Follitropin beta belongs to the class of medications called gonadotropins. Follitropin beta contains a hormone similar to the human hormone called follicle stimulating hormone (FSH). Follitropin beta is used as a fertility medication in both women and men.

In women, it is used when FSH levels are low or as part of assisted reproductive technology (ART) procedures such as in-vitro fertilization. Follitropin beta causes eggs to become mature and ready for release by the ovary. In men, follitropin beta helps increase sperm production.

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 being given 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 dose of this medication varies according to the treatment and individual response.

To help induce ovulation, the recommended initial dose of follitropin beta is 50 IU given daily, usually for 7 to 14 days. The dose may be adjusted according to response, which is measured by an ultrasound or by a blood test. When an adequate response is achieved, this medication is stopped and another medication, human chorionic gonadotropin (hCG), is given to induce ovulation.

For ART procedures, the usual initial dose is 150 IU to 225 IU daily for 4 days. The dose is then adjusted according to response and is usually continued for 6 to 12 days. When an adequate response is achieved, this medication is stopped and another medication, hCG, is given to induce ovulation.

In men, the usual dose is 150 IU given 3 times a week or 225 IU twice a week. Treatment is usually given for at least 3 to 4 months. It is usually given along with another medication, hCG. Response to this medication for men is determined by analysis of semen after 4 to 6 months of treatment.

The injections can be given under the skin (subcutaneous) or into a muscle (intramuscular) in women and under the skin (subcutaneous) in men. The best place for subcutaneous injections is around the navel or the upper thigh. The place of injection should be varied for each injection. The best place for intramuscular injections is the upper outer part of the buttock muscle.

A health care professional will show you how to use this medication properly. Read the enclosed patient information carefully and ask your doctor any question you might 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 very important to use this medication on a regular schedule as prescribed by the doctor. If you miss a dose of this medication, check with your health care professional. Do not administer a double dose to make up for a missed dose.

Store this medication in the refrigerator at 2°C to 8°C (do not freeze). It can also be stored at room temperature (below 25°C) for a maximum of 3 months. Protect it from light, and keep it out of the reach of children. Once the cartridges have been punctured by a needle, store for a maximum of 28 days.

Solution for injection in cartridges

Solution for injection in cartridges contain 833 IU/mL. Cartridges contain a minimum of 400 IU FSH activity in 0.48 mL aqueous solution, which is sufficient for a net deliverable dose of 300 IU; a minimum of 700 IU FSH activity in 0.84 mL aqueous solution, which is sufficient for a net deliverable dose of 600 IU; or a minimum of 1,025 IU FSH activity in 1.23 mL, which is sufficient for a net dose of 900 IU. Nonmedicinal ingredients: benzyl alcohol, L-methionine, polysorbate 20, sodium citrate, and sucrose. Hydrochloric acid 0.1 N and sodium hydroxide 0.1 N (trace amounts for pH adjustment to pH 7.0). May contain traces of streptomycin and neomycin.

The net deliverable dose of 300 IU, 600 IU, and 900 IU are based upon a maximum of six 50 IU injections, six 100 IU injections and nine 100 IU injections respectively. When more injections are given the net total dose may be lowered, because each injection has to be preceded by an air shot.

This medication should not be used by women who:

• are allergic to follitropin beta or any ingredients of the medication
• are pregnant or breast-feeding
• have conditions where pregnancy cannot or should not occur (e.g., malformation of sexual organs or fibroid tumours of the uterus)
• have heavy or irregular vaginal bleeding of unknown cause
• have high levels of the hormone FSH in the blood
• have ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOD)
• have tumours of the ovary, breast, uterus, hypothalamus, or pituitary gland
• have uncontrolled thyroid or adrenal dysfunction

This medication should not be used by men who:

• are allergic to follitropin beta or any ingredients of the medication
• have tumours of the testicles, pituitary gland, or hypothalamus
• have primary testicular failure

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.

• aches and pains
• acne
• breast development (in men)
• breast tenderness
• chills
• constipation
• diarrhea
• dry skin
• fatigue
• flu-like symptoms (e.g., fever, chills, muscle aches, joint pain, headache, fatigue)
• general feeling of being unwell)
• hair loss
• headache
• itchiness
• nausea
• pain, redness, or irritation at the place of injection (temporary)
• rash
• skin redness
• 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:

• abdominal pain or bloating
• feeling faint
• hardening at the injection site
• pelvic pain
• redness, pain, or swelling at injection site (continued)
• signs of a blood clot in blood vessels, such as sudden vision change or dizziness, chest pain, pain and swelling in one leg muscle
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
• testicular cyst
• vaginal bleeding

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

• symptoms of a severe allergic reaction (shortness of breath, swelling of the face or throat, or hives)
• symptoms of ovarian hyperstimulation syndrome (OHSS; abdominal or pelvic discomfort or pain, nausea, vomiting, weight gain, difficulty breathing, diarrhea, decreased urination, 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 risk of blood clots, especially if you are already at risk of blood clots. Risk factors for blood clots include being severely overweight and having a personal or family history of blood clots. However, pregnancy itself can also increase the risk of a blood clot.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

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

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

Ovarian enlargement: Some people using this medication may experience ovarian enlargement associated with abdominal bloating or pain. In most cases, the pain and bloating 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 people may experience difficulty breathing, diarrhea, and decreased urination. OHSS can progress rapidly and may become serious. It can occur even after treatment has stopped. If you experience any of these symptoms, contact your doctor immediately.

Ovarian torsion: Ovarian torsion or twisting of an ovary is a serious potential complication of treatment with follitropin beta and other similar medications. This condition can cause permanent damage to the ovary if it is not treated promptly. If you experience symptoms such as severe pelvic pain, nausea, vomiting, fever and abnormal bleeding, seek immediate medical attention.

Pregnancy: This medication should not be used by pregnant people. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication should not be used by anyone who is breast-feeding.

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

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

There may be an interaction between follitropin beta and any of the following:

• clomiphene

If you are taking any of these medications, speak with your doctor or pharmacist. 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.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications 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.