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|Teriparatide

Teriparatide

Teriparatide is used for:

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

Teriparatide 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 Teriparatide if:

• you are allergic to any ingredient in Teriparatide
• 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 Teriparatide :

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

• if you are planning to become pregnant
• 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 Teriparatide . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin because the risk of side effects may be increased by Teriparatide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Teriparatide 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 Teriparatide :

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

• Teriparatide comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Teriparatide refilled.
• Teriparatide is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Teriparatide at home, carefully follow the injection procedures taught to you by your health care provider.
• If Teriparatide contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Use the proper technique taught to you by your doctor. Inject under the skin into your thigh or lower stomach area, NOT into muscle.
• Using Teriparatide at the same time each day will help you remember to use it.
• Use Teriparatide regularly to receive the most benefit from it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Teriparatide , 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 Teriparatide .

Important safety information:

• Teriparatide may cause dizziness or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Teriparatide . Using Teriparatide alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Teriparatide may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
• Some patients experience dizziness or a fast heartbeat after the first few doses of Teriparatide . For the first few doses, inject Teriparatide 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, weight-bearing exercise, quitting smoking, and limiting alcohol intake.
• LAB TESTS, including blood calcium levels and uric acid levels, may be performed to monitor your progress or check for side effects. Be sure to keep all doctor and lab appointments.
• Teriparatide is not recommended for use in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Teriparatide if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Teriparatide is excreted in breast milk. Do not breast-feed while taking Teriparatide .

Possible side effects of Teriparatide :

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 cramps; neck pain; pain; rash; runny nose; sleeplessness; sore throat; sweating; vomiting; weakness.

Severe allergic reactions (rash; hives; 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/findyour.htm), or emergency room immediately. Symptoms may include dizziness or weakness especially on standing; headache; nausea; vomiting.

Store Teriparatide 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 Teriparatide out of the reach of children and away from pets.

General information:

• If you have any questions about Teriparatide , please talk with your doctor, pharmacist, or other health care provider.
• This medicine 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 Teriparatide . 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.