Talking to your loved one

If FORTEO^® (teriparatide [rDNA origin] injection) has been recommended to your loved one, you should discuss the potential of beginning FORTEO treatment. Your loved one may have specific concerns about FORTEO and may look to you for advice.

While it is ultimately your loved one's choice whether or not to begin FORTEO, you can help him or her make an informed health decision by learning the facts about FORTEO, including the potential benefits and risks.

The following are specific concerns that prospective FORTEO patients may have.

"What If I Can't Give Myself the Injections?"

Your loved one may be worried about the daily injections, fearing that he or she won't be able to administer the injections successfully or that they will be painful or unpleasant.

You might offer, if you are in a position to do so, to help with the injections in the beginning. You can also direct him or her to the many resources created to help patients use the FORTEO Delivery Device, including the step-by-step instructional Usage Video on this Web site.

"Should I Be Worried about Side Effects?"

As with any medication, taking FORTEO may cause certain side effects. These side effects include:

nausea.
dizziness or fast heartbeat. Some people get dizzy or get a fast heartbeat 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.
leg cramps.
joint aches.
increased calcium in your blood. Tell your healthcare provider if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
injection site reactions including redness, swelling, pain, itching, a few drops of blood, and bruising. Your healthcare provider may take samples of blood and urine during treatment to check your response to FORTEO. Also, your healthcare provider may ask you to have follow-up tests of bone mineral density. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of FORTEO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

As part of drug testing, teriparatide, the active ingredient in FORTEO, was given to rats for a significant part of their lifetime. In these studies, teriparatide caused some rats to develop osteosarcoma, a bone cancer. Osteosarcoma in humans is a serious but very rare cancer. Osteosarcoma occurs in about 4 out of every million older adults each year. It is not known if humans treated with FORTEO also have a higher chance of getting osteosarcoma. Encourage your loved one to consult his or her doctor for more information.

"How Will I Know if the Treatment Is Working?"

Just as osteoporosis is often a "silent" disease, the treatment of osteoporosis can be "silent" as well. This means that patients may not feel any different after beginning FORTEO treatment. This may lead them to question whether the medication is working to strengthen their bones. They may even get discouraged and want to discontinue their FORTEO injections.

To help your loved one stay on track, you can encourage him or her to learn more about what to reasonably expect from FORTEO. Within clinical studies, FORTEO was shown to:

Increase bone mineral density (BMD) in postmenopausal women with osteoporosis by 11.8% at 18 months
Significantly reduce the risk of fractures in a median of 19 months
Increase BMD in osteoporotic men (mean age of 59) by 6.1% at 12 months

Important Safety Information about FORTEO

WARNING: POTENTIAL RISK OF OSTEOSARCOMA

During the drug testing process, 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 been reported rarely 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.

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

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.

Do not use FORTEO if you are allergic to any of the ingredients in FORTEO. Serious allergic reactions have been reported.

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.

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 such as redness, swelling, pain, itching, a few drops of blood, and bruising. These are not all the possible side effects of FORTEO.

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.

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 (see the User Manual).

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For more information about severe osteoporosis, contact your doctor or health care professional.
FORTEO® and FORTEO.com are trademarks of Eli Lilly and Company.
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