ATC Class: G03GA08
VA Class: HS400
CAS Number: 9002-61-3
Brands: Novarel, Pregnyl
Uses for Gonadotropin, Chorionic
Differential diagnosis (hCG stimulatory test) of cryptorchidism in prepubertal boys to predict whether subsequent orchidopexy will be required.a b c e bb In general, hCG is thought to induce testicular descent in patients in whom descent would have occurred at puberty.a b c e
Start corrective therapy for cryptorchidism before pubescence to prevent irreparable testicular damage; opinions differ regarding optimum age for treatment.e f mm Manufacturers recommend instituting u-hCG therapy for prepubertal cryptorchidism in boys 4–9 years of age.a b c e
Hypogonadotropic Hypogonadism in Males
Stimulation of spermatogenesis in males with hypogonadotropic hypogonadism secondary to pituitary deficiency†.e f ee ff jj Full response may require concurrent FSH or menotropins therapy†.f ee ff jj nn
Used in conjunction with follicle-stimulating agent(s) (e.g., menotropins as fixed-combination preparations or separate components, FSH†) to induce ovulation in anovulatory, infertile women in whom anovulation is secondary (e.g., pituitary insufficiency).a b c e g n q
Gonadotropin, Chorionic Dosage and Administration
Should be prescribed only by clinicians experienced in infertility treatment and who are familiar with criteria for patient selection and cautions, precautions, and contraindications associated with hCG/follicle-stimulating therapy.a b c e r hh
When ultrasound assessment and serum estradiol concentrations show sufficient follicular maturation, discontinue follicle-stimulating therapy and administer hCG to complete final follicular maturation and induce ovulation.g n q gg hh
Withhold further follicle-stimulating therapy and delay or withhold hCG if ovaries show an excessive response to treatment with gonadotropins because of increased risk of ovarian hyperstimulation syndrome (OHSS).g n p q r t gg hh (See Ovarian Hyperstimulation Syndrome under Cautions.)
Encourage daily sexual intercourse beginning 1 day prior to administration of hCG until ovulation occurs (as determined by rise in basal body temperature, increase in serum progesterone concentrations, and menstruation following shift in basal body temperature).q (See Adequate Patient Evaluation and Monitoring under Cautions.)
If stimulation of ovulation is unsuccessful, adjust dosage of follicle-stimulating agent administered in subsequent cycles based on woman’s response in preceding cycle.ii
Dosage regimens vary widely; individualize dosage carefully based on condition being treated, patient age and weight, and clinician’s judgment.a b c e Following treatment regimens suggested by various experts:a b c
Alternatively, 500 units may be given 3 times weekly for 4–6 weeks for boys ≥4 years of age.a b c e If this course of therapy is not successful, may administer a subsequent course of therapy 1 month later and increase dosage to 1000 units 3 times weekly for 4–6 weeks.a b c e
Hypogonadotropic Hypogonadism in Males
Hypogonadotropic Hypogonadism in Males
Cautions for Gonadotropin, Chorionic
Risk of mild to moderate uncomplicated ovarian enlargement when used in conjunction with follicle-stimulating agent(s); may be accompanied by abdominal distention and/or pain but generally regresses without treatment within 2–3 weeks.p q gg hh Careful monitoring of ovarian response recommended.p q r gg
Ovarian Hyperstimulation Syndrome
Risk of potentially severe OHSS, characterized by apparent dramatic increase in vascular permeability that may result in rapid accumulation of fluid in peritoneal cavity, thorax, and potentially, pericardium.e p q r gg hh
May progress rapidly (within 24 hours to several days) and is initially manifested by pelvic pain, nausea, vomiting, and weight gain.p q gg hh Other symptoms include abdominal pain/distention, diarrhea, severe ovarian enlargement, dyspnea, and oliguria.p q r t gg hh Hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events may occur.p q r t gg hh
Occurs most often after completion of gonadotropin therapy, reaching maximum severity after 7–10 days; usually resolves spontaneously with onset of menses.p q r t gg hh Monitor patients for ≥2 weeks after hCG administration.p q gg hh OHSS may be more severe and protracted if pregnancy occurs.p q r gg hh
Fetal/Neonatal Morbidity and Mortality
Exclude pregnancy before initiating treatment with hCG and menotropins.gg (See Contraindications under Cautions.)
Benzyl Alcohol in Neonates
Bacteriostatic water for injection or water for injection diluent contains benzyl alcohol as a preservative, which has been associated with toxicity (fatalities) in neonates.a b c v w x y z aa (See Pediatric Use under Cautions.)
Testicular tumors reported occasionally in young men with secondary infertility.e
Adequate Patient Evaluation and Monitoring
Monitor follicular development (e.g., using ovarian ultrasound, serum estradiol concentrations) to correctly identify follicular maturation, determine timing of hCG administration, detect ovarian enlargement, and minimize risks of OHSS and multiple gestation.q r t gg hh
Obtain clinical confirmation of ovulation from direct and indirect indices of progesterone production (e.g., rise in basal body temperature, increase in serum progesterone concentrations, menstruation following shift in basal body temperature).p q gg hh Sonographic evidence of ovulation includes findings of fluid in cul-de-sac, ovarian stigmata, collapsed follicle, and secretory endometrium.p q gg hh
Category X.c (See Fetal/Neonatal Morbidity and Mortality and also Contraindications under Cautions.)
Carefully monitor prepubertal males with cryptorchidism during u-hCG therapy since induction of precocious puberty may occur.a b c e If signs of precocious puberty (phallic enlargement, testicular enlargement and redness, development of pubic hair, aggressive behavior) occur, discontinue therapy;a b c e these signs are reversible ≤4 weeks after cessation of therapy.e (See Contraindications under Cautions.)
Large amounts of benzyl alcohol (i.e., 100–400 mg/kg daily) have been associated with toxicity (fatal “gasping syndrome”) in neonates; each multiple-dose vial of reconstituted drug contains 0.9% benzyl alcohol.a b c v w x y z aa
Safety and efficacy not established.b
Common Adverse Effects
Headache,a b c e g irritability,a b c e restlessness,a b c e depression,a b c e fatigue or tiredness,a b c e edema,a b c e precocious puberty,a b c gynecomastia,a b e ee ff pain at injection site.a b c e
Interactions for Gonadotropin, Chorionic
Radioimmunoassays for gonadotropins
Gonadotropin, Chorionic Pharmacokinetics
Following single injection in hypogonadotropic men, onset and peak stimulation of testosterone production (as indicated by plasma testosterone concentrations) occur at 24 and 80 hours, respectively.j
Following single injection in prepubertal and early pubertal boys with cryptorchidism, peak stimulation of testosterone production occurs at 2–5 days.kk
Following midcycle administration, stimulation of luteal-phase progesterone production (as indicated by serum progesterone concentrations) persists for approximately 1 week.n (See Actions.)
Following single injection in prepubertal boys with cryptorchidism, stimulation of testosterone production persists for ≥6 days.kk
Bioavailability is less in obese infertile women than in nonobese women.u
Distributed mainly into testes and ovaries; smaller amounts may be distributed into proximal tubules of renal cortex.e
Extensively metabolized, principally in liver and kidneys, to active metabolites.d
Excreted in urine (20%) as metabolites.d
Powder for Injection
Stimulates differentiation of and early maturation of the cells lining the seminiferous tubules (spermatogenic and Sertoli cells) of the testes.e
Substitutes for the endogenous LH surge responsible for ovulation;e k l stimulates late maturation of ovarian follicle,m t u resumption of oocytic meiosis,l m and initiation of rupture of preovulatory ovarian follicle.l m
Advice to Patients
Importance of discussing duration of treatment and required monitoring procedures.p
Importance of patients informing a clinician if severe pain or bloating in stomach or pelvic area, severe upset stomach, vomiting, or weight gain occurs.oo
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
For injection, for IM use only
10,000 USP units*
Chorionic Gonadotropin (with bacteriostatic water for injection diluent with benzyl alcohol)
Pregnyl (with water for injection diluent with benzyl alcohol)
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions June 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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