Teriparatide

What is the most important information I should know about teriparatide?

This medication has been found to cause an increased risk of bone cancer in animal studies. It is not known if this risk is also increased in humans treated with teriparatide. Talk with your doctor if your individual risk.

Teriparatide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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

Avoid drinking alcohol, which also may affect your bone mineral density.

What is teriparatide?

Teriparatide is a man-made form of a hormone called parathyroid that exists naturally in the body. Teriparatide increases bone density and increases bone strength to help prevent fractures.

Teriparatide is used to treat osteoporosis in men and women who have a high risk of bone fracture.

Teriparatide may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using teriparatide?

Do not use this medication if you are allergic to teriparatide.

Before using teriparatide, tell your doctor if you are allergic to any drugs, or if you have:

• Paget's disease or other bone disorders (besides osteoporosis);
• high levels of calcium or alkaline phosphatase in your blood;
• a condition called hyperparathyroidism;
• a bone disease other than osteoporosis;
• a history of bone cancer or radiation treatment involving your bones; or
• if you have ever had kidney stones.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use teriparatide.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether teriparatide passes into breast milk. Do not use teriparatide without telling your doctor if you are breast-feeding a baby.

This medication has been found to cause an increased risk of bone cancer in animal studies. It is not known if this risk is also increased in humans treated with teriparatide. Talk with your doctor if your individual risk.

How should I use teriparatide?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Teriparatide is given as an injection under the skin of the thigh or stomach. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Teriparatide can cause you to feel dizzy or light-headed. It may help to sit or lie down for a short time after injecting the medication.

Do not use teriparatide for longer than 2 years unless your doctor tells you to.

Teriparatide is only part of a complete program of treatment that also includes diet, exercise, vitamins or mineral supplements, and changing certain behaviors. Follow your diet and exercise routines very closely.

It is important to use teriparatide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Teriparatide can be injected at any time of the day. It may be easier to remember to use teriparatide if it is used at about the same time each day.

Do not teriparatide that is discolored or cloudy or that has particles in it. It should be clear and colorless. Do not use teriparatide after the expiration date printed on the pen or pen packaging.

Store the teriparatide injection pen in the refrigerator but do not allow it to freeze. Take the pen out of the refrigerator only long enough to use it. After use, recap the pen and put it back into the refrigerator.

Throw away the injection pen after 28 days of use, even if it still has medicine in it.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek medical attention if you think you have used too much of this medicine.

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

What should I avoid while using teriparatide?

Teriparatide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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

Avoid drinking alcohol, which also may affect your bone mineral density.

What are the possible side effects of teriparatide?

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

Stop using teriparatide and call your doctor at once if you have any of these serious side effects:

• feeling light-headed or fainting every time you inject this medicine;
• fast or pounding heartbeats every time you inject this medicine; or
• nausea, vomiting, constipation, and muscle weakness.

Less serious side effects may include:

• mild dizziness;
• pain, redness, bruising, itching, or swelling where the medicine was injected;
• leg cramps;
• joint pain;
• cough, sore throat, runny nose;
• headache or neck pain; or
• nausea, constipation, diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect teriparatide?

Before using teriparatide, tell your doctor if you are taking digoxin (digitalis, Lanoxin, Lanoxicaps). You may need a dose adjustment or special tests to safely use teriparatide.

There may be other drugs not listed that can interact with teriparatide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about teriparatide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 1.06. Revision date: 10/09/2007.