- 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 http://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 http://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 degrees F to 46 degrees F (2 degrees C to 8 degrees 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 (http://pi.lilly.com/us/forteo-medguide.pdf) and Prescribing Information, including Boxed Warning (http://pi.lilly.com/us/forteo-pi.pdf). Please see full user manual that accompanies the delivery device.
TE Con ISI 07Mar2011
This press release contains certain forward-looking statements about the collaboration between Synthes and Lilly and about Forteo for the treatment of osteoporosis in patients who are at high risk for a fracture. It reflects Synthes' and Lilly's current beliefs. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that the product will be commercially successful. There is also no guarantee that the collaboration will be successful. For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
The securities of Synthes have been offered and sold outside the United States and have not been and will not be registered under the U.S. Securities Act of 1933, as amended ("Securities Act"). Such securities may not be offered, sold or transferred in the U.S. or to U.S. Persons (as defined in the regulations of the Securities Act), except pursuant to a registration statement filed under the Securities Act or under an applicable exemption under the Securities Act. Hedging transactions involving such securities may not be conducted unless in compliance with the Securities Act. The Synthes securities are deemed "Restricted Securities" as that term is defined in Rule 144 under the Securities Act.
FORTEO(R) and FORSTEO(R) are registered trademarks of Eli Lilly and Company.
P--LLY
(Logo: http://photos.prnewswire.com/prnh/200312... )
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(1) FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 2, Section 1.1. Accessed on April 21, 2011.
(2) FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 2, Section 1.2. Accessed on April 21, 2011.
(3) FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 2, Section 1.3. Accessed on April 21, 2011.
(4) FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 2, Sections 2.1, 2.2, 2.3. Accessed on April 21, 2011.
(5) FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 3, Section 3. Accessed on April 21, 2011.
(6) FORTEO PI. Available at http://pi.lilly.com/us/forteo-pi.pdf. Page 3, Section 5.1. Accessed on April 21, 2011.
CONTACT: Gilgian Eisner, Synthes, Inc., +41-32-720-47-45,eisner.gilgian@synthes.com; Tammy Hull, Eli Lilly and Company,+1-317-651-9116, hullta@lilly.com