Drugs 2012; 72 (17): 2187-2205 Adis ª 2012 Springer International Publishing AG. All rights reserved. Advances in Drug Development forAcute MigraineRyan J. Cady,1 Candace L. Shade2 and Roger K. Cady2 1 Center of Biomedical & Life Sciences, Missouri State University, Springfield, MO, USA2 Banyan Group, Inc., Springfield, MO, USA Triptans revolutionized medical recognition and the acute treatment of
Tyv_int_ddg-taking-abc.inddQUESTIONS TO ASK YOUR DOCTORTo get the most out of your care, it's important to take an active role in your treatment. This includes speaking openly with your doctor and sharing any concerns you have. Review these questions with your doctor, and fi nd out if you can do even more to manage your PAH.
Am I doing OK with my PAH?Even if you feel like you're doing fi ne, ask your doctor if there is more you could be doing to manage your PAH. Discuss your PAH
Check al that apply:
❑ Shortness of breath when ❑ Weight gain or loss ❑ Loss of appetite ❑ Walking to the mailbox ❑ Missed any work or school ❑ Trouble sleeping ❑ Getting dressed due to PAH symptoms ❑ Memory problems ❑ Less able to do normal daily ❑ 6-minute walk distance is no longer improving or declining ❑ Swollen abdomen ❑ Swol en legs or ankles ❑ Irregular heartbeat Ask these questions
How do I know if my current treatment plan is working? Can I take more than one medication for my PAH? Would adding another medication help improve my symptoms? Do my current 6-minute walk distance test results mean I should try another treatment? 2013 United Therapeutics Corporation. All rights reserved. US/TYV/MAY13/216 Printed in USA.
I've noticed changes. What do they mean?Share any changes you've noticed with your doctor to ensure you are getting the care that's right for you.
Discuss the changes you've noticed
Have you experienced shortness of breath? ❑ Walking on level ground ❑ Walking up hills ❑ Making the bed ❑ Getting dressed How often have you missed work, school, or normal daily activities due to your PAH symptoms? ❑ Occasional y Has your activity level changed? ❑ I can't walk as far ❑ I'm having trouble with normal activities ❑ I'm out of breath or tire easily Ask these questions
Has my 6-minute walk distance improved? When should we talk about what's next for my treatment? Can I take more than one medication? Would that improve my symptoms? How would it be diff erent from my current medication? 2013 United Therapeutics Corporation. All rights reserved. US/TYV/MAY13/216 Printed in USA.
Can I continue to do the activities I enjoy?The fol owing questions can help you and your doctor determine what goals are right for you and then develop a plan to help you work toward them.
Think about your activities
List activities you enjoy:1.
List activities you would like to be able to do:1.
Ask these questions
Can I continue to do the things I enjoy? Do I need to modify or change my activities? Will my PAH aff ect my physical activity more over time? Can I change my treatment plan to help me do more? 2013 United Therapeutics Corporation. All rights reserved. US/TYV/MAY13/216 Printed in USA.
I am taking TyvasoRegardless of when you started taking Tyvaso, you may have questions. Here are some suggestions to start the conversation with your doctor. Questions about Tyvaso
Are there other patients on Tyvaso I can talk with? How do I know I'm using my Tyvaso Inhalation System correctly? Do you have any tips to help me fit Tyvaso treatments into my day? How important is it that I take every dose? What is my goal dose, and when do you expect me to reach that dose? Can you help me manage my side effects, if I have them? Where can I find support to help me manage my PAH? Here's what has changed since my last appointment: Symptoms/Side effects: How am I doing? Is my condition getting better or worse, or is it staying the same? Has my 6-minute walk distance changed since my last test? Is there anything else I can do to help my condition? Please see Important Safety Information for Tyvaso on last page.
2013 United Therapeutics Corporation. All rights reserved. US/TYV/MAY13/216 Printed in USA.
Tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH)
(WHO Group 1), which is high blood pressure in the arteries of your lungs. Tyvaso can improve exercise ability in people who also take bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase-5 inhibitor). The effects decrease over 4 hours; treatment timing can be adjusted for planned activities.
Studies establishing effectiveness included predominately patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
Important Safety Information for Tyvaso
» Tyvaso is breathed in (inhaled) through your mouth into your lungs. Tyvaso should only be used
with the Tyvaso Inhalation System » The effects of Tyvaso are unknown in patients with lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age » If you have low blood pressure, Tyvaso may cause symptomatic hypotension (low blood pressure)» Because Tyvaso reduces the ability of your blood to clot (coagulate), it may increase your risk for bleeding if you are taking blood thinners (anticoagulants), such as warfarin or heparin » The use of Tyvaso with diuretics (water pil s), antihypertensives (medications used to treat high blood pressure or heart disease), or other vasodilators (medications that lower blood pressure) may increase your risk for hypotension (low blood pressure) Other medical conditions and medicines may affect your use of Tyvaso by increasing the risk of side effects or decreasing effectiveness. It is important to tell your doctor about your medical conditions and any medicines you may be taking, including:» If you are taking gemfibrozil (for high cholesterol) or rifampin (for infection), your Tyvaso dosage may need adjustment » If you have liver or kidney problems, your ability to tolerate Tyvaso may be affected » If you are pregnant, breast-feeding, or planning to become pregnant, talk with your healthcare provider about whether you should take Tyvaso The most common side effects of Tyvaso are coughing, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), and fainting or loss of consciousness. These are not all the possible side effects of Tyvaso. Tell your doctor about any side effects that bother you or do not go away. Your doctor may be able to help you manage the side effects.
Please see the Patient Package Insert included in this download, and see the Full Prescribing
Information and the Tyvaso Inhalation System Instructions for Use Manual at Tyvaso.com.
This discussion guide is intended for US consumers only.
This Doctor Discussion Guide was printed from Tyvaso.com.
2013 United Therapeutics Corporation. All rights reserved. US/TYV/MAY13/216 Printed in USA.
PATIENT PACKAGE INSERT
Read this Patient Package Insert before you start taking Tyvaso and each time you get a refil . There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is Tyvaso?
Tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH),
which is high blood pressure in the arteries of your lungs. Tyvaso can improve the ability to do exercise in people who also take bosentan (an endothelin receptor antagonist (ERA)) or sildenafil (a phosphodiesterase-5 (PDE-5) inhibitor). Your ability to do exercise decreases 4 hours after taking Tyvaso.
It is not known if Tyvaso is safe or effective in people under 18 years of age.
What should I tell my healthcare provider before taking Tyvaso?
Before taking Tyvaso, tel your healthcare provider about all of your medical conditions,
including if you: • have lung disease, such as asthma or chronic obstructive pulmonary disease (COPD) • have a lung infection • have liver problems or kidney problems • have low blood pressure • are pregnant or plan to become pregnant. It is not known if Tyvaso wil harm your unborn baby. Women who can become pregnant should use effective birth control while • are breast-feeding or plan to breast-feed. It is not known if Tyvaso passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while Tell your healthcare provider about all the medicines you take, including prescription
and non-prescription medicines, vitamins, and herbal supplements. Tyvaso and other medicines may affect each other. Especial y tel your healthcare provider if you take any of these medicines: • medicines that decrease blood clotting • water pil s (diuretics) • medicines used to treat high blood pressure or heart disease • gemfibrozil (Lopid) (for high cholesterol) • rifampin (Rimactane, Rifadin, Rifamate, Rifater) (for infection) Know the medicines you take. Keep a list of them and show it to your healthcare provider and specialty pharmacist when you get a new medicine.
How should I take Tyvaso?
• Take Tyvaso each day exactly as your healthcare provider tel s you. • See the detailed Tyvaso Inhalation System Instructions for Use. • Tyvaso is breathed in (inhaled) through your mouth into your lungs. Tyvaso should only be used with the Tyvaso Inhalation System. • Tyvaso is taken in 4 treatment sessions each day during waking hours. The sessions should be at about 4 hours apart. • At the beginning of each day, it wil take about 5 minutes to prepare the Tyvaso Inhalation System. Each treatment session will take 2 to 3 minutes. • Take your first Tyvaso treatment session in the morning and take your last treatment session before bedtime. • Your healthcare provider may change your dose if needed. • If you miss a dose of Tyvaso take it as soon as you remember. • Do not let Tyvaso solution get into your eyes or onto your skin. If it does, rinse your skin or eyes right away with water. • Using the Treatment Tracker, record the number of breaths you inhale during each treatment session (4 times a day). You should bring your Treatment Tracker to your medical appointments, as your doctor may want to review it with you. What are the possible side effects of Tyvaso?
Tyvaso can cause serious side effects, including:
• Tyvaso may increase the risk of bleeding in people who take blood thinners (anticoagulants). • If you have low blood pressure, Tyvaso may lower your blood pressure further. Ask your healthcare provider if you are not sure if this applies to you. The most common side effects of Tyvaso include: • reddening of your face and neck (flushing) • throat irritation and pain • fainting or loss of consciousness Tel your healthcare provider if you have any side effect that bothers you or that does not go away. These are not al the possible side effects of Tyvaso. For more information, ask your healthcare provider or specialty pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Tyvaso?
• Store Tyvaso ampules in the unopened foil pack between 59°F to 86°F (15°C to 30°C) until ready to use. • When the foil pouch is opened, Tyvaso ampules should be used within 7 days. • Tyvaso is sensitive to light. The unopened Tyvaso ampules should be stored in the foil • After a Tyvaso ampule is opened and put into the medicine cup in the Tyvaso Inhalation System, Tyvaso can be kept in the medicine cup for no more than 1 day (24 hours). • Tyvaso that is left in the medicine cup at the end of the day must be thrown away. • The Tyvaso Inhalation System can be stored in the carrying case when not in use (Example: between treatment sessions or overnight). If storing between treatment sessions, ensure that the plugs are firmly in place in the dome assembly to prevent spil age of Tyvaso. See the Instructions for Use for additional information regarding storage of your Tyvaso Inhalation System.
Keep Tyvaso and all medicines out of the reach of children.
General information about the safe and effective use of Tyvaso.
Medicines are sometimes prescribed for conditions that are not mentioned in a patient
information leaflet. Do not use Tyvaso for a condition for which it was not prescribed. Do not give Tyvaso to other people, even if they have the same symptoms you have. It may harm them. This patient information leaflet summarizes the most important information about Tyvaso. You can ask your healthcare provider or specialty pharmacist for information about Tyvaso that is written for health professionals. For more information, go to www.tyvaso.com or cal 1-877-UNITHER (1-877-864-8437). What are the ingredients in Tyvaso?
Active ingredient: treprostinil Inactive ingredients: sodium chloride, sodium citrate, sodium hydroxide, hydrochloric acid, and water for injection. Tyvaso is a registered trademark of United Therapeutics Corporation. Literature issued May 2013. United Therapeutics Corp.
Research Triangle Park, NC 27709 USA
Copyright 2013, United Therapeutics Corp. Al rights reserved.
European Heart Journal (2004) 25, 1341–1362 ESC Expert consensus document Expert consensus document on b-adrenergicreceptor blockers The Task Force on Beta-Blockers of the European Societyof Cardiology Task Force Members, Jos on, Chairperson* (Spain), Karl Swedberg (Sweden), John McMurray (UK), Juan Tamargo (Spain), Aldo P. Maggioni (Italy),Henry Dargie (UK), Michal Tendera (Poland), Finn Waagstein (Sweden), Jan Kjekshus(Norway), Philippe Lechat (France), Christian Torp-Pedersen (Denmark)