Medicine guide

Novarel

Kit

Prescription only

Active substance: Gonadotrophin, Chorionic
Made by: Ferring Pharmaceuticals Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-08-27

Used for

Hcg has not been demonstrated to be effective adjunctive therapy in the treatment of obesity.

Do not take it if

Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY.
THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS.
Prepubertal cryptorchidism not due to anatomic obstruction.
In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty.
HCG thus may help to predict whether or not orchiopexy will be needed in the future.
Although, in some cases, descent following HCG administration is permanent, in most cases the response is temporary.
Therapy is usually instituted between the ages of 4 and 9.
Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males.
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, and who has been appropriately pretreated with human menotropins.

From the official label · 2025-08-27 · DailyMed

How it works

From this product’s own US prescribing label.

The action of HCG is virtually identical to that of pituitary LH, although HCG appears to have a small degree of FSH activity as well.
It stimulates production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-08-27

Do not take it if

Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG.
HCG may cause fetal harm when administered to a pregnant woman.
Combined HCG/PMS (pregnant mare's serum) therapy has been noted to induce high incidences of external congenital anomalies in the offspring of mice, in a dose-dependent manner.
The potential extrapolation to humans has not been determined.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

(Intramuscular Use Only):
The dosage regimen employed in any particular case will depend upon the indication for use, the age and weight of the patient, and the physician's preference.
The following regimens have been advocated by various authorities.
Prepubertal cryptorchidism not due to anatomical obstruction:
4,000 USP Units three times weekly for three weeks. 5,000 USP Units every second day for four injections. 15 injections of 500 to 1,000 USP Units over a period of six weeks. 500 USP Units three times weekly for four to six weeks.
If this course of treatment is not successful, another is begun one month later, giving 1,000 USP Units per injection.
Selected cases of hypogonadotropic hypogonadism in males:
500 to 1,000 USP Units three times a week for three weeks, followed by the same dose twice a week for three weeks. 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.
Table 1.
Final Concentration after Reconstitution Reconstitution volume of bacteriostatic water for injection 10,000 IU Vial Concentration 5,000 IU Vial Concentration Administration 1 mL 10,000 IU/mL 5,000 IU/mL Administer entire dose at once 10 mL 1,000 IU/mL 500 IU/mL Multiple dose administration, refrigerate between doses NOTE:
Prior to diluting NOVAREL with Bacteriostatic Water for Injection (Table 1):
Remove the flip caps off the vial of bacteriostatic water and the vial of NOVAREL Wipe the tops of the vials with an alcohol pad or alcohol soaked gauze Do not touch the tops of the vials after you wipe them.
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 and who has been appropriately pretreated with human menotropins (See prescribing information for menotropins for dosage and administration for that drug product). 5,000 to 10,000 USP Units one day following the last dose of menotropins.
(A dosage of 10,000 USP Units is recommended in the labeling for menotropins).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Disposing of Needles and Syringes To safely dispose of medical sharps, place used needles and syringes in a closeable, puncture-resistant container, such as a red biohazard sharps container.
Sharps containers should then be taken to a collection center for proper disposal.
Ask your physician or pharmacist or reference our website for more information about safely disposing used sharps.
In some states, it is illegal to throw away medical sharps in household garbage, recycling, and compost bins.
Needles and other sharps must be placed in an approved sharps container and disposed of at an approved drop-off site.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

HCG should be used in conjunction with human menopausal gonadotropins only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in the package insert for menotropins.
The principal serious adverse reactions during this use are:
(1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion;
(2) Enlargement of preexisting ovarian cysts or rupture of ovarian cysts with resultant hemoperitoneum;
(3) Multiple births, and (4) Arterial thromboembolism.
The recommended diluent for reconstitution is Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%.
Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.
Anaphylaxis has been reported with urinary-derived HCG products.
General Induction of androgen secretion by HCG may induce precocious puberty in patients treated for cryptorchidism.
Therapy should be discontinued if signs of precocious puberty occur.
Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.
Drug/Laboratory test HCG can crossreact in the radioimmunoassay of gonadotropins, especially luteinizing hormone.
Each individual laboratory should establish the degree of crossreactivity with their gonadotropin assay.
Physicians should make the laboratory aware of patients on HCG if gonadotropin levels are requested.
Carcinogenesis, Mutagenesis, Impairment of Fertility There have been sporadic reports of testicular tumors in otherwise healthy young men receiving HCG for secondary infertility.
A causative relationship between HCG and tumor development in these men has not been established.
Defects of forelimbs and of the central nervous system, as well as alterations in sex ratio, have been reported in mice on combined gonadotropin and HCG regimens.
The dose of gonadotropin used was intended to induce superovulation.
No mutagenic effect has been clearly established in humans.
Fertility—see " INDICATIONS AND USAGE ." Pregnancy See " CONTRAINDICATIONS " section.
Nursing Mothers It is not known whether this drug is excreted in human milk.
Pediatric Use Safety and effectiveness in children below the age of 4 have not been established.
General Induction of androgen secretion by HCG may induce precocious puberty in patients treated for cryptorchidism.
Therapy should be discontinued if signs of precocious puberty occur.
Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

See " CONTRAINDICATIONS " section.
Combined HCG/PMS (pregnant mare's serum) therapy has been noted to induce high incidences of external congenital anomalies in the offspring of mice, in a dose-dependent manner.
The potential extrapolation to humans has not been determined.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HCG is administered to a nursing woman.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

Safety and effectiveness in children below the age of 4 have not been established.

Quoted from the official label, section “Pediatric Use”.

Side effects

(see WARNINGS ) Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, pain at the site of injection.
Hypersensitivity reactions both localized and systemic in nature, including erythema, urticaria, rash, angioedema, dyspnea and shortness of breath, have been reported.
The relationship of these allergic-like events to the polypeptide hormone or the diluent containing benzyl alcohol is not clear.

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

NOVAREL (chorionic gonadotropin) for Injection, USP, is available as individually packaged multiple-dose vials containing 5,000 or 10,000 USP Units per vial.
Each vial of NOVAREL is accompanied by a vial of sterile diluent containing 10 mL of Bacteriostatic Water for Injection, USP containing 0.9% benzyl alcohol.
NOVAREL is available in the following presentations:
NDC 55566-1501-1 :
10,000 USP units of chorionic gonadotropin injection in 1 vial with blue cap and 1 vial of diluent NDC 55566-1502-1 :
5,000 USP units of chorionic gonadotropin injection in 1 vial with aqua cap and 1 vial of diluent
Store at room temperature at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F) [See USP Controlled Room Temperature].
REFRIGERATE RECONSTITUTED PRODUCT AT 2° to 8°C (36° to 46°F) AND USE WITHIN 30 DAYS.

Quoted from the official label, section “How Supplied”.

How to store it

Store at room temperature at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F) [See USP Controlled Room Temperature]. REFRIGERATE RECONSTITUTED PRODUCT AT 2° to 8°C (36° to 46°F) AND USE WITHIN 30 DAYS.

Quoted from the official label, section “Storage and Handling”.

What is in it

Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta subunit.
The alpha subunit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha subunit of human thyroid-stimulating hormone (TSH).
The beta subunits of these hormones differ in amino acid sequence.
NOVAREL (chorionic gonadotropin) for injection is a water soluble glycoprotein derived from human pregnancy urine and administered intramuscularly after reconstitution.
The sterile lyophilized powder is stable.
When reconstituted with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, the solution should be refrigerated and used within 30 days.
Each 5,000 USP units vial contains:
chorionic gonadotropin 5,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg.
Each 10,000 USP units vial contains:
chorionic gonadotropin 10,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Details

Made by	Ferring Pharmaceuticals Inc.
Active substance	Gonadotrophin, Chorionic
Form	Kit
Packs	1 KIT in 1 CARTON * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL
NDC	55566-1502

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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