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Novarel

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Overview

What is Novarel?

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.

Chorionic Gonadotropin is a water soluble glycoprotein derived from human pregnancy urine. 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 USP units vial contains:

Chorionic Gonadotropin USP Units, Mannitol 100 mg, Dibasic Sodium Phosphate 16 mg, and Monobasic Sodium Phosphate 4 mg.

Each USP units vial contains:

Chorionic Gonadotropin USP Units, Mannitol 100 mg, Dibasic Sodium Phosphate 16 mg, and Monobasic Sodium Phosphate 4 mg.



What does Novarel look like?



What are the available doses of Novarel?

Sorry No records found.

What should I talk to my health care provider before I take Novarel?

Sorry No records found

How should I use Novarel?

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.

(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:

Selected cases of hypogonadotropic hypogonadism 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 (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.


What interacts with Novarel?

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.



What are the warnings of Novarel?

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.


What are the precautions of Novarel?

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 " ."

Pregnancy

Nursing Mothers

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.

Pediatric Use

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


What are the side effects of Novarel?

(see ) 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.


What should I look out for while using Novarel?

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.

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.


What might happen if I take too much Novarel?

Sorry No Records found


How should I store and handle Novarel?

Chorionic Gonadotropin for Injection, USP, is available as individually packaged 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: Chorionic Gonadotropin for Injection, USP, is available as individually packaged 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: Chorionic Gonadotropin for Injection, USP, is available as individually packaged 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: