Follitropin Alfa for Injection

Follitropin alfa is prescribed to supplement or replace naturally occurring FSH, an essential hormone to treat infertility in both women and men. Follitropin alfa has been approved in around 100 countries worldwide for stimulating the growth of ovarian follicles and ovulation in women.

For males, Follitropin alfa has been approved in more than 80 countries worldwide, including Japan, for gonadal dysfunction associated with absence of sperm in the semen or male hypogonadotropic hypogonadism. In certain markets where Follitropin alfa  is approved for this indication, the therapy needs to be in combination with human chorionic gonadotropin (hCG).

Indications and Usage for Follitropin Alfa

Women

Follitropin alfa for injection is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Follitropin Alfa is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.

Selection of Patients
Before treatment with Follitropin Alfa is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Follitropin Alfa only if enrolled in an in vitro fertilization program.
Primary ovarian failure should be excluded by the determination of gonadotropin levels.
Appropriate evaluation should be performed to exclude pregnancy.
Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting Follitropin Alfa therapy.
Evaluation of the partner’s fertility potential should be included in the initial evaluation.
Men

Follitropin Alfa for injection is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Selection of Patients
Before treatment with Follitropin Alfa is instituted for azoospermia, a thorough medical and endocrinologic evaluation must be performed.
Hypogonadotropic hypogonadism should be confirmed, and primary testicular failure should be excluded by the determination of gonadotropin levels.
Prior to Follitropin Alfa therapy for azoospermia in patients with hypogonadotropic hypogonadism, serum testosterone levels should be normalized.
Contraindications

Follitropin Alfa for injection is contraindicated in women and men who exhibit:

Prior hypersensitivity to recombinant FSH preparations or one of their excipients.
High levels of FSH indicating primary gonadal failure.
Uncontrolled thyroid or adrenal dysfunction.
Sex hormone dependent tumors of the reproductive tract and accessory organs.
An organic intracranial lesion such as a pituitary tumor. And in women who exhibit:
Abnormal uterine bleeding of undetermined origin (see “Selection of Patients”).
Ovarian cyst or enlargement of undetermined origin (see “Selection of Patients”).
Pregnancy.

Some women using this medicine have developed a sudden buildup of fluid in the stomach or chest area. This condition is called ovarian hyperstimulation syndrome (OHSS), and can be a life-threatening. Avoid having sex and call your doctor right away if you have any of the following symptoms of OHSS:

• severe pain in your lower stomach;
• nausea, vomiting, diarrhea, bloating;
• feeling short of breath;
• swelling in your hands or legs;
• weight gain;
• urinating less than usual.

Get emergency medical help if you have any of these signs of an allergic reaction while taking follicle stimulating hormone (the active ingredient contained in Follitropin Alfa) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using follicle stimulating hormone and call your doctor at once if you have a serious side effect such as:

sudden numbness or weakness (especially on one side of the body);

• pain, swelling, warmth, or redness in your arms or legs; or
• severe pelvic pain on one side.
• Less serious side effects of follicle stimulating hormone may include:
• headache;
• mild nausea or stomach pain;
• mild numbness or tingly feeling;
• mild pelvic pain, tenderness, or discomfort;
• runny or stuffy nose, sore throat;
• breast swelling or tenderness;
• acne;
• mild skin rash; or
• pain, bruising, redness, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.