Pronunciation:

fol-i-TROE-pin BAY-ta

Brand Names:

• Follistim
• Follistim AQ
• Gonal-f RFF

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Human Follicle Stimulating Hormone Combination

Pharmacologic—

Human Follicle Stimulating Hormone

Uses of This Medicine:

Follitropin beta injection is used to treat infertility in both men and women. This medicine is a man-made hormone called follicle-stimulating hormone (FSH). FSH is produced in the body by the pituitary gland. FSH helps to develop eggs in the ovaries of women and sperm in the testes of men. Follitropin beta replaces natural FSH in the body.

Follitropin beta injection is used as a fertility medicine to develop eggs in women who have not been able to become pregnant because of problems with ovulation. Also, many women wanting to become pregnant will use this medicine while enrolled in a fertility program called Assisted Reproductive Technology (ART). ART uses procedures such as in vitro fertilization (IVF) or embryo transfer (ET). Follitropin beta is used together with human chorionic gonadotropin (hCG) in these procedures.

Follistim® AQ Cartridge is also used in women with healthy ovaries who are undergoing reproductive procedures such as IVF or intracytoplasmic sperm injection (ICSI) cycle. This medicine is used together with human chorionic gonadotropin (hCG) in these procedures.

Follitropin beta is also used as a fertility medicine to help men with low sperm counts produce more sperms. Treatment with human chorionic gonadotropin should come before treatment with follitropin beta.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of follitropin beta injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of follitropin beta injection have not been performed in the geriatric population.

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.

Other 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.

Other interactions—

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal gland problems, uncontrolled or
• Allergy to certain antibiotics (eg, neomycin, streptomycin), or history of or
• Cysts in the ovaries or enlarged ovaries or
• High levels of follicle stimulating hormone (FSH) or
• Pituitary gland problems, uncontrolled or
• Thyroid gland problems, uncontrolled or
• Tumor in the brain (hypothalamus area or pituitary gland) or
• Tumor in the breast or
• Tumor in the ovary or uterus or
• Tumor in the testis or
• Vaginal bleeding of unknown cause, heavy or irregular—Should not be used in patients with these conditions.

• Blood clots (eg, pulmonary embolism, venous thromboembolism), or history of or
• Blood vessel problems or
• Lung or breathing problems or
• Ovary problems, history of or
• Stroke, history of or
• Surgery, history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under the skin (for men and women), usually in the stomach or thigh, or into a muscle (for women only).

Follitropin beta is used with another hormone called human chorionic gonadotropin (hCG). At the proper time, your doctor or nurse will give you this medicine.

This medicine comes with patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in two forms: a cartridge and a vial. Ask your doctor which dosage form is right for you.

You might be taught how to give your medicine at home. If you are using this medicine at home:

• Wash your hands with soap and water and use a clean work area to prepare your injection.
• Make sure you understand and carefully follow your doctor's instructions on how to give yourself an injection, including the proper use of a needle and syringe, or a cartridge and pen.
• Do not mix this medicine with other medicines in the same cartridge, vial, or syringe.
• Check the solution in the cartridge or vial. It should be clear and colorless. If it is cloudy, discolored, or contains large flecks (particles), do not use it.
• Do not inject more or less of the medicine than your doctor ordered.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will prevent skin problems. Do not inject into skin areas that are tender, red, bruised, or hard.
• Use a new needle and syringe each time you inject your medicine.
• It is very important that you keep track of each dose you inject. Your doctor or nurse will help you with this.

If you are using the Follistim® AQ cartridge:

• This medicine should only be used with the Follistim® pen.
• Do not use this medicine if you are blind or have vision problems, unless another person with good vision who is trained in the proper use of the cartridge injects your medicine.
• Do not re-use the BD Micro-Fine™ pen needle.

Dosing—

The dose of this medicine 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 this medicine. 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 (solution):
  • For the treatment of infertility in men:
    • Adults—450 international units (IU) per week injected under the skin, divided and given as either 225 IU two times per week or 150 IU three times per week.
    • Children—Use is not recommended.
  • For the treatment of infertility in women:
    • Adults—
      • Follistim® AQ injection: At first, 75 international units (IU) once a day injected under the skin or into a muscle. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 IU per day.
      • Follistim® AQ cartridge: At first, 50 IU once a day injected under the skin for at least the first 7 days. Your doctor may increase your dose as needed. However, the dose is usually not more than 250 IU per day.
    • Children—Use is not recommended.
  • For use with assisted reproductive technology procedures:
    • Follistim® AQ injection: Adults—150 to 225 international units (IU) once a day injected under the skin or into a muscle. Your doctor may increase your dose as needed. However, the dose is usually not more than 600 IU per day.
    • Children—Use is not recommended.
  • For women with healthy ovaries undergoing reproductive procedures (such as IVF or ICSI):
    • Follistim® AQ cartridge: Adults—At first, 200 international units (IU) once a day injected under the skin for at least the first 7 days of treatment. Your doctor may increase your dose as needed. However, the dose is usually not more than 500 IU per day.
    • Children—Use is not recommended.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

You may store Follistim® AQ cartridge or injection in a refrigerator or at room temperature for 3 months or until expiration date. If the Follistim® AQ cartridge has been pierced by a needle, you may store it up to 28 days. Keep the cartridge away from light.

Throw away used needles and syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Ask your pharmacist, doctor, or nurse about the best way to dispose of any leftover medicine, glass containers (vials), cartridges, and other supplies. You should not use any leftover medicine in the glass container (vial) or cartridge.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits while you are using this medicine, to make sure that the medicine is working properly and to check for unwanted effects. Blood and urine tests, semen testing, and ultrasound examinations are needed to check for any unwanted effects caused by this medicine.

Call your doctor right away if you think you have become pregnant while you are using this medicine. You may have a higher risk of an ectopic pregnancy if you get pregnant while undergoing IVF or ICSI procedures. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

This medicine may increase your risk of having a blood clot, heart attack, or stroke. This is more likely in people who already have heart disease. Contact your doctor right away if you have chest pain or tightness, a fast or irregular heartbeat, unusual flushing or warmth of the skin, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart problems or blood clots.

For women who are using this medicine:

• If your doctor has asked you to record your basal body temperature (BBT) each day, make sure that you understand how to do this. Carefully follow your doctor's instructions.
• This medicine may increase your risk of having a problem with the ovaries called ovarian hyperstimulation syndrome (OHSS), which can be life-threatening. Check with your doctor right away if you have bloating, diarrhea, severe nausea, stomach pain, rapid weight gain, or vomiting.
• This medicine may cause more than one egg to be released from your ovary at the same time. This means you may become pregnant with more than one baby. Talk with your doctor about this possibility before you start using this medicine.
• This medicine may cause serious lung problems (eg, atelectasis or acute respiratory distress syndrome). Check with your doctor right away if you have blue lips, fingernails, or skin, chest tightness, coughing, difficulty or fast breathing, fever, rapid heartbeat, or trouble breathing.
• This medicine may increase your risk of having ovarian cancer if you received it more than one time to get pregnant. Talk to your doctor about this risk.

Side Effects of This Medicine:

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.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloating

diarrhea

severe nausea or vomiting

severe stomach pain

stomach or pelvic discomfort, aching, or heaviness

weight gain that is rapid

Less common

Heavy non-menstrual vaginal bleeding

redness, pain, or swelling at the injection site

unusual tiredness or weakness

Incidence not known

Difficulty with breathing

pain in the chest, groin, or legs, especially the calves

severe, sudden headache

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

trouble breathing

vision changes

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:

More common

Blemishes on the skin

headache

pimples

Less common

Body aches or pain

chills

difficulty having a bowel movement (stool)

dizziness

dry skin

fast or racing heart

fever

hair loss

hives

quick or shallow breathing

rash

swelling of the breasts or breast soreness in both females and males

Incidence not known

Breast tenderness

normal menstrual bleeding occurring earlier, possibly lasting longer than expected

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.