General Dosing Information

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Gonal-f® RFF Redi-ject® is a pre-filled disposable auto-injection device intended for multiple dose use.
• Gonal-f® RFF Redi-ject® can be set in 12.5 International Units increments.
• Administer Gonal-f® RFF Redi-ject® subcutaneously in the abdomen as described in Instructions for Use
• Do not attempt to mix any other medications inside of the device with Gonal-f® RFF Redi-ject®.
• Instruct women to remove the Gonal-f® RFF Redi-ject® from the refrigerator at least 30 minutes prior to use in order to allow Gonal-f® RFF Redi-ject® to warm to room temperature and avoid the discomfort of a cold injection.

Recommended Dosing for Ovulation Induction

The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1)]. Starting doses less than 37.5 International Units have not been studied in clinical trials and are not recommended.

• A starting daily dose of 75 International Units of Gonal-f® RFF Redi-ject® is administered subcutaneously daily for 14 days in the first cycle of use.

  In subsequent cycles of treatment, the starting dose (and dosage adjustments) of Gonal-f® RFF Redi-ject® should be determined based on the history of the ovarian response to Gonal-f® RFF Redi-ject®.

• The following should be considered when planning the woman's individualized dose:
  • Appropriate Gonal-f® RFF Redi-ject® dose adjustment(s) should be used to prevent multiple follicular growth and cycle cancellation.
  • The maximum, individualized, daily dose of Gonal-f® RFF Redi-ject® is 300 International Units per day.
  • In general, do not exceed 35 days of treatment.
• If indicated by the ovarian response after the initial 14 days, make an incremental adjustment in dose, up to 37.5 International Units.
• If indicated by the ovarian response, make additional incremental adjustments in dose, up to 37.5 International Units, every 7 days.
• Treatment should continue until follicular growth and/or serum estradiol levels indicate an adequate ovarian response.
• When pre-ovulatory conditions are reached, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation.

  Withhold hCG in cases where the ovarian monitoring suggests an increased risk of ovarian hyperstimulation syndrome (OHSS) on the last day of Gonal-f® RFF Redi-ject® therapy [see Warnings and Precautions (5.2, 5.3, 5.11)].

• Encourage the woman and her partner to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent.

  Discourage intercourse when the risk for OHSS is increased [see Warnings and Precautions (5.2, 5.3)].

Recommended Dosing for Assisted Reproductive Technology

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

• Beginning on cycle day 2 or 3, a starting dose of 150 International Units of Gonal-f® RFF Redi-ject® is administered subcutaneously daily until sufficient follicular development, as determined by ultrasound in combination with measurement of serum estradiol levels, is attained. In most cases, therapy should not exceed 10 days.
  In women under 35 years of age whose endogenous gonadotropin levels are suppressed, initiate Gonal-f® RFF Redi-ject® administration at a dose of 150 International Units per day.
  In women 35 years of age and older whose endogenous gonadotropin levels are suppressed, initiate Gonal-f® RFF Redi-ject® administration at a dose of 225 International Units per day.
• Adjust the dose after 5 days based on the woman's ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels.
• Do not make additional dosage adjustments more frequently than every 3-5 days or by more than 75-150 International Units at each adjustment.
• Continue treatment until adequate follicular development is evident, and then administer hCG.
  The administration of hCG should be withheld in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of Gonal-f® RFF Redi-ject® therapy [see Warnings and Precautions (5.2, 5.3, 5.11)].
• Doses greater than 450 International Units per day are not recommended.