Pronunciation:

fol-i-TROE-pin AL-fa

Brand Names:

• Gonal-F
• Gonal-F RFF
• Gonal-F RFF Redi-ject

Dosage Forms:

• Solution
• Powder for Solution

Classifications:

Therapeutic—

Female Reproductive Agent

Pharmacologic—

Human Follicle Stimulating Hormone

Uses of This Medicine:

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

Follitropin alfa injection 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 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 alfa may be used with other medicines for these purposes.

Follitropin alfa injection 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 alfa. This pretreatment elevates the amount of testosterone to the correct level. Treatment with human chorionic gonadotropin should continue as long as follitropin alfa is being used.

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

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 alfa 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 alfa injection have not been performed in the geriatric population. Safety and efficacy have not been established.

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:

• Abnormal or unusual vaginal bleeding or
• Adrenal gland problems, uncontrolled 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, uterus, or testes—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—Use with caution. May make these conditions worse.

• Primary testicular failure— Follitropin alfa will not work in patients who no longer are able to produce sperms.

• Primary ovarian failure—Follitropin alfa will not work in patients whose ovaries no longer develop eggs.

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.

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

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.
• Check the solution in the vial. It should be clear and colorless. If it is cloudy, discolored, or contains large 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 (eg, stomach, upper arm, or upper leg) 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.
• 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.

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

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 (powder for solution):
  • For treatment of female infertility:
    • Adults—At first, 75 international units (IU) injected under the skin once a day for 14 days. Your doctor will adjust your dose up to 37.5 IU every 7 days. However, the dose is usually not more than 300 IU per day.
    • Children—Use is not recommended.
  • For use with assisted reproductive technology (ART) procedures:
    • Adults—At first, 150 international units (IU) injected under the skin once a day for not more than 10 days beginning on Day 2 or Day 3 of your menstrual cycle. Your doctor will adjust your dose by 75 to 150 IU every 3 to 5 days. However, the dose is usually not more than 450 IU per day. Some patients may start treatment at a dose of 225 IU once a day.
    • Children—Use is not recommended.
  • For treatment of male infertility
    • Adults—150 international units (IU) injected under the skin 3 times a week together with 1000 USP Units of human chorionic gonadotropin (hCG) 3 times a week. Your doctor will adjust your dose if needed. However, dose is not usually more than 300 IU 3 times a week. You may be given this medicine up to 18 months.
    • 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Gonal-F®: Store the unused powder in the refrigerator or at room temperature. Protect from light. You may store the mixed medicine in the refrigerator or at room temperature. Throw away unused mixed medicine after 28 days.

Gonal-F RFF®: Store the unused powder in the refrigerator or at room temperature. Protect from light. Use this medicine right away after mixing. Throw away unused mixed medicine.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits 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.

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. 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 or miscarriage if you get pregnant while undergoing IVF 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.

If your doctor has asked you to record your basal body temperature (BBT) daily, make sure that you know how to do this. Carefully follow your doctor's instructions.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may increase your risk of having problems with the ovaries including twisting or enlargement of the ovaries, or ovarian hyperstimulation syndrome (OHSS). OHSS is a serious problem that can be life-threatening. Call your doctor right away if you have severe pain in the lower stomach area, nausea, vomiting, weight gain, diarrhea, decreased urine output, or trouble breathing.

This medicine may cause serious lung problems (eg, atelectasis, acute respiratory distress syndrome, or asthma). 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 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 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.

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 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

Acid or sour stomach

anxiety

backache

belching

bloating

chest pain or tightness

confusion

cough

diarrhea

difficulty breathing

difficulty in speaking

dizziness or lightheadedness

double vision

excess air or gas in the stomach or intestines

fainting

fast heartbeat

fast, weak pulse

full feeling

headache

heartburn

inability to move the arms, legs, or facial muscles

indigestion

loss of appetite

noisy breathing

passing gas

pelvic pain, discomfort, aching, or heaviness

rapid weight gain

severe nausea

slow speech

stomach discomfort, upset, or pain, or swelling

sudden increase in stomach or shoulder pain

sweating

trouble breathing

unusual or large amount of vaginal bleeding

uterine bleeding between menstrual periods

vomiting

Incidence not known

Difficulty swallowing

dizziness

hives, itching, skin rash

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

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

unusual tiredness or weakness

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

Acne

bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

dandruff

oily skin

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

Less common

Decreased interest in sexual intercourse

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

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.