• Induction of ovulation and pregnancy in anovulatory infertile women whose infertility is not due to primary ovarian failure.
• Pregnancy in normal ovulatory women undergoing controlled ovarian stimulation as part of an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
• Induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism (HH) whose infertility is not due to primary testicular failure.

Contraindicated in:

• Hypersensitivity to FSH or antibiotics, streptomycin or neomycin (may contain traces of these antibiotics)
• Abnormal vaginal bleeding
• Risk factors for thromboembolism
• Uncontrolled adrenal, thyroid, or pituitary dysfunction
• Intracranial or hormone-dependent tumors
• Ovarian cyst/enlargement not due to polycystic ovary syndrome
• Primary ovarian or testicular failure
• OB: Pregnancy

Use Cautiously in:

• Lactation: Lactation.

CV: tachycardia, THROMBOEMBOLISM.

Derm: acne, rash.

Endo: breast pain/enlargement.

GI: flatulence, nausea, constipation.

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

Local: injection site reactions.

MS: back pain.

Neuro: dizziness, headache.

Resp: ACUTE RESPIRATORY DISTRESS SYNDROME, dyspnea, tachypnea, upper respiratory tract infection.

Misc: flu-like symptoms, multiple births.

Drug-Drug:

• None reported.

• Solution for injection (multi-dose cartridges): 175 IU/vial (delivers 150 IU); 350 IU/vial (delivers 300 IU); 650 IU/vial (delivers 600 IU); 975 IU/vial (delivers 900 IU);

Ovarian and Pregnancy Induction in Anovulatory Infertile Women

• SC (Adults): 50 IU/day for up to 7 days, then ↑ by 25–50 IU at weekly intervals as needed by assessment (250 IU/day maximum); followed by hCG.

Pregnancy in Normal Ovulatory Women Undergoing IVF or ICSI

• SC (Adults): 200 IU daily for at least the first 7 days of treatment; dose may be then adjusted based upon ovarian response (500 IU/day maximum); followed by hCG.

Spermatogenesis Induction

• SC (Adults): Pretreat with hCG prior to use of Follistim AQ; once normal serum testosterone levels achieved, give 450 IU/week (as 225 IU twice weekly or 150 IU 3 times weekly) with hCG; continue for at least 3–4 mo.

Follistim AQ

• Stimulates follicle recruitment, growth, and maturation (in women) and spermatogenesis (in men).

• Ovulation.
• Pregnancy.
• Spermatogenesis.

Therapeutic Classification: hormones (ovulation stimulant)

Absorption: Well absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: 26.9–43.9 hr (dose-dependent).

Puregon

• 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.
• Advise patient to notify health care professional if worsening or strong abdominal pain occurs or if any side effect that is persistent or bothersome occurs.
• Rep: Advise females of reproductive potential to notify health care professional if breastfeeding.

foll-i-TRO-pin BAY-ta

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