Menopur

What is Menopur?

Menopu is a prescription medicine that contains follicle stimulating hormone (FSH) and luteinizing hormone (LH). Menopur causes your ovaries to make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) cycle.

Description

MENOPUR is a preparation of gonadotropins (FSH and LH activity), extracted from the urine of postmenopausal women, which has undergone additional steps for purification.

MENOPUR is a sterile, lyophilized powder intended for subcutaneous (SC) injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of MENOPUR contains 75 International Units of follicle-stimulating hormone (FSH) activity and 75 International Units of luteinizing hormone (LH) activity, plus 21 mg lactose monohydrate and 0.005 mg Polysorbate 20 and Sodium Phosphate Buffer (Sodium Phosphate Dibasic, Heptahydrate and Phosphoric Acid).

The biological activity of MENOPUR is determined using the bioassays for FSH (ovarian weight gain assay in female rats) and LH (seminal vesicle weight gain assay in male rats), modified to increase the accuracy and reproducibility of these assays. The FSH and LH activity assays are standardized using the Fourth International Standard for Urinary FSH and Urinary LH, November 2000, by the Expert Committee on Biological Standardization of the World Health Organization (WHO ECBS). Both FSH and LH are glycoproteins that are acidic and water-soluble. Human Chorionic Gonadotropin (hCG) is detected in MENOPUR.

MENOPUR has been mixed in vitro with BRAVELLE with no evidence of aggregation.

Therapeutic class: Infertility

 Mechanism of Action

MENOPUR, administered for 7 to 20 days, produces ovarian follicular growth and maturation in women who do not have primary ovarian failure. Treatment with MENOPUR in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.

Who should not use Menopur?

Do not use Menopur if you:

• are allergic to menotropins or any of the ingredients in Menopur. See the end of this leaflet for a complete list of ingredients in Menopur.
• have ovaries that no longer make eggs (primary ovarian failure)
• are pregnant or think you may be pregnant. If Menopur is taken while you are pregnant, it may harm your baby.
• have problems with your thyroid gland, adrenal gland or pituitary gland that are not controlled by taking medicine.
• have a tumor in your female organs, including your ovaries, breast, or uterus that may get worse with high levels of estrogen
• have a tumor of your pituitary gland or hypothalamus
• have abnormal bleeding from your uterus or vagina and the cause is not known
• have ovarian cysts or enlarged ovaries, not due to a problem called polycystic ovary syndrome (PCOS)

What should I tell my healthcare provider before using Menopur?

Before you use Menopur, tell your healthcare provider if you:

• have been told by a healthcare provider that you are at an increased risk for blood clots (thrombosis)
• have ever had a blood clot (thrombosis), or anyone in your family has ever had a blood clot
• had twisting of your ovary (ovarian torsion)
• had or have a cyst in your ovary
• have any other medical conditions
• are breast feeding or plan to breast feed. It is not known if Menopur passes into your breast milk. You and your healthcare provider should decide if you will use Menopur or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Menopur?

• Read the Instructions for Use come with Menopur or Menopur mixed with Bravelle (urofollitropin for injection, purified).
• Use Menopur exactly as your healthcare provider tells you to use it.
• Your healthcare provider will tell you how much Menopur to use and when to use it.
• Your healthcare provider may change your dose of Menopur if needed.
• If you miss a dose of Menopur, call your healthcare provider right away. Do not double the amount of Menopur you are using.
• You may need more than 1 vial of Menopur for your dose.
• Menopur may be mixed with Bravelle in the same syringe.

What are the possible side effects of Menopur?

Menopur may cause serious side effects, including:

• ovaries that are too large. Menopur may cause your ovaries to be abnormally large. Symptoms of large ovaries include bloating or pain in your lower stomach (pelvic) area. If your ovaries become too large your healthcare provider may tell you that you should not have intercourse (sex) so you do not rupture an ovarian cyst.
• ovarian hyperstimulation syndrome (OHSS). Using Menopur may cause OHSS. OHSS is a serious medical condition that can happen when your ovaries produce too many eggs (overstimulated). OHSS can cause fluid to suddenly build up in the area of your stomach, chest, heart, and cause blood clots to form. OHSS may also happen after you stop using Menopur. Stop using Menopur and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following symptoms of OHSS:
  • severe pelvic or stomach pain
  • nausea
  • vomiting
  • sudden weight gain
  • swollen stomach
  • diarrhea
  • trouble breathing
  • decreased or no urine
• lung problems. Menopur may cause serious lung problems that can sometimes lead to death including fluid in the lungs, trouble breathing, and worsening of asthma.
• blood clots. Menopur may increase your chance of having blood clots in your blood vessels. Blood clots can cause:
  • blood vessel problems (thrombophlebitis)
  • stroke
  • loss of your arm or leg
  • blood clot in your lung (pulmonary embolus)
• twisting (torsion) of your ovary. Menopur may increase the chance of your ovary twisting, if you already have certain conditions such as OHSS, pregnancy, and previous abdominal surgery. Twisting of your ovary may lead to blood flow being cut off to your ovary.
• pregnancy with and birth of multiple babies. Menopur may increase your chance of having a pregnancy with more than 1 baby. Having a pregnancy and giving birth to more than 1 baby at a time increases the health risk for you and your babies. Your healthcare provider should talk to you about your chances of multiple births before you start using Menopur.
• birth defects. Babies born after ART may have an increased chance of birth defects. Your age, certain sperm problems, your genetic background, and that of your partner, and a pregnancy with more than 1 baby at a time may increase the chance that your baby may have birth defects.
• ectopic pregnancy (pregnancy outside your womb). Menopur may increase your chance of having a pregnancy that is abnormally outside of your womb. Your chance of having a pregnancy outside of your womb is increased if you also have fallopian tube problems.
• miscarriage. Your chance of loss of an early pregnancy may be increased if you had difficulty becoming pregnant.
• tumors of the ovary. If you have used medicines like Menopur more than 1 time to get pregnant, you may have an increased chance of having tumors in your ovaries, including cancer.

The most common side effects of Menopur include:

• stomach cramps, fullness or pain
• headache
• injection site swelling, heat, redness and pain

These are not all the possible side effects of Menopur. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

General information about the safe and effective use of Menopur

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Menopur for a condition for which it was not prescribed. Do not give Menopur to other people, even if they have the same condition you have. It may harm them.

This Patient Information summarizes the most important information about Menopur. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Menopur that is written for health professionals.

For more information go to www.menopur.com, or call 1-888-FERRING (1-888-337-7464).

How should I store Menopur?

• Before mixing, store Menopur powder in the refrigerator or at room temperature between 37ºF to 77ºF (3ºC to 25ºC).
• Protect Menopur from light.
• Menopur should be used right after mixing.
• Throw away any unused Menopur.

Keep Menopur and all medicines out of the reach of children.

What are the ingredients in Menopur?

Active ingredient: menotropins

Inactive ingredients: lactose monohydrate, polysorbate, sodium phosphate buffer (sodium phosphate dibasic, heptahydrate and phosphoric acid)

Label

PRINCIPAL DISPLAY PANEL – KIT CARTON

• NDC 55566-7501-2
• Menopur® 75 IU
  (menotropins for injection)
• 5 single dose vials of Menotropins for Injection
  5 single dose vials of 0.9% Sodium Chloride Injection, USP, 2 mL
  5 Q•Cap® Vial Adapters
• FOR SUBCUTANEOUS
  INJECTION ONLY
• Rx only
• Q•Cap®
  Vial Adapters
  for Needle-Free
  Reconstitution
• For exclusive use with
  Ferring reproductive health products
• FERRING
  PHARMACEUTICALS

SRC: NLM .