Traveling with FORTEO

FORTEO Travel Bag

Instructions

You can use your FORTEO Travel Bag for up to 10 hours when you need an easy and safe way to transport your delivery device. The insulated travel bag is designed for occasional use only. It is not intended for use on a frequent basis, such as for daily travel or daily storage.

Preparing gel packs for travel.

Place 2 gel packs in freezer. Freeze until solid.

Traveling with your FORTEO Delivery Device

Unzip travel bag.
Remove gel packs from freezer and insert into front and back gel pack compartments.
Remove storage case from refrigerator.
Insert into delivery device compartment. Secure delivery device compartment cover.
Zip travel bag closed.

Returning from travel

Remove gel packs from travel bag and put back into freezer.
Remove storage case from travel bag and store in refrigerator. DO NOT store delivery device in the freezer.

If instructions are followed, the FORTEO Travel Bag and 2 frozen gel packs will protect the medication in your delivery device when exposed to room temperature conditions (up to 86°F) for up to 10 hours. If your travel plans require that the delivery device remain out of the refrigerator for longer than 10 hours, please contact FORTEO Connect at 1-866-4-FORTEO (1-866-436-7836) to receive specific instructions for extended travel with your medication.

If you are not able to freeze the gel packs, refrigerated gel packs will provide 3 hours of safe storage temperature in the travel bag.

Important reminders

Your delivery device should be stored in a refrigerator between 36° to 46°F (2° to 8°C).
Your FORTEO Travel Bag is intended for occasional use only. The time that the delivery device is out of the refrigerator should be minimized.
Do not store the travel bag itself in the freezer or refrigerator. It is best to pack your travel bag immediately prior to leaving.
Keep your travel bag with you while traveling. Do not pack the travel bag containing your delivery device in checked baggage when flying. Do not store the travel bag in a car trunk when driving.
Extremely hot temperatures or using ice packs other than those originally provided with your travel bag may shorten the amount of time your medication will be protected.

FORTEO and Airplane Travel

Given the safety regulations at many airports, you may be concerned about traveling by plane with your FORTEO supplies. But you don't need to worry–it is your right to bring medically-necessary supplies on board. Just follow the steps below:

Before you travel, make sure you have a copy of your FORTEO prescription label tucked in your Travel Bag. You may be asked for this label by a Transportation Security Officer, to verify that the FORTEO pen/delivery device and needles belong to you.
Be sure your needles are sealed and not attached to your FORTEO pen/delivery device; rather, store them in a separate compartment in your Travel Bag. (Airlines may not allow you to bring unsealed needles onto a plane.)
Obtain a letter signed by your doctor, explaining why you need to bring FORTEO with you on board. You can download the letter here and have your doctor sign it.
Do not check your FORTEO Travel Bag with the rest of your checked luggage; instead, you should bring it as a carry-on. Also, keep your Travel Bag separate from the rest of your carry-on luggage as you pass through airport security, as you do not want it to go through the X-ray machine (see #6 for more information).
When you reach the security checkpoint, be sure to tell the Transportation Security Officers that you are carrying medication that you need to bring on board with you. They may request supporting documentation, such as the copy of your prescription label or the letter signed by your doctor.
Be sure to request that that the security officers inspect your Travel Bag by hand rather than with an X-ray. X-rays can damage your FORTEO pen/delivery device and make it less effective. (You may want to contact your airline ahead of time, to find out if they will allow visual inspection of your FORTEO pen/delivery device.) At the security checkpoint, let the Transportation Security Officers know right away that you are requesting a visual inspection rather than an X-ray.

If you follow these steps, you should not experience any problems bringing your FORTEO medication on board. If you have further questions about airplane travel and FORTEO, visit the Transportation Security Administration's Web site at www.tsa.gov.

Airplane Travel with FORTEO: Physician Letter

Important Safety Information about FORTEO

WARNING: POTENTIAL RISK OF OSTEOSARCOMA

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. Before you take FORTEO, you should tell your healthcare provider if you have Paget's disease of bone, are a child or young adult whose bones are still growing, or have had radiation therapy.

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. For information about how to sign up for this patient registry, call 1-866-382-6813 or go to www.forteoregistry.rti.org.

Do not use FORTEO if you are allergic to any of the ingredients in FORTEO. Serious allergic reactions have been reported.

Before you take FORTEO, you should tell your healthcare provider if you have a bone disease other than osteoporosis, have cancer in your bones, have trouble injecting yourself and do not have someone who can help you, have or have had kidney stones, have or have had too much calcium in your blood, take medications that contain digoxin (Digoxin, Lanoxicaps, Lanoxin), or have any other medical conditions.

You should also tell your healthcare provider, before you take FORTEO, if you are pregnant or thinking about becoming pregnant. It is not known if FORTEO will harm your unborn baby. If you are breastfeeding or plan to breastfeed, it is not known if FORTEO passes into your breast milk. You and your healthcare provider should decide if you will take FORTEO or breastfeed. You should not do both.

FORTEO can cause serious side effects including a 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. FORTEO may also cause 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, leg cramps, and injection site reactions such as redness, swelling, pain, itching, a few drops of blood, and bruising. These are not all the possible side effects of FORTEO.

The FORTEO Delivery Device has enough medicine for 28 days. It is set to give a 20-microgram dose of medicine each day. 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. Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). 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 take more FORTEO than prescribed, call your healthcare provider. If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness.

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).

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For more information about severe osteoporosis, contact your doctor or health care professional.
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