foll-i-TRO-pin AL-fa

Therapeutic Classification: hormones (ovulation stimulant)

• 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).

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

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

Absorption: Well absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: 24 hr.

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.

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.

• 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;

• Monitor follicular maturation during therapy via ovarian ultrasound and serum estradiol levels.
• Assess patient for ovarian enlargement (abdominal distention, abdominal pain). Usually regresses without treatment within 2–3 wks.
• For men, monitor serum testosterone levels and sperm counts. Prior to concomitant therapy with follitropin alfa and hCG, pretreatment with hCG alone is required to achieve normal serum testosterone levels. Pretreatment with hCG may require 3–6 mo. Serum testosterone levels should be normalized prior to initiation of therapy.

• Assess patient for signs of ovarian hyperstimulation syndrome (severe ovarian enlargement, abdominal pain and distention, nausea, vomiting, weight gain, diarrhea, dyspnea, oliguria). May be accompanied by ascites, pleural effusion, hypovolemia, electrolyte imbalance, hemoperitoneum, thromboembolic events.

• SC: Administer via SUBQ injection only. Vials:Dissolve the contents of each vial with sterile or bacteriostatic water for injection provided in accompanying pre-filled syringe. For single-dose vial, use immediately after reconstitution and discard unused solution. Multi-dose vials may be stored in refrigerator or at room temperature for up to 28 days. Dose from multi-dose vials should be administered with calibrated syringes provided by manufacturer. Protect all vials from light. Pre-filled pens:Pens should be at room temperature before using. Remove protective pen cap. Remove peel tab from outer needle cap on single-use disposable needle (provided in carton). Press threaded tip of pen into open end of outer needle cap and twist it clockwise until securely fixed. Remover outer needle cap (but don't throw away). Do not remove the inner needle cap at this time. Select prescribed dose by turning dosage dial to proper dose mark. Pull out injection button on pen as far as it will go. Remover inner needle cap on pen. Insert needle into abdominal skin at 90 degree angle and push injection button. Allow needle to remain in skin for at least 5 sec to ensure that full dose is injected. Remove needle. Replace outer needle cap onto needle. Remove needle by unscrewing pen counter-clockwise and dispose of in safety container. Replace protective pen cap. Unused pens may be stored in refrigerator until expiration date or at room temperature for up to 1 mo or until expiration date, whichever occurs first. Used pens may be stored in refrigerator or at room temperature for up to 28 days. Pens should be protected from light.

• 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.

• Successful pregnancy.
• Increased sperm count.

Gonal-F, Gonal-F RFF

• Deficient knowledge, Relate med (Patient/Family Teaching).

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