Novarel® (chronic gonadotropin for injection, USP)

What it is

NOVAREL is a human chorionic gonadotropin (hCG) used to trigger ovulation in women whose infertility is not due to primary ovulation failure.¹

Before using NOVAREL, patients should be appropriately pretreated with human menotropins, such as MENOPUR® (menotropins for injection).¹

How it’s used

NOVAREL comes in a vial as a sterile powder and is self-administered by the patient, injected intramuscularly. Explore the tools below that can support you and your patient during the self-injection process.¹

Injection Instructions

5,000 USP Units

Printable Injection Guide

A PDF of step-by-step instructions for preparing patients to self-inject NOVAREL is available to download or print in the languages below.

NOVAREL® (chorionic gonadotropin for injection, USP)

INDICATION FOR USE

NOVAREL is indicated for the 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 pre-treated with human menotropins.

IMPORTANT SAFETY INFORMATION

NOVAREL should not be used in patients with prior allergic reaction to HCG. HCG may cause fetal harm when administered to a pregnant woman.
NOVAREL 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.
Anaphylaxis has been reported with urinary-derived HCG products.
Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.
HCG can cross react in the radioimmunoassay of gonadotropins, especially luteinizing hormone. Each individual laboratory should establish the degree of cross reactivity with their gonadotropin assay. Physicians should make the laboratory aware of patients on HCG if gonadotropin levels are requested.
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.
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.
Adverse reactions include 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.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch, or call 1.800.FDA.1088.

Please see full Prescribing Information.

Taking the next step with fertility patients

About

What it is

Administration

How it’s used

Injection Instructions

Printable Injection Guide

Reference

NOVAREL® (chorionic gonadotropin for injection, USP)

INDICATION FOR USE

IMPORTANT SAFETY INFORMATION

NOVAREL® (chorionic gonadotropin for injection, USP)

INDICATION FOR USE

IMPORTANT SAFETY INFORMATION