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Taking Your Daily Dose of FORTEO

FORTEO is injected in the thigh or abdomen, with the easy-to-use FORTEO Delivery Device. FORTEO must be injected. You cannot take FORTEO as a pill because your stomach would digest the medicine before it has a chance to work.

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. You should also review the FORTEO Delivery Device User Manual and Demonstration Video.

The FORTEO Delivery Device

The FORTEO Delivery Device is easy to use.

FORTEO Delivery Device

The needle is significantly smaller than a typical flu shot needle.

FORTEO Delivery Device Needle

The FORTEO Delivery Device

Watch this video to see, step-by-step, how to prepare and use your delivery device to administer FORTEO and help build new bone. To view this entire video, "Getting Started on FORTEO," click here.

How to 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.
  • 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.
  • Do not freeze the FORTEO Delivery Device. Do not use FORTEO if it has been frozen.
  • 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.
  • 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 (see the User Manual).
  • For information on disposal of your sharps (needles and delivery devices), please see the sharps disposal brochure or call 1-800-LillyRx (1-800-545-5979).

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.

If you've been prescribed FORTEO, it's important to remember that FORTEO Connect offers you a personal support specialist to help teach you how to inject yourself with FORTEO. You can also talk to your doctor about having a caregiver, such as a relative or neighbor, go through training with you to help with the injection.

The FORTEO Connect program was created to be there with you every step of the way. This complimentary service provides insurance specialists, treatment guidance, and one-on-one support for 24 months.

You should not take FORTEO for more than 2 years over your lifetime.

Ongoing Patient Support

FORTEO Connect can set you up with an injection training nurse to teach you how to give yourself FORTEO.

Learn More

How to Store Your FORTEO Delivery Device

  • Your FORTEO Delivery Device should be placed inside the FORTEO Storage Case and kept inside the refrigerator.
  • The temperature should be 36°F to 46°F (2°C to 8°C).
  • Do not freeze the delivery device, and don't use FORTEO if it has been frozen.
  • After each use, safely remove the needle and recap the delivery device to protect it from physical damage and light.
  • If the delivery device has been left out of the refrigerator for more than a few minutes or stored incorrectly, please call 1-866-4-FORTEO (1-866-436-7836).

The FORTEO Storage Case

Your FORTEO Storage Case keeps everything you need organized in one convenient place in your refrigerator. Your case includes:

  • A place for your FORTEO Delivery Device.
  • Tabs to track the total number of delivery devices you'll use during your entire course of treatment (up to a maximum of 24 months over your lifetime) with FORTEO—so you know where you stand in your treatment progress.
  • Sunday through Saturday slots to organize needles for the upcoming week (the same way a weekly pillbox works).
  • Storage for your needles (located behind the tabs).

Are You Caring for Someone on FORTEO?

Help empower your patient or loved one with your care and support. It'll help them along their journey. If they have concerns about injections, watch the FORTEO Delivery Device Demonstration Video and get support from FORTEO Connect. FORTEO Connect was created to be there with patients every step of the way.

Indications for FORTEO:

  • FORTEO is used in both men and postmenopausal women with osteoporosis who are at high risk for having broken bones or fractures.
  • 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 or 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 cannot use other osteoporosis treatments.

FORTEO is a prescription medicine given as a 20-microgram once-daily dose available in a 2.4-mL delivery device for subcutaneous injection over 28 days.

Important Safety Information About FORTEO

What is the most important information I should know about FORTEO?

WARNING: POTENTIAL RISK OF OSTEOSARCOMA

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. Before you take FORTEO, you should tell your healthcare provider if you have Paget's disease of bone, are a child or young adult whose bones are still growing, or have had radiation therapy.

Who should not take FORTEO?

  • You should not take FORTEO for more than 2 years over your lifetime.
  • Do not use FORTEO if you are allergic to any of the ingredients in FORTEO. Serious allergic reactions have been reported.

What should I tell my healthcare provider before taking FORTEO?

  • Before you take FORTEO, you should tell your healthcare provider if you have a bone disease other than osteoporosis, have cancer in your bones, have trouble injecting yourself and do not have someone who can help you, have or have had kidney stones, have or have had too much calcium in your blood, take medications that contain digoxin (Digoxin, Lanoxicaps, Lanoxin), or have any other medical conditions.
  • You should also tell your healthcare provider, before you take FORTEO, if you are pregnant or thinking about becoming pregnant. It is not known if FORTEO will harm your unborn baby. If you are breastfeeding or plan to breastfeed, it is not known if FORTEO passes into your breast milk. You and your healthcare provider should decide if you will take FORTEO or breastfeed. You should not do both.

What are the possible side effects of FORTEO?

  • FORTEO can cause serious side effects including a decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. This usually happens within 4 hours of taking FORTEO and goes away within a few hours. For the first few doses, take your injections of FORTEO in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking FORTEO and call your healthcare provider. FORTEO may also cause increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
  • Common side effects of FORTEO include nausea, joint aches, pain, leg cramps, and injection site reactions including injection site pain, swelling and bruising. These are not all the possible side effects of FORTEO. You are encouraged to report negative side effects of Prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Additional safety information about FORTEO

  • 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.org.
  • The FORTEO Delivery Device has enough medicine for 28 days. It is set to give a 20-microgram dose of medicine each day. 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. Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). 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 take more FORTEO than prescribed, call your healthcare provider. If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness.

How should I store FORTEO?

  • Keep your FORTEO Delivery Device in the refrigerator between 36°F to 46°F (2°C 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 (see the User Manual).

For more safety information, please see Medication Guide and Full Prescribing Information, including Boxed Warning regarding osteosarcoma.

See Full Delivery Device User Manual that accompanies the Delivery Device.

TE Con ISI 09Sep2013