follitropin beta (Rx)

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Brand and Other Names:Follistim AQ

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 75 Units/0.5mL
  • 150 Units/0.5mL

injectable SC cartridge

  • 300 International Unit/0.36mL (0.42mL)
  • 600 International Unit/0.72mL (0.78mL)
  • 900 International Unit/1.08mL (1.17mL)
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Assisted Reproductive Technology

Development of multiple follicles in ovulatory women participating in ART program

Starting dose: 150-225 units SC/IM for at least 4 days

Dose may be adjusted based upon individual ovarian response

Maintenance doses 375-600 units SC/IM may be required in low or poor responders (10% during clinical studies)

Administer human chorionic gonadotropin (hCG) 5000 units-10,000 units to induce final follicle maturation when sufficient number of follicles of adequate size are present

Oocyte retrieval performed 34-36 hr later

Administration of hCG must be withheld if ovaries are abnormally enlarged on final day of follitropin therapy to reduce chance of developing OHSS

Ovulation Induction

Induction of ovulation and pregnancy in anovulatory infertile women when cause of infertility is functional (not due to primary ovarian failure)

Starting dose: 75 units/day SC/IM for at least 7 days

Increase dose by 25/ or 50 units qweek until adequate response as measured by follicular growth or serum estradiol levels

Maximum daily dose used during clinical trials: 300 units

Continue treatment until ultrasonic visualizations and/or serum estradiol indicate desired pre-ovulatory conditions

Administration of hCG must be withheld if ovaries abnormally enlarged on final day of follitropin therapy to reduce chance of developing OHSS

Administration

To effect final phase of follicle maturation, resumption of meiosis and rupture of follicle in absence of endogenous LH surge, human chorionic gonadotropin (hCG) must be given following treatment with follitropin beta when patient monitoring indicates appropriate follicular development parameters have been reached

Administration of hCG must be withheld if ovaries abnormally enlarged on final day of follitropin therapy to reduce chance of developing OHSS

Spermatogenesis

Indicated for induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism (HH) in whom the cause of infertility is not due to primary testicular failure

Step 1: Pretreat with hCG alone 1500 units twice weekly; if serum testosterone levels have not normalized after 8 weeks, may increase dose to 3000 units twice weekly

Step 2: After normalization of serum testosterone levels, administer follitropin beta 450 units SC (ie, 225 units 2 times/week or 150 units 3 times/week) with the same pretreatment hCG dose used to normalize testosterone levels

Safety and efficacy not established

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Adverse Effects

1-10%

ART

  • Ovarian Hyperstimulation Syndrome (5.2%)
  • Ectopic pregnancy (3%)
  • Abdominal pain (2.5%)
  • Injection site pain (1.7%)
  • Vaginal hemorrhage (1.5%)

Ovulation induction

  • Miscarriage (9.5%)
  • Ovarian Hyperstimulation Syndrome (7.6%)
  • Abdominal discomfort (2.9%)
  • Abdominal pain, lower (2.9%)
  • Ovarian cyst (2.9%)
  • Abdominal pain (1.9%)

Spermatogeneis

  • Headache (6.7%)
  • Acne (6.7%)
  • Injection site reaction (6.7%)
  • Injection site pain (6.7%)
  • Gynecomastia (3.3%)
  • Rash (3.3%)
  • Dermoid cyst (3.3%)

Frequency Not Defined

Dizziness

Febrile reactions

Hemoperitoneum

Tachycardia

Dyspnea

Tachypnea

Flu-like symptoms

Adnexal torsion (as a complication of ovarian enlargement)

Breast tenderness

Dry skin

Erythema

Body rash

Hair loss

Hives

Postmarketing Reports

Ovarian neoplasms (infrequent reports in women who have undergone multiple drug regimens for ovulation induction; causal relationship has not been established)

Incidence of congenital malformations after ART may be slightly higher than after spontaneous conception; thought to be related to differences in parental characteristics (maternal age, sperm characteristics) and to higher incidence of multiple gestations; no indications that use of gonadotropins during ART is associated with increased risk of congenital malformations

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Warnings

Contraindications

Contraindicated in men and women

  • Prior hypersensitivity to recombinant hFSH products
  • High levels of FSH indicating primary ovarian failure
  • Uncontrolled thyroid or adrenal dysfunction
  • Hypersensitivity reactions to streptomycin or neomycin (may contain traces of these antibiotics)
  • Tumor of ovary, breast, uterus, testis, hypothalamus, or pituitary gland

Contraindicated in women

  • Pregnancy
  • Heavy or irregular vaginal bleeding of undetermined origin
  • Ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS)

Cautions

Should be used only by physicians who are experienced in infertility treatment

Follistim beta is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) with or without pulmonary or vascular complications and multiple births

May cause abnormal ovarian enlargement

Pulmonary complications (eg, atelectasis, acute respiratory distress syndrome) reported

Thromboembolic reactions, both in association with, and separate from OHSS have been reported

Gonadotropin therapy requires the availability of appropriate monitoring facilities

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Pregnancy & Lactation

Pregnancy Category: X

Lactation: Unknown whether distributed in breast milk, caution advised

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Follicle-stimulating hormone (FSH), the active component in follitropin beta injection, is required for normal follicular growth, maturation, and gonadal steroid production; stimulates ovarian follicular growth in women who do not have primary ovarian failure; when administered with hCG, stimulates spermatogenesis in men with hypogonadotropic hypogonadism

Pharmacokinetics

Half-Life: 43.9 hr (single IM dose); 26.9-30.1 hr (7 day IM treatment)

Absorption: 77.8% (SC); 76.4% (IM)

Vd: 8 L

Peak ptime: 27 hr (IM); 13 hr (SC)

Peak plasma concentration: 5.41 IU/L (SC); 6.86 IU/L (IM)

Metabolism: Recombinant FSH in product is biochemically very similar to urinary FSH and is anticipated to be metabolized in the same manner

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Administration

Administer SC or IM

Storage

Store refrigerated 2–8°C (36–46°F) until dispensed; upon dispensing, may be stored by patient at 2–8°C (36–46°F) until the expiration date, or at or below 25°C (77°F) x 3 months or until expiration date, whichever occurs first

Protect from light, keep container in carton

Do not freeze

Vials are for single use

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Formulary

FormularyPatient Discounts

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Tier Description
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Code Definition
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