Usual Adult Dose for Ovulation Induction

Anovulatory Infertility:
Follitropin alpha:
Initial dose: 75 international units subcutaneously (SC) daily for 14 days
Maximum dose: 300 international units daily
Follitropin beta:
Initial dose: 50 international units SC daily for 7 days
Maximum dose: 250 international units daily
Duration of therapy: Until an adequate ovarian response is achieved

Comments:

• When pre-ovulatory condition is obtained, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation.
• Adequate ovarian response is assessed with serum estrogen concentrations and/or ultrasound examination.
• Withhold hCG when monitoring suggests an increased risk of Ovarian Hyperstimulation Syndrome (OHSS).
• Recommend daily intercourse, beginning the day prior to hCG administration and until ovulation becomes apparent.
• Discourage intercourse when the risk for OHSS is increased.
• If an excessive response is obtained, stop treatment and withhold hCG.
• In general, do not exceed 35 days of treatment.

Assisted Reproduction:
Follitropin alpha:
Initial dose: 150 international units SC daily for 5 days
Maximum dose: 450 international units daily
Follitropin beta:
Initial dose: 200 international units SC daily for 7 days
Maximum dose: 500 international units daily

Comments:

• When sufficient follicular development is obtained, as determined by ultrasound and estradiol levels, administer hCG.
• Withhold hCG when monitoring suggests an increased risk of OHSS.

Spermatogenesis:
Follitropin beta:
Initial dose: 225 international units SC twice a week; or 150 international units SC three times a week (total of 450 international units every week)

Comments:

• Pretreatment with hCG is required prior to concomitant therapy with follitropin beta and hCG.
• At least 3 to 4 months of concomitant therapy are needed before any improvement in spermatogenesis can be expected.
• Response to treatment may take up to 12 months.

Uses:

• Induction of ovulation and pregnancy in anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure.
• Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) Cycle.
• Follitropin beta: 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.

Usual Adult Dose for Hypogonadism - Male

Anovulatory Infertility:
Follitropin alpha:
Initial dose: 75 international units subcutaneously (SC) daily for 14 days
Maximum dose: 300 international units daily
Follitropin beta:
Initial dose: 50 international units SC daily for 7 days
Maximum dose: 250 international units daily
Duration of therapy: Until an adequate ovarian response is achieved

Comments:

• When pre-ovulatory condition is obtained, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation.
• Adequate ovarian response is assessed with serum estrogen concentrations and/or ultrasound examination.
• Withhold hCG when monitoring suggests an increased risk of Ovarian Hyperstimulation Syndrome (OHSS).
• Recommend daily intercourse, beginning the day prior to hCG administration and until ovulation becomes apparent.
• Discourage intercourse when the risk for OHSS is increased.
• If an excessive response is obtained, stop treatment and withhold hCG.
• In general, do not exceed 35 days of treatment.

Assisted Reproduction:
Follitropin alpha:
Initial dose: 150 international units SC daily for 5 days
Maximum dose: 450 international units daily
Follitropin beta:
Initial dose: 200 international units SC daily for 7 days
Maximum dose: 500 international units daily

Comments:

• When sufficient follicular development is obtained, as determined by ultrasound and estradiol levels, administer hCG.
• Withhold hCG when monitoring suggests an increased risk of OHSS.

Spermatogenesis:
Follitropin beta:
Initial dose: 225 international units SC twice a week; or 150 international units SC three times a week (total of 450 international units every week)

Comments:

• Pretreatment with hCG is required prior to concomitant therapy with follitropin beta and hCG.
• At least 3 to 4 months of concomitant therapy are needed before any improvement in spermatogenesis can be expected.
• Response to treatment may take up to 12 months.

Uses:

• Induction of ovulation and pregnancy in anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure.
• Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) Cycle.
• Follitropin beta: 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.

Usual Adult Dose for Follicle Stimulation

Anovulatory Infertility:
Follitropin alpha:
Initial dose: 75 international units subcutaneously (SC) daily for 14 days
Maximum dose: 300 international units daily
Follitropin beta:
Initial dose: 50 international units SC daily for 7 days
Maximum dose: 250 international units daily
Duration of therapy: Until an adequate ovarian response is achieved

Comments:

• When pre-ovulatory condition is obtained, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation.
• Adequate ovarian response is assessed with serum estrogen concentrations and/or ultrasound examination.
• Withhold hCG when monitoring suggests an increased risk of Ovarian Hyperstimulation Syndrome (OHSS).
• Recommend daily intercourse, beginning the day prior to hCG administration and until ovulation becomes apparent.
• Discourage intercourse when the risk for OHSS is increased.
• If an excessive response is obtained, stop treatment and withhold hCG.
• In general, do not exceed 35 days of treatment.

Assisted Reproduction:
Follitropin alpha:
Initial dose: 150 international units SC daily for 5 days
Maximum dose: 450 international units daily
Follitropin beta:
Initial dose: 200 international units SC daily for 7 days
Maximum dose: 500 international units daily

Comments:

• When sufficient follicular development is obtained, as determined by ultrasound and estradiol levels, administer hCG.
• Withhold hCG when monitoring suggests an increased risk of OHSS.

Spermatogenesis:
Follitropin beta:
Initial dose: 225 international units SC twice a week; or 150 international units SC three times a week (total of 450 international units every week)

Comments:

• Pretreatment with hCG is required prior to concomitant therapy with follitropin beta and hCG.
• At least 3 to 4 months of concomitant therapy are needed before any improvement in spermatogenesis can be expected.
• Response to treatment may take up to 12 months.

Uses:

• Induction of ovulation and pregnancy in anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure.
• Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) Cycle.
• Follitropin beta: 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.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Follitropin beta:

• The pen injector device delivers on average an 18% higher amount of follitropin beta when compared to a conventional syringe and needle.
• Consider a lower starting dose when using the pen.
• Switching brands (manufacturers), types (recombinant, urinary), and/or methods of administration (pen, conventional syringe) may require dose adjustment.

Ovulation induction:

• The dosing scheme is stepwise and is individualized for each woman.
• Use dose adjustments to prevent multiple follicular growth and cycle cancellation.

Follitropin alpha:

• Starting doses less than 37.5 international units have not been studied and are not recommended.
• After the first cycle, determine the starting dose and dosage adjustments based on ovarian response.
• If needed, after the initial 14 days, make incremental dose adjustments, up to 37.5 international units, every 7 days.

Follitropin beta:

• After the first cycle, make dose adjustments weekly intervals based upon ovarian response.
• Make adjustments by 25 or 50 international units at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate ovarian response.

Assisted Reproduction:
Follitropin alpha:

• In women aged 35 years or older whose endogenous gonadotropin levels are suppressed, initiate treatment at 225 international units subcutaneously daily for 5 days.
• Adjust the dose after the first 5 days based on ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels.
• Do not adjust dose more than every 3 to 5 days or by more than 75 to 150 international units at each adjustment.
• In most cases, therapy should not exceed 10 days.

Follitropin beta:

• Adjust the dose after the first 7 days of treatment based on ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels.
• For high responding women [those at particular risk of abnormal ovarian enlargement and/or ovarian hyperstimulation syndrome (OHSS)], decrease or temporarily stop the daily dose, or discontinue the cycle according to individual response.

Spermatogenesis:

• Based on delivery of a higher dose of follitropin beta with the pen injector, a lower dose may be considered.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Inspect for particulate matter and discoloration prior to administration.
• Alternate injection site daily.
• Administer subcutaneously in the abdomen or intramuscularly.
• If using intramuscularly, a healthcare provider should administer the product.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

General:

• Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.

Patient advice:

• Prior to beginning therapy, inform patients about the time commitment and monitoring procedures necessary for treatment.
• If a dose is missed, the next dose should not be doubled. The patient should call the healthcare provider for further dosing instructions.
• Caution patients not to change the dosage or the schedule of administration unless told to do so by their healthcare provider.