Classes
DEA Class; Rx
Common Brand Names; Follistim AQ
- Gonadotropins;
- Ovulation Stimulators
Description
Products ar recombinant versions of human follicle stimulating hormone (FSH), a gonadotropin; available as follitropin alfa or follitropin beta
Used for infertility protocols for ovulation induction in selected females and for induction of spermatogenesis in selected males
Used in combination with human chorionic gonadotropin (hCG)
Indications
Indicated for the treatment of infertility in females.
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)
Adverse Effects
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%)
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
Warnings
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
Pregnancy and Lactation
Pregnancy Category: X
Lactation: Unknown whether distributed in breast milk, caution advised
Maximum Dosage
No specific maximum dosage limit recommendations are available. Dosage regimens of follitropin, r-FSH depend upon the patient’s age, sex, weight, condition being treated or ART procedure to be used, the specific product used, the patient’s response to treatment, and the prescribing clinician’s judgment. The following maximum dosages are reflective of common recommendations in the package inserts.
Females:
Anovulatory patients: 300 International Units/day subcutaneously for Gonal-f or Gonal-f RFF Redi-ject (follitropin alfa products); 250 International Units/day for Follistim AQ (follitropin beta).
ART indications: 450 International Units/day subcutaneously for Gonal-f or Gonal-f RFF Redi-ject (follitropin alfa products); 500 International Units/day for Follistim AQ (follitropin beta).
Males:
Spermatogenesis: 450 International Units/week subcutaneously for Gonal-f or Follistim AQ products, given in divided doses throughout the week as specified for each product.
Not usually indicated; see adult dosing for rare exceptions.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
How supplied
Follitropin Beta