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What is Forteo?

Forteo is a man-made form of the naturally occurring hormone parathyroid. Forteo forms new bone, increases bone mineral density and bone strength, and as a result, reduces the chance of getting a broken bone.

Forteo is used for men and women with osteoporosis who are at high risk for bone fractures.

Forteo may also be used for purposes other than those listed in this medication guide.

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

Do not use Forteo without first talking to your doctor if you:

– Have Paget’s disease of the bone – Have unexplained high levels of alkaline phosphatase in the blood, which may indicate Paget’s disease – Are a child or young adult – Have ever been diagnosed with bone cancer or other cancers that have spread (metastasized) to the bones – Have had radiation therapy involving the bone – Have a bone disease other than osteoporosis or – Have a high level of calcium in the blood (hypercalcemia).

You may not be able to take Forteo, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

– Forteo is in the FDA pregnancy category C. This means that it is not known whether Forteo will be harmful to an unborn baby. Do not use Forteo without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether Forteo passes into breast milk. Do not use Forteo without first talking to your doctor if you are breast-feeding a baby.

How should I use Forteo?

Use Forteo exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Forteo is administered by injection using a prefilled delivery device. Your doctor or other healthcare provider will give you detailed instructions on how to inject the medication.

Forteo is usually injected once a day into the thigh or abdomen (lower stomach area). Follow your doctor’s instructions.

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

It is important to use Forteo regularly to get the most benefit.

Forteo may cause dizziness or fast heartbeats after an injection. Inject the medication in a location where you can sit or lie down following the injection should dizziness or fast heartbeats occur.

Use Forteo shortly after you take the pen out of the refrigerator. Recap the pen and put it back into the refrigerator right after use.

The same pen can be used for up to 28 days after the first injection from the pen. Throw away the pen after 28 days of use, even if it is not completely empty.

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

Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.

Your doctor may want to perform blood or urine tests during treatment to determine your response to Forteo.

Store Forteo pens in the refrigerator at 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius). Do not freeze the medication. Do not use any medication that has been frozen.

What happens if I miss a dose?

Use the missed dose as soon as you remember within the same day. If you do not remember until the next day, skip the missed dose and only use the dose for that day. Do not use a double dose.


What should I avoid while using Forteo?

• There are no restrictions on food, beverages, or activity during treatment with Forteo unless otherwise directed by your doctor.

What are the possible side effects of Forteo?

• Stop using the medication and seek emergency medical attention if you experience a rare allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to Forteo.

• As a part of drug testing, Forteo was given to rats. Some of these rats developed osteosarcoma, a bone cancer. Osteosarcoma in humans is a serious but very rare cancer. It is not known if humans treated with Forteo also have a higher chance of getting osteosarcoma. Discuss with your doctor the risks and benefits associated with use of Forteo.

• Most side effects from Forteo are mild and include dizziness and leg cramps. If you become lightheaded or have fast heartbeats after an injection, sit or lie down until you feel better. If you do not feel better, call your healthcare provider before continuing treatment.

• Contact your healthcare provider if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.

• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Forteo?

• Before using Forteo, tell your doctor if you are taking digoxin (Lanoxin, Lanoxicaps, Digitek). You may require a dosage adjustment or special monitoring during treatment.

• Drugs other than those listed here may also interact with Forteo. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

• Your pharmacist has additional information about Forteo written for health professionals that you may read.

• 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: 1.02. Revision Date: 2/14/03.