Forteo

Forteo is a prescription medication used to treat both men and postmenopausal women with osteoporosis who are at high risk for having broken bones. Forteo is a synthetic hormone that is similar to the one the body makes naturally (parathyroid hormone). It works by causing the body to build new bone and increase bone strength by regulating calcium and phosphate.

Forteo comes in an injectable form that is given once daily. It is injected just under the skin of the stomach area or thigh.

Common side effects include nausea, joint aches, and pain.

Forteo is a prescription medication used to treat both men and postmenopausal women with osteoporosis who are at high risk for having broken bones.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Eli Lilly and Company

• Lilly, Eli & Company

Forteo can cause serious side effects including:

• Decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. This usually happens within 4 hours of taking Forteo and goes away within a few hours.
• For the first few doses, take your injections of Forteo in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking Forteo and call your healthcare provider.
• Increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.

Common side effects of Forteo include:

• nausea
• joint aches
• pain

Your healthcare provider may take samples of blood and urine during treatment to check your response to Forteo. Also, your healthcare provider may ask you to have follow-up tests of bone mineral density.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Your healthcare provider needs this information to help keep you from taking Forteo with other medicines that may harm you. Especially tell your doctor if you take medicines that contain digoxin (Digoxin, Lanoxicaps, Lanoxin).

• During the drug testing process, the medicine in Forteo caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has been reported rarely in people who took Forteo. It is not known if people who take Forteo have a higher chance of getting osteosarcoma.
• You should not take Forteo for more than 2 years over your lifetime.
• There is a voluntary Patient Registry for people who take Forteo. The purpose of the registry is to collect information about the possible risk of osteosarcoma in people who take Forteo.

Do not use Forteo if you are allergic to any of the ingredients in Forteo.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Forteo there are no specific foods that you must exclude from your diet when receiving Forteo.

Tell your doctor if you are allergic to any of the ingredients in Forteo.

Before you take Forteo, tell your healthcare provider if you:

• have Paget's disease or other bone disease
• have cancer in your bones
• have trouble injecting yourself and do not have someone who can help you
• are a child or young adult whose bones are still growing
• have or have had kidney stones
• have had radiation therapy
• have or had too much calcium in your blood
• have any other medical conditions
• are pregnant or thinking about becoming pregnant. It is not known if Forteo will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Forteo passes into your breast milk. You and your doctor should decide if you will take Forteo or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Your healthcare provider needs this information to help keep you from taking Forteo with other medicines that may harm you. Especially tell your doctor if you take medicines that contain digoxin (Digoxin, Lanoxicaps, Lanoxin).

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if Forteo is excreted in human breast milk or if it will harm your nursing baby.

• Inject Forteo one time each day in your thigh or abdomen (lower stomach area). Talk to a healthcare provider about how to rotate injection sites.
• Before you try to inject Forteo yourself, a healthcare provider should teach you how to use the Forteo delivery device to give your injection the right way.
• You can take Forteo with or without food or drink.
• The Forteo delivery device has enough medicine for 28 days. It is set to give a 20 microgram dose of medicine each day. Do not inject all the medicine in the Forteo delivery device at any one time.
• Do not transfer the medicine from the Forteo delivery device to a syringe. This can result in taking the wrong dose of Forteo. If you do not have pen needles to use with your Forteo delivery device, talk with your healthcare provider.
• Forteo should look clear and colorless. Do not use Forteo if it has particles in it, or if it is cloudy or colored.
• Inject Forteo right away after you take the delivery device out of the refrigerator.
• After each use, safely remove the needle, recap the delivery device, and put it back in the refrigerator right away.
• You can take Forteo at any time of the day. To help you remember to take Forteo, take it at about the same time each day.
• If you forget or can not take Forteo at your usual time, take it as soon as you can on that day. Do not take more than one injection in the same day.
• If you take more Forteo than prescribed, call your healthcare provider. If you take too much Forteo, you may have nausea, vomiting, weakness or dizziness.
• Follow your healthcare provider's instructions about other ways you can help your osteoporosis, such as exercise, diet, and reducing or stopping your use of tobacco and alcohol. If your healthcare provider recommends calcium and vitamin D supplements, you can take them at the same time you take Forteo.

The recommended Forteo dose is 20 mcg given subcutaneously once a day. Your doctor will determine the best dose for you. Take Forteo exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

If you take too much Forteo, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Forteo is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep your Forteo delivery device in the refrigerator between 36° to 46°F (2° to 8°C).
• Do not freeze the Forteo delivery device. Do not use Forteo if it has been frozen.
• Do not use Forteo after the expiration date printed on the delivery device and packaging.
• Throw away the Forteo delivery device after 28 days even if it has medicine in it (see the User Manual). Keep Forteo and all medicines out of the reach of children.

WARNING: POTENTIAL RISK OF OSTEOSARCOMA