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Chorionic Gonadotropin (Recombinant)

Medically reviewed by Drugs.com. Last updated on May 27, 2020.

Pronunciation

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

Index Terms

  • Choriogonadotropin Alfa
  • r-hCG

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injectable, Subcutaneous:

Ovidrel: 250 mcg/0.5 mL (0.5 mL)

Brand Names: U.S.

  • Ovidrel

Pharmacologic Category

  • Gonadotropin
  • Ovulation Stimulator

Pharmacology

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

Distribution

Vd: 21.4L

Excretion

Urine (10% of dose)

Time to Peak

12-24 hours

Half-Life Elimination

Initial: 4 hours; Terminal: 29 hours

Use: Labeled Indications

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

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

Dosing: Adult

Assisted reproductive technologies (ART) and ovulation induction in females: SubQ: 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.

Dosing: Geriatric

Safety and efficacy have not been established.

Administration

SubQ: For SubQ use only; inject into stomach area.

Storage

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.

Drug Interactions

There are no known significant interactions.

Test Interactions

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

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

Miscellaneous: Postoperative pain (5%)

<2%, postmarketing, and/or case reports: Abdominal swelling, albuminuria, back pain, breast pain, cardiac arrhythmia, cervical carcinoma, cervical lesion, cough, diarrhea, dizziness, dysuria, ectopic pregnancy, emotional lability, fever, flatulence, headache, heart murmur, herpes genitalis, hiccups, hot flash, hyperglycemia, hypersensitivity reaction, insomnia, intermenstrual bleeding, leukocytosis, leukorrhea, malaise, mastalgia, paresthesia, pharyngitis, pruritus, skin rash, upper respiratory tract infection, urinary incontinence, urinary tract infection, vaginal discomfort, vaginal hemorrhage, vaginitis, vulvovaginal candidiasis

Warnings/Precautions

Concerns related to adverse effects:

• Ovarian enlargement: The lowest effective dose should be used to decrease the risk of abnormal ovarian enlargement. If ovaries are abnormally enlarged on the last day of follicle stimulating hormone treatment, follow current clinical practice to reduce the risk of ovarian hyperstimulation syndrome (OHSS).

• Ovarian hyperstimulation syndrome: OHSS is a rare exaggerated response to ovulation induction therapy (Corbett 2014; Fiedler 2012). This syndrome may begin within 24 hours of human chorionic gonadotropin treatment but may become most severe 7 to 10 days after therapy (Corbett 2014). Mild/moderate OHSS signs/symptoms may include abdominal distention/discomfort, diarrhea, nausea, vomiting, and mild/moderate enlargement of ovaries/ovarian cysts. Severe OHSS signs/symptoms may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, hydrothorax, nausea/vomiting (intractable), pleural effusion, rapid weight gain, venous thrombosis, and large ovarian cysts. Decreased CrCl, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM 2016; Corbett 2014; Fiedler 2012). Treatment is primarily symptomatic and includes fluid and electrolyte management, analgesics, and prevention of thromboembolic complications (ASRM 2016; Shmorgun 2017).

• Thromboembolism: In association with and separate from OHSS, thromboembolic events have been reported. Risk may be increased in patients with a personal or family history of thromboembolic events, severe obesity, or thrombophilia.

Special populations:

• Elderly: Safety and efficacy have not been established in the elderly.

• Pediatric: Safety and efficacy have not been established in children.

Other warnings/precautions:

• Experienced physician: These medications should only be used by physicians who are thoroughly familiar with infertility problems and their management.

• Multiple births: May result from the use of these medications; advise patients of the potential risk of multiple births before starting the treatment.

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)

OHSS: Monitoring of hospitalized patients should include abdominal circumference, albumin, cardiorespiratory status, electrolytes, fluid balance, hematocrit, hemoglobin, serum creatinine, urine output, urine specific gravity, vital signs, weight (all daily or as necessary) and liver enzymes (weekly) (SOGC-CFAS 2011)

Reproductive Considerations

Chorionic gonadotropin (recombinant) is approved to be used as part of an assisted reproductive technology (ART) program; for use only by physicians who are thoroughly familiar with infertility problems and their management. Multiple births may result from use of this medication.

Pregnancy Considerations

Chorionic gonadotropin (recombinant) is approved to be used as part of an assisted reproductive technology (ART) program; use is contraindicated in an established pregnancy.

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.

Patient Education

What is this drug used for?

• It is used to help women get pregnant.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Injection site pain

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight

• Swelling, warmth, numbness, change of color, or pain in a leg or arm

• Chest pain

• Coughing up blood

• Ovarian hyperstimulation syndrome like severe abdominal pain or bloating; severe nausea, vomiting, or diarrhea; excessive weight gain; shortness of breath; or change in amount of urine passed

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.