Lutropin Alfa

Take lutropin alfa exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Lutropin Alfa dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Lutropin Alfa is available in the following doses:

• Lutropin Alfa 75 Intl Units Subcutaneous Powder For Injection

• If you have an allergy to lutropin alfa or any other part of lutropin alfa.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Adrenal gland disease, brain tumor, pituitary gland disease, or thyroid gland disease.
• If you have any of these health problems: A tumor in your female organs, enlarged ovaries or ovarian cysts, or vaginal bleeding where the cause is not known.
• If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
• If you are breast-feeding. Do not breast-feed while you take lutropin alfa.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take lutropin alfa with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may raise the chance of getting pregnant with more than one baby.
• This medicine may raise the chance of very bad side effects like blood clots and lung problems. Rarely, these effects have been deadly. Talk with the doctor.
• This medicine may raise the chance of very bad side effects like enlarged ovaries and ovarian cysts that burst. Rarely, these effects have been deadly. Talk with the doctor.
• This medicine may raise the chance of twisting of the ovaries (ovarian torsion) in women with some health problems. This can cause blood flow to the ovary to be cut off. Talk with the doctor.
• The chance of pregnancy outside of the uterus (ectopic pregnancy) may be raised in some women. Talk with your doctor.
• Limit working out while undergoing ovarian stimulation. Talk with your doctor.
• Do not take lutropin alfa if you are 65 or older. Talk with your doctor.
• Do not give to a child. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.
• Your doctor may teach you how to give the shot.
• Follow how to use carefully.
• Wash your hands before and after use.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Hypersensitivity to lutropin alfa or any component of the formulation; primary ovarian failure; uncontrolled thyroid or adrenal dysfunction; active, untreated tumors of the hypothalamus and pituitary gland; ovarian, uterine, or breast cancer; abnormal uterine bleeding of undetermined origin; ovarian cyst or enlargement unrelated to polycystic ovarian disease and of undetermined origin; malformations of sexual organs incompatible with pregnancy; fibroid tumors of the uterus incompatible with pregnancy; pregnancy; breastfeeding

Infertility: Females (≥16 years to ≤60 years): SubQ: 75 units daily until adequate follicular development is noted (maximum dose: 75 units daily); maximum duration of treatment: 14 days, unless signs of imminent follicular development are present. Duration of stimulation may be extended in any one cycle up to 5 weeks (treatment should be individualized based on response to prior cycle). Administer concomitantly with follitropin alfa. Administer hCG one day after the last dose of lutropin alfa and follitropin alfa. Encourage patients to have daily intercourse beginning the day prior to hCG administration and until ovulation is apparent. If the ovaries are abnormally enlarged or if abdominal pain occurs, withhold hCG, discontinue lutropin alfa and follitropin alfa, and advise patient to avoid intercourse.

Reconstitute lutropin alfa powder with 1 mL SWFI. Mix gently; do not shake. If bubbles appear, allow to settle prior to use. May add follitropin alfa to lutropin alfa vial and administer in the same syringe.

SubQ: Administer in the stomach or thigh; rotate injection sites. Do not shake solution; allow any bubbles to settle prior to administration. Contents of lutropin alfa vial may be mixed in the same syringe with follitropin alfa. Refer to manufacturer labeling for instructions on how to use lutropin alfa prefilled syringe.

Prior to therapy: Baseline LH <1.2 units/L, FSH <5 units/L

Monitor sufficient follicular maturation. This may be directly estimated by sonographic visualization of the ovaries and endometrial lining alone or in combination with measurement of serum estradiol levels. The combination of both ultrasonography and measurement of estradiol levels is useful for monitoring for the growth and development of follicles and timing hCG administration.

The clinical evaluation of estrogenic activity (changes in vaginal cytology and changes in appearance and volume of cervical mucus) provides an indirect estimate of the estrogenic effect upon the target organs and, therefore, it should only be used adjunctively with more direct estimates of follicular development (ultrasonography and serum estradiol determinations).

The clinical confirmation of ovulation is obtained by direct and indirect indices of progesterone production. The indices most generally used are: rise in basal body temperature, increase in serum progesterone, and menstruation following the shift in basal body temperature. Sonographic evidence of ovulation includes collapsed follicle, fluid in the cul-de-sac, ovarian stigmata, and secretory endometrium.

Monitor for signs and symptoms of OHSS for at least 2 weeks following hCG administration.

OHSS: Monitoring of hospitalized patients should include abdominal circumference, albumin, cardiorespiratory status, electrolytes, fluid balance, hematocrit, hemoglobin, serum creatinine, urine output, urine specific gravity, vital signs, weight (all daily or as necessary) and liver enzymes (weekly) (SOGC-CFAS 2011).

Use is contraindicated in women who are pregnant.

Adverse events have been observed in animal reproduction studies. Ectopic pregnancy, miscarriage, spontaneous abortion, and multiple births have been reported. The incidence of congenital abnormality may be slightly higher after assisted reproductive techniques than with spontaneous conception; higher incidence may be related to parenteral characteristics (maternal age, sperm characteristics). Lutropin alfa is used to stimulate follicular development.