What HCG is
HCG is human chorionic gonadotropin. The approved labels describe it as a polypeptide hormone produced by the human placenta, composed of an alpha and a beta sub-unit. The Fresenius Kabi label says chorionic gonadotropin is obtained from human pregnancy urine and "is standardized by a biological assay procedure".
That's why an HCG vial is labelled in units of activity and not in milligrams. The labels count in USP units. The Novarel label's own table calls its 10,000 and 5,000 USP unit vials the 10,000 IU and 5,000 IU vials, and gives their strengths in IU/mL. This page says IU.
The units on an insulin syringe are something else. They measure volume, 100 to the mL on a U-100 syringe. How many IU of HCG one of those units holds depends on how much water went into the vial.
Where it stands with the FDA
HCG is FDA-approved as a prescription drug. This page rests on three labels on DailyMed, the National Library of Medicine's collection of drug labels: Novarel from Ferring Pharmaceuticals Inc., Pregnyl from Organon LLC, and Chorionic Gonadotropin from Fresenius Kabi USA, LLC. The Novarel label gives its initial U.S. approval as 1974.
All three are a powder in a multiple-dose vial that comes with a 10 mL vial of diluent to mix it with. The Novarel label lists vials of 5,000 or 10,000 USP units. The Pregnyl and Fresenius Kabi labels list 10,000 USP units per vial.
All three labels say the product is for intramuscular use only. None of them mentions an insulin syringe or an injection under the skin. This calculator converts into the units of a U-100 insulin syringe and shows mL beside them, so the mL figure is the one to hold against a label.
The labels list three uses: prepubertal cryptorchidism not due to anatomical obstruction, selected cases of hypogonadotropic hypogonadism in males, and induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure.
HCG isn't approved for weight loss. All three labels say, in capital letters, that HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity, and that it has no known effect on fat mobilization, appetite or sense of hunger, or body fat distribution. An FDA consumer page, current as of July 13, 2020, says "HCG is not approved for use without a prescription for any purpose. It is not approved for weight loss." That page advises consumers to avoid HCG weight-loss products, which it says are typically sold in the form of oral drops, pellets and sprays.
An FDA list of approved applications for biological products that were deemed to be licenses on March 23, 2020 includes chorionic gonadotropin, as Pregnyl, Novarel and Fresenius Kabi's product among others. An FDA guidance dated January 2018 says biological products subject to licensure "are not eligible for the exemptions for compounded drugs under sections 503A and 503B" of the Federal Food, Drug, and Cosmetic Act. That guidance is about biological products in general. It doesn't name HCG.
What the labels say
The labels don't give one dose. All three say the dosage regimen employed in any particular case will depend upon the indication, "the age and weight of the patient" and the physician's preference, and that the regimens they list "have been advocated by various authorities".
For selected cases of hypogonadotropic hypogonadism in males, the Fresenius Kabi label lists two regimens: "500 to 1,000 USP units three times a week for three weeks, followed by the same dose twice a week for three weeks", and "4,000 USP units three times weekly for six to nine months, following which the dosage may be reduced to 2,000 USP units three times weekly for an additional three months".
For induction of ovulation, in a woman appropriately pretreated with human menotropins, it lists "5,000 to 10,000 USP units one day following the last dose of menotropins", and adds that a dosage of 10,000 USP units is recommended in the labeling for menotropins.
For prepubertal cryptorchidism it lists four regimens, among them "4,000 USP units three times weekly for three weeks" and "500 USP units three times weekly for four to six weeks". The label says therapy for that use is usually instituted between the ages four and nine.
Those regimens are the labels', for the uses the labels cover and at a physician's direction. This page reports them and doesn't suggest a dose.
The Novarel and Fresenius Kabi labels warn that HCG should be used in conjunction with human menopausal gonadotropins "only by physicians experienced with infertility problems". For that use, the Novarel label names the principal serious adverse reactions as ovarian hyperstimulation, enlargement of preexisting ovarian cysts or rupture of ovarian cysts with resultant hemoperitoneum, multiple births and arterial thromboembolism. The Fresenius Kabi label says "Anaphylaxis and other hypersensitivity reactions have been reported with urinary-derived HCG products."
The Fresenius Kabi and Novarel labels list the same contraindications: "Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG." The Pregnyl label's list is longer and worded differently. The Fresenius Kabi label says HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine or asthma, since androgens may cause fluid retention.
The adverse reactions the Fresenius Kabi label lists are "Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia and pain at the site of injection." The Novarel label adds that there have been sporadic reports of testicular tumors in otherwise healthy young men receiving HCG for secondary infertility, and that a causative relationship "has not been established".
On pregnancy, the Fresenius Kabi label says chorionic gonadotropin "may cause fetal harm when administered to a pregnant woman". It says safety and effectiveness in children below the age of four have not been established.
The diluent matters too. The Novarel label says its recommended diluent is Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, and that "Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants." The Pregnyl label says its solvent, which contains benzyl alcohol, is not for use in newborns.
How the labels mix a vial
The Fresenius Kabi label has 10 mL of its diluent added to a vial of 10,000 USP units. The Novarel label's table gives two volumes of bacteriostatic water for a 10,000 IU vial and a 5,000 IU vial: 10 mL, for "Multiple dose administration, refrigerate between doses", and 1 mL, for which the table says "Administer entire dose at once". The concentrations below match that table.
| Vial | Water | Concentration | 10 units hold |
|---|---|---|---|
| 10,000 IU | 10 mL | 1,000 IU/mL | 100 IU |
| 5,000 IU | 10 mL | 500 IU/mL | 50 IU |
| 10,000 IU | 1 mL | 10,000 IU/mL | 1,000 IU |
| 5,000 IU | 1 mL | 5,000 IU/mL | 500 IU |
More water spreads the same HCG over more units. Less water packs it into fewer.
Storing HCG
The three labels give different times for a mixed vial. The Novarel label says the reconstituted solution "should be refrigerated and used within 30 days". The Fresenius Kabi label says to refrigerate after reconstitution and use completely within 60 days. The Pregnyl label says the reconstituted solution is stable for 60 days when refrigerated, and not to freeze it.
Before mixing, the Novarel label says to store the vial at room temperature at 20° to 25°C (68° to 77°F). The Pregnyl label says to store the unopened vial at controlled room temperature 15°C to 25°C (59°F to 77°F). The Pregnyl label also says each multiple-dose vial is only for use in one patient.
Those times are each label's, for its own vial and its own diluent. None of the labels says how long any other HCG vial keeps once it's mixed.
HCG dosage calculator questions
How do I turn an HCG dose into syringe units?
Divide the dose in IU by the concentration in IU per mL to get millilitres, then multiply by 100. The Novarel label's table says a 10,000 IU vial reconstituted with 10 mL of bacteriostatic water is 1,000 IU/mL. At that strength one unit on a U-100 insulin syringe holds 10 IU and ten units hold 100 IU. Units on the syringe measure volume. They aren't IU. The labels themselves don't mention an insulin syringe, and all three say intramuscular use only.
How much bacteriostatic water goes in an HCG vial?
The approved labels say. The Fresenius Kabi label has 10 mL of its diluent added to its vial of 10,000 USP units. The Pregnyl label says to remove 1 to 10 mL of its solvent and add it to the vial. The Novarel label's table gives two volumes. With 10 mL, a 10,000 IU vial is 1,000 IU/mL and a 5,000 IU vial is 500 IU/mL. With 1 mL, they're 10,000 IU/mL and 5,000 IU/mL, and the table says to administer the entire dose at once.
Is HCG approved by the FDA?
Yes, as a prescription drug. This page rests on three labels on DailyMed: Novarel, Pregnyl and Fresenius Kabi's Chorionic Gonadotropin, each a powder to mix for intramuscular use only. FDA says HCG is not approved for use without a prescription for any purpose, and is not approved for weight loss.
Does this page tell me how much HCG to take?
No. The approved labels list regimens that "have been advocated by various authorities" for the uses those labels cover, and this page reports them as what the labels say and nothing more. The dose box starts empty, and the chart only converts.
Are the units on my syringe the same as IU of HCG?
No. Units on a U-100 insulin syringe measure volume, 100 to the mL. IU of HCG measure activity. The Novarel label's table says a 10,000 IU vial is 1,000 IU/mL with 10 mL of water and 10,000 IU/mL with 1 mL, so the same mark on the syringe holds ten times as much HCG from the second vial as from the first.
Is HCG approved for weight loss?
No. An FDA consumer page says HCG "is not approved for weight loss", and the approved labels say there is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction.
Do the approved labels say to inject HCG under the skin?
No. All three labels say for intramuscular use only, and none mentions an injection under the skin or an insulin syringe.
More peptide calculators by name
The same instrument, set up one peptide at a time. For any other vial, use the peptide reconstitution calculator.