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FOLLISTIM AQ- follitropin injection, solution


  1. Patient Information
  2. Do Not Take Follistim Aq Cartridge If You Are A Woman Or Man Who:
  3. Do Not Take Follistim Aq Cartridge If You Are A Woman Who:
  4. Before You Take Follistim Aq, Tell Your Healthcare Provider If You:
  5. How Should I Use Follistim Aq Cartridge?
  6. What Are The Possible Side Effects Of Follistim Aq Cartridge?
  7. Serious Side Effects In Women Include:
  8. In Women:
  9. How Should I Store Follistim Aq Cartridge?
  10. What Are The Ingredients In Follistim Aq Cartridge?
  11. How Do I Care For The Follistim Pen?

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

17.1 Dosing and Use of Follistim AQ Cartridge with Pen

Instruct women and men on the correct usage and dosing of Follistim AQ Cartridge in conjunction with the Follistim Pen. Make sure that individuals who have used other gonadotropin products delivered by a syringe are aware of differences arising from use of the pen. Women and men should read and follow all instructions in the Follistim Pen "Instructions for Use" Manual prior to administration of Follistim AQ Cartridge.

Advise women and men of the number of doses which can be extracted from the full unused Follistim AQ Cartridge that you have prescribed.

17.2 Therapy Duration and Necessary Monitoring in Women and Men Undergoing Treatment

Prior to beginning therapy with Follistim AQ Cartridge, inform women and men about the time commitment and monitoring procedures necessary to undergo treatment[

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

Do Not Take Follistim Aq Cartridge If You Are A Woman Or Man Who: 

  • is allergic to recombinant human FSH products
  • has a high level of FSH in your blood indicating that your ovaries (women only) or testes (men only) may be permanently damaged and do not work at all
  • has uncontrolled thyroid, pituitary, or adrenal gland problems
  • is allergic to streptomycin or neomycin (types of antibiotics)
  • has a tumor of the hypothalamus, pituitary gland, breast, uterus (women only), ovary (women only), or testis (men only)

Do Not Take Follistim Aq Cartridge If You Are A Woman Who: 

  • is pregnant or think you may be pregnant
  • has heavy or irregular vaginal bleeding and the cause is not known
  • has ovarian cysts or enlarged ovaries, not due to polycystic ovary syndrome (PCOS)

Talk to your healthcare provider before taking this medicine if you have any of the conditions listed above.

Before You Take Follistim Aq, Tell Your Healthcare Provider If You: 

  • have ever had Ovarian Hyperstimulation Syndrome (OHSS).
  • are pregnant or think you may be pregnant. Follistim AQ Cartridge should not be used in pregnant women.
  • 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).
  • have ever had stomach (abdominal) surgery.
  • have ever had twisting of your ovary (ovarian torsion).
  • have or have had a cyst in your ovary.
  • have polycystic ovarian syndrome (PCOS).
  • have any other medical conditions (for example, diabetes, heart disease, or any other long-term disease).
  • 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. You should not do both at the same time.
  • have been told by a doctor that pregnancy would be dangerous for you.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them and show your healthcare provider and pharmacist when you get a new medicine.

How Should I Use Follistim Aq Cartridge? 

  • Be sure that you read, understand, and follow the "Patient Instructions for Use" that come with Follistim AQ Cartridge.
  • Use Follistim AQ Cartridge exactly as your healthcare provider tells you to.
  • Your healthcare provider will tell you how much Follistim AQ Cartridge to use, how to inject it, and how often it should be injected.
  • Do not inject Follistim AQ Cartridge at home until your healthcare provider has taught you the right way to put the cartridge and pen device together and to inject yourself.
  • Do not mix any other medicines into the 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.
  • Use Follistim AQ Cartridge only with the Follistim Pen.
  • Do not use the Follistim Pen if you are blind or visually impaired unless you have assistance from an individual with good vision who is trained in the right way to use the pen.
  • Do not re-use the BD Micro-Fine Pen Needle.
  • Your healthcare provider may do blood hormone tests while you are taking Follistim AQ Cartridge. Make sure you follow-up with your healthcare provider to have your blood tested when told to do so.

Women:

  • Your healthcare provider will do ultrasound scans of your ovaries to monitor how the follicles are growing. 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 taking 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.

Serious Side Effects In Women Include: 

  • Ovarian enlargement. Your ovaries may become very large at the end of your fertility treatment cycle. Therefore, close supervision by your healthcare provider is very important. To check the effects of your fertility treatment, your healthcare provider will take ultrasound scans of your ovaries and may also check blood hormone levels.
  • Ovarian hyperstimulation syndrome (OHSS). OHSS is a serious medical problem that can happen when the ovaries are over stimulated. In rare cases, OHSS may be life-threatening and has caused death. OHSS causes fluid to build up suddenly in your stomach and chest areas and can cause blood clots to form. Call your healthcare provider right away if you have:
    • pain in your lower stomach area.
    • nausea.
    • vomiting.
    • sudden weight gain due to fluid buildup.
    • diarrhea.
    • decreased urine output.
    • trouble breathing.
  • Lung problems. Treatment with gonadotropic hormones like Follistim AQ Cartridge can cause you to have trouble breathing (acute respiratory distress syndrome).
  • Blood clots. Treatment with gonadotropic hormones like Follistim AQ Cartridge may (just as with pregnancy) increase your chance of having blood clots (thrombosis) in your blood vessels. Thrombosis is the formation of a blood clot in a blood vessel. Blood clots can lead to:
    • blockage in your lungs (pulmonary embolus).
    • stroke.
    • heart attack.
    • blood vessel problems (thrombophlebitis).
    • a lack of blood flow (deep venous thrombosis) that may result in a loss of your arm or leg.
  • 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 stomach (abdominal) surgery, past history of a twisting of an ovary, past or current cysts in your ovary or ovaries, or polycystic ovaries. Twisting of the ovary could cause the blood flow to the ovary to be cut off.
  • Pregnancy and birth of multiple babies. There is an increased chance of having twins or more than two babies, even when only one embryo is transferred into the uterus. 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 a birth defect.
  • Ectopic pregnancy (pregnancy outside of the uterus). If treatment with Follistim AQ Cartridge results in pregnancy, there is a higher chance of pregnancy outside the uterus. Therefore, your healthcare provider should perform an early ultrasound examination to exclude the possibility of pregnancy occurring outside of the uterus.
  • Miscarriage. Miscarriages have been reported for all gonadotropin treatments, including Follistim AQ Cartridge. However, it is not known if miscarriages are related to treatment with fertility medicines or the underlying infertility.
  • Ovarian and Other Reproductive System Tumors. There have been reports of ovarian and other reproductive system tumors in women who have had infertility treatment. It is not known if treatment with fertility medicines increases the risk of these tumors in infertile women.

In Women: 

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

In men:

  • headache
  • pain at the injection site
  • bruising, swelling or redness at the injection site
  • breast enlargement
  • acne

These are not all the possible side effects of Follistim AQ Cartridge. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider immediatelyif you get worsening or strong pain in the lower stomach area (abdomen). Also, call your healthcare provider immediately if this happens some days after the last injection has been given.

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

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 Follistim AQ Cartridge in the refrigerator between 2 -8 C (36 -46 F) until the expiration date.
  • Follistim AQ can be stored at or below 25 C (77 F) for 3 months or until the expiration date, whichever comes first. Once the rubber inlay of the Follistim AQ Cartridge has been pierced by a needle, the product may be stored only for a maximum of 28 days at 2 -25 C (36 -77 F).
  • Keep Follistim AQ Cartridge away from light.
  • Do not freeze.

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

General information about Follistim AQ Cartridge

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Follistim AQ 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.

This Patient Information leaflet summarizes the most important information about Follistim AQ Cartridge. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for more information about Follistim AQ Cartridge that is written for healthcare professionals.

For more information, go towww.follistim.comor call 1-866-836-5633.

What Are The Ingredients In Follistim Aq Cartridge? 

Active ingredient: follitropin beta

Inactive ingredients: sucrose, sodium citrate, benzyl alcohol NF-10 mg/mL, L-methionine, polysorbate 20, water for injection, hydrochloric acid, and/or sodium hydroxide.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC.,Whitehouse Station, NJ 08889, USA

Manufactured by: Vetter Pharma-Fertigung GmbH & Co. KG, Ravensburg, Germany

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

For patent information: www.merck.com/product/patent/home.html

Copyright 2004-2019 Merck Sharp & Dohme B.V., a subsidiary ofMerck & Co., Inc.
All rights reserved.

Revised: 09/2019

usppi-mk8328-SOi-1909r014

PATIENT INSTRUCTIONS FOR USE

Follistim (Fol -lis-tim) AQ Cartridge
(follitropin beta injection)

Read the Patient Instructions for Use that comes with FollistimAQ Cartridge before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

A.
Getting Ready
  • Follistim Pen is not recommended for the blind or visually impaired user without the assistance of an individual with good vision, trained in the proper use of the injection device.
  • Learn about all of the parts of the Follistim Pen (

    Check with your healthcare provider or pharmacist for instructions about the right way to throw away used cartridges and needles. There may be special local or state laws about how to throw away used syringes and needles.
    • Do notthrow away used cartridges and needles in the household trash and do not recycle them.
    • Put used and empty cartridges and needles in a closeable, puncture-resistant container. You may use a sharps container (such as a red bio-hazard container), a hard plastic container with a screw-on cap (such as an empty detergent bottle) or in a metal container with a plastic lid, (such as a coffee can).
    • When the container is full, tape around the cap or lid to make sure the cap or lid does not come off.
    • When your injection is given by another person, this person must also be careful when removing the cartridge and needle and disposing of the cartridge and needle to prevent accidental needle stick injury and passing infection.

How Do I Care For The Follistim Pen? 

1.
Clean all exposed surfaces of the Follistim Pen with a clean, damp cloth such as a paper towel. Never wash it in water, detergent or strong medical cleaners.
2.
Handle the Follistim Pen carefully to avoid causing damage. You could damage the Follistim Pen by dropping it or handling it roughly.
3.
Keep the Follistim Pen away from dust and dirt.
4.
Never store the Follistim Pen with a needle attached to it. If you store the Follistim Pen with the needle attached, the drug could leak out and there is risk of contamination.
5.
If the Follistim Pen breaks or is damaged, do not try to fix it yourself. Contact your healthcare provider.
6.
Do not share your Follistim Pen with another person.


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