When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to teriparatide.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• This medicine comes in a special pre-filled pen. Be sure you understand how to use the pen to give yourself a shot.
• Give yourself the shot in your thigh muscle or in your lower stomach area. Be sure to put the cap back on the pen after giving yourself a shot. Put the pen back in the refrigerator right after you are done giving yourself the shot.
• You can use this medicine at any time of the day, however using it at the same time each day may help you remember to take your shot.
• When you first start using this medicine, give yourself a shot while you are in an area where it is easy for you to sit or lay down right away if you become dizzy.
• Do not use this medicine if it looks cloudy, colored, or if it has specks in it. The medicine inside the pen should be clear and colorless.
• Do not use a pen for more than 28 days (4 weeks) after it has been opened, even if there is still some medicine in it.
• You should not use this medicine for longer than 2 years. It is only part of a complete plan for treating osteoporosis. Ask your doctor about other things you can do to help yourself. This may include taking vitamin or mineral supplements, getting regular exercise, and not smoking.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using digoxin (Lanoxin®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have heart disease, liver disease, kidney disease, kidney stones, or if you are on dialysis.
• Make sure your doctor knows if you have hypercalcemia (high levels of calcium in your blood), or if you have a disease that may cause you to have hypercalcemia, such as hyperparathyroidism (overactive parathyroid gland).
• When this medicine was tested in rats, some of the rats developed bone cancer. It is not known if the same thing could happen in people. Your risk of bone cancer may be higher if you have Paget's disease or another bone disease, or if you are still growing. Your risk may also be higher if you have ever had bone cancer, or if you have had external beam or implant radiation treatment on your bones. Make sure your doctor knows if you have ever had any of these bone conditions or treatments.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• You are more likely to get dizzy, lightheaded, or have a pounding heartbeat when you first start using this medicine. Sit or lie down if this happens. Call your doctor if these side effects do not go away, or get worse.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, fast heartbeat.
• Leg cramps, joint pain, or muscle spasms.
• Lightheadedness or fainting.
• Nausea, vomiting, or constipation.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea or upset stomach.
• Headache or neck pain.
• Redness, pain, swelling, itching, bruising, or bleeding where the shot was given.
• Runny or stuffy nose, cough.
• Skin rash.
• Sweating.
• Trouble sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088