FOLIGRAF 75

• Brand Name: FOLIGRAF 75

• Generic Name: Follitropin alfa

• Therapeutic Class: Recombinant Follicle-Stimulating Hormone (rFSH)

• Presentation:

  • Lyophilized powder in vials (with solvent for reconstitution)

  • Prefilled pens (available in some markets)

2. Composition

• Active Ingredient: Follitropin alfa 75 IU

• Excipients:

  • Sucrose (stabilizer)

  • Sodium citrate (buffer)

  • Polysorbate 20 (surfactant)

  • Methionine (antioxidant)

3. Mechanism of Action

• Binds to FSH receptors in ovarian granulosa cells

• Stimulates:

  • Follicular growth and development

  • Estradiol production

  • Selection of dominant follicle(s)

• In men: Supports Sertoli cell function for spermatogenesis

4. Dosage and Administration

For Women

For Men

• 75-150 IU SC 2-3 times weekly (with hCG)

• Minimum treatment duration: 3 months

Administration Guide

1. Reconstitution:

   • Add 1 mL sterile water to vial

   • Gently swirl (do not shake)

2. Injection:

   • Preferred route: Subcutaneous

   • Alternate route: Intramuscular

   • Best time: Evening administration

5. Indications

✔ Anovulatory infertility (WHO Group I/II) ✔ Controlled ovarian stimulation for:

• IVF

• ICSI

• IUI cycles ✔ Male infertility (hypogonadotropic hypogonadism)

6. Storage Conditions

• Unopened:

  • Store at 2-8°C (refrigerate)

  • Do not freeze

• Reconstituted:

  • Use immediately

  • Discard unused portions

• Travel:

  • May be stored ≤25°C for max 3 months

  • Protect from light

7. Key Recommendations

• Baseline Requirements:

  • Pelvic ultrasound

  • Estradiol levels

  • Semen analysis (for male patients)

• Monitoring During Treatment:

  • Follicular tracking (ultrasound)

  • Estradiol measurements

  • Cervical mucus assessment

• Special Populations:

  • PCOS patients: Start with 37.5-75 IU

  • Poor responders: May require higher doses

8. Important Safety Information

Warnings and Precautions

⚠ Ovarian Hyperstimulation Syndrome (OHSS):

• Risk factors: PCOS, high estradiol, many follicles

• Prevention strategies:

  • Coasting

  • GnRH agonist trigger

  • Cycle cancellation if needed

⚠ Multiple Pregnancy Risk (20-30% with ovulation induction)

⚠ Thromboembolic Events (higher risk in OHSS)

Contraindications

❌ Ovarian enlargement/cysts of unknown origin ❌ Primary ovarian failure ❌ Sex hormone-dependent tumors ❌ Pituitary tumors

Adverse Effects

• Common (≥10%):

  • Injection site reactions

  • Mild ovarian enlargement

  • Headache

• Serious (<1%):

  • Severe OHSS

  • Thromboembolism

  • Ovarian torsion

9. Comparison with Other Fertility Agents

10. Patient Counseling Points

• Proper injection technique training

• Importance of regular monitoring

• Signs of OHSS to report immediately:

  • Severe abdominal pain

  • Nausea/vomiting

  • Shortness of breath

  • Decreased urine output

• Family planning considerations:

  • Multiple pregnancy risks

  • Need for contraception if not pursuing pregnancy

11. Regulatory Status

• Prescription-only medication

• Requires specialist supervision

• Included in most national ART guidelines