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FORTEO- teriparatide injection, solution


  1. Patient Information
  2. What Is Forteo?
  3. Do Not Use Forteo If You:
  4. Have The Condition Listed In The Section Who Should Not Use Forteo?
  5. How Should I Use Forteo?
  6. Forteo Can Cause Serious Side Effects Including:
  7. What Is Osteoporosis?
  8. The Following Risk Factors Increase Your Chance Of Getting Fractures From Osteoporosis:
  9. After Each Use, Refrigerate The Forteo Delivery Device Right Away. Read And Follow The Instructions In The Medication Guide Sectionhow Should I Store Forteo?
  10. Revised: 10/2019document Id:

Patient Information 

  1. Possible bone cancer.During drug testing, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has rarely been reported in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma.
  2. You should not take FORTEO for more than 2 years over your lifetime.
  3. There is a voluntary Patient Registry for people who take FORTEO.The purpose of the registry is to collect information about the possible risk of osteosarcoma in people who take FORTEO. For information about how to sign up for this patient registry, call 1-866-382-6813 or go to www.forteoregistry.rti.org.

What Is Forteo? 

  • FORTEO is a prescription medicine that is like a hormone made by the body called parathyroid hormone or PTH. FORTEO may help to form new bone, increase bone mineral density and bone strength.
  • FORTEO can lessen the number of fractures of the spine and other bones in postmenopausal women with osteoporosis.
  • The effect on fractures has not been studied in men.
  • FORTEO is used in both men and postmenopausal women with osteoporosis who are at high risk for having fractures. FORTEO can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who can not use other osteoporosis treatments.
  • FORTEO is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures). These include men and women with either a history of broken bones, who have several risk factors for fracture, or who can not use other osteoporosis treatments.

It is not known if FORTEO is safe and effective in children.

FORTEO should not be used in children and young adults whose bones are still growing.

Do Not Use Forteo If You: 

  • are allergic to any of the ingredients in FORTEO.

Have The Condition Listed In The Section Who Should Not Use Forteo? 

  • have Paget's disease or other bone disease
  • have cancer in your bones
  • have trouble injecting yourself and do not have someone who can help you
  • are a child or young adult whose bones are still growing
  • have or have had kidney stones
  • have had radiation therapy
  • have or had too much calcium in your blood
  • have any other medical conditions
  • are pregnant or thinking about becoming pregnant. It is not known if FORTEO will harm your unborn baby.
  • are breast-feeding or plan to breast-feed. You should not breast-feed while taking FORTEO.
  • Tell your healthcare provider about all the medicines you takeincluding prescription and non-prescription medicines, vitamins, and herbal supplements. Your healthcare provider needs this information to help keep you from taking FORTEO with other medicines that may harm you.

    • Especially tell your doctor if you take medicines that contain digoxin (Digoxin, Lanoxicaps, Lanoxin).

    How Should I Use Forteo? 

    • Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). Talk to a healthcare provider about how to rotate injection sites.
    • Before you try to inject FORTEO yourself, a healthcare provider should teach you how to use the FORTEO delivery device to give your injection the right way.
    • Read the detailed User Manual at the end of this Medication Guide.
    • You can take FORTEO with or without food or drink.
    • The FORTEO delivery device has enough medicine for 28 days. It is set to give a 20 microgram dose of medicine each day. Do not inject all the medicine in the FORTEO delivery device at any one time.
    • Do not transfer the medicine from the FORTEO delivery device to a syringe. This can result in taking the wrong dose of FORTEO. If you do not have pen needles to use with your FORTEO delivery device, talk with your healthcare provider.
    • FORTEO should look clear and colorless. Do not use FORTEO if it has particles in it, or if it is cloudy or colored.
    • Inject FORTEO right away after you take the delivery device out of the refrigerator.
    • After each use, safely remove the needle, recap the delivery device, and put it back in the refrigerator right away.
    • You can take FORTEO at any time of the day. To help you remember to take FORTEO, take it at about the same time each day.
    • If you forget or cannot take FORTEO at your usual time, take it as soon as you can on that day. Do not take more than one injection in the same day.
    • If you take more FORTEO than prescribed, call your healthcare provider. If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness.

    Follow your healthcare provider's instructions about other ways you can help your osteoporosis, such as exercise, diet, and reducing or stopping your use of tobacco and alcohol. If your healthcare provider recommends calcium and vitamin D supplements, you can take them at the same time you take FORTEO.

    Forteo Can Cause Serious Side Effects Including: 

      • Keep your FORTEO delivery device in the refrigerator between 36 to 46 F (2 to 8 C).
      • Do not freeze the FORTEO delivery device. Do not use FORTEO if it has been frozen.
      • Do not use FORTEO after the expiration date printed on the delivery device and packaging.
      • Throw away the FORTEO delivery device after 28 days even if it has medicine in it (

        Active ingredient: teriparatide

        Inactive ingredients: glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4.

    What Is Osteoporosis? 

    Osteoporosis is a disease in which the bones become thin and weak, increasing the chance of having a broken bone. Osteoporosis usually causes no symptoms until a fracture happens. The most common fractures are in the spine (backbone). They can shorten height, even without causing pain. Over time, the spine can become curved or deformed and the body bent over. Fractures from osteoporosis can also happen in almost any bone in the body, for example, the wrist, rib, or hip. Once you have had a fracture, the chance for more fractures greatly increases.

    The Following Risk Factors Increase Your Chance Of Getting Fractures From Osteoporosis: 

    • past broken bones from osteoporosis
    • very low bone mineral density (BMD)
    • frequent falls
    • limited movement, such as using a wheelchair
    • medical conditions likely to cause bone loss, such as some kinds of arthritis
    • taking steroid medicines called glucocorticoids, such as prednisone
    • other medicines that may cause bone loss, for example: seizure medicines (such as phenytoin), blood thinners (such as heparin), and high doses of vitamin A

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    *The brands listed are trademarks of their respective owners and are not trademarks of Eli Lilly and Company.

    Medication Guide revised: October 3, 2019

    Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA

    Copyright 2002, 2019, Eli Lilly and Company. All rights reserved.

    FOR-0001-MG-20191003

    FORTEO(for-TAY-o)
    teriparatide injection

    User Manual

    Important: First read the Medication Guide that comes inside your FORTEO carton.

    Before you use your new FORTEO delivery device, please read the entire front and back of this User Manual completely. Follow the directions carefully when using the FORTEO delivery device.

    Do not share your delivery device or needles because infection or disease can be spread from one person to another.

    The FORTEO delivery device contains 28 days of medicine. Throw away the FORTEO delivery device after 28 days, even if it is not completely empty. Do not inject more than one dose of FORTEO in the same day.

    Do not transfer FORTEO to a syringe.

    Figure

    Wash your hands before every injection. Prepare the injection site as your healthcare provider instructed.

    1
    Pull off white cap
    Figure Check the FORTEO delivery device label to make sure you have the right medicine and that it has not expired.

    Do not use if the FORTEO delivery device looks damaged, if the medicine in the cartridge is not clear and colorless, or if it has particles in it.
    2
    Attach new
    needle
    Figure Figure Figure Figure
    Pull off paper
    tab.
    Push needlestraight
    onto medicine cartridge.
    Screw on needle clockwise
    until firmly attached.
    Pull off large needle cover andsave it.
    3
    Set
    dose
    Figure Figure Figure
    Pullout black injection
    buttonuntil it stops.

    If you cannot pull out the
    black injection button

    Figure

    Figure

    To reset the FORTEO delivery device, follow the steps below.
    1. If you have already injected, DO NOT inject yourself a second time on the same day.
    2. Remove the needle.
    3. Attach a new needle, pull off the large needle cover and save it.
    4. Pull out the black injection button until it stops. Check to make sure the red stripe shows.
    5. Pull off the small needle protector and throw away.
    6. Point the needle down into an empty container. Push in the black injection button until it stops. Hold it in andslowly count to five.You may

    Figure

    The black injection button should be all the way in to show that the full dose of medicine has been injected from the FORTEO delivery device.
    Use a new needle every time you inject to be sure your FORTEO delivery device will work properly.

    C.I

    Figure

    Change to a new FORTEO delivery device to take your dose as instructed by your healthcare provider.

    When the black injection button becomes hard to pull out, this means there is not enough medicine in your FORTEO delivery device for another dose. You may still see some medicine left in the cartridge.
    Cleaning and Storage
    Cleaning Your FORTEO Delivery Device
    • Wipe the outside of the FORTEO delivery device with a damp cloth.
    • Do not place the FORTEO delivery device in water, or wash or clean it with any liquid.

    Storing Your FORTEO Delivery Device

    After Each Use, Refrigerate The Forteo Delivery Device Right Away. Read And Follow The Instructions In The Medication Guide Sectionhow Should I Store Forteo? 

    .
  • Do not store the FORTEO delivery device with a needle attached. Doing this may cause air bubbles to form in the medicine cartridge.
  • Store the FORTEO delivery device with the white cap on.
  • Do not freeze FORTEO. If the FORTEO delivery device has been frozen, throw the device away and use a new FORTEO delivery device.
  • If the FORTEO delivery device has been left out of the refrigerator, do not throw the delivery device away. Place the delivery device back in the refrigerator and call Eli Lilly and Company at 1-866-4FORTEO (1-866-436-7836).
  • Other Important Notes
    • The FORTEO delivery device contains 28 days of medicine.
    • Do not transfer FORTEO to a syringe. This may result in you taking the wrong dose of medicine.
    • Read and follow the instructions in the User Manual so that you use your FORTEO delivery device the right way.
    • Check the FORTEO delivery device label to make sure you have the right medicine and that it has not expired.
    • Do not use the FORTEO delivery device if it looks damaged. Look at the FORTEO medicine in the cartridge. If the medicine is not clear and colorless, or if it has particles, do not use it. Call Eli Lilly and Company if you notice any of these (seeContact Information).
    • Use a new needle for each injection.
    • During injection, you may hear one or more clicks this is normal.
    • The FORTEO delivery device is not recommended for use by the blind or by those who have vision problems without help from a person trained in the proper use of the device.
    • Keep your FORTEO delivery device and needles out of the reach of children.
    Disposal of Pen Needles and Delivery Device
    Disposal of Pen Needles and the FORTEO Delivery Device
    • Before throwing away the FORTEO delivery device, be sure to remove the pen needle.
    • Throw away your FORTEO delivery device and used needles as instructed by your healthcare provider, local or state laws, or institutional policies.
    Dispose of the FORTEO delivery device 28 days after first use.1stuse date ______ / ______ / ______

    Throw away after ______ / ______ / ______

    Contact Information

    If you have questions or need help with your FORTEO delivery device, contact Eli Lilly and Company at 1-866-4FORTEO (1-866-436-7836) or your healthcare provider.

    For more information about FORTEO, go to www.FORTEO.com


    Marketed by: Lilly USA, LLC
    Indianapolis, IN 46285, USA


    FORTEO is a registered trademark of Eli Lilly and Company.
    Registered trademarks owned by Eli Lilly and Company; used under license.

    Copyright 2008, 2019, Eli Lilly and Company. All rights reserved.

    Figure

    Literature revised October 3, 2019

    FOR-0002-IFU-20191003

    PACKAGE LABEL FORTEO 20 mcg per dose, 2.4 mL

    Do NOT transfer contents to a syringe

    NDC 0002-8400-01

    ATTENTION PHARMACIST: Medication Guide and device User Manual for patient inside carton

    MS8400

    FORTEO

    teriparatide injection

    20 mcg per dose

    Each prefilled pen will deliver 28 subcutaneous doses, 20 mcg per dose

    600 mcg / 2.4 mL

    REFRIGERATE / DO NOT FREEZE

    For subcutaneous use / Rx only

    Needles not included

    600 mcg / 2.4 mL

    Becton, Dickinson and Company pen needles are recommended for use with this device

    www.forteo.com

    Lilly

    PACKAGE LABEL     FORTEO 20 mcg per dose, 2.4 mL
    FORTEO
    teriparatide injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0002-8400
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Teriparatide(UNII: 10T9CSU89I) (Teriparatide - UNII:10T9CSU89I)Teriparatide250 ug in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    acetic acid(UNII: Q40Q9N063P)0.41 mg in 1 mL
    sodium acetate anhydrous(UNII: NVG71ZZ7P0)0.1 mg in 1 mL
    mannitol(UNII: 3OWL53L36A)45.4 mg in 1 mL
    Metacresol(UNII: GGO4Y809LO)3.0 mg in 1 mL
    water(UNII: 059QF0KO0R)
    hydrochloric acid(UNII: QTT17582CB)
    sodium hydroxide(UNII: 55X04QC32I)
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0002-8400-011 in 1 CARTON10/01/2008
    12.4 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:0002-8400-991 in 1 CARTON10/01/200801/31/2021
    22.4 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02131811/26/2002
    Labeler -Eli Lilly and Company (006421325)

    Revised: 10/2019document Id: 

    3e33d86c-fffd-4d49-81fc-34bd323c5d77Set id: aae667c5-381f-4f92-93df-2ed6158d07b0Version: 28Effective Time: 20191003Eli Lilly and Company



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