choriogonadotropin alfa (Ovidrel, Novarel, Pregnyl, chorionic gonadotropin)

Dosing and uses of Ovidrel, Novarel (choriogonadotropin alfa)

• Adult
• Pediatric

 

Adult dosage forms and strengths

prefilled syringe

• 250mcg

powder for reconstitution

• 10,000 units/vial

 

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

 

Pediatric dosage forms and strengths

prefilled syringe

• 250mcg

powder for injection

• 10,000 units

 

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

 

Ovidrel, Novarel (choriogonadotropin alfa) adverse (side) 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

 

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

 

Pregnancy and 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.

 

Pharmacology of Ovidrel, Novarel (choriogonadotropin alfa)

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