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follitropin beta (Subcutaneous route)

fol-i-TROE-pin BAY-ta

Commonly used brand name(s):

In the U.S.

Follistim
Follistim AQ
Gonal-f RFF

Available Dosage Forms:

Kit
Solution
Powder for Solution

Therapeutic Class: Human Follicle Stimulating Hormone Combination

Pharmacologic Class: Human Follicle Stimulating Hormone

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Uses For follitropin beta

Follitropin beta is a hormone identical to follicle-stimulating hormone (FSH) produced by the pituitary gland. FSH helps to develop eggs in the ovaries.

Follitropin beta is used as a fertility medicine to develop eggs in women who have not been able to become pregnant because of problems in ovulation. Also, many women wanting to become pregnant will use follitropin beta while enrolled in a fertility program that uses procedures such as in vitro fertilization (IVF) or embryo transfer (ET). Follitropin beta may be used with other medicines for these purposes.

Some patients may be treated with another hormone called gonadotropin-releasing hormone agonist (GnRHa) before starting treatment with follitropin beta. GnRHa reduces the amount of FSH released from the pituitary gland. This is done so that the doctor can replace their FSH by using follitropin beta in the proper amounts each day to achieve fertility.

Follitropin beta is available only with your doctor's prescription.

Before Using follitropin beta

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For follitropin beta, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to follitropin beta or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of follitropin beta

To make using follitropin beta as safe and reliable as possible, you should understand how and when to use follitropin beta and what effects may be expected. A paper with information for the patient will be given to you with your filled prescription, and will provide many details concerning the use of follitropin beta. Read this paper carefully and ask your health care professional for any additional information or explanation.

Sometimes follitropin beta can be given by injection at home. If you are using follitropin beta at home:

Understand and use the proper method of safely preparing the medicine if you are going to prepare your own medicine.
Wash your hands with soap and water and use a good, clean work area to prepare your injection.
Make sure you clearly understand and carefully follow your doctor's instructions on how to give yourself an injection, including using the proper needle and syringe.
Do not inject more or less of the medicine than your doctor ordered.
Remember to move the site of injection to different areas to prevent skin problems from developing.
Throw away needles, syringes, bottles, and unused medicine after the injection in a safe manner.

Tell your doctor when you use your last dose of follitropin beta. Follitropin beta often requires that another hormone called human chorionic gonadotropin (hCG) be given as a single dose the day after the last dose of follitropin beta is given. Your doctor will give you follitropin beta or arrange for you to get follitropin beta at the right time.

Dosing

The dose of follitropin beta will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of follitropin beta. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form:
- For treatment of female infertility:
  - Adults—75 international units (IU) injected under the skin or into a muscle once a day for up to fourteen days. The dose may be increased at weekly intervals by 37.5 IU, up to a total dose of 300 IU a day. Tell your doctor when you receive your last dose of follitropin beta. If abdominal pain occurs with the use of follitropin beta, report it to your doctor immediately, discontinue treatment, do not receive the dose of hCG, and avoid sexual intercourse.
- For use with assisted reproductive technology (ART) procedures:
  - Adults—150 international units (IU) injected under the skin or into a muscle once a day for four days beginning on Day 2 or Day 3 of your menstrual cycle. Then your dose may be increased by 75 to 150 IU up to a total daily dose of 600 IU. Some patients may start at 375 IU. Tell your doctor when you receive your last dose of follitropin beta.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using follitropin beta

It is very important that your doctor check your progress often at regular visits, such as every other day, to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will probably want to follow the developing eggs inside the ovaries by doing an ultrasound examination and measuring hormones in your blood stream. After you no longer receive follitropin beta, your progress still must be checked every other day for at least 2 weeks.

If your doctor has asked you to record your basal body temperature (BBT) daily, make sure that you do this every day. Using a BBT record or some other method, your doctor will help you decide when you are most fertile and when ovulation occurs. It is important that sexual intercourse take place around the time when you are most fertile to give you the best chance of becoming pregnant. Follow your doctor's directions carefully.

If abdominal pain occurs with use of follitropin beta, discontinue treatment and report the problem to your doctor immediately. Do not receive the injection of hCG and avoid sexual intercourse.

follitropin beta may cause some people to become dizzy. If this side effect occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert while you are using follitropin beta and for 24 hours after you stop using it.

follitropin beta Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

There is a rare chance that serious lung and blood problems can occur with use of follitropin beta. Discuss these possible effects with your doctor.

Stop taking follitropin beta and get emergency help immediately if any of the following effects occur:

Abdominal pain (severe), nausea, vomiting, and weight gain (rapid)

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

Less commonFor patients treated for female infertility or patients pretreated with a gonadotropin-releasing hormone agonist (GnRHa) undergoing assisted reproduction technologies (ART)

Abdominal pain

For patients pretreated with a GnRHa undergoing ART

Redness, pain, or swelling at injection site

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Body aches or pain
breast tenderness
chills
difficulty in breathing
dizziness
dry skin
fast, racing heart
fever
hair loss
headache
hives
nausea
quick, shallow breathing
skin rash
unusual tiredness

After you stop using follitropin beta, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Abdominal pain (severe), nausea, vomiting, and weight gain (rapid)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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