Menopur
Pronunciation: men-oh-pyoor
Generic name: menotropins for injection
Dosage form: injection for subcutaneous use
Drug class: Gonadotropins
What is Menopur?
Menopur is used during fertility treatment to stimulate your ovaries to make multiple eggs. It is a gonadotropin injection that contains follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Menopur is administered by subcutaneous (under the skin) injection for 7 to 20 days of a cycle.
Fertility treatment is also called Assisted Reproductive Technology (ART) or in vitro fertilization (IVF).
Menopur gained FDA approval on October 29, 2004.
How Does Menopur Work?
Gonadotropin Mechanism
Menopur contains FSH and LH hormones that stimulate ovarian follicles to mature and produce eggs in women who do not have primary ovarian failure. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.
Menopur belongs to the drug class called gonadotropins.
Menopur Side Effects
Common Side Effects
The most common side effects of Menopur include:
- stomach cramps, fullness, or pain
- headache
- injection site swelling, heat, redness, and pain.
Serious Menopur Side Effects and Warnings
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, and 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 have 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.
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.
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Who should not use Menopur? Contraindications
Do not use Menopur if you:
- are allergic to menotropins or any of the 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 if 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 breastfeeding or plan to breastfeed. 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.
How should I use Menopur?
Read the Instructions for Use about the right way to use Menopur or Menopur mixed with Bravelle (urofollitropin for injection, purified).
- Use Menopur exactly as your healthcare provider tells you to use it.
Menopur is injected under the skin of your abdomen.
- Choose a site on the lower abdomen, 1-2 inches below the navel, alternating between left and right sides.
- Each day, inject in a different site to help reduce soreness and skin problems. For example, on day 1, inject yourself on the right side of your abdomen. The next day, inject yourself on the left side of your abdomen.
- Changing your injection sites every day will help reduce soreness and skin problems.
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.
- You may need more than 1 vial of Menopur for your dose.
Menopur Dosing Information for Follicle Stimulation
Begin on cycle day 2 or 3.
- Initial starting dose of the first cycle: 225 International Units administered subcutaneously daily
- Adjust the dose after 5 days based on the woman’s ovarian response as determined by ultrasound evaluation of follicular growth and serum estradiol levels.
- Do not make additional dosage adjustments more frequently than every 2 days or by more than 150 International Units at each adjustment.
- Continue treatment until adequate follicular development is evident, and then administer hCG.
- Therapy should not exceed 20 days.
Important: Withhold the administration of hCG in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of Menopur therapy.
Menopur use: Development of multiple follicles and pregnancy in ovulatory women as part of an assisted reproductive technology (ART) cycle.
Concurrent Bravelle Administration
Menopur may be administered together with Bravelle (urofollitropin for injection, purified).
- Only the total starting dose of 225 International Units (150 International Units of Menopur and 75 International Units of Bravelle or 75 International Units of Menopur and 150 International Units of Bravelle) was studied in a clinical trial.
- Do not administer daily doses of Menopur or Menopur in combination with BRAVELLE that exceed 450 International Units.
- Menopur may be mixed with Bravelle in the same syringe.
Missed Dose Information
What to do if You Miss a Menopur Dose
- If you miss a dose of Menopur, call your healthcare provider right away. Do not double the amount of Menopur you are using.
Menopur Drug Interactions
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.
Storage
How to Store Menopur
- Before mixing, store Menopur powder in the refrigerator or at room temperature between 37ºF to 77ºF (3ºC to 25ºC).
- Protect from light.
- Use Menopur right after mixing.
- Throw away any unused Menopur.
- Keep out of the reach of children.
Menopur Ingredients and Manufacturer Information
Active and inactive ingredients
Active ingredient: menotropins
Inactive ingredients: lactose monohydrate, polysorbate, sodium phosphate buffer (sodium phosphate dibasic, heptahydrate and phosphoric acid).
Available as a lyophilized powder for injection: containing 75 IU FSH and 75 IU of LH activity, supplied as lyophilized powder or pellet in sterile vials with diluent vials and Q.Cap® vial adapters
Manufacturer Information
Menopur is manufactured by Ferring Pharmaceuticals Inc., Parsippany, NJ 07054.
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