Health Guide
Drug Guide

Follitropin beta (Subcutaneous route)

Pronunciation:

fol-i-TROE-pin BAY-ta

Brand Names:

Dosage Forms:

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 will help develop eggs in women who have not been able to become pregnant because of problems with ovulation. Some women 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 used together with human chorionic gonadotropin (hCG) to increase sperm production in men.

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.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersXStudies 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.

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:

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) 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 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:

If you are using the Follistim® AQ cartridge:

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.

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. If you store the medicine at room temperature, it will only be good for a maximum of 3 months unless the expiration date is less than 3 months. 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 will be needed to make sure that the medicine is working properly.

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, tightness in the chest, 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:

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
Abdominal or stomach pain that is severe
bloating
diarrhea
severe nausea or vomiting
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
sudden, unexplained shortness of breath
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.


Last Updated: 10/12/2016

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