Teriparatide (rDNA origin) Injection

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).

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.

<p></p> <p></p> <p></p> <p>Teriparatide injection may cause side effects. Tell your doctor if any of these symptoms or those listed in the SPECIAL PRECAUTIONS section are severe or do not go away:

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pain</li>
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weakness</li>
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heartburn or sour stomach</li>
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leg cramps</li>
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dizziness</li>
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depression</li>
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redness, pain, swelling, bruising, a few drops of blood or itching at the injection site</li>
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back spasms</li></ul></p> <p></p> <p>Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

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chest pain</li>
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fainting</li>
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difficulty breathing</li>
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nausea</li>
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vomiting</li>
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constipation</li>
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lack of energy</li>
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muscle weakness</li></ul>Teriparatide injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at <a href='http://www.fda.gov/Safety/MedWatch'>http://www.fda.gov/Safety/MedWatch</a>] or by phone [1-800-332-1088].</p>

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 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.

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:

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nausea</li>
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vomiting</li>
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dizziness</li>
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headache</li>
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lightheadedness and fainting on standing</li>
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constipation</li>
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lack of energy</li>
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muscle weakness</li></ul>