Usual Adult Dose for Follicle Stimulation

75 international units subcutaneously once a day

Comments:

• This drug should be administered simultaneously with follitropin alpha injection (75 to 150 international units per day).
• Treatment should be tailored to the individual patient as assessed by measuring follicle size by ultrasound and estrogen response.
• Treatment can begin at any time and should not normally exceed 14 days unless signs of imminent follicular development are present; it may be acceptable to extend the duration of stimulation in any 1 cycle up to 5 weeks.
• Human chorionic gonadotropin (hCG) should be given 1 day after the last dose of lutropin alfa and follitropin alpha to complete follicular development and effect ovulation; precautions should be followed regarding ovarian hyperstimulation syndrome.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active substance or any product excipients
• Uncontrolled thyroid or adrenal failure
• Active, untreated tumors of the hypothalamus and pituitary gland
• Pregnancy and Lactation
• Ovarian, uterine, or mammary carcinoma
• Ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin
• Abnormal uterine bleeding of unknown origin

• Primary ovarian failure
• Malformations of sexual organs incompatible with pregnancy
• Fibroid tumors of the uterus incompatible with pregnancy

Dialysis

Data not available

Other Comments

Administration advice:

• Administer subcutaneously once a day with follitropin alpha
• Patients should be instructed on self-administration

• Pre-filled Pens: Store in refrigerator (2C to 8C); do not freeze; protect from light
• Pre-filled Pens (In-use): Store refrigerated for up to 28 days after opening; discard unused portion
• Lyophilized vials: Store at 2C to 25C; protect from light

• Lyophilized powder for reconstitution: dissolve contents with supplied sterile water for injection; may be mixed in same syringe with Gonal-F lyophilized powder and given in one injection; mix gently, do not shake

• This drug is to be administered concomitantly with follitropin alpha; the safety and effectiveness of concomitant administration with other recombinant human FSH are unknown.
• A definitive effect on pregnancy in this population has not been demonstrated.
• Women with a history of tubal disease are at increased risk for ectopic pregnancy whether they conceive spontaneously or with fertility treatments; however, the prevalence of ectopic pregnancy after assistive reproductive technology is higher than in the general population.

• Monitor follicular development by ultrasound alone or in combination with serum estradiol levels

• Instruct patient to read the approved patient labeling.
• Patients should understand the duration of treatment and monitoring that will be required.
• Patients should understand their risk of ovarian hyperstimulation syndrome.
• Patients should understand their risk of multiple births.