Follitropin alpha belongs to the class of medications called gonadotropins. It is a synthetic version of the naturally-occurring follicle stimulating hormone (FSH), a hormone produced by the pituitary gland that helps egg development in the ovaries. Follitropin alpha is used as a fertility medication by women who have not been able to become pregnant as a result of problems with ovulation.

Follitropin alpha works by helping to stimulate the development of eggs in the ovaries. Follitropin alpha is also used by women having assisted reproductive technology (ART) procedures (e.g., in-vitro fertilization) in fertility clinics. It is usually given in combination with a medication called human chorionic gonadotropin (hCG), which causes ovulation to occur by mimicking a natural hormone called luteinizing hormone (LH).

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 using this medication, speak to your doctor. Do not stop using 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 use this medication if their doctor has not prescribed it.

The recommended dose of follitropin alpha varies according to individual circumstances. The goal is to use the lowest dose that is expected to achieve good results. Doses usually range from 75 IU to 450 IU (5.5 µg to 33 µg) per day.

To induce ovulation, treatment is usually started at a dose of 75 IU once daily. The dose can be increased by up to 37.5 IU by the doctor after 14 days, and then every 7 days after that. One course of treatment should not exceed 35 days under normal circumstances. Intercourse should be attempted at a consistent frequency of at least 3 times per week from the day prior to administration of hCG until ovulation becomes apparent. If there is evidence of ovulation but pregnancy does not occur, the regimen is repeated for at least 2 more courses before the dose is increased to 150 IU per day for 7 to 12 days.

For ART procedures, treatment is usually started at a dose of 150 IU or 225 IU (depending on your circumstances) once a day. After the first 5 days, your doctor may consider increasing the dose by 37.5 IU to 150 IU. Additional dose increases can be made every 3 to 5 days.

After preparation, follitropin alpha is injected either under the skin (subcutaneous) or into a muscle (intramuscular) as directed, usually into the thigh or abdomen.

If you are giving the injection to yourself, be sure you completely understand the proper method of safely preparing and injecting your medication.

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 very important to use this medication on a regular schedule and exactly as prescribed by your doctor. If you miss a dose of this medication, discuss with your doctor when you should receive your next dose. Do not administer a double dose to make up for a missed one.

Vials with powder should be stored at or below room temperature, protected from light, not allowed to freeze, and kept out of the reach of children. The medication should be used immediately after mixing and any unused medication should be discarded.

The pen may be stored in the refrigerator. It may also be stored at room temperature for a single period of not more than 3 months. After first use, the pen can be kept at room temperature for up to 28 days. Do not freeze the pen. Protect it from light, and keep it out of the reach of children.

75 IU (5.5 µg)
Each single dose vial of sterile, lyophilized powder, intended for SC or IM injection after reconstitution, contains FSH activity 75 IU. Diluent provided for reconstitution is sterile water for injection USP. Nonmedicinal ingredients: disodium phosphate dehydrate, methionine, polysorbate 20, sodium dihydrogen phosphate monohydrate, and sucrose. O-phosphoric acid and/or sodium hydroxide may be used for pH adjustment prior to lyophilization.

Do not use this medication if you:

• are allergic to follitropin alpha, FSH, or any ingredients of the medication
• are breast-feeding
• are pregnant
• have a lesion in the brain (such as a pituitary or hypothalamus tumour)
• have abnormal uterine bleeding with an unknown cause
• have an unexplained ovarian cyst or enlargement
• have any cause of infertility other than lack of ovulation (unless you are a candidate for assisted reproductive technologies [ART])
• have high levels of FSH
• have sex hormone-dependent tumours (tumours whose growth is stimulated by sex hormones) of the reproductive organs and breasts
• have uncontrolled thyroid or adrenal dysfunction

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.

• bloating (not severe or continuing)
• breast tenderness
• fatigue
• headache
• nausea or diarrhea (not severe or continuing)
• pain, rash, swelling, or irritation at the place of injection
• rash
• vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• signs of a blood clot in the blood vessels (e.g., difficulty breathing, chest pain, pain and swelling in one leg muscle)
• signs of stroke (e.g., sudden trouble with vision, dizziness, sudden severe and unusual headache, weakness, difficulty speaking)
• symptoms of a severe allergic reaction (shortness of breath, swelling of the face or throat, or hives)
• symptoms of ovarian hyperstimulation syndrome (difficulty breathing, abdominal or pelvic pain or discomfort, bloating, nausea, vomiting, diarrhea, decreased amount of urine, rapid 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. 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.

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 and therefore, 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 and therefore, 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.