Patient information: uses, side effects, how to take - Follistim AQ

What is FOLLISTIM AQ Cartridge?

FOLLISTIM AQ Cartridge is a prescription medicine that contains follicle-stimulating hormone (FSH). The medicine is taken with the FOLLISTIM Pen.

FOLLISTIM AQ Cartridge is used:

In women:

to help healthy ovaries to develop (mature) and release eggs
as part of Assisted Reproductive Treatment programs that use special techniques (skills) to help women get pregnant by causing their ovaries to produce more mature eggs

In men:

to help produce and develop mature sperm

FOLLISTIM AQ Cartridge is not for use in children.

Do not use FOLLISTIM AQ Cartridge if you are a woman or man who:

is allergic to recombinant human FSH products or any of the ingredients in FOLLISTIM AQ Cartridge. See the end of this leaflet for a complete list of ingredients in FOLLISTIM AQ Cartridge.
has a high level of FSH in your blood that show your ovaries (women only) or testes (men only) may be permanently damaged and do not work at all.
has uncontrolled thyroid, adrenal, or pituitary problems.
is allergic to streptomycin or neomycin which are antibiotics that may be found in small amounts in FOLLISTIM AQ Cartridge.
has a tumor in your sex organs (uterus, ovaries, breasts, testes).
has a tumor in your brain (hypothalamus), or in your pituitary gland.

Do not use FOLLISTIM AQ Cartridge if you are a woman that:

is pregnant or thinks they may be pregnant.
has abnormal bleeding from your uterus or vagina from an unknown cause.
has or have had ovarian cysts or large ovaries from an unknown cause.

Before using FOLLISTIM AQ Cartridge, tell your healthcare provider about all of your medical conditions, including if you:

have an increased risk of blood clots (thrombosis).
have ever had a blood clot (thrombosis), or anyone in your immediate family has ever had a blood clot (thrombosis).
had stomach (abdominal) surgery.
had twisting of your ovary (ovarian torsion).
have polycystic ovary disease.
are pregnant or think you may be pregnant. Your healthcare provider will give you a pregnancy test before you start using FOLLISTIM AQ Cartridge. FOLLISTIM AQ Cartridge is not for pregnant women.
are breastfeeding or plan to breastfeed. It is not known if the medicine in FOLLISTIM AQ Cartridge passes into your breast milk. You and your healthcare provider should decide if you will take FOLLISTIM AQ Cartridge or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use FOLLISTIM AQ Cartridge?

Read the Instructions for Use that comes with FOLLISTIM AQ Cartridge about the right way to use FOLLISTIM AQ Cartridge.
Use FOLLISTIM AQ Cartridge exactly as your healthcare provider tells you to.
FOLLISTIM AQ Cartridge is injected subcutaneously (beneath the skin) only.
Your healthcare provider will tell you how much FOLLISTIM AQ Cartridge to use, how to inject it, and how often it should be injected.
Use FOLLISTIM AQ Cartridge only with the FOLLISTIM Pen.
FOLLISTIM Pen is not recommended for use if you are blind or visually impaired without the help of a person trained to use the pen.
Do not inject FOLLISTIM AQ Cartridge at home until your healthcare provider has taught you the right way to put the FOLLISTIM AQ Cartridge and FOLLISTIM Pen device together and to inject yourself.
Do not add any other medicines into the FOLLISTIM AQ Cartridge.
Do not change your dose of FOLLISTIM AQ Cartridge unless your healthcare provider tells you to.
Call your healthcare provider immediately if you use too much FOLLISTIM AQ Cartridge.
If you miss or forget to take a dose, do not double your next dose. Ask your healthcare provider for instructions.
Do not re-use the Pen Needle.
Your healthcare provider will do blood and urine hormone tests while you are using FOLLISTIM AQ Cartridge. Make sure you follow-up with your healthcare provider to have your blood and urine tested when told to do so.

Women:

Your healthcare provider may do ultrasound scans of your ovaries. Make sure you follow-up with your healthcare provider to have your ultrasound scans.

Men:

Your healthcare provider may test your semen while you are using FOLLISTIM AQ Cartridge. Make sure you follow-up with your healthcare provider to give a semen sample for testing.

What are the possible side effects of FOLLISTIM AQ Cartridge?

FOLLISTIM AQ Cartridge may cause serious side effects in women, including:

Ovarian enlargement. FOLLISTIM AQ may cause your ovaries to be abnormally large. Symptoms of large ovaries include bloating or pain in your lower stomach (pelvic) area.
Ovarian hyperstimulation syndrome (OHSS). OHSS is a serious side effect that can happen when the ovaries produce too many eggs (overstimulated). In rare cases it has caused death. OHSS causes fluid to build up suddenly in your stomach and chest areas and can cause blood clots to form. OHSS may also happen after you stop using FOLLISTIM AQ Cartridge. Stop using FOLLISTIM AQ Cartridge and call your healthcare provider right away if you have symptoms of OHSS, including:

severe lower stomach (pelvic) area pain
nausea
vomiting
weight gain
stomach (abdomen) pain

bloating
diarrhea
trouble breathing
decreased urine output

Lung problems. FOLLISTIM AQ Cartridge may cause you to have fluid in your lungs (atelectasis) and trouble breathing (acute respiratory distress syndrome).
Blood clots. FOLLISTIM AQ Cartridge may increase your chance of having blood clots in your blood vessels. Blood clots can cause:
- blood vessel problems (thrombophlebitis)
- stroke
- loss of your arm or leg
- blood clot in your lungs (pulmonary embolus)
- heart attack
Ovarian torsion. FOLLISTIM AQ Cartridge may increase the chance of twisting of the ovaries in women with certain conditions such as OHSS, pregnancy and previous abdominal surgery. Twisting of the ovary could cause the blood flow to the ovary to be cut off.
Pregnancy and birth of multiple babies. Having a pregnancy with more than one baby at a time increases the health risk for you and your babies. Discuss your chances of multiple births with your healthcare provider.
Birth defects. A woman’s age, certain sperm problems, genetic background of both parents and a pregnancy with multiple babies can increase the chance that your baby might have birth defects.
Ectopic pregnancy (pregnancy outside of the womb). The chance of a pregnancy outside of the womb is increased in women with damaged fallopian tubes.
Miscarriage. The chance of loss of an early pregnancy may be increased in women who have difficulty with becoming pregnant at all.
Tumors of the ovary. There have been infrequent reports of ovarian tumors in women who have had multiple ovarian stimulation treatments, however there is no confirmed direct link with FOLLISTIM AQ Cartridge.

The most common side effects of FOLLISTIM AQ Cartridge include:

In women:

cyst (closed sac) in the ovary
stomach discomfort or pain
discomfort or pain in the lower stomach (pelvic) area
headache
nausea
feeling tired

In men:

headache
acne
pain at the injection site
bruising, swelling or redness at the injection site
breast enlargement
rash
testicular dermoid cyst (closed sac under the skin)

Tell your healthcare provider if you have any side effects that bothers you or that does not go away.

These are not all the possible side effects of FOLLISTIM AQ Cartridge. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store FOLLISTIM AQ Cartridge?

Store unused FOLLISTIM AQ Cartridge in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date, or at room temperature up to 77°F (25°C) for 3 months or until the expiration date, whichever comes first.
After first use store FOLLISTIM AQ Cartridge either in the refrigerator or at room temperature between 36°F to 77°F (2°C to 25°C) and throw away (discard) after 28 days.
Keep FOLLISTIM AQ Cartridge in the original carton to protect from light.
Do not freeze.

Keep FOLLISTIM AQ Cartridge and all medicines out of the reach of children.

General information about the safe and effective use of FOLLISTIM AQ Cartridge.

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use FOLLISTIM AQ Cartridge for a condition for which it was not prescribed. Do not give FOLLISTIM AQ Cartridge to other people, even if they have the same condition that you have. It may harm them. You can ask your pharmacist or healthcare provider for more information about FOLLISTIM AQ Cartridge that is written for healthcare professionals.

What are the ingredients in FOLLISTIM AQ Cartridge?

Active ingredient: follitropin beta

Inactive ingredients: benzyl alcohol, methionine, polysorbate 20, sodium citrate, sucrose, Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH.

Manufactured by: Organon USA LLC, a subsidiary of

ORGANON & Co.,

Jersey City, NJ 07302, USA

U.S. License No. 2331

BD, BD Logo and BD Micro-Fine are trademarks of Becton, Dickinson and Company.

For patent information: www.organon.com/our-solutions/patent/

For more information, go to www.follistim.com or call 1-844-674-3200.

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Follistim AQ (Follitropin): Uses, Side Effects and Dosage