RONAK
About US/Products/Reproductive Health & Fertility/Gonarex®

Gonarex®

Patient Details

Gonarex®

Generic name: Human Chorionic Gonadotropin (hCG)
Dosage form: Lyophilized powder containing 5000 IU of human chorionic gonadotropin for preparation of injectable solution
Drug class: Gonadotropin; Ovulation Stimulator
Indications: Induction of ovulation in women; stimulation of testosterone production, treatment of cryptorchidism, and hypogonadism due to gonadotropin deficiency in men

Description

Gonarex® is a human chorionic gonadotropin (hCG) produced by the human placenta. Available preparations contain purified luteinizing hormone (LH) activity extracted from the urine of pregnant women.
In women, Gonarex® acts as an LH substitute to trigger ovulation.
In men, Gonarex® stimulates testicular androgen production, leading to sex steroid synthesis and development of secondary sexual characteristics.

Indications for Use

  • Induction of ovulation and achievement of pregnancy in women with infertility not due to primary ovarian failure.
  • Treatment of cryptorchidism (undescended testes) before puberty when not due to anatomical obstruction.
  • Treatment of hypogonadism due to gonadotropin deficiency in men.

Dosage Form

Lyophilized powder containing 5000 IU hCG for preparation of injectable solution.

Preparation Instructions

  1. Wash and dry hands with soap and water.
  2. Remove the plastic caps from one vial of drug and one vial of solvent; clean both rubber stoppers with an alcohol pad.
  3. Using a 2 mL syringe, withdraw 1 mL of solvent from the vial with the white cap.
  4. Inject the solvent into the vial containing the powder (yellow cap).
  5. Without removing the syringe, gently swirl until a clear, particle and bubble free solution is obtained (do not shake vigorously). Then withdraw the entire contents back into the syringe.

Dosage and Administration

The dose is individualized by the specialist based on indication, age, and weight.
Gonarex® may be administered intramuscularly (IM) or subcutaneously (SC) according to clinical need.
Only perform home injections if you are fully trained in preparation and administration; otherwise, attend a medical facility.
Injection steps (SC or IM):

  1. Clean the site with an alcohol pad and allow to dry.
  2. Gently pinch the skin.
  3. Insert the needle at 90° (or 45° in thin patients), inject the full dose, count to three, then release.
  4. Withdraw the needle and apply pressure with an alcohol pad.                  Note: Each vial (drug and solvent), syringe, and needle is single use only. Dispose of safely after use.

Missed Dose

If a dose is missed, consult your physician.

Overdose

If more than the recommended dose is administered, inform your doctor.

Monitoring During Treatment

  • In men with hypogonadism due to gonadotropin deficiency monitor serum testosterone and perform semen analysis.
  • For ovulation induction perform transvaginal ultrasound and tests such as serum estradiol.
  • For at least 2 weeks after hCG administration, monitor for ovarian hyperstimulation syndrome (OHSS). moderate–severe abdominal pain, abdominal enlargement/firmness, nausea, vomiting.

Contraindications

  • Severe hypersensitivity to hCG or any component of the formulation
  • Precocious puberty
  • Tumors of the hypothalamus, pituitary, ovary, breast (female or male), uterus, or prostate
  • Unexplained abnormal vaginal bleeding
  • Uncontrolled disorders of the thyroid, adrenal, or pituitary
  • Elevated FSH (suggestive of primary ovarian failure)
  • Genital abnormalities incompatible with pregnancy
  • Uterine fibroids incompatible with pregnancy
  • Pregnancy

Warnings and Precautions

  • Prescribe Gonarex® only by a specialist.
  • Inform your doctor about cardiovascular disease, renal failure, seizures, migraine, or asthma.
  • hCG may precipitate precocious puberty; report symptoms promptly.
  • Seek urgent care for signs of hypersensitivity (hives, pruritus, redness, swelling or blistering of skin, wheeze, chest/throat tightness, breathing/swallowing/speaking difficulty, unusual hoarseness, swelling of mouth/face/lips/tongue/throat).
  • Risk of thromboembolism may increase in patients with positive family history or obesity; report leg pain/redness/swelling or dyspnea immediately.

Use in Pregnancy and Lactation

  • Contraindicated in pregnancy.
  • During lactation, use with caution and under specialist supervision.

Adverse Reactions

  • Hypersensitivity reactions
  • OHSS (abdominal pain/distension, nausea, vomiting)
  • Injection-site pain
  • Headache, restlessness, fatigue, depression
  • Edema
  • Ovarian torsion
  • Gynecomastia in males

Drug Interactions

Consult your physician or pharmacist before using hCG with other medicines or supplements.

Packaging

Each box contains four vials of lyophilized hCG (5000 IU) and four vials of solvent (0.9% sodium chloride).

Storage Conditions

  • Keep out of the sight and reach of children.
  • Store below 25°C, away from light and humidity.
  • Use before the expiry date stated on the pack; do not use expired medicine.
  • Keep in the original package until use.

References

  1. Urine-derived human chorionic gonadotropin: Drug information, UpToDate 2025

  2. http://www.drugs.com/hcg.html

Gonarex®
Prescribing Information