Consumer Drug Information

Forteo

Generic Name: Teriparatide (tare-ree-PAIR-ah-tide)
Brand Name: Forteo

Forteo has been shown to increase the rate of bone tumors in lab animals. It is unknown if there is a higher risk of bone tumors in humans. Forteo should not be used in patients who are at risk for bone tumors, including patients with Paget disease, open epiphyses, prior radiation involving the skeleton, or unexplained high levels of alkaline phosphatase in their blood.

Forteo is used for:

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Treating bone weakening (osteoporosis) in postmenopausal women and men who are at high risk for having fractures, have had fractures, or cannot use other osteoporosis treatments.

Forteo is a man-made (synthetic) form of parathyroid hormone. It works by increasing bone mass and bone strength, which helps decrease your chance of getting a fracture.

Do NOT use Forteo if:

you are allergic to any ingredient in Forteo
you have high levels of alkaline phosphatase, calcium, or parathyroid hormone in your blood
you have deformed bones, softening of the bones (osteomalacia), bone tumors, Paget disease, pseudohypoparathyroidism, or rickets
you have had radiation therapy involving the bones
you have a bone disease other than osteoporosis
you are pregnant or breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Forteo :

Some medical conditions may interact with Forteo . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of kidney stones

Some MEDICINES MAY INTERACT with Forteo . Tell your health care provider if you are taking any other medicines, especially any of the following:

Digoxin because the risk of its side effects may be increased by Forteo

This may not be a complete list of all interactions that may occur. Ask your health care provider if Forteo may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Forteo :

Use Forteo as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Forteo comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Forteo refilled.
Forteo is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Forteo at home, a health care provider will teach you how to use it. Be sure you understand how to use Forteo . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Forteo if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
Using Forteo at the same time each day will help you remember to use it.
Use Forteo on a regular schedule to get the most benefit from it.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Forteo , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Forteo .

Important safety information:

Forteo may cause dizziness or lightheadedness. These effects may be worse if you use it with alcohol or certain medicines. Use Forteo with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Forteo may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
Some patients experience dizziness or a fast heartbeat after the first few doses of Forteo . For the first few doses, inject Forteo where you can sit or lie down right away if you get dizzy or have a fast heartbeat.
Learn about other means of preventing bone loss, including taking regular calcium or vitamin D supplements, doing weight-bearing exercise, quitting smoking, and limiting alcohol intake.
Lab tests, including blood calcium levels and uric acid levels, may be performed while you use Forteo . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Forteo should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Do not use Forteo if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Forteo is found in breast milk. Do not breast-feed while using Forteo .

Possible side effects of Forteo :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; feeling of a whirling motion; headache; increased cough; indigestion; joint pain; leg or back cramps; neck pain; runny nose; sleeplessness; sore throat; sweating; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; constipation; depression; fainting; lack of energy; muscle weakness; persistent nausea or vomiting; pneumonia; pounding in the chest; sluggishness; tooth disorder.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http: / / www.aapcc.org / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately. Symptoms may include dizziness or weakness, especially on standing; headache; nausea; vomiting.

Proper storage of Forteo :

Store Forteo in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Do not use the pen if it has been frozen. Keep Forteo out of the reach of children and away from pets.

General information:

If you have any questions about Forteo , please talk with your doctor, pharmacist, or other health care provider.
Forteo is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Forteo . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: August 6, 2008

Database Edition 08.3.1.002