Follistim AQ

FOLLISTIM AQ- follitropin injection, solution
Merck Sharp & Dohme LLC

1 INDICATIONS AND USAGE

Follistim® AQ (follitropin beta injection) Cartridge is indicated:

In Women for:

1.1 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 Follistim AQ 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.

1.2 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 Follistim AQ Cartridge:

  • Women should have a complete gynecologic and endocrinologic evaluation and diagnosis of cause of infertility.
  • The possibility of pregnancy should be excluded.
  • The fertility status of the male partner should be evaluated.

In Men for:

1.3 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 Follistim AQ 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.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If the solution is not clear and colorless or has particles in it, the solution should not be used.
  • Do not add any other medicines into the Follistim AQ Cartridge.
  • Follistim AQ Cartridge with the pen injector device delivers on average an 18% higher amount of follitropin beta when compared to reconstituted Follistim delivered with a conventional syringe and needle. When administering Follistim AQ Cartridge, a lower starting dose and lower dose adjustments (as compared to reconstituted Follistim) should be considered. For that purpose the following Dose Conversion Table is provided:
Table 1: Follistim AQ Cartridge Administered Subcutaneously With the Follistim Pen Dose Conversion Table *
Lyophilized recombinant FSH dosing withampules or vials, using conventional syringe Follistim AQ Cartridgedosing with the Follistim Pen
*
Each value represents an 18% difference rounded to the nearest 25 IU increment.
75 IU 50 IU
150 IU 125 IU
225 IU 175 IU
300 IU 250 IU
375 IU 300 IU
450 IU 375 IU

2.2 Recommended Dosing in Anovulatory Women Undergoing Ovulation Induction

The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1)].

  • A starting daily dose of 50 international units of Follistim AQ Cartridge is administered [see Dosage and Administration (2.1)] subcutaneously daily for at least the first 7 days.
  • Subsequent dosage adjustments are made at weekly intervals based upon ovarian response. If an increase in dose is indicated by the ovarian response, the increase should be made by 25 or 50 international units of Follistim AQ Cartridge at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate ovarian response.
    The following should be considered when planning the woman’s individualized dose:

    • Appropriate Follistim AQ Cartridge dose adjustment(s) should be used to prevent multiple follicular growth and cycle cancellation.
    • The maximum, individualized, daily dose of Follistim AQ Cartridge is 250 international units.
  • Treatment should continue until ultrasonic visualizations and/or serum estradiol determinations approximate the pre-ovulatory conditions seen in normal individuals.
  • When pre-ovulatory conditions are reached, 5,000 to 10,000 international units of hCG are used to induce final oocyte maturation and ovulation.
    The administration of hCG must be withheld in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of Follistim AQ Cartridge therapy [see Warnings and Precautions (5.1, 5.2, 5.10)].
  • The woman and her partner should be encouraged to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent [see Warnings and Precautions (5.10) ].
  • During treatment with Follistim AQ Cartridge and during a two-week post-treatment period, the woman should be assessed at least every other day for signs of excessive ovarian stimulation.
    It is recommended that Follistim AQ Cartridge administration be stopped if the ovarian monitoring suggests an increased risk of OHSS or abdominal pain occurs. Most OHSS occurs after treatment has been discontinued and reaches its maximum at about seven to ten days post-ovulation.

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

The dosing scheme follows a stepwise approach and is individualized for each woman.

  • A starting dose of 200 international units (actual cartridge doses) of Follistim AQ Cartridge is administered [see Dosage and Administration (2.1)] subcutaneously daily for at least the first 7 days of treatment.
  • Subsequent to the first 7 days of treatment, the dose can be adjusted down or up based upon the woman’s 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.The following should be considered when planning the woman’s individualized dose:

    • For most normal responding women, the daily starting dose can be continued until pre-ovulatory conditions are achieved (seven to twelve days).
    • For low or poor responding women, the daily dose should be increased according to the ovarian response. The maximum, individualized, daily dose of Follistim AQ Cartridge is 500 international units.
    • 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 [see Warnings and Precautions (5.1, 5.2, 5.10)].
  • When a sufficient number of follicles of adequate size are present, dosing of Follistim AQ Cartridge is stopped and final maturation of the oocytes is induced by administering hCG at a dose of 5,000 to 10,000 international units. The administration of hCG should be withheld in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of Follistim AQ Cartridge therapy [see Warnings and Precautions (5.1, 5.2, 5.10)].
  • Oocyte (egg) retrieval should be performed 34 to 36 hours following the administration of hCG.

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