Frequently Asked Questions About FORTEO
If you don't see your question here, talk to your healthcare professional to get answers. Or, call our patient support team, FORTEO Connect, at: 1-866-4-FORTEO (1-866-436-7836).
How soon does FORTEO start working?
After you inject FORTEO, you might not notice anything happening. However, in clinical studies, FORTEO increased bone mineral density in the spine at
3 months and continued to increase BMD throughout the treatment period.*†‡ See the description of FORTEO clinical trials below.
||In a clinical study of FORTEO involving 1,637 postmenopausal women with osteoporosis at high risk for fracture (of whom 90% had a spine fracture), 541 women took a daily 20-mcg dose of FORTEO and
544 took a placebo for a median time of 19 months. All women took calcium and vitamin D daily.
||FORTEO was examined in an 18-month clinical study of 428 patients who had been treated with a daily dose of 5 mg or more of oral prednisone for a minimum of 3 months.
30% of patients had fractures in the spine and 43% had prior fractures in other locations. In the study, the 214 patients who took FORTEO had taken a median prednisone dose
of 7.5 mg daily, and the median usage time was 1.5 years. All patients took calcium and vitamin D daily.
||In a clinical study of FORTEO involving 437 men with primary or hypogonadal (low testosterone) osteoporosis, 151 men took a daily 20-mcg dose of FORTEO and 147 took
a placebo for a median time of 10 months. All men took calcium and vitamin D daily.
I am a male patient. Is FORTEO right for me?
In a clinical study*, FORTEO has been shown to increase bone mineral density in men with primary or hypogonadal (low testosterone) osteoporosis who are at high risk of fracture.
If you are a man, talk to your doctor about whether FORTEO therapy is appropriate for your condition. See the description of FORTEO clinical trial below.
||In a clinical study of FORTEO involving 437 men with primary or hypogonadal (low testosterone) osteoporosis, 151 men took a daily 20-mcg dose of
FORTEO and 147 took a placebo for a median time of 10 months. All men took calcium and vitamin D daily.
The effect of FORTEO on fractures has not been studied in men.
I've never had a bone fracture. Is FORTEO right for me?
FORTEO is approved for patients who are at high risk for fracture. 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.
If you have osteoporosis, some factors that can put you at higher risk for osteoporotic fracture include:
Your risk of osteoporotic fracture goes up with age.
History of Fracture
One fracture may put you at risk for future fractures.
This is measured by your T-score. The lower, or more negative your T-score (e.g. -2.5 or lower), the more likely you are to fracture due to osteoporosis.
In the end, only your doctor can decide whether you are "high risk" and if FORTEO is right for you.
Is FORTEO a bisphosphonate?
No. FORTEO is the only anabolic (bone-building) osteoporosis treatment approved by the FDA. FORTEO is not a bisphosphonate.
Can I take FORTEO with other medications?
Tell your healthcare provider about all the medicines you take, including 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 (such as Digoxin, Lanoxicaps, and Lanoxin).
What are the most common side effects of FORTEO?
The most common side effects of FORTEO include nausea, joint aches, pain, leg cramps, and injection site reactions such as swelling, pain, and bruising.
These are not all the possible side effects of FORTEO. For more information, ask your healthcare provider or pharmacist.
Click here to see Full Important Safety Information. You are encouraged to report negative side effects of Prescription drugs to the FDA.
Visit or call 1-800-FDA-1088.
What are some signs that the fracture I had is due to osteoporosis?
If you've recently broken a bone, your healthcare professional is the best person to determine if it was due to osteoporosis. However, you may have broken a bone in your back and not realized it.
Height loss could be one sign of an osteoporotic fracture in your spine. Your doctor can perform tests to determine if you've had a spine fracture. Remember, one osteoporotic
fracture can increase your risk of another fracture.*
*It is not known if FORTEO reduces the risk of fracture in men. Consistent with the FORTEO Prescribing Information, fracture data
in GIO patients is not shown.
How do I take 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. You can take FORTEO with or without food or drink.
See Taking FORTEO for more information.
How often do I need to take FORTEO, and how long does treatment last?
Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). You should not take FORTEO for more than 2 years over your lifetime.
Do I need to inject at the same time every day? What if I forget to take my FORTEO injection?
You should take FORTEO 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.
Once my injection delivery device has been started, how long is it good for?
The FORTEO Delivery Device contains 28 days of medicine. It is set to give a 20-microgram dose of medicine each day. Throw away the FORTEO Delivery Device after 28 days, even if it is not completely empty.
How can I learn to inject myself? Is it difficult?
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.
This site provides a FORTEO Delivery Device User Manual and
a FORTEO Delivery Device Demonstration Video, which show you how to use your FORTEO Delivery Device to
give yourself injections (or how a caregiver can do them for you). Call 1-866-4-FORTEO (1-866-436-7836) if you need help on how to use your delivery device.
How do I know I injected myself correctly?
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. For further assistance, you should consult the User Manual accompanying the delivery device.
You can also call 1-866-4-FORTEO (1-866-436-7836) and/or view the FORTEO Delivery Device Demonstration Video. Use a new needle every time you
inject to be sure your FORTEO Delivery Device will work properly.
I can't do the injections myself. Am I still able to take FORTEO?
Yes. Talk with your healthcare provider about arranging for a caregiver, such as a neighbor or relative who can help you with your injections.
Is the injection painful?
You may experience some pain, swelling, or bruising immediately after your injection, but these effects should go away quickly. If they do not, be sure to contact your healthcare provider.
To learn more about the side effects you may experience, visit Potential Side Effects.
Why do I need to take FORTEO through an injection? Why can't I just take a pill?
FORTEO only works when injected directly into your body. There is no pill form available. Taking a pill would not work, as your stomach would digest the medicine before it has the chance to work.
What if there is medicine left in the delivery device after 28 days?
Do not use it. The medicine in each FORTEO Delivery Device should only be used for 28 days. 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.
FORTEO Delivery Device
I left my FORTEO Delivery Device out of the refrigerator by accident. Is it still safe to use my FORTEO Delivery Device?
If for some reason your delivery device is exposed to temperatures above the recommended
36°F to 46°F (2°C to 8°C) longer than the few minutes it takes to complete giving yourself your injection, do not throw the delivery device away.
Put it back in the refrigerator and call FORTEO Connect at 1-866-4-FORTEO (1-866-436-7836) and they will be able to help you determine if your delivery device is still safe to use.
What do I do if my delivery device is frozen?
Do not use FORTEO if it has been frozen. If the delivery device has been frozen, please phone
How do I store FORTEO?
- Your FORTEO Delivery Device should be placed inside the FORTEO Storage Case and kept inside the refrigerator at temperatures between 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).
What is 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)
Traveling With FORTEO
How do I pass through airport security while traveling with my FORTEO Delivery Device?
Read Traveling With FORTEO on this website. Due to increasing and constantly changing security concerns, you should also consult the Transportation Security Administration (TSA).
For the latest guidance in traveling with medicine and needles, visit the , call the TSA Contact Center toll-free at 1-866-289-9673 or email the TSA at TSA-ContactCenter@dhs.gov.
I have questions about my specific travel plans. Whom do I call?
If you have questions about your specific travel plans, please call 1-800-LillyRx (1-800-545-5979) for more information.
Ongoing Patient Support
FORTEO Connect is more than a support program.
It's an entire team that's dedicated to helping you fight osteoporosis every day.