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Chorionic Gonadotropin (Human)

Medically reviewed by Drugs.com. Last updated on Jun 16, 2020.

Pronunciation

(kor ee ON ik goe NAD oh troe pin, HYU man)

Index Terms

  • CG
  • hCG

Dosage Forms

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

Solution Reconstituted, Intramuscular:

Novarel: 5000 units (1 ea); 10,000 units (1 ea) [contains benzyl alcohol]

Pregnyl: 10,000 units (1 ea) [contains benzyl alcohol, sodium chloride]

Generic: 10,000 units (1 ea)

Brand Names: U.S.

  • Novarel
  • Pregnyl

Pharmacologic Category

  • Gonadotropin
  • Ovulation Stimulator

Pharmacology

Human chorionic gonadotropin (hCG) is produced by the human placenta; available preparations provide purified luteinizing hormone obtained from the urine of pregnant women. hCG stimulates production of gonadal steroid hormones by causing production of androgen by the testes and the development of secondary sex characteristics in males. In females, hCG acts as a substitute for luteinizing hormone (LH) to stimulate ovulation.

Distribution

Distributes mainly into the testes in males and into the ovaries in females

Excretion

Urine (~10% to 12%) within 24 hours

Time to Peak

Plasma: IM: Within 6 hours

Duration of Action

IM: ~36 hours

Half-Life Elimination

Biphasic: Initial: 6 to 11 hours; Terminal: 23 to 37 hours

Use: Labeled Indications

Hypogonadotrophic hypogonadism: Treatment of hypogonadism secondary to a pituitary deficiency in males.

Ovulation induction: Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not caused by primary ovarian failure, and who has been appropriately pretreated with human menotropins.

Prepubertal cryptorchidism: Treatment of prepubertal cryptorchidism not caused by anatomic obstruction.

Off Label Uses

Spermatogenesis induction associated with hypogonadotropic hypogonadism

Based on the American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hypogonadism in Adult Male Patients, chorionic gonadotropin (human) given in combination with human menopausal gonadotropin (or follicle-stimulating hormone [FSH]) for spermatogenesis induction in male patients with hypogonadotropic hypogonadism of prepubertal onset is effective and recommended in this setting. Men with partial gonadotropin deficiency, men who have been peri-pubertally stimulated with chorionic gonadotropin (human), and men with postpubertal acquired hypogonadotropic hypogonadism who previously had normal production of sperm may be given chorionic gonadotropin (human) monotherapy.

Contraindications

Hypersensitivity to chorionic gonadotropin or any component of the formulation; precocious puberty; prostatic carcinoma or other androgen-dependent neoplasms

Canadian labeling: Additional contraindications (not in US labeling): Prepubertal males with signs of anatomical obstruction; sex hormone-dependent tumors (eg, ovary, breast and uterine carcinoma in females; breast carcinoma males); malformations of the reproductive organs incompatible with pregnancy; fibroid tumors of the uterus incompatible with pregnancy; abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.

Dosing: Adult

Ovulation induction: Females: IM: 5,000 to 10,000 units 1 day following last dose of menotropins

Hypogonadotropic hypogonadism: Males: IM: Various regimens:

500 to 1,000 units 3 times/week for 3 weeks, followed by the same dose twice weekly for 3 weeks or

4,000 units 3 times/week for 6 to 9 months, then reduce dosage to 2,000 units 3 times/week for additional 3 months

Spermatogenesis induction associated with hypogonadotropic hypogonadism (off-label use): Males: IM: 1,000 to 2,000 units 2 to 3 times/week. Administer hCG until serum testosterone levels are normal (may require 2 to 3 months of therapy), then may add menopausal gonadotropin of FSH if needed to induce spermatogenesis; continue hCG at the dose required to maintain testosterone levels (AACE 2002).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Hypogonadotropic hypogonadism, puberty induction: Limited data available: Children ≥12 years and Adolescents: Males: IM: 500 to 3,000 units 2 to 3 times weekly; adjust dose based on serum testosterone levels, every 3 to 6 months (AACE 2002; Sato 2015; Sperling 2014)

Prepubertal cryptorchidism: Children ≥4 years and Adolescents: Males: IM: Various regimens reported by manufacturer:

Note: Therapy is usually instituted between the ages of 4 and 9 years:

4,000 units 3 times weekly for 3 weeks or

5,000 units every second day for 4 injections or

500 units 3 times weekly for 4 to 6 weeks (if not successful may repeat course one month later using 1,000 units/dose) or

15 injections of 500 to 1,000 units administered over 6 weeks

Reconstitution

Depending on desired concentration, add 1 to 10 mL of provided diluent to lyophilized powder; agitate gently until powder is completely dissolved. Use immediately after reconstitution or store ≤60 days in the refrigerator (product dependent).

Administration

IM: For IM administration only.

Storage

Store at intact vials at 15°C to 30°C (59°F to 86°F). Following reconstitution, solution is stable when refrigerated (2ºC to 8ºC [36ºF to 46ºF]) for 30 days (Novarel) or 60 days (Pregnyl).

Drug Interactions

There are no known significant interactions.

Test Interactions

Cross-reacts with radioimmunoassay of gonadotropins, especially LH

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Cardiovascular: Arterial thrombosis, edema

Central nervous system: Depression, fatigue, headache, irritability, restlessness

Endocrine & metabolic: Gynecomastia, ovarian hyperstimulation syndrome

Genitourinary: Precocious puberty, rupture of ovarian cyst

Local: Pain at injection site

<1%, postmarketing, and/or case reports: Anaphylaxis, hypersensitivity reaction (local or systemic; including angioedema, dyspnea, erythema, skin rash, urticaria), testicular neoplasm

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Anaphylaxis has been reported with urinary-derived human chorionic gonadotropin (hCG) products.

• Thromboembolism: Arterial or venous thromboembolism may occur; patients with a history of family history of thrombosis, severe obesity, or thrombophilia are at an increased risk.

Disease-related concerns:

• Asthma: Use with caution in patients with asthma; hCG may cause fluid retention.

• Cardiovascular disease: Use with caution in patients with cardiovascular disease; hCG may cause fluid retention.

• Cryptorchidism: May induce precocious puberty in children being treated for cryptorchidism; discontinue if signs of precocious puberty occur.

• Migraine: Use with caution in patients with a history of migraines; hCG may cause fluid retention.

• Renal impairment: Use with caution in patients with renal impairment; hCG may cause fluid retention.

• Seizure disorders: Use with caution in patients with a history of seizure disorders; hCG may cause fluid retention.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.

Other warnings/precautions:

• Obesity: Not effective adjunctive therapy in the treatment of obesity.

• Ovulation induction: Appropriate use: These medications should only be used by physicians who are thoroughly familiar with infertility problems and their management. May cause ovarian hyperstimulation syndrome (OHSS). OHSS is a rare exaggerated response to ovulation induction therapy (Corbett 2014; Fiedler 2012). This syndrome may begin within 24 hours of treatment but may become most severe 7 to 10 days after therapy (Corbett 2014). Symptoms of mild/moderate OHSS may include abdominal distention/discomfort, diarrhea, nausea, and/or vomiting. Severe OHSS symptoms may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, or nausea/vomiting (intractable). Decreased creatinine clearance, 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). 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

Male: Serum testosterone levels, semen analysis (AACE 2002).

Female: 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).

Ovarian hyperstimulation syndrome: 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) (Shmorgun 2017).

Reproductive Considerations

When needed for ovulation induction, should only be used by physicians who are thoroughly familiar with infertility problems and their management. Multiple births may result from use of this medication.

Testicular tumors in otherwise healthy men have been reported when treating secondary infertility.

Pregnancy Considerations

Studies in animals have shown evidence of fetal abnormalities at doses intended to induce superovulation (used in combination regimens).

Patient Education

What is this drug used for?

• It is used to help women get pregnant.

• It is used to help the body make more testosterone in some people.

• It is used to treat delays in a male's normal growth pattern.

• 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

• Headache

• Loss of strength and energy

• Agitation

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

• Swelling

• Irritability

• Enlarged breasts

• Chest pain

• Depression

• Weight gain

• Trouble breathing

• Puberty

• 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.