Brand Name(s):

• Forteo®
• Parathar®

IMPORTANT WARNING

Teriparatide injection causes osteosarcoma (cancer of the bones) in laboratory rats. It is possible that teriparatide injection may also increase the chances that humans will develop this rare but serious cancer. Because of this risk, teriparatide injection should not be used to prevent osteoporosis, to treat mild osteoporosis, or by people who can take other medications for osteoporosis. You should not use teriparatide injection unless you have osteoporosis and at least one of the following conditions is met: you have already had at least one bone fracture; your doctor has determined that you are at high risk of fractures; or you cannot take or do not respond to other medications for osteoporosis. Tell your doctor if you have or have ever had a bone disease such as Paget's disease, bone cancer or a cancer that has spread to the bone, or radiation therapy of the bones. Your doctor will order certain tests to see if teriparatide injection is right for you.

WHY is this medicine prescribed?

Teriparatide injection is used to treat osteoporosis (a condition in which the bones become thin and weak and break easily) in men and in women who have undergone menopause ('change in life,' end of menstrual periods), who are at high risk of fractures (broken bones). This medication is also used to treat osteoporosis in men and women who are taking corticosteroids (a type of medication that may cause osteoporosis in some patients). Teriparatide injection contains a synthetic form of natural human hormone called parathyroid hormone (PTH). It works by causing the body to build new bone and by increasing bone strength and density (thickness).

HOW should this medicine be used?

Teriparatide injection comes as a solution (liquid) to inject subcutaneously (under the skin) in your thigh or lower stomach area. This medication comes in prefilled dosing pens. It is usually injected once a day for up to 2 years. To help you remember to use teriparatide injection, use it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use teriparatide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You can inject teriparatide injection yourself or have a friend or relative perform the injections. Before you use teriparatide injection yourself the first time, read the User Manual that comes with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it. The User Manual includes solutions to problems you may have when you try to use teriparatide injection. Be sure to ask your pharmacist or doctor if you have any questions about how to inject this medication.

Teriparatide injection comes in a pen that contains enough medication for 28 doses. Do not transfer the medication to a syringe. Use a new needle for each injection. Needles are sold separately. Ask your doctor or pharmacist if you have questions about the type of needles to use. Dispose of used needles in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Teriparatide injection controls osteoporosis but does not cure it. Continue to use teriparatide injection even if you feel well. Do not stop using teriparatide injection without talking to your doctor.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using teriparatide injection,

• tell your doctor and pharmacist if you are allergic to teriparatide, mannitol, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain anticoagulants ('blood thinners') such as heparin; digoxin (Digitek, Lanoxin); hydrochlorothiazide (HCTZ, HydroDIURIL, Microzide); certain medications for seizures such as phenytoin; certain steroids such as prednisone; certain vitamins such as vitamins A and D. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• in addition to the conditions listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had any condition that causes you to have too much calcium in your blood, such as disease of the parathyroid gland; kidney or urinary tract stones; and liver, kidney, or heart disease.
• you should know that teriparatide injection should only be used by women once they have passed menopause and, therefore, cannot become pregnant or breast-feed. Teriparatide injection should not be used during pregnancy or while breast-feeding.
• you should know that teriparatide injection may cause fast heartbeat, dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using teriparatide injection. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. Be sure a chair is nearby when you inject teriparatide injection so you can sit down if you get dizzy.
• talk to your doctor about other things you can do to prevent osteoporosis from worsening. Your doctor will probably tell you to avoid smoking and drinking large amounts of alcohol and to follow a regular program of weight-bearing exercise.

What SPECIAL DIETARY instructions should I follow?

You should eat and drink plenty of foods and drinks that are rich in calcium and vitamin D while you are using teriparatide injection. Your doctor will tell you which foods and drinks are good sources of these nutrients and how many servings you need each day. If you find it difficult to eat enough of these foods, tell your doctor. In that case, your doctor may prescribe or recommend a supplement.

What should I do IF I FORGET to take a dose?

Use the missed dose as soon as you remember it that day. However, if the day has already passed, skip the missed dose and continue your regular dosing schedule. Never inject more than one dose per day.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the pen it came in with the cap on and without a needle attached, tightly closed, and out of reach of children. Store it in the refrigerator but do not freeze it. Protect it from light. Throw away any medication that is outdated or no longer needed. Throw away the pen after 28 days of use, even if it is not empty. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• nausea
• vomiting
• dizziness
• headache
• lightheadedness and fainting on standing
• constipation
• lack of energy
• muscle weakness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to teriparatide injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using teriparatide injection.

Do not let anyone else use your medication. Never share a teriparatide injection pen. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: August 1, 2009.