Menopur

Menopur is a prescription medication used as part of certain fertility treatments in women to promote ovulation and pregnancy.

Menopur belongs to a group of drugs called hormonal fertility agents. These work to promote pregnancy and ovulation by mimicking the effects of naturally-occurring hormones in the body that are critical to the development of the follicle and embryo implantation.

This medication is available in an injectable form to be given directly under the skin, typically on a daily basis.

Common side effects of Menopur include stomach pain, headache, and injection site reactions (swelling, heat, redness, and pain).

Menopur can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Menopur affects you.

Menopur is a prescription medication used as part of Assisted Reproductive Technology (ART) fertility treatments in women to promote ovulation and pregnancy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Ferring Pharmaceuticals, Inc.

Serious side effects have been reported with Menopur. See the “Drug Precautions” section.

Common side effects of Menopur include the following:

• stomach cramps 
• stomach pain
• stomach fullness and bloating
• enlarged ovaries
• headache
• injection site swelling, heat, redness, and pain

This is not a complete list of Menopur side effects. Ask your doctor or pharmacist for more information.

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Menopur including the following:

• 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 doctor may recommend you do not have sex so you do not rupture an ovarian cyst. 
• Blood clots. Consult with your physician if you have a history of heart disease and/or blood clots. Get medical attention immediately if you experience sudden difficulty breathing, persistent leg or other extremity pain and/or sudden severe headaches.
• Ovarian Hyperstimulation Syndrome (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. Discontinue use of Menopur and get medical attention immediately if you experience the following combination of symptoms:
  • severe pelvic pain or stomach pain
  • nausea
  • vomiting
  • sudden weight gain
  • swollen stomach
  • diarrhea
  • trouble breathing
  • decreased or no urine
• Lung problems. Asthma exacerbations and acute respiratory distress syndrome have been reported with use of Menopur. Consult with your physician if you have asthma or lung problems before taking Menopur.
• Birth defects. The risk of birth defects is slightly higher when using fertility treatments. Consult with your doctor about your risk for having birth defects.
• Twisted (torsion) of your ovary. Menopur may increase the chance of your ovary twisting. This can occur if you already have certain conditions such as OHSS, pregnancy and previous abdominal surgery. When the ovary twists, this can 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.
• 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.

Do not take Menopur if you:

• are allergic to Menopur or to any of its ingredients
• have thyroid, pituitary gland, and/or adrenal gland disease
• have active cancer
• have abnormal vaginal bleeding
• have ovarian cysts
• are pregnant 

Menopur can also cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Menopur affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Menopur, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Menopur, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Menopur or to any of its ingredients
• have asthma or lung diseases
• have abnormal vaginal bleeding
• are at an increased risk for blood clots
• have ever had a blood clot, or if anyone in your family has ever had a blood clot
• have ovarian cysts
• are breastfeeding or plan to breastfeed
• have heart disease
• have thyroid, pituitary gland and/or adrenal gland disease
• have active cancer

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Menopur falls into category X. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Menopur crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. You should not do both. 

Use Menopur exactly as prescribed.

Menopur is available in an injectable form to be given directly under the skin, typically on a daily basis.

If your physician determines you may self-inject Menopur, follow their instructions exactly. You may use the following information to support the instructions provided by your physician.

Preparing your Menopur

1. Wash your hands well with soap and water. Dry your hands with a clean towel
2. Place all the supplies you need on the clean surface you already prepared
3. Open the Q•Cap by peeling back the label
4. Set aside the blister pouch with the Q•Cap. Do not take the Q•Cap out of the pouch at this time. Do not touch the ends of the Q•Cap
5. Remove the plastic caps from the vials of Menopur and 0.9% Sodium Chloride, USP (and Bravelle if needed)
6. Check the vial of Menopur (and Bravelle if needed) to make sure there is powder or a pellet in the vial. Check the 0.9% Sodium Chloride, USP vial to make sure that there are no particles in the liquid and the liquid in the vial is clear. If you do not see powder or see particles or the liquid is discolored, do not use the vial and call your pharmacist or healthcare provider.
7. Wipe the tops of the vials with alcohol and allow them to dry. Do not touch the tops of the vials after you have wiped them.
8. Place the vial of 0.9% Sodium Chloride, USP on the table. Remove the Q•Cap from the blister pouch by holding the sides with your fingers
9. Carefully twist the syringe onto the connector end (luer) of the Q•Cap until it is tight. Do not touch the spike at the end of the Q•Cap
10. Pull down on the syringe plunger until you have withdrawn the amount of 0.9% Sodium Chloride, USP from the vial that your healthcare provider told you to use. The usual amount of 0.9% Sodium Chloride, USP used to mix your Menopur is 1 mL, but you should use the amount that your healthcare provider tells you to use
11. Hold the syringe and place the spike end of the Q•Cap over the top of the 0.9% Sodium Chloride, USP vial. Push the tip of the Q•Cap into the rubber stopper of the vial until it stops. Be careful not to push down on the syringe plunger during this step.
12. Slowly push down on the syringe plunger to push the air from the syringe into the vial. Keeping the syringe and Q•Cap together, turn the vial upside down and pull down on the syringe plunger to withdraw the right amount of 0.9% Sodium Chloride, USP from the vial. Your healthcare provider should tell you the right amount of 0.9% Sodium Chloride, USP to use.
13. Place the 0.9% Sodium Chloride, USP vial on the table. Remove the Q•Cap and syringe from the vial by pulling up on the syringe barrel. Throw away the 0.9% Sodium Chloride, USP vial in your household trash.
14. Hold the vial of Menopur powder in 1 hand. Hold the sides of the syringe with your other hand and place the tip of the Q•Cap over the top of the vial. Push the tip of the Q•Cap into the rubber stopper of the vial until it stops. Be very careful not to push down on the syringe plunger during this step.
15. Slowly push down on the syringe plunger to push the 0.9% Sodium Chloride, USP into the vial with the Menopur powder in it. Gently swirl the vial until the Menopur powder is completely dissolved. Do not shake the vial as this will cause bubbles.
16. As soon as the powdered medicine has completely dissolved, turn the vial upside down and pull down on the plunger to withdraw all of the Menopur into the syringe,

If your healthcare provider tells you to use more than 1 vial of Menopur or tells you to mix Menopur with Bravelle in the same syringe:

• Mix your first vial of Menopur powder OR Bravelle powder with 0.9% Sodium Chloride, USP. Do not inject your dose yet.
• Use the liquid in the syringe you have just mixed to mix the next vial of Menopur or Bravelle.
• You can use the liquid in the syringe to mix up to 5 more vials of medicine
• Your healthcare provider will tell you how many vials of Menopur and Bravelle to use. 

Removing the Q•Cap and adding your needle for injection.

1. When you have finished mixing the last vial needed for your injection and have withdrawn all the medicine into the syringe, remove the syringe from the Q•Cap
2. Twist the syringe counter-clockwise while holding the Q•Cap steady. Carefully remove the syringe from the Q•Cap
3. Throw away the Q•Cap with the attached medicine vial into your household trash. Carefully set the syringe with the medicine down on the table, being careful not to touch the tip of the syringe
4. You are now ready to attach the needle to the syringe for your injection. Your healthcare provider will tell you what needle you should use for your injection
5. While holding the syringe with the syringe tip pointing up, place the needle on the top of the syringe. Gently push down on the needle and twist the needle onto the syringe in a clockwise direction until it is tight
6. Hold the syringe with the needle pointing straight up. Pull down slightly on the plunger and tap the barrel of the syringe so that any air bubbles rise to the top. Slowly press the plunger up until all the air is out of the syringe and a small drop of liquid is seen at the tip of the needle
7. Tap the syringe to remove the small drop of liquid at the tip of the needle
8. Carefully set the syringe with needle down on the table. Do not let the needle touch anything to keep it sterile. The medicine is now ready for you to inject

Injecting Menopur

1. Select a site to inject Menopur on your stomach area (abdomen)
2. Pick a site a site on your lower abdomen, 1-2 inches below the navel, alternating between left and right sides
3. 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
4. Clean your injection site with an alcohol pad. Let the alcohol dry
5. Carefully remove the needle cap from the syringe
6. Hold the syringe in 1 hand. Use your other hand to gently hold a fold of skin where you will insert your needle. Hold the skin between your thumb and index finger
7. Hold your syringe at a right angle to your skin, like a dart. Quickly insert the needle all the way into your skin fold
8. Push down the plunger of the syringe with a steady motion. Keep pushing until all the fluid is injected into your skin
9. Let go of your skin fold and pull the needle straight out of your skin

After your injection

• If there is any bleeding at your injection site, place a gauze pad over your injection site. Apply gentle pressure to stop the bleeding. Do not rub the site

• If your injection site becomes sore or red, you may put ice on your injection site for 1 minute and then take it off for 3 minutes. If needed, you may repeat this 3 or 4 times

Disposing of your used needles and syringes

• Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash
• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
  • upright and stable during use
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. 

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Menopur at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

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

The recommended dose range of Menopur when used as part of Assisted Reproductive Technology (ART) fertility treatments in women to promote ovulation and pregnancy is 225 international units (IU) to 450 IU injected subcutaneously once per day.

If you take too much Menopur, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Before mixing, store Menopur powder in the refrigerator or at room temperature between 37° to 77°F
• Protect from light
• Use immediately after reconstitution
• Discard unused material