Lutropin Alfa Dosage

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.

Use: For stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound leutinizing hormone (LH) deficiency (LH less than 1.2 international units/L).

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

This drug must not be used when a condition exists which would make a normal pregnancy impossible, such as:

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

Safety and efficacy have not been established in pediatric patients.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

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

Missed Dose: If a dose is missed, patient should be instructed to contact her doctor

Storage requirements:

• 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

Reconstitution/preparation techniques:

• 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

General:

• 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.

Monitoring:

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

Patient advice:

• 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer