This combination product contains 2 medications: follitropin alfa and lutropin alfa. Both medications belong to the class of medications known as gonadotropins.

Lutropin alfa is a synthetic version of the human hormone luteinizing hormone (LH). Follitropin alfa is a synthetic version of the naturally occurring follicle stimulating hormone (FSH). Both of these hormones play a role in the development and maturing of eggs in the ovaries.

Together, these medications are used as a fertility treatment by women who have not been able to become pregnant as a result of problems with ovulation.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The usual recommended starting dose of follitropin alfa - lutropin alfa is follitropin 150 IU - lutropin alfa 75 IU injected subcutaneously (under the skin), once daily. The medication should be injected at approximately the same time every day. Your doctor will monitor how your ovaries are responding to the medication and frequent appointments will be necessary. Your doctor may adjust your dose according to your response to the medication.

If you are injecting this medication yourself, your doctor will show you how to use this medication properly. If you are not sure how to use it or have questions about how to use it, contact your doctor. Before using this medication, thoroughly read the patient information provided and ask your doctor if you have any questions. If a family member will be giving you the injections, your doctor should instruct them on how to give the injection.

If you are using the vial of follitropin - lutropin alfa, the contents of the vial should be mixed with the contents of the diluent vial that is provided. After preparation, the medication is injected under the skin (subcutaneous) as directed, usually into the thigh or abdomen.

Once the dose of medication has been prepared, it should be used immediately. Discard any unused material after use. Do not use your injectable solution if it appears cloudy, lumpy, or discoloured. Read the patient information carefully and ask your doctor or health care professional any questions you may have.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important that you follow the dosing schedule closely and that you keep all doctor's appointments. If you miss a dose of this medication, contact your doctor to see when your next dose should be given.

Vials with powder should be stored at room temperature, protected from light, and kept out of the reach of children. Prefilled pens containing solution for injection should be stored in the refrigerator, in the original package. Do not freeze. Once opened, the prefilled pen may be kept at room temperature for up to 28 days. Do not store the pen with the needle still attached.

Powder for Injection
Each vial of powder to be reconstituted for injection contains 150 international units (equivalent to 11 µg) of follitropin alfa and 75 international units (equivalent to 3 µg) of lutropin alfa. Nonmedicinal ingredients: 30 mg sucrose, 1.11 mg disodium phosphate dehydrate, 0.45 mg sodium dihydrogen phosphate monohydrate, 0.1 mg methionine, 0.05 mg polysorbate 20, phosphoric acid and/or sodium hydroxide for pH adjustment.

Prefilled Pen

300 IU/150 IU
Each 0.48 mL of clear, colourless to slightly yellow solution, contains 300 international units (equivalent to 22 µg) of follitropin alfa and 150 international units (equivalent to 6 µg) of lutropin alfa. Nonmedicinal ingredients: sucrose, arginine monohydrochloride, phenol, disodium phosphate dehydrate, sodium dihydrogen phosphate monohydrate, poloxamer 188, methionine, sodium hydroxide (for pH adjustment), phosphoric acid (for pH adjustment).

450 IU/225 IU
Each 0.72 mL clear, colourless to slightly yellow solution, contains 450 international units (equivalent to 33 µg) of follitropin alfa and 225 international units (equivalent to 9 µg) of lutropin alfa. Nonmedicinal ingredients: sucrose, arginine monohydrochloride, phenol, disodium phosphate dehydrate, sodium dihydrogen phosphate monohydrate, poloxamer 188, methionine, sodium hydroxide (for pH adjustment), phosphoric acid (for pH adjustment).

900 IU/450 IU
Each 1.44 mL clear, colourless to slightly yellow solution, contains 900 international units (equivalent to 66 µg) of follitropin alfa and 450 international units (equivalent to 18 µg) of lutropin alfa. Nonmedicinal ingredients: sucrose, arginine monohydrochloride, phenol, disodium phosphate dehydrate, sodium dihydrogen phosphate monohydrate, poloxamer 188, methionine, sodium hydroxide (for pH adjustment), phosphoric acid (for pH adjustment).

Do not take this medication if you:

• are allergic to follitropin alfa, lutropin alfa, or any ingredients of the medication
• are not ovulating, but have normal LH and FSH levels
• have uncontrolled, irregular thyroid or adrenal gland function
• have a lesion in the brain (such as a tumour of the hypothalamus or pituitary gland)
• have unexplained ovarian enlargement or cysts
• have undiagnosed vaginal bleeding
• have or may have a tumour that depends on estrogen for growth
• are or may be pregnant
• are breast-feeding

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal, breast or pelvic pain
• constipation
• diarrhea
• headache
• painful menstruation
• nausea
• reactions at the injection site (e.g., pain, redness, bruising)
• stomach or intestinal gas

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of ovarian hyperstimulation syndrome (e.g., severe abdominal pain, nausea, vomiting and weight gain)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities. You are at higher risk of developing blood clots if you are over 35 years of age, have a history of blood clots, or have a close family member who has experienced blood clots. If you experience pain in the chest or leg, unexplained shortness of breath, fast and irregular heartbeat, severe headache, blurred vision, or slurred speech, get immediate medical attention. Talk to your doctor about the risks and benefits of using this medication.

Ectopic pregnancies: This medication may increase the risk of having an ectopic pregnancy (i.e., the baby develops in one of the fallopian tubes instead of in the uterus). It is important to have an early ultrasound to ensure that the baby is developing inside the uterus.

Instructions: It is extremely important to understand your treatment and to follow instructions closely. Be sure to ask your doctor any questions you might have.

Lung problems: Rarely, this medication can cause problems with the lungs. Get immediate medical attention if you experience wheezing or difficulty breathing.

Multiple births: This medication may increase the risk of multiple births (e.g., twins). Talk to your doctor about the risks of multiple births before beginning treatment.

Ovarian enlargement: Some women using this medication may experience ovarian enlargement associated with abdominal bloating or pain. In most cases, the bloating and pain stop without treatment within 2 or 3 weeks. If you experience these symptoms, contact your doctor.

Ovarian hyperstimulation syndrome (OHSS): Treatment with this medication can cause a condition called ovarian hyperstimulation syndrome (OHSS). With OHSS, too many follicles grow and cause abdominal or pelvic discomfort or pain, nausea, vomiting, and weight gain. Some women may experience difficulty breathing, diarrhea, and decreased urination. OHSS can progress rapidly and may become serious. If you experience any of these symptoms while using this medication, contact your doctor immediately.

Porphyria: If you have a porphyria, a rare condition that affects the production of heme in the body, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy.

Breast-feeding: It is not known if this medication passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. This medication should not be used while breast-feeding.

Children: This medication is intended for use by women of child-bearing age. The safety and effectiveness of this medication have not been established for children.

Seniors: This medication is intended for use by women of child-bearing age. The safety and effectiveness of this medication have not been established for seniors.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.