Teva’s Teriparatide Injection

Important Safety Information

What is the most important information I should know about Teriparatide Injection?

Possible bone cancer. During drug testing, the medicine in Teriparatide Injection caused some rats to develop a bone cancer called osteosarcoma. Studies in people have not shown that Teriparatide Injection increases your chance of getting osteosarcoma. There is little information about the chance of getting osteosarcoma in patients using Teriparatide Injection beyond 2 years.

Who should not use Teriparatide Injection?

Do not use Teriparatide injection if you:

• are allergic to any of the ingredients in Teriparatide Injection. See the end of the Medication Guide for a complete list of the ingredients in Teriparatide Injection.

Symptoms of a serious allergic reaction of Teriparatide Injection 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 using Teriparatide Injection?

Before you use Teriparatide Injection, 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 Teriparatide Injection will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Teriparatide passes into your breastmilk. You should not breastfeed while taking Teriparatide Injection.

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 Teriparatide Injection?

Teriparatide Injection may cause serious side effects including:

• See “What is the most important information I should know about Teriparatide Injection?”
• 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 Teriparatide Injection 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 Teriparatide Injection. This usually happens within 4 hours of taking Teriparatide Injection and goes away within a few hours. For the first few doses, give your injections of Teriparatide Injection 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 Teriparatide Injection.

The most common side effects of Teriparatide Injection include pain, nausea, and joint aches. These are not all the possible side effects of Teriparatide Injection. 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 FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is Teriparatide Injection?

Teriparatide Injection 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. Teriparatide Injection can lessen the chance of broken bones (fractures) in the spine and other bones in postmenopausal women with osteoporosis.
• 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.
• 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.

It is not known if Teriparatide Injection is safe and effective in children. Teriparatide Injection should not be used in children and young adults whose bones are still growing.

Please read the Medication Guide in the full Prescribing Information.