Choriogonadotropin Alfa

Choriogonadotropin Alfa is a prescription medication used to induce Ovulation for Pregnancy as well as Spermatogenesis. 

• Choriogonadotropin Alfa is available under the following different brand names: Ovidrel, Novarel, Pregnyl, chorionic gonadotropin

Common side effects of Choriogonadotropin Alfa include:

• Nausea, 
• Vomiting, 
• Mild abdominal pain/swelling, 
• Headache, and pain/bruising/redness/swelling at the injection site

Serious side effects of Choriogonadotropin Alfa include:

• Pain, warmth, redness, numbness, or tingling in the arm or leg,
• Confusion,
• Extreme dizziness, and
• Severe headache
• Specific to women:
• Severe pelvic pain,
• Swelling of the hands or legs,
• Stomach pain and swelling,
• Shortness of breath,
• Weight gain,
• Diarrhea,
• Nausea,
• Vomiting, and
• Urinating less than normal

Rare side effects of Choriogonadotropin Alfa include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Prefilled syringe

• 250 mcg

Powder for reconstitution

• 10,000 units/vial

Induction of Ovulation & Pregnancy

Adult dosage

• Ovidrel: 250 mcg subcutaneous one day following the last dose of the follicle-stimulating agent; use only after adequate follicular development has been determined; hold treatment if there is an excessive ovarian response
• Novarel, Pregnyl, Generics: 5,000-10,000 units 1 day following the last dose of menotropins

Induction of Spermatogenesis

Adult dosage

• Novarel, Pregnyl, Generics
  • Hypogonadotropic and hypogonadism in males: 1000-2000 units 2-3 times/week (may require 2-3 months of therapy); if needed, add follitropin Alfa or menopausal gonadotropin to induce spermatogenesis; continue hCG therapy at the dose required to maintain testosterone levels

Prepubertal Cryptorchidism Not Caused by Anatomical Obstruction

Pediatric dosage

• Novarel, Pregnyl
  • May institute therapy between the ages of 4 and 9
  • 4,000 units Intramuscular 3 times/week for 3 weeks
  • 5,000 units Intramuscular every second day for 4 injections
  • 15 injections of 500 to 1,000 units Intramuscular over a period of 6 weeks
  • 500 units Intramuscular 3 times/week for 4-6 weeks; if the course of treatment is not successful, begin another 1 month later, giving 1,000 units/injection

Male Hypogonadotropic Hypogonadism

Pediatric dosage

• Novarel, Pregnyl
  • 500-1,000 units Intramuscular 3 times/week for 3 weeks, followed by the same dose twice/week for 3 weeks
  • 4,000 units Intramuscular 3 times/week for 6-9 months; following that dosage may be reduced to 2,000 units 3 times/week for an additional 3 months

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Choriogonadotropin Alfa has no noted severe interactions with any other drugs.
• Choriogonadotropin Alfa has no noted serious interactions with any other drugs.
• Choriogonadotropin Alfa has no noted moderate interactions with any other drugs.
• Choriogonadotropin Alfa has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Ovidrel
• Hypersensitivity to component
• Primary ovarian failure
• Uncontrolled thyroid or adrenal dysfunction
• Uncontrolled organic intracranial lesions such as pituitary tumor
• Undiagnosed abnormal uterine bleeding
• Ovarian cyst or enlargement of undetermined origin
• Sex hormone-dependent tumors of the reproductive tract and accessory organs
• Pregnancy
• Novarel, Pregnyl
• Hypersensitivity to drugs or components
• Precocious puberty
• Prostatic carcinoma or another androgen-dependent neoplasm

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Choriogonadotropin Alfa?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Choriogonadotropin Alfa?”

Cautions

• Administer only after assessing adequate follicular development by serum estradiol & vaginal ultrasonography
• Ovidrel
• Potent gonadotropic substance capable of causing ovarian hyperstimulation syndrome (OHSS) in women with or without pulmonary or vascular complications
• Withhold were clinically significant ovarian enlargement or excessive estradiol production to reduce the risk of ovarian hyperstimulation syndrome
• Safe and effective induction of ovulation and use of the prefilled syringe in women requires monitoring of ovarian response with serum estradiol and transvaginal ultrasound regularly
• Ovarian hyperstimulation syndrome is characterized by mild to moderate ovarian enlargement may occur, accompanied by abdominal distension and/or abdominal pain; usually regresses without treatment in 2-3 weeks; may progress rapidly to a serious medical event characterized by a dramatic increase in vascular permeability, which may result in rapid fluid accumulation in the peritoneal cavity, thorax and/or pericardium
• Potential for arterial thromboembolism
• Risk of enlargement of preexisting ovarian cysts or rupture of ovarian cysts with resultant hemoperitoneum
• If ovaries are abnormally enlarged on the last day of FSH therapy, choriogonadotropin Alfa should not be administered in this course of therapy; this will reduce the risk of development of ovarian hyperstimulation syndrome
• Early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain; symptomatology seen with cases of OHSS include abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting, and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria
• Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events
• Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, reported in association with ovarian hyperstimulation syndrome
• OHSS may be more severe and more protracted if pregnancy occurs; OHSS develops rapidly; therefore, patients should be followed for at least two weeks after hCG administration; most often, OHSS occurs after treatment has been discontinued and reaches its maximum at about seven to ten days following treatment; usually, OHSS resolves spontaneously with the onset of menses; if there is evidence that OHSS may be developing before hCG administration hCG must be withheld
• If severe OHSS occurs, treatment with gonadotropins must be stopped and the patient should be hospitalized; a physician experienced in the management of this syndrome, or who is experienced in the management of fluid and electrolyte imbalances should be consulted
• As with other hCG products, reports of multiple births have been associated with treatment; in ART, the risk of multiple births correlates to the number of embryos transferred; multiple births were experienced by 30.9% of women receiving 250 μg in the ART studies. In the ovulation induction clinical trial, 2 of 15 live deliveries (13.3%) were associated with multiple births in women receiving therapy; the patient should be advised of the potential risk of multiple births before starting treatment
• A combination of both ultrasound and serum estradiol measurement is useful for monitoring the development of follicles, for the timing of ovulatory triggers, as well as for detecting ovarian enlargement and minimizing the risk of ovarian hyperstimulation syndrome and multiple gestations; recommended that the number of growing follicles be confirmed using ultrasonography because serum estrogens do not indicate size or number of follicles
• Novarel, Pregnyl
  • To be used in conjunction with human menopausal gonadotropins only by physicians experienced with infertility problems who are familiar with criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in the package insert for menotropins
  • Use with caution in cardiovascular disease, asthma, history of migraines, renal impairment, seizure disorders
  • Not effective in the treatment of obesity
  • May induce precocious puberty in children being treated for cryptorchidism (discontinue if signs of precocious puberty occur
  • Safety and efficacy not established in children below 4 years of age
  • Anaphylaxis reported with urinary-derived HCG products
  • Principal serious adverse reactions during this use are ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion, rupture of ovarian cysts with resultant hemoperitoneum, multiple births, and arterial thromboembolism
  • For pediatric use, induction of androgen secretion by HCG may induce precocious puberty in pediatric patients treated for cryptorchidism; therapy should be discontinued if signs of precocious puberty occur

Pregnancy and Lactation

• Intrauterine death and impaired parturition were observed in pregnant rats given a dose of urinary hCG (500 IU) equivalent to three times the maximum human dose of 10,000 USP, based on body surface area
• Lactation
  • Not known whether a drug is excreted in human milk; because many drugs are excreted in human milk, exercise caution if hCG is administered to a nursing woman