Follitropin Alfa

DEA Class; Rx

Common Brand Names; Gonal-f, Gonal-f RFF

Indicated for the treatment of infertility in females.

Prior hypersensitivity to recombinant FSH preparations

High levels of FSH indicating primary gonadal failure

Uncontrolled thyroid or adrenal dysfunction

Sex hormone dependent tumors of the reproductive tract and accessory organs

Organic intracranial lesion (e.g. pituitary tumor)

Women with abnormal uterine bleeding of undetermined origin; ovarian cyst or enlargement of undetermined origin

Pregnancy

GONAL-f

• Intermenstrual bleeding
• Ovarian hyperstimulation
• Abdominal pain
• Acne
• Flatulence
• Diarrhea
• Back pain
• Emotional lability

Gonal-f RFF Pen

• Diarrhea
• Dizziness
• OHSS (for ovulation induction)
• Flatulence
• Acne
• Toothache
• Intermenstrual bleeding
• Breast pain, Injection site reactions, Ovarian cyst, Nausea, Sinusitis

Asthma exacerbation

Thromboembolism

May cause ovarian hyperstimulation syndrome (OHSS, dramatic increase in vascular permeability which can result in rapid fluid accumulation in peritoneal cavity, thorax and pericardium; accompanied by severe pelvic pain, nausea, vomiting and weight gain) in women with or without pulmonary or vascular complications

If ovaries are abnormally enlarged on last day of therapy, inform women not to administer hCG and to avoid intercourse

Pulmonary conditions (atelactasis, ARDS, & asthma exacerbation) have been reported; in women with recognized risk factors, the benefits of induction of ovulation and ART need to be weighed against risks; during or after use of drug, monitor for venous or arterial thromboembolic events

Possibility of multiple births (range 12.3%-44.0% live births)

In ovarian torsion, early diagnosis and immediate detorsion limit damage to ovary due to reduced blood supply

A thorough gynecologic & endocrinological evaluation should be conducted prior to treatment to rule out primary ovarian failure, early pregnancy & partner’s fertility potential

The rate of multiple births is dependent on number of embryos transferred; advise the woman and her partner of the potential risk of multi-fetal gestation and birth before beginning therapy

Advise women who become pregnant following ART and have: abdominal/pelvic pain (particularly on one side); shoulder, neck or rectal pain; and nausea and vomiting to seek immediate medical attention; confirm the presence of an intrauterine pregnancy early by β-hCG testing and transvaginal ultrasound

The risk of spontaneous abortion (miscarriage) is increased with gonadotropin products, however, causality has not been established

Both benign and malignant ovarian neoplasms are reported in women who have had multiple drug therapy for controlled ovarian stimulation, however, causality has not been established

Drug not indicated in pregnant women

There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; because secretion of prolactin during lactation can result in inadequate response to ovarian stimulation, advise women not to breastfeed during treatment