Gonarex^® is a human-derived chorionic gonadotropin (hCG) hormone naturally produced by the human placenta. Commercially available hCG preparations consist of a highly purified luteinizing hormone (LH)-like glycoprotein isolated from the urine of pregnant women. In women, Gonarex^® acts as a substitute for luteinizing hormone (LH), promoting final follicular maturation and triggering ovulation.

In men, Gonarex^® stimulates androgen production by the testes, leading to the synthesis of sex steroid hormones and the development of secondary sexual characteristics.

• Induction of ovulation and achievement of pregnancy in women with secondary infertility not caused by primary ovarian failure.
• Treatment of prepubertal cryptorchidism (undescended testes), which the condition is not due to anatomical or mechanical obstruction.
• Treatment of hypogonadotropic hypogonadism in males resulting from gonadotropin deficiency.

Lyophilized powder containing 5,000 IU of human chorionic gonadotropin (hCG) for the preparation of a solution for injection.

1. Wash and dry your hands thoroughly with soap and water.
2. Remove the plastic caps from both the drug vial and the diluent vial, and disinfect the rubber stoppers using an alcohol swab.
3. Using a 2 mL syringe, withdraw 1 mL of diluent from the vial with the white cap.
4. Inject the diluent into the vial containing the lyophilized powder (yellow-capped vial).
5. Without removing the syringe, gently swirl the vial until a clear, particle-free solution is formed. Do not shake vigorously.
6. Withdraw the entire reconstituted solution into the syringe.
7. Use the medication according to the instructions provided in the Gonarex^® injection section.

The dose of Gonarex^® is individually determined for each patient based on the physician’s clinical judgment, the indication for use, as well as the patient’s age and body weight.

Gonarex^® may be administered either intramuscularly (IM) or subcutaneously (SC) depending on the indication.

Patients should only self-inject Gonarex^® at home if they are fully trained in the preparation and administration technique. Otherwise, the injection should be performed in a healthcare facility.

Injection procedure

1. Clean the injection site using an alcohol swab and allow the skin to dry.
2. Gently pinch the skin at the injection site using one hand.
3. For both subcutaneous and intramuscular injections, the needle is inserted at a 90-degree angle to the skin surface. Intramuscular injections are administered deeper into the tissue. A quick needle insertion helps reduce pain.
4. In intramuscular injections, proper needle placement is typically confirmed by difficulty in pulling back the plunger. If blood enters the syringe, withdraw the needle immediately and apply pressure to the site with an alcohol pad until bleeding stops.
5. After injection, gently massaging the site with light pressure may help distribute the medication and reduce pain.
6. Remove the needle from the skin while applying pressure with an alcohol swab.

Important Note

The vial included in the Gonarex^® package, as well as the syringe and needle obtained from the pharmacy, are intended for single use only. Dispose of all used materials appropriately after administration.

In case a dose of Gonarex^® is missed, consult your physician.

In case of administration of a dose higher than recommended, the physician should be informed immediately.

• In male patients with hypogonadotropic hypogonadism, monitoring of serum testosterone levels and semen analysis is required.
• During ovulation induction, transvaginal ultrasound and laboratory assessments such as serum estradiol measurement are recommended.
• For at least two weeks following administration of human chorionic gonadotropin (hCG), patients should be closely monitored for signs of ovarian hyperstimulation syndrome (OHSS). Symptoms may include moderate to severe abdominal pain, abdominal distension and firmness, nausea, and vomiting.

Gonarex^® is contraindicated in patients with:

• History of severe hypersensitivity to human chorionic gonadotropin or any component of the formulation
• Precocious puberty
• Tumors of the hypothalamus, pituitary gland, ovary, breast (in females or males), uterus, or prostate
• Unexplained abnormal vaginal bleeding
• Uncontrolled thyroid, adrenal, or pituitary disorders
• Elevated follicle-stimulating hormone (FSH) levels
• Congenital or acquired abnormalities of the reproductive tract incompatible with pregnancy
• Uterine fibroid tumors incompatible with pregnancy
• Pregnancy

Gonarex® should only be prescribed by a specialist physician.

Patients with cardiovascular disease, renal impairment, seizure disorders, migraine, or asthma should inform their physician before starting treatment.

Administration of hCG may lead to precocious puberty. In case of signs of early puberty, the physician should be notified immediately.

If any signs of hypersensitivity reactions occur—such as urticaria, pruritus, erythema, skin swelling or blistering, wheezing, chest or throat tightness, difficulty in breathing, swallowing or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat—urgent medical attention should be sought immediately.

During hCG therapy, the risk of thromboembolic events may increase, particularly in patients with a positive family history of thrombosis or those with obesity. In case of symptoms such as shortness of breath, redness, pain, or swelling in the lower limbs, the physician should be informed immediately.

• Administration of human chorionic gonadotropin (hCG) is contraindicated during pregnancy.
• During lactation, hCG should be used with caution and only under the supervision of a specialist physician.

Like all medications, Gonarex^® may cause adverse effects in addition to its intended therapeutic benefits; however, not all patients will experience them.

• Possible adverse effects include:
• Hypersensitivity reactions
• Ovarian hyperstimulation syndrome (OHSS), including moderate to severe abdominal pain, abdominal distension and firmness, nausea, and vomiting
• Injection site pain
• Headache, restlessness, fatigue, and depression
• Edema
• Ovarian torsion
• Abnormal breast tissue growth in males

For concomitant use of human chorionic gonadotropin (hCG) with other medications or supplements, consult your physician or pharmacist.

Each package contains four vials of lyophilized human chorionic gonadotropin powder and four vials of diluent (0.9% sodium chloride solution).

• Keep the medicine out of the sight and reach of children.
• Store below 25°C, protected from light and moisture.
• The product may be used until the end of the month stated on the expiry date. Do not use or store expired medication.
• Keep the medicine in its original packaging until use.

1. Urine-derived human chorionic gonadotropin: Drug information, UpToDate 2025
2. http://www.drugs.com/hcg.html