INDICATIONS
FORTEO is a prescription medicine used to treat postmenopausal women who have osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. FORTEO can lessen the chance of broken bones (fractures) in the spine and other bones in postmenopausal women with osteoporosis. FORTEO is used to increase the bone mass in men with primary or hypogonadal osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. FORTEO is used to treat 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) or who cannot use other osteoporosis treatments.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT FORTEO?
Possible bone cancer. During drug testing, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. Studies in people have not shown that FORTEO increases your chance of getting osteosarcoma. There is little information about the chance of getting osteosarcoma in patients using FORTEO beyond 2 years.
WHO SHOULD NOT TAKE FORTEO?
- Do not use FORTEO if you are allergic to any of the ingredients in FORTEO. Symptoms of a serious allergic reaction to FORTEO may include swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing. Call your healthcare provider right away or get emergency medical help if you get any of these symptoms.
WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE TAKING FORTEO?
- Before you use FORTEO, tell your healthcare provider about all of your medical conditions, including if you:
- have a certain bone disease called Paget’s disease or other bone disease, have bone cancer or have had a history of bone cancer
- are a young adult whose bones are still growing
- have had radiation therapy
- are affected with a condition that runs in your family that can increase your chance of getting cancer in your bones
- have or have had too much calcium in your blood (hypercalcemia)
- have or have had a skin condition with painful sores or wounds caused by too much calcium
- have or have had kidney stones,
- take medicines that contain digoxin,
- are pregnant or plan to become pregnant. It is not known if FORTEO will harm your unborn baby, are breastfeeding or plan to breastfeed. It is not known if FORTEO passes into your breastmilk. You should not breastfeed while taking FORTEO.
- Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF FORTEO?
FORTEO may cause serious side effects, including:
- Bone cancer (osteosarcoma): Tell your healthcare provider right away if you have pain in your bones, pain in any areas of your body that does not go away, or any new or unusual lumps or swelling under your skin that is tender to touch.
- 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.
- Worsening of your kidney stones.If you have or have had kidney stones, your healthcare provider may check the calcium levels in your urine while you use FORTEO to see if there is worsening of this condition.
- Decrease in blood pressure when you change positions. Some people may feel dizzy, get a fast heartbeat, or feel light-headed right after the first few doses of FORTEO. This usually happens within 4 hours of taking FORTEO and goes away within a few hours. For the first few doses, give 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, contact your healthcare provider before you continue using FORTEO.
The most common side effects of FORTEO include: pain, nausea, and joint aches.
These are not all the possible side effects of FORTEO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the Food and Drug Administration (FDA). Visit
www.fda.gov/medwatch
or call 1-800-FDA-1088
ADDITIONAL SAFETY INFORMATION ABOUT 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.
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
).
FORTEO® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Any brands other than FORTEO are trademarks of their respective owners and are not trademarks of Eli Lilly and Company.
