Menopur 75 IU - Consumer Medicine Information
|Condition:||Female Infertility, Follicle Stimulation, Ovulation Induction|
|Form:||Subcutaneous (SC), Powder|
|Ingredients:||menotropins, lactose monohydrate, polysorbate 20, and sodium phosphate, phosphoric buffer (sodium phosphate dibasic, heptahydrate, phosphoric acid)|
About This Medication
What the Medication is Used For
Menotropins contain Follicle Stimulating Hormone and Luteinizing Hormone, two natural hormones produced in both males and females, and obtained from the urine of post menopausal women. These hormones help to maintain the normal function of the reproductive organs in both males and females.
Your doctor may have prescribed Menopur because your pituitary gland does not release FSH (Follicle Stimulating Hormone), or it releases FSH and LH (Luteinizing Hormone) in an improper balance. This imbalance means the follicles are unable to mature, so ovulation cannot take place. Menopur helps to provide the required amount of FSH to the ovaries, thereby allowing the ovarian follicles to develop.
Menopur is used in IVF (in–vitro fertilization or ❝test tube❞) procedures or other assisted conception techniques to induce multiple follicular development.
What It Does
Menopur provides you with the FSH (Follicle Stimulating Hormone) that is necessary for the recruitment, growth and maturation of the ovarian follicles which contain eggs known as ova. This occurs at the beginning of the cycle. After Menopur is given to develop the ovarian follicle, another hormone, hCG (human chorionic gonadotropin) is given mid cycle to mature the egg and induce ovulation.
How Long Will One Treatment Cycle Last
The length of treatment depends on the average follicular response to therapy. Every cycle treatment is individualized and your doctor will need to carefully evaluate how you respond.
When It Should not be Used
Menopur should not be used if:
- You are pregnant.
- You are breast–feeding.
Menopur should also not be used if you have:
- A high level of FSH indicating primary ovarian failure.
- Uncontrolled thyroid or adrenal dysfunction.
- An organic intracranial lesion such as pituitary tumour.
- Abnormal vaginal bleeding of undetermined origin.
- Ovarian cyst or enlargement not due to Polycystic Ovarian Syndrome.
- Allergy to menotropins, lactose monohydrate, polysorbate 20, sodium phosphate buffer (sodium phosphate dibasic, heptahydrate and phosphoric acid).
- Tumour of the ovaries, fallopian uterus, vagina, breast and cervix.
Menopur should only be used under the supervision of a specialist having the required facilities for laboratory monitoring.
What the Medicinal Ingredient Is
Menopur is a highly purified, sterile, freeze–dried powder for injection. It contains the active ingredient menotropins USP, 75 units FSH and 75 units LH.
What the Nonmedicinal Ingredients Are
Menopur also contains lactose monohydrate, polysorbate 20, and sodium phosphate and phosphoric buffer (sodium phosphate dibasic, heptahydrate and phosphoric acid).
What Dosage Form It Comes In
Menopur is a sterile, lyophilized form intended for reconstitution with sterile 0.9% sodium chloride solution for injection. Menopur is administered by subcutaneous (SC) [tissue under your skin] injection.
Warnings and Precautions
Will Menopur Put Me at Risk for Reproductive Complications
Treatment with gonadotropin preparations may lead to unwanted overstimulation of the ovaries known as Ovarian Hyperstimulation Syndrome (OHSS). The first symptoms of ovarian stimulation may be noticed as pain in the abdomen, feeling sick or diarrhea. More severe cases may have accumulation of fluid in the abdomen and/or chest, weight gain and the occurrence of blood clots. Contact your doctor without delay if you experience any of these symptoms during treatment or within a few days after the last injection.
The incidence of multiple births with Menopur is no different from any other gonadotropin and is dependent upon the protocol used by the clinic. Your doctor will monitor you closely to help minimize the possibility of multiple gestations. The majority of births – about 85% are single babies. Of those women who have multiple births, the majority of these are twins. Only few women conceive 3 or more babies. Even so, neither single nor multiple births can be totally guaranteed.
Since women with infertility undergoing infertility assisted reproduction, and particularly IVF, often have tubal abnormalities, the incidence of ectopic pregnancies may be increased. Early ultrasound confirmation of pregnancy in the uterus is therefore of importance.
Interactions With This Medication
There have been no drug interactions reported with this medication.
Proper Use of This Medication
Menopur must be taken by injection.
Every treatment is individualized. Yours has been carefully designed for you by your doctor according to your own specific needs. It is very important that you keep your appointments and follow your doctor‘s instructions, particularly with regard to the amount and frequency of the medication you are taking. If you have concerns regarding your dosage, consult your doctor. Do not adjust your dosage without being instructed to do so. If you forget or miss an injection, do not panic, but you should call your doctor for advice.
The dose is chosen by your doctor. Women participating in assisted reproduction programs are usually started on a dose of 225 IU Menopur. Based on clinical monitoring including ovarian ultrasound scans, and blood and urine tests, you doctor may adjust the dose once every two days. The maximum daily dose of Menopur is 450 IU daily.
Instructions for Reconstitution and Subcutaneous Administration
Your doctor has prescribed Menopur for subcutaneous injection. This means that is it injected through a short injection needle into the tissue just under your skin. This instruction sheet will help you prepare and inject your medication at home. Please review it completely prior to starting the procedure. Do not attempt this procedure if you are unsure of how to prepare or administer the injection. If you have any questions, call your doctor or nurse.
- Before You Start
- Wash your hands with antibacterial soap and use alcohol to clean the area you will be working on.
- Have these supplies ready:
- Vial (or vials) of Menopur, 75 IU
- A vial of Sodium Chloride 0.9% (sterile diluent) that is conveniently packaged with Menopur
- A syringe and sterile needles (check with your doctor about which syringe and needle size to use)
- Alcohol pads and rubbing alcohol
- Gauze and cotton balls
- A needle disposal container
- Preparing your medicine and filing the syringe
Remember: Only the Sodium Chloride (sterile diluent) provided must be used to reconstitute Menopur.
- Remove syringe and larger needle from the wrapper. While holding the protective cap, twist needle clockwise to make sure needle is secure. Set syringe and needle aside.
- Remove plastic caps from tops of vials of Menopur and sterile diluent.
- Wipe tops of vials with alcohol to sterilize them. Don’t touch tops of vials once you have sterilized them.
- Uncap needle by carefully twisting needle cap clockwise and pulling cap upward. Avoid twisting needle counterclockwise, as this can cause needle to separate from syringe.
- Insert needle through rubber stopper of sterile diluent vials.
- Tip sterile diluent vial and, with needle in fluid, pull back on plunger to withdraw fluid into syringe up to the amount instructed by your doctor.
- Withdraw needle from sterile diluent vial. Slowly inject sterile diluent into vial containing Menopur powder, aiming sterile diluent at side of vial to avoid creating bubbles. The solution should be clear and colourless.
The Menopur powder will dissolve quickly. Do not shake vial because this will create bubbles.
For patients requiring a single injection from multiple vials of Menopur, up to 6 vials can be reconstituted with 1 ml of sterile saline for injection, USP.
This can be accomplished by reconstituting a single vial as described above (see step 2). Then draw the entire contents of the first vial into a syringe, and inject the contents into a second vial of lyophilized Menopur. Gently swirl the second vial as described above, once again checking to make sure the solution is clear and free of particles. This step can be repeated with 4 additional vials for a total of up to 6 vials of lyophilized Menopur into 1 mL of diluent.
- As soon as powder has completely dissolved, withdraw all Menopur solution into syringe. There are two ways of doing this:
- Leave vial on counter, tilt it, pull back on plunger to withdraw all solution, OR
- Turn vial upside down, pull back on plunger to withdraw solution as you slowly lower needle.
- Changing the Needle
- While holding syringe upward, replace needle cap and remove large needle by twisting it counterclockwise. Replace with the small, subcutaneous needle by twisting it clockwise onto syringe.
- Hold syringe straight up. Draw back slightly on plunger and tap syringe so that any air bubbles rise to top. Slowly press plunger until all air is out of syringe and small drop of solution forms at tip of needle.
- Tap the syringe to remove the drop of solution at the tip of the needle.
- Carefully recap needle to keep it sterile.
- Menopur solution is now ready for injection.
If an uncapped needle EVER comes into contact with anything except Menopur or sterile diluent, do not inject yourself with it. Immediately remove needle and replace it with a new sterile needle.
- Injecting the Medicine
Menopur should be injected into a skin fold on your abdomen a few inches below your navel, to the left or right.
Each day, use the alternate side of your abdomen to help prevent soreness.
- Carefully clean injection site area with an alcohol pad and allow site to air–dry.
- Remove needle cap from syringe.
- Hold syringe in one hand. Use your other hand to gently grasp a fold of skin in the injection site area between your thumb and index finger.
- Hold syringe perpendicular (at right angle) to skin like a dart and quickly insert needle all the way into skin fold.
- Depress plunger of syringe with a steady motion until all fluid is injected beneath skin.
- Release skin fold and pull needle straight out. Recap needle and discard syringe and needle into a disposal container. If any bleeding should occur, simply place a small piece of gauze or cotton over the injection site and apply gentle pressure to stop bleeding.
- If injection site becomes sore, application of ice for brief intervals may help relieve any discomfort.
- Dispose of the Syringe and Needles
Safely dispose of all used syringes and needles in a needle disposal container with a lid. Extra sterile diluent should be thrown away. After you finish your course of treatment, ask your healthcare provider how to properly dispose of the needle disposal container.
Side Effects and What to Do About Them
Fertility drugs are safe to take with close monitoring by your doctor. As with all medications, there is a potential for side effects. Some patients undergoing gonadotropin therapy may experience breast tenderness, bloating, flushing, vomiting, nausea and diarrhea. They are temporary and will resolve once treatment is stopped. Other adverse reactions may include allergic sensitivity such as a rash or local swelling at the injection site.
The greatest concern your doctor will have is Ovarian Hyperstimulation Syndrome (OHSS). To avoid the development of OHSS, your doctor will carefully monitor your response to Menopur. Ovarian enlargement, sometimes accompanied by abdominal bloating and pain, may occur in about 20% of women taking gonadotropins. This is generally reversed with cessation of treatment and severe life–threatening cases are rare.
A causal relationship between treatment of fertility drugs and ovarian cancer has not been established.
If you experience any unusual symptoms or side effects, you should report them to your doctor immediately. It is also wise to discuss the possibility of side effects with your doctor before your treatment.
Serious Side Effects, how Often They Happen and What to Do About Them
|Symptom ⁄ effect||Talk with your
This is not a complete list of side effects. If you have any unexpected effects after receiving Menopur, contact your doctor or pharmacist.
Reporting Suspected Side Effects
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: firstname.lastname@example.org
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
This document plus the full product monograph, prepared for health professionals, can be found by contacting the sponsor, Ferring Inc., at: 1-866-373-1333.