specific drug interaction studies have not been conducted

Stability

Powder for reconstitution: Store in original package under refrigeration or at room temperature of 2°C to 25°C (36°F to 77°F). Protect from light. Mix vial with 1 mL sterile water for injection. Gently mix by rotating vial to dissolve powder; do not shake. Use immediately following reconstitution.

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.

Mechanism of Action

Luteinizing hormone analogue produced by recombinant DNA techniques; stimulates rupture of the ovarian follicle once follicular development has occurred.

Pharmacodynamics/Kinetics

Distribution: Vd: 5.9 ± 1 L

Bioavailability: 40%

Half-life elimination: Initial: 4 hours; Terminal: 29 hours

Time to peak: 12-24 hours

Excretion: Urine (10% of dose)

Dosage

SubQ:

Adults: Female:

Assisted reproductive technologies (ART) and ovulation induction: 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.

Elderly: Safety and efficacy have not been established

Dosage adjustment in renal impairment: Safety and efficacy have not been established

Dosage adjustment in hepatic impairment: Safety and efficacy have not been established

Administration

Prior to administration, mix vial with 1 mL sterile water for injection. Gently mix by rotating vial to dissolve powder; do not shake. Use only if solution is clear and colorless. For SubQ use only; inject into stomach area. Use immediately following reconstitution.

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)

Test Interactions

May interfere with interpretation of pregnancy tests; may cross-react with radioimmunoassay of luteinizing hormone and other gonadotropins

Patient Education

Note that there is a risk of multiple births associated with treatment. This drug must be administered exactly as scheduled (1 day following last dose of follicle stimulating agent); maintain a calendar of treatment days. Follow administration directions exactly (see below). Keep all ultrasound and laboratory appointments as instructed by prescriber. Avoid strenuous exercise, especially those with pelvic involvement. You may experience nausea, vomiting, or GI upset (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help), hot flashes (cool clothes, cool room, adequate rest may help) if persistent consult prescriber. Report immediately any persistent abdominal pain, vomiting, or acute pelvic pain; chest pain or palpitations; shortness of breath; or urinary tract or vaginal infection or urinary incontinence. Pregnancy/breast-feeding precautions: Do not take this medicine if you are pregnant and report to prescriber immediately if you suspect you are pregnant. Consult prescriber if breast-feeding.

Administration: Wash hands and prepare medication in clean environment. Use only if solution is clear and colorless. Inject exactly as directed into stomach area. Do not rub area of injection. Dispose of syringe, needle, and vial in sealed container (do not dispose where others could have access to materials). Wash hands.

Nursing Implications

Should be administered by SubQ injection only. Patients should be taught how to reconstitute, administer r-hCG, and dispose of needles and syringes properly.

Additional Information

Clinical studies have shown r-hCG to be clinically and statistically equivalent to urinary-derived hCG products.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May cause dizziness, emotional lability, and insomnia

Mental Health: Effects on Psychiatric Treatment

None reported

Dosage Forms

Injection, powder for reconstitution: 285 mcg [packaged with 1 mL SWFI; delivers 250 mcg r-hCG following reconstitution] [DSC]

Injection, solution : 257.5 mcg/0.515 mL (0.515 mL) [prefilled syringe; delivers 250 mcg r-hCG/0.5 mL]