Dosage form:

Powder and solvent for solution for injection 150 IU/75 IU

What is Pergoveris® (follitropin alfa/lutropin alfa) used for?

Pergoveris® is used to help women aged 18 years old or above, who have a severe deficiency of follicle stimulating hormone (FSH) and luteinizing hormone (LH), in getting pregnant. This medicine is used to stimulate the development of follicles in the ovaries.

Important notes before taking Pergoveris® (follitropin alfa/lutropin alfa):

• Tell your doctor or pharmacist if you are allergic to this medicine, any part of this medicine, or any other medicines, foods, or substances.
• Tell your doctor or pharmacist if you have any of these health problems: Adrenal gland disease, thyroid gland, pituitary gland disease, or brain tumor.
• Tell your doctor or pharmacist if you have any of these health problems: Cancer of the ovary or uterus, enlarged ovaries or ovarian cysts, fibroid tumors in the uterus, or vaginal bleeding where the cause is not known.
• Tell your doctor or pharmacist if you are not able to get pregnant because of problems with your sex organs.
• Tell your doctor or pharmacist if you are pregnant or may be pregnant. This drug is not for use during pregnancy. A pregnancy test will be done to show that you are not pregnant before starting this drug.
• Tell your doctor or pharmacist if you are breastfeeding. Do not breastfeed while you take this drug.
• This is not a list of all drugs or health problems that interact with this drugTell 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 this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Important notes while taking Pergoveris® (follitropin alfa/lutropin alfa):

• Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
• You should have blood work checked as you have been told by the doctor.
• You should have ultrasounds done while using this drug as you have been told by the doctor.
• This drug may raise the chance of getting pregnant with more than one baby.
• This drug may raise the chance of side effects like blood clots, lung problems, and enlarged ovaries and ovarian cysts. Rarely, these effects have been deadly. Talk with the doctor.
• If your ovaries get too big, your doctor may tell you that you need to avoid sex. Talk with your doctor.
• This drug may raise the chance of twisting of the ovaries (ovarian torsion) in people 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 the uterus (ectopic pregnancy) may be raised in some people. If you have questions, talk with the doctor.
• Limit working out while undergoing ovarian stimulation. Talk with your doctor.
• The rate of miscarriage is higher when using drugs like this one than in a natural pregnancy. It is not known if these drugs caused this effect. If you have questions, talk with the doctor.
• If you have used drugs like this one more than 1 time to get pregnant, the chance of having tumors in your ovaries or other sex organs may be raised.
• If you have any signs of pregnancy or if you have a positive pregnancy test, call your doctor right away.

Pergoveris® (follitropin alfa/lutropin alfa) side effects:

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat;
• Breast pain;
• Menstrual pain;
• Pelvic pain or pressure;
• Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may happen in some people who use this drug. Call your doctor right away if you have severe stomach pain or bloating; very upset stomach, throwing up, or diarrhea; a big weight gain; shortness of breath; or change in how much urine is passed;
• Blood clots have happened with this drug. Sometimes, these blood clots have been deadly. Call your doctor right away if you have chest, arm, back, neck, or jaw pain or pressure; coughing up blood; numbness or weakness on 1 side of your body, trouble speaking or thinking, change in balance, or change in eyesight; shortness of breath; or swelling, warmth, or pain in the leg or arm.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given;
• Upset stomach;
• Headache;
• Stomach pain;
• Diarrhea or constipation;
• Gas;
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

How do I store and/or throw out this drug?

• Do not store above 25℃.
• Store in the original package in order to protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• The reconstituted solution should not be administered if it contains particles or is not clear.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.