• Induction of ovulation in anovulatory patients whose infertility is not due to primary ovarian failure (Gonal-F and Gonal-F RFF).
• Stimulation of multiple oocytes in ovulatory patients undergoing assisted reproduction technology (ART) (Gonal-F and Gonal-F RFF).
• Induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism whose infertility is not due to primary testicular failure (Gonal-F only).

Contraindicated in:

• Hypersensitivity
• Primary ovarian or testicular failure
• OB: Pregnancy
• Uncontrolled thyroid, adrenal, or pituitary dysfunction
• Abnormal uterine bleeding
• Intracranial or hormone-dependent tumors
• Ovarian cyst/enlargement not due to polycystic ovarian syndrome.

Use Cautiously in:

• .

CV: THROMBOEMBOLIC EVENTS.

EENT: pharyngitis, rhinitis.

GI: constipation, diarrhea, dyspepsia, flatulence.

GU: OVARIAN HYPERSTIMULATION SYNDROME, abdominal/pelvic pain, dysmenorrhea, irregular bleeding, ovarian enlargement, ovarian torsion.

Derm: acne.

Endo: breast pain.

Neuro: dizziness, headache.

Resp: cough.

Local: injection site reactions.

Misc: ANAPHYLAXIS, flu-like symptoms, multiple births.

Drug-Drug:

• Unknown.

• Powder for injection: 75 IU/vial (Gonal-F RFF); 450 IU/vial (Gonal-F); 1050 IU/vial (Gonal-F);
• Pre-filled multidose pen (Gonal-F RFF Redi-ject): 300 IU/pen; 450 IU/pen; 900 IU/pen;

Female infertility

• SC (Adults): 75 IU/day for 14 days, then increased by 37.5 IU at weekly intervals as needed by assessment (up to 300 IU/day); followed by hCG.

Assisted Reproduction Technologies

• SC (Adults): 150 IU/day starting on day 2 or 3 of cycle until follicles develop sufficiently; if needed may be increased by 75–150 IU/day every 3–5 days (not to exceed 10 days or 450 IU/day); followed by hCG.

Male Patients with Hypogonadotropic Hypogonadism (Gonal-F only)

• SC (Adults): After normal serum testosterone levels are achieved with hCG, Gonal–F can be initiated at 150 IU 3 times weekly (must be given with hCG). If azoospermia persists, dose can be increased up to 300 IU 3 times weekly; may be given for up to 18 mo.

Gonal-F, Gonal-F RFF

• Stimulates follicle recruitment, growth and maturation.
• Induces spermatogenesis.

• Ovulation.
• Improved production/harvest of oocytes in patients undergoing ART.
• Spermatogenesis.

Therapeutic Classification: hormones (ovulation stimulant)

Absorption: Well absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: 24 hr.

• Prior to initiation of therapy discuss with patient the duration of therapy, required monitoring, potential adverse reactions, and risk of multiple births.
• Encourage couple to have intercourse daily, beginning on the day prior to administration of hCG until ovulation becomes apparent based on indices to determine progestational activity. Care should be taken to ensure insemination.

foll-i-TRO-pin AL-fa

NDC Code^*

• 0052- Organon USA Inc.
  • 0052-0313- Follistim AQ
    • 0052-0313-01- 1 KIT in 1 CARTON (0052-0313-01) > 1 CARTRIDGE in 1 KIT >.42 mL in 1 CARTRIDGE

• 0052- Organon USA Inc.
  • 0052-0313- Follistim AQ
    • 0052-0313-81- 1 KIT in 1 CARTON (0052-0313-81) > 1 CARTRIDGE in 1 KIT >.42 mL in 1 CARTRIDGE

• 0052- Organon USA Inc.
  • 0052-0316- Follistim AQ
    • 0052-0316-01- 1 KIT in 1 CARTON (0052-0316-01) > 1 CARTRIDGE in 1 KIT >.78 mL in 1 CARTRIDGE

• 0052- Organon USA Inc.
  • 0052-0316- Follistim AQ
    • 0052-0316-81- 1 KIT in 1 CARTON (0052-0316-81) > 1 CARTRIDGE in 1 KIT >.78 mL in 1 CARTRIDGE

• 0052- Organon USA Inc.
  • 0052-0326- Follistim AQ
    • 0052-0326-01- 1 KIT in 1 CARTON (0052-0326-01) > 1 CARTRIDGE in 1 KIT > 1.17 mL in 1 CARTRIDGE

• 44087- EMD Serono, Inc.
  • 44087-1115- Gonal-f RFF Redi-ject
    • 44087-1115-1- 1 PACKAGE in 1 CARTON (44087-1115-1) >.5 mL in 1 PACKAGE

• 44087- EMD Serono, Inc.
  • 44087-1116- Gonal-f RFF Redi-ject
    • 44087-1116-1- 1 PACKAGE in 1 CARTON (44087-1116-1) >.75 mL in 1 PACKAGE

• 44087- EMD Serono, Inc.
  • 44087-1117- Gonal-f RFF Redi-ject
    • 44087-1117-1- 1 PACKAGE in 1 CARTON (44087-1117-1) > 1.5 mL in 1 PACKAGE

• 44087- EMD Serono, Inc.
  • 44087-1118- Gonal-f RFF Redi-ject
    • 44087-1118-1- 1 PACKAGE in 1 CARTON (44087-1118-1) >.25 mL in 1 PACKAGE

• 44087- EMD Serono, Inc.
  • 44087-9005- GONAL-F RFF
    • 44087-9005-1- 1 BLISTER PACK in 1 CARTON (44087-9005-1) > 1 KIT in 1 BLISTER PACK * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS (44087-9998-1)

• 44087- EMD Serono, Inc.
  • 44087-9005- GONAL-F RFF
    • 44087-9005-6- 10 BLISTER PACK in 1 CARTON (44087-9005-6) > 1 KIT in 1 BLISTER PACK * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS (44087-9998-1)

• 44087- EMD Serono, Inc.
  • 44087-9030- Gonal-f
    • 44087-9030-1- 1 KIT in 1 CARTON (44087-9030-1) * 1 mL in 1 VIAL * 1 mL in 1 SYRINGE

• 44087- EMD Serono, Inc.
  • 44087-9070- Gonal-f
    • 44087-9070-1- 1 KIT in 1 CARTON (44087-9070-1) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE