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choriogonadotropin alfa (Rx)Brand and Other Names:Ovidrel, Novarel, more...Pregnyl, chorionic gonadotropin

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

prefilled syringe

  • 250mcg

powder for reconstitution

  • 10,000 units/vial
more...

Induction of Ovulation & Pregnancy

Ovidrel: 250 mcg SC one day following last dose of follicle stimulating agent; use only after adequate follicular development has been determined; hold treatment if there is excessive ovarian response

Novarel, Pregnyl, Generics: 5,000-10,000 units 1 day following last dose of menotropins

Induction of Spermatogenesis

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 dose required to maintain testosterone levels

Other Indications & Uses

Novarel: Induction of ovulation & pregnancy in infertile women with secondary anovulation who have been appropriately pretreated with menotropins/FSH

Ovidrel: Induction of final follicular maturation & early luteinization in infertile women who have undergone pituitary desensitization & who have been appropriately retreated with follicle stimulating hormones

Novarel, Pregnyl

  • Prepubertal cryptorchidism not due to anatomical obstruction
  • Selected cases of male secondary hypogonadotropic hypogonadism

Dosage Forms & Strengths

prefilled syringe

  • 250mcg

powder for injection

  • 10,000 units
more...

Prepubertal Cryptorchidism Not Caused By Anatomical Obstruction

Novarel, Pregnyl

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

Male Hypogonadotropic Hypogonadism

Novarel, Pregnyl

  • 500-1,000 units IM 3 times/week for 3 weeks, followed by same dose twice/week for 3 weeks
  • 4,000 units IM 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
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Adverse Effects

1-10%

Ovidrel

  • Ovarian cyst (3%)
  • Ovarian hyperstimulation (2-3%)
  • Abdominal pain (3-4%)
  • Nausea (3%)
  • Vomiting (3%)
  • Injection site inflammation (<2%)

<1%

Ovidrel

  • Breast pain
  • Cervical lesion
  • Cough
  • Albuminuria
  • Back pain
  • Breast pain
  • Cardiac arrhythmia
  • Dizziness
  • Emotional lability
  • Genial herpes
  • Hyperglycemia
  • Pruritus
  • Urinary tract infection
  • Vaginal hemorrhage
  • Vaginitis

Frequency Not Defined

Novarel, Pregnyl

  • Headache
  • Irritability
  • Depression
  • Edema
  • Restlessness
  • Gynecomastia
  • Precocious puberty
  • Fatigue
  • Arterial thrombus
  • Ovarian hyperstimulation syndrome
  • Overian cyst rupture
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Warnings

Contraindications

Ovidrel

  • Hypersensitivity to component
  • Primary ovarian failure
  • Uncontrolled thyroid or adrenal dysfunction
  • Uncontrolled organic intracranial lesion such as pituitary tumor
  • Undiagnosed abnormal uterine bleeding
  • Ovarian cyst or enlargement of undetermined origin
  • Sex hormone dependent tumor of reproductive tract and accessory organs
  • Pregnancy

Novarel, Pregnyl

  • Hypersensitivity to drug or components
  • Precocious puberty
  • Prostatic carcinoma or other androgen-dependent neoplasm

Cautions

Administer only after assessing adequate follicular development by serum estradiol & vaginal ultrasonography

Ovidrel

  • Withhold where clinically significant ovarian enlargement or excessive estradiol production to reduce risk of ovarian hyperstimulation syndrome
  • 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 wk; may progress rapidly to a serious medical event characterized by dramatic increase in vascular permeability, which may result in rapid fluid accumulation in peritoneal cavity, thorax and/or pericardium
  • Risk of multiple births
  • Potential for arterial thromboembolism
  • Risk of enlargement of preexisting ovarian cysts or rupture of ovarian cysts with resultant hemoperitoneum

Novarel, Pregnyl

  • Use with caution in cardiovascular disease, asthma, history of migraines, renal impairment, seizure disorders
  • Not effective in 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 <4 years of age
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Pregnancy & Lactation

Pregnancy Category: X

Lactation: Not known if distributed in breast milk; use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

more...
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Pharmacology

Mechanism of Action

Ovidrel

  • Produced by recombinant DNA techniques: human chorionic gonadotropin; stimulates late follicular maturation & resumption of oocyte meiosis & initiates rupture of pre-ovulatory ovarian follicle

Novarel, Pregnyl

  • Obtained from the urine of pregnant women; stimulates production of gonadal steroid hornones by causing production of androgen by the testes
  • Stimulates ovulation by acting as a substitute for luteinizing hormone

Pharmacokinetics

Ovidrel

  • Vd: 21.4 L
  • Time to peak: 12-24 hr
  • Bioavailability: 40%
  • Half-life: 4 hr
  • Time to peak: 12-24 hr
  • Excretion: Urine (10%)

Novarel, Pregnyl

  • Half-life: 11 hr intial; 23 hr terminal
  • Excretion: Urine
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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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