Teriparatide

Generic Name: teriparatide (TER-i-PAR-a-tide)
Brand Name: Forteo

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


Teriparatide is used for:

Treating bone weakening (osteoporosis) in men and postmenopausal women who are at high risk for having fractures, have had fractures, or cannot use other osteoporosis treatments. It is also used to treat patients with osteoporosis due to prolonged use of glucocorticoid medicines (eg, prednisone).

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), Paget disease, pseudohypoparathyroidism, or rickets
  • you have a history of bone tumors, bone cancer, or other cancers that have spread to your bones
  • you have had radiation therapy involving the bones
  • you have a bone disease other than osteoporosis
  • the patient is a child or young adult whose bones may still be growing
  • you are pregnant or breast-feeding

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

Slideshow: Flashback: FDA Drug Approvals 2013

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 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
  • if you smoke, drink alcohol, or have a history of alcohol abuse or dependence

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 its 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 extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get teriparatide refilled.
  • Teriparatide is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using teriparatide at home, a health care provider will teach you how to use it. Be sure you understand how to use teriparatide. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use teriparatide 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 teriparatide at the same time each day will help you remember to use it.
  • Use teriparatide on a regular schedule to get the most benefit from it.
  • Use of teriparatide for more than 2 years is not recommended.
  • Do not share pen or cartridge devices with another person. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
  • 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 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. These effects may be worse if you use it with alcohol or certain medicines. Use teriparatide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Teriparatide 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 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, doing weight-bearing exercise, quitting smoking, and limiting alcohol intake.
  • Lab tests, including blood calcium levels, uric acid levels, and bone density tests, may be performed while you use teriparatide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Teriparatide 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: Teriparatide may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using teriparatide while you are pregnant. It is not known if teriparatide is found in breast milk. Do not breast-feed while using 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:

Constipation; diarrhea; headache; increased cough; indigestion; joint pain; leg or back cramps; mild dizziness or fast heartbeat; minor bruising, itching, pain, redness, and swelling at the injection site; nausea; runny nose; sore throat; 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; unusual hoarseness); blurred vision; chest pain; depression; fainting; persistent fast heartbeat; persistent trouble sleeping; severe or persistent dizziness or lightheadedness when sitting or standing; severe or persistent nausea, vomiting, constipation, muscle weakness, or tiredness; shortness of breath; sudden, severe headache; tooth problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness or weakness, especially when standing; headache; nausea; vomiting.

Proper storage of teriparatide:

Store teriparatide in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Do not use teriparatide if it has been frozen. Recap the pen after each use. Discard teriparatide after 28 days of use, even if it is not completely empty. 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.
  • Teriparatide 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take teriparatide or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about teriparatide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to teriparatide. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using teriparatide.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Hide
(web4)