Gonal-F RFF Redi-ject Follitropin Alfa Injection 300 iU/ 0.48 mL Prefilled Syringe 0.5 mL (RX) ***Refrigerated Required

Gonal-F RFF (Recombinant Follicle-Stimulating Hormone) Redi-ject is a prescription medication designed to assist individuals struggling with fertility issues. It contains the active ingredient Follitropin Alfa, which is a synthetic version of the naturally occurring human follicle-stimulating hormone (FSH). This hormone plays a critical role in reproductive health by stimulating the production and maturation of ovarian follicles in women and the production of sperm in men. The product is specifically formulated in a prefilled syringe for ease of use.

Product Composition:

• Active Ingredient: Follitropin Alfa
  
• Concentration: 300 International Units (iU) per 0.48 mL of solution
  Presentation: Prefilled Syringe
  
• Volume: 0.5 mL total volume
  
• Other Ingredients: May include excipients such as disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, polysorbate 20, benzyl alcohol, and sucrose for stabilization.

Indications:

Gonal-F RFF Redi-ject is used in the treatment of the following conditions:

• Women: To stimulate the ovaries as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization (IVF), for the treatment of anovulation (including polycystic ovarian syndrome), and in follicle development in ovulatory patients to produce multiple follicles.
  
• Men: For the treatment of hypogonadotropic hypogonadism to stimulate sperm production.

Mechanism of Action:

Follitropin Alfa in Gonal-F mimics the natural FSH, binding to the FSH receptors on the surface of ovarian granulosa cells or on the Sertoli cells in the testes. This interaction stimulates the maturation of the ovarian follicles in women or induces spermatogenesis in men, ultimately aiding in fertility.

Administration and Dosage:

• Administration: Subcutaneous injection, usually in the lower abdomen or thigh.
  
• Dosage: Should be individualized based on the patient’s response to the medication and the recommendations of a healthcare provider. The typical starting dose for women is 75-300 iU per day, while it may vary for men based on specific diagnoses.
  
• Instructions for Use: Patients are typically instructed to self-administer after receiving proper training from a healthcare professional.

Storage:

• Unopened: Store refrigerated (2°C to 8°C). Can also be stored at room temperature (up to 25°C) but must be used within a month and protected from light.
  
• In-Use: Refrigerate between injections or keep at room temperature, and protect from light. The medication should be used within 28 days of first use.

Warnings and Precautions:

• Hypersensitivity Reactions: Patients with known hypersensitivity to Follitropin Alfa or any component in the formulation should not use this product.
  
• Ovarian Hyperstimulation Syndrome (OHSS): This is a potential risk and requires careful monitoring.
  
• Multiple Births: The use of Gonal-F can increase the risk of multiple pregnancies.
  
• Thromboembolic Events: A rare side effect, but precautions should be taken, especially in patients with predisposing factors.
  
• Cancer: There may be an increased risk of ovarian and other reproductive cancers with the treatment.

Possible Side Effects:

• Local reactions at the injection site, such as redness, bruising, or swelling
  
• Abdominal pain or bloating
  
• Nausea or vomiting
  
• Headache
  
• Ovarian cysts or enlargement in women
  
• Respiratory symptoms 
  
• Gynecomastia in men

Gonal-F RFF Redi-ject Follitropin Alfa Injection is a crucial pharmaceutical option for individuals undergoing fertility treatments. Its recombinant nature ensures consistency and purity, and the prefilled syringe format offers convenience and ease of administration. As with any prescription medication, it should be used under strict medical supervision to optimize efficacy and minimize risks.