Indications

Teriparatide Injection is a prescription medicine used in both men and postmenopausal women with osteoporosis who are at high risk for having bone fractures—defined as those who have had a fracture related to osteoporosis, who are at high risk for fracture, or who cannot use other osteoporosis treatments. It is also used for treating osteoporosis associated with glucocorticoid medicines, such as prednisone, in patients who are at high risk for fracture.

Important Safety Information

WARNING: Potential Risk of Osteosarcoma

During drug testing, Teriparatide Injection caused some rats to develop a serious, but rare, bone cancer called osteosarcoma. It is not known if people who take Teriparatide Injection are at a higher risk of contracting osteosarcoma. Before taking, advise your healthcare provider if you have Paget’s disease of bone, are a child or young adult whose bones are still growing, or have undergone radiation therapy.

Do not use Teriparatide Injection if you are allergic to any of its ingredients. Serious allergic reactions may occur.

Before taking Teriparatide Injection, inform your healthcare provider if you have a bone disease other than osteoporosis, have cancer in your bones, have trouble injecting yourself, are a child or young adult whose bones are still growing, have or have had kidney stones, have had radiation therapy, have been diagnosed with too much calcium in your blood, are pregnant or thinking about becoming pregnant, are breastfeeding or plan to breastfeed, or have any other medical conditions. Tell your healthcare provider about all the medicines you take, especially medicines that contain digoxin.

Teriparatide can cause serious side effects, including a decrease in blood pressure upon changing positions. Dizziness, accelerated heartbeat, or a feeling of faintness may occur, usually within four hours of taking Teriparatide Injection, and typically subside within a few hours. You should not use Teriparatide Injection for more than two years during your lifetime.

Other side effects include nausea, vomiting, constipation, low energy, joint aches, pain, leg cramps, or muscle weakness, which may be signs of too much calcium in your blood.

Injection site reactions can include pain, swelling and bruising.

If symptoms persist, stop taking Teriparatide Injection and call your healthcare provider.

Visit www.fda.gov/medwatch or call 1.800.FDA.1088 to report any additional negative side effects to the FDA.

For additional safety information, please see the Medication Guide and Prescribing Information, including the full User Manual which accompanies the delivery device.