Novarel

Name: Novarel

Novarel Overview

Novarel is a prescription medication used to help with descent of the testicles in young boys, promote hormone production in men, and promote ovulation and pregnancy in women. Novarel belongs to a group of drugs called synthetic hormones, which work by helping to balance the levels of natural hormones in the body.

This medication comes in injectable form and is typically given three times per week directly into the muscle by a healthcare professional. 

Common side effects of Novarel include headache, irritability, and fatigue.

 

Side Effects of Novarel

Serious side effects have been reported with Novarel. See the “Novarel Precautions” section.

Common side effects of Novarel include the following:

  • headache
  • rash
  • irritability
  • restlessness
  • edema
  • shortness of breath
  • early-onset puberty
  • swelling of breast tissue
  • pain at the site of injection
  • depression
  • tiredness

This is not a complete list of Novarel side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Novarel and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Novarel crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Novarel.

Novarel Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your height
  • your age
  • your gender

The recommended dose of Novarel to promote descent of the testicles in young boys is:

  1. 4000 units 3 times weekly for 3 weeks
  2. Then, 5000 units every second day for 4 injections
  3. Then, 15 injections for 500 to 1000 units over a period of 6 weeks
  4. Then, 500 units 3 times weekly for 4 to 6 weeks.
  5. If this course of treatment is not successful, another series is begun 1 month later, giving 1000 units per injection

The recommended dose of Novarel to promote hormone production in men is:

  1. 500 to 1000 units 3 times a week for 3 weeks, followed by the same dose twice a week for 3 weeks
  2. Then, 4000 units 3 times weekly for 6 to 9 months, following which the dosage may be reduced to 2000 units 3 times weekly for an additional 3 months

The recommended dose range of Novarel to promote ovulation and pregnancy in women is:

  • 5000 to 10,000 USP units given once

How is this medicine (Novarel) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into a muscle.
  • Your doctor may teach you how to give the shot.
  • Follow how to use carefully.
  • Wash your hands before and after use.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

How do I store and/or throw out Novarel?

  • Store at room temperature.
  • Protect from light.
  • After mixing, store in a refrigerator. Check with the doctor or pharmacist if you have questions about how long this medicine may be used after mixing.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Novarel Description

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 5,000 USP units vial contains:

Chorionic Gonadotropin 5,000 USP Units, Mannitol 100 mg, Dibasic Sodium Phosphate 16 mg, and Monobasic Sodium Phosphate 4 mg.

Each 10,000 USP units vial contains:

Chorionic Gonadotropin 10,000 USP Units, Mannitol 100 mg, Dibasic Sodium Phosphate 16 mg, and Monobasic Sodium Phosphate 4 mg.

Indications and Usage for 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.

  1. 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.
  2. Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males.
  3. 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.

Precautions

General

  1. 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.
  2. 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. Fertilitysee "INDICATIONS AND USAGE."

Pregnancy

Teratogenic effects

Category X

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.

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.

How is Novarel Supplied

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:

  • NDC 55566-1501-1: 10,000 USP units of Chorionic Gonadotropin injection in 1 vial with blue cap and 1 vial of diluent
  • NDA 55566-1502-1: 5,000 USP units of Chorionic Gonadotropin injection in 1 vial with aqua cap and 1 vial of diluent

Store dry product 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.

Manufactured for:
Ferring Pharmaceuticals Inc.
Parsippany, NJ 07054

8109000021
Rev. 09/2016

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