Forteo is a man-made form of parathyroid hormone that exists naturally in the body. Teriparatide increases bone mineral density and bone strength, which may prevent fractures.

Forteo is used to treat osteoporosis caused by menopause, steroid use, or gonadal failure.

Forteo is for use when you have a high risk of bone fracture due to osteoporosis.

Forteo has caused bone cancer (osteosarcoma) in animals but it is not known whether this would occur in people using this medicine. Talk with your doctor about your own risk.

Tell your doctor if you have conditions such as Paget's disease, high blood levels of calcium or alkaline phosphatase, or a history of bone cancer or radiation treatment involving your bones.

Avoid smoking cigarettes or drinking alcohol. Smoking or heavy drinking can reduce your bone mineral density, making fractures more likely.

Use Forteo exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Forteo is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Forteo is usually given once per day at the same time each day.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare the Forteo injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject Forteo. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Use only the injection pen provided with Forteo. Do not transfer the medicine to a syringe or other injection device or you could get an overdose.

Teriparatide can cause you to feel dizzy or light-headed. Always give your injection at a time and place where you can sit or lie down for a short time afterward.

Each prefilled injection pen contains enough teriparatide for 28 separate injections. Throw the pen away after 28 injections, even if there is still medicine left inside.

Forteo may be only part of a complete treatment program that also includes diet, exercise, taking vitamin or mineral supplements, and changing certain behaviors. Follow your doctor's instructions very closely.

Store the Forteo injection pen in a refrigerator when not in use. Take the pen out of the refrigerator only long enough to use it. After use, remove the needle, recap the pen, and return it to the refrigerator.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Do not freeze Forteo, and throw away the medicine if it has become frozen.

Your doctor will determine how long to treat you with this medicine. Forteo is sometimes given for only 2 years.

Usual Adult Dose for Osteoporosis:

20 mcg subcutaneously once a day into the thigh or abdominal wall
-Duration of Therapy: Lifetime use greater than 2 years should only be considered if fracture risk remains high

Comments:
-This drug is indicated for men and women as described below who are at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.
-High fracture is defined as history of osteoporotic fracture or multiple risk factors for fracture.
-Supplemental calcium and vitamin D should be taken if daily dietary intake is inadequate.

Uses:
-For the treatment of postmenopausal women with osteoporosis
-To increase bone mass in men with primary or hypogonadal osteoporosis
-For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid (equivalent to prednisone 5 mg/day or greater)

You should not use Forteo if you are allergic to teriparatide.

Forteo is not for use in children or young adults whose bones are still growing.

To make sure Forteo is safe for you, tell your doctor if you have ever had:

• Paget's disease or a bone disease other than osteoporosis;

• bone cancer or radiation treatment;

• a genetic condition that increases your risk of bone cancer;

• overactive parathyroid glands;

• high blood levels of calcium;

• a painful skin condition caused by too much calcium;

• kidney failure;

• a kidney stone; or

• an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis.

It is not known whether teriparatide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether teriparatide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Forteo.

Use the missed dose on the same day you remember it. Use your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, dizziness, headache, feeling light-headed, or fainting.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

Get emergency medical help if you have signs of an allergic reaction to Forteo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• bone pain;

• new or unusual swelling or lumps under your skin;

• a light-headed feeling, like you might pass out (may occur within 4 hours after injection);

• pounding heartbeats or fluttering in your chest after using an injection; or

• high calcium levels - confusion, muscle weakness, nausea, vomiting, lack of energy, constipation, increased thirst or urination, weight loss.

Common Forteo side effects may include:

• nausea;

• joint pain; or

• pain anywhere in your body.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• digoxin, digitalis.

• warfarin (Coumadin, Jantoven); or

• a steroid medicine (such as hydrocortisone, prednisone, methylprednisolone, and others).

This list is not complete. Other drugs may interact with teriparatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.