follitropin beta

REMS

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.

Action ⬆ ⬇

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

Therapeutic effects:

Ovulation.
Pregnancy.
Spermatogenesis.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

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

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
SUBQ (men or women)	unknown	unknown	unknown

Contraind./Precautions ⬆ ⬇

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.

Adv. Reactions/Side Effects ⬆ ⬇

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

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

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.

Availability ⬆ ⬇

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)

Assessment ⬆ ⬇

Monitor follicular maturation during therapy via ovarian ultrasound and serum estradiol levels.
Assess for ovarian enlargement (abdominal distention, abdominal pain). Usually regresses without treatment within 2–3 weeks.

Toxicity and Overdose:

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.

Implementation ⬆ ⬇

SC: Follistim AQ cartridge: Administer via SUBQ injection. Remove protective cap on pen. Unscrew the entire pen body from cartridge holder. Place Follistim AQ Cartridge into cartridge holder (placing metal rimmed cap end first). Screw pen body onto cartridge holder. Screw cartridge holder into BD Micro-Fine Pen Needle. Best place for injection is area below navel (belly button) or in upper thigh. Unused cartridges may be stored in refrigerator until expiration date or at room temperature for 3 mo or until expiration date, whichever occurs first. Used cartridges may be stored in refrigerator or at room temperature for up to 28 days. Protect from light.

Patient/Family Teaching ⬆ ⬇

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.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇