Gonal-F RFF Redi-ject (Subcutaneous)

Follitropin alfa is a hormone that is the same as follicle-stimulating hormone (FSH) made by the pituitary gland. FSH helps develop eggs in the ovaries.

Follitropin alfa injection is used as a fertility medicine to help develop eggs in women who have difficulty becoming pregnant due to ovulation problems. Additionally, many women trying to get pregnant will use this medicine while participating in a fertility program called assisted reproductive technology (ART). ART includes procedures such as in vitro fertilization (IVF) or embryo transfer (ET). Follitropin alfa may be used along with other medicines for these purposes.

Follitropin alfa injection is also used as a fertility medicine to assist men with low sperm counts in producing more sperm. Treatment with human chorionic gonadotropin should be done before starting follitropin alfa. This pretreatment raises the testosterone level to the correct amount. Treatment with human chorionic gonadotropin should continue while follitropin alfa is being used.

Some patients may receive another hormone called gonadotropin-releasing hormone agonist (GnRHa) before beginning treatment with follitropin alfa. GnRHa lowers the amount of FSH released from the pituitary gland. This allows the doctor to replace the FSH with the right amount of follitropin alfa each day to achieve fertility.

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

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

If you are a woman who can get pregnant, your doctor may do tests to ensure you are not pregnant before starting treatment. Call your doctor right away if you think you might be pregnant while 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 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 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 (e.g., atelectasis, acute respiratory distress syndrome, or asthma). Check with your doctor right away if you have blue lips, fingernails, or skin, coughing, difficulty or fast breathing, fever, rapid heartbeat, tightness in the chest, 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, sudden difficulty 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 receive it more than once to get pregnant. Talk to your doctor about this risk.

In deciding to use a medicine, you and your doctor will need to think about the risks and benefits of the medicine. For this medicine, consider the following:

Allergies

Inform your doctor if you have had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the use of follitropin alfa injection in children. Safety and effectiveness have not been established.

Geriatric

There have not been appropriate studies on how age affects the use of follitropin alfa injection in older adults. Safety and effectiveness have not been established.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might happen. In such cases, your doctor may need to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used during meals or around certain foods due to possible interactions. Using alcohol or tobacco with certain medicines can also lead to interactions. Discuss with your healthcare professional how your medicine interacts with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works for you. Be sure to tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Uncontrolled adrenal gland problems or
• Cysts in the ovaries or enlarged ovaries or
• High levels of follicle stimulating hormone (FSH) or
• Uncontrolled pituitary gland problems or
• Uncontrolled thyroid gland problems or
• Tumor in the brain (hypothalamus area or pituitary gland) or
• Tumor in the breast or
• Tumor in the ovary or uterus—Should not be used in patients with these conditions.

• Blood clots (for example, pulmonary embolism, venous thromboembolism), or history of or
• Blood vessel problems or
• Lung or breathing problems or
• History of ovary problems or
• History of stroke—Use with caution. May worsen these conditions.

• Primary testicular failure—Follitropin alfa will not work in patients who can no longer produce sperm.

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

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

In the U.S.

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

Available Dosage Forms:

• Solution
• Powder for Solution

Therapeutic Class: Female Reproductive Agent

Pharmacologic Class: Human Follicle Stimulating Hormone

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. 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 to 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.