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Follitropin Alfa

    DEA Class; Rx

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

    • Gonadotropins; 
    • Ovulation Stimulators

    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)

    Indicated for the treatment of infertility in females.

    For infertility in males with oligospermia (to induce spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not primary testicular failure).

    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

    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.

    Adults

    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.

    Geriatric

    Not usually indicated; see adult dosing for rare exceptions.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Not indicated.

    Follitropin Alfa

    multi-dose vial (Gonal-f)

    • 450 IU/vial (ie, 600 IU/vial delivers 450 IU)
    • 1050 IU/vial (ie, 1200 IU/vial delivers 1050 IU)

    single-dose vial (Gonal-f RFF)

    • 75 IU (ie, 82 IU/vial delivers 75 IU)

    Redi-ject pen (Gonal-f RFF)

    • 300 IU
    • 450 IU
    • 900 IU