Follitropin Beta

Follitropin Beta is a recombinant human follicle-stimulating hormone (r-hFSH) used in reproductive medicine to induce follicular development and support assisted reproductive technologies.

Approved Indications:

• Female infertility due to anovulation: For women who do not ovulate naturally, including those with polycystic ovary syndrome (PCOS).
• Assisted reproductive technology (ART): Controlled ovarian stimulation in women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
• Hypogonadotropic hypogonadism in women: To stimulate follicular growth in women with insufficient endogenous gonadotropins.
• Male infertility: To induce spermatogenesis in men with hypogonadotropic hypogonadism in combination with human chorionic gonadotropin (hCG).

Off-label / Clinically Accepted Uses:

• Mild ovarian stimulation protocols in ART cycles.
• Follicular development in donor egg programs or fertility preservation cycles.

Adults (Females):

• Ovulation induction in anovulatory women: Start at 75–150 IU daily subcutaneously; adjust based on ovarian response. Duration continues until adequate follicular development is achieved.
• ART cycles (IVF/ICSI): Initial dose 150–225 IU daily subcutaneously; adjust according to individual response; typical duration 8–12 days.

Adults (Males):

• Hypogonadotropic hypogonadism: 75–150 IU subcutaneously 3 times per week in combination with hCG; continue 3–12 months until sufficient spermatogenesis is achieved.

Special Populations:

• Elderly: Not indicated for postmenopausal women.
• Renal or hepatic impairment: No specific dose adjustment recommended; clinical monitoring advised.

Administration Route:

• Subcutaneous injection preferred; intramuscular injection is alternative.
• Administer at the same time daily for consistent serum levels.

Follitropin Beta is a recombinant human FSH that binds specifically to FSH receptors on ovarian granulosa cells in females and Sertoli cells in males. In women, this promotes follicular growth, maturation of oocytes, and estrogen production. In men, binding to Sertoli cells supports spermatogenesis. The drug essentially mimics natural FSH, enhancing gamete development and improving fertility outcomes.

• Absorption: Rapid after subcutaneous injection; peak levels achieved in 12–24 hours.
• Bioavailability: Approximately 70–80% subcutaneously.
• Distribution: Targeted mainly to gonadal tissues; minimal systemic distribution.
• Metabolism: Protein catabolism into inactive peptides; primarily renal clearance.
• Half-life: 24–36 hours after subcutaneous administration.
• Excretion: Metabolites eliminated via kidneys; minimal unchanged hormone in urine.

• Pregnancy: Not indicated during pregnancy; discontinue once pregnancy is confirmed. Classified as Pregnancy Category X.
• Lactation: Limited data; caution advised. Minimal transfer into breast milk expected, but use during breastfeeding is generally not recommended.

• Primary Class: Gonadotropin
• Subclass: Recombinant human FSH (r-hFSH)

• Known hypersensitivity to Follitropin Beta or any excipients.
• Primary ovarian failure or ovarian cysts unrelated to hypogonadotropic hypogonadism.
• Uncontrolled thyroid or adrenal dysfunction.
• Pituitary or hypothalamic tumors.
• Pregnancy or active lactation (unless clinically indicated).

• Ovarian Hyperstimulation Syndrome (OHSS): Monitor women at high risk (PCOS, multiple follicle development).
• Multiple pregnancy: Risk increases with gonadotropin therapy; adjust dosing to minimize multiple follicles.
• Fluid retention and thromboembolic events: Rare; monitor at-risk patients.
• Injection-site reactions: Mild pain, redness, or swelling may occur.
• Early discontinuation: Recommended if excessive ovarian response or OHSS develops.

Common:

• Headache, fatigue, abdominal discomfort, breast tenderness.
• Injection-site reactions: redness, pain, swelling.

Serious / Rare:

• OHSS: abdominal pain, ascites, rapid weight gain.
• Multiple pregnancies.
• Rare thromboembolic events.

Timing & Severity:

• Adverse effects usually occur during stimulation phase and may be dose-dependent.

• hCG therapy: Required for final oocyte maturation; dose timing must be coordinated.
• Estrogen/progestin therapy: May affect ovarian response; dose adjustment may be required.
• CYP450-metabolized drugs: No significant interactions, as Follitropin Beta is a protein hormone.
• Alcohol: No significant interaction reported.

• Individualized dosing based on ovarian reserve markers (AMH, AFC) recommended.
• Recombinant FSH is preferred for ART cycles due to predictable purity and dosing.
• Emphasis on minimizing OHSS and multiple gestations.
• Use in male infertility remains specific to hypogonadotropic hypogonadism.

• Store at 2°C to 8°C; do not freeze.
• Protect from light and heat; keep vials in original packaging until use.
• Reconstituted solution should be used immediately; if required, store up to 24 hours at 2°C–8°C.
• Avoid vigorous shaking; gently invert to dissolve powder.