Usual Adult Dose for Gonadotropin Inhibition

During the mid to late portion of the follicular phase:

• Administer 250 mcg subcutaneously once a day until the day of human chorionic gonadotropin (hCG) administration

• Follicle stimulating hormone (FSH) therapy should be initiated on day 2 or 3 of the cycle.
• With the assist of ultrasound, hCG should be administered when a sufficient number of follicles of adequate size are present; final maturation of follicles is induced by administering hCG.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to active substance or any product components
• Hypersensitivity to GnRH or any other GnRH analog
• Known or suspected pregnancy

Dialysis

Data not available

Other Comments

Administration advice:

• For subcutaneous administration only
• Patient should receive instructions for subcutaneous administration; convenient administration sites include abdomen around the navel or upper thigh
• Rotate injection sites

• Protect from light

• Available as single-use prefilled syringes
• The prefilled syringe is affixed with a needle, the needle shield contains natural rubber latex

• During clinical trials, the average duration of GnRH days was 5.4 days (range: 2 to 14 days).
• The administration of hCG should be withheld in cases where the ovaries are abnormally enlarged on the last day of FSH therapy to reduce the chance of developing OHSS (Ovarian Hyperstimulation Syndrome).

• Ultrasound monitoring may be used to assess final maturation of follicles

• Patients should be instructed to read the US FDA-approved patient labeling.
• Patients should be informed of the duration of treatment and monitoring procedures that will be required.
• Patients should understand that hypersensitivity reactions have been reported and should understand what action to take if they were to experience a hypersensitivity reaction.