In Women for:

Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure

Prior to initiation of treatment with Follitropin Beta Cartridge:

• Women should have a complete gynecologic and endocrinologic evaluation.

• Primary ovarian failure should be excluded.

• The possibility of pregnancy should be excluded.

• Tubal patency should be demonstrated.

• The fertility status of the male partner should be evaluated.

Pregnancy in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle

Prior to initiation of treatment with Follitropin Beta Cartridge:

• Women should have a complete gynecologic and endocrinologic evaluation and diagnosis of the cause of infertility.

• The possibility of pregnancy should be excluded.

• The fertility status of the male partner should be evaluated.

In Men 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

Prior to initiation of treatment with Follitropin Beta Cartridge:

• Men should have a complete medical and endocrinologic evaluation.

• Hypogonadotropic hypogonadism should be confirmed and primary testicular failure should be excluded.

• Serum testosterone levels should be normalized with human chorionic gonadotropin (hCG) treatment.

• The fertility status of the female partner should be evaluated.

Women: Follicle-stimulating hormone (FSH), the active component in Follitropin Beta Cartridge, is required for normal follicular growth, maturation, and gonadal steroid production. In women, the level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching maturity. Follitropin Beta Cartridge stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to effect the final phase of follicle maturation, resumption of meiosis and rupture of the follicle in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following treatment with Follitropin Beta Cartridge when patient monitoring indicates appropriate follicular development parameters have been reached.

Men: Follitropin Beta when administered with hCG stimulates spermatogenesis in men with hypogonadotropic hypogonadism. FSH, the active component of Follitropin Beta, is the pituitary hormone responsible for spermatogenesis.

In Anovulatory Women Undergoing Ovulation Induction:

Starting daily dose of 50 international units of Follitropin Beta Cartridge is administered subcutaneously for at least the first 7 days. The dose is increased by 25 or 50 international units at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate response.

• When an acceptable pre-ovulatory state is achieved, final oocyte maturation is achieved with 5,000 to 10,000 international units of urinary human chorionic gonadotropin (hCG).
• The woman and her partner should have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent.

In Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization or Intracytoplasmic Sperm Injection Cycle:

Starting dose of 200 international units (actual cartridge doses) of Follitropin Beta Cartridge is administered subcutaneously for at least the first 7 days of treatment. Subsequent doses can be adjusted down or up based upon ovarian response as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Dosage reduction in high responders can be considered from the 6th day of treatment onward according to individual response.

• Final oocyte maturation is induced with a dose of 5,000-10,000 international units of urinary hCG.

• Oocyte (egg) retrieval is performed 34 to 36 hours later.

Induction of Spermatogenesis in Men:

Pretreatment with urinary hCG alone (1,500 international units twice weekly) is required. If serum testosterone levels have not normalized after 8 weeks of hCG treatment, the dose may be increased to 3,000 international units twice a week.

After normalization of serum testosterone levels, administer 450 international units per week (225 international units twice weekly or 150 international units three times weekly) of Follitropin Beta Cartridge.

Women and men who exhibit:

• Prior hypersensitivity to recombinant hFSH products
• High levels of FSH indicating primary gonadal failure
• Presence of uncontrolled non-gonadal endocrinopathies
• Hypersensitivity reactions related to streptomycin or neomycin
• Tumors of the ovary, breast, uterus, testis, hypothalamus or pituitary gland

Women who exhibit:

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

The most common adverse reactions (≥2%) in women undergoing ovulation induction are ovarian hyperstimulation syndrome, ovarian cyst, abdominal discomfort, abdominal pain, and lower abdominal pain.

The most common adverse reactions (≥2%) in women undergoing controlled ovarian stimulation as part of an IVF or ICSI cycle are pelvic discomfort, headache, ovarian hyperstimulation syndrome, pelvic pain, nausea, and fatigue.

The most common (≥2%) adverse reactions in men undergoing induction of spermatogenesis are headache, acne, injection site reaction, injection site pain, gynecomastia, rash, and dermoid cyst.

Pregnancy: Follitropin Beta Cartridge is contraindicated for use in pregnant women and offers no benefit during pregnancy.

Lactation: It is not known whether this drug is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Follitropin Beta Cartridge and any potential adverse effects on the breastfed child from Follitropin Beta Cartridge or from the underlying maternal condition.

Treatment with Follitropin Beta may result in:

• Abnormal Ovarian Enlargement
• Ovarian Hyperstimulation Syndrome (OHSS)
• Pulmonary and Vascular Complications
• Ovarian Torsion
• Multi-fetal Gestation and Birth
• Congenital Anomalies
• Ectopic Pregnancy
• Spontaneous Abortion
• Ovarian Neoplasms

Pediatric Use: Follitropin Beta Cartridge is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population.

Geriatric Use: Clinical studies of Follitropin Beta Cartridge have not been conducted in patients 65 years of age and older.

Drugs for Infertility

Store unused cartridge refrigerated at 2°C to 8°C until the expiration date, or at room temperature at up to 25°C for 3 months or until the expiration date, whichever occurs first. After first use, store at 2°C to 25°C and discard after 28 days. Store in the original carton to protect from light. Do not freeze.