Follistim Aq

Follistim Aq Manufacturers

• Organon Usa Inc.
  

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  Follistim Aq | Organon Usa Inc.

  

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  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 with
  ampules or vials, using conventional syringe Follistim AQ Cartridge
  dosing 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. 2.4 Recommended Dosing for Induction of Spermatogenesis in Men Pretreatment with hCG is required prior to concomitant therapy with Follistim AQ Cartridge and hCG. An initial dosage of 1,500 international units of hCG should be administered at twice weekly intervals to normalize serum testosterone levels. If serum testosterone levels have not normalized after 8 weeks of hCG treatment, the hCG dose can be increased to 3,000 international units twice weekly [see Clinical Studies (14.3)]. After normal serum testosterone levels have been reached, Follistim AQ Cartridge should be administered by subcutaneous injection concomitantly with hCG treatment. Follistim is given at a dosage of 450 international units per week, as either 225 international units twice weekly or 150 international units three times per week, in combination with the same hCG dose used to normalize testosterone levels. Based on delivery of a higher dose of follitropin beta with the Follistim AQ Cartridge and pen injector [see Dosage and Administration (2.1)], a lower dose of Follistim AQ Cartridge may be considered.
  
  The concomitant therapy should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected. If a man has not responded after this period, the combination therapy may be continued. Treatment response has been noted at up to 12 months.

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• Organon Usa Inc.
  

  ×

  Follistim Aq | Organon Usa Inc.

  

  ---

  2.1 General Dosing 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 mix Follistim AQ with any other medicines in the same vial or in the same syringe. 2.2 Recommended Dosing for Ovulation Induction

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

  A starting daily dose of 75 international units of Follistim AQ is administered 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 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 dose adjustment(s) should be used to prevent multiple follicular growth and cycle cancellation. The maximum, individualized, daily dose of Follistim AQ is 300 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, 5000 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 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 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 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 for ART

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

  A starting dose of 150 to 225 international units of Follistim AQ is administered subcutaneously or intramuscularly daily for at least the first 4 days of treatment. Subsequent dosing beyond the first 4 days of treatment is adjusted based upon the woman's ovarian response as determined by ultrasound evaluation of follicular growth and serum estradiol levels.
  
  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 (six 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 is 600 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 is stopped and final maturation of the oocytes is induced by administering hCG at a dose of 5000 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 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. 2.4 Recommended Dosing for Induction of Spermatogenesis in Men Pretreatment with hCG is required prior to concomitant therapy with Follistim AQ and hCG. An initial dosage of 1500 international units of hCG should be administered at twice weekly intervals to normalize serum testosterone levels. If serum testosterone levels have not normalized after 8 weeks of hCG treatment, the hCG dose can be increased to 3000 international units twice weekly [see Clinical Studies (14.3)]. After normal serum testosterone levels have been reached, Follistim AQ should be administered by subcutaneous injection concomitantly with hCG treatment. Follistim AQ should be given at a dosage of 450 international units per week, as either 225 international units twice weekly or 150 international units three times per week, in combination with the same hCG dose used to normalize testosterone levels.

  The concomitant therapy should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected. If a man has not responded after this period, the combination therapy may be continued. Treatment response has been noted at up to 12 months.

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