choriogonadotropin alfa (Ovidrel, Novarel, Pregnyl, chorionic gonadotropin)
Classes: Gonadotropins; Ovulation Stimulators
Dosing and uses of Ovidrel, Novarel (choriogonadotropin alfa)
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