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FAQs

Frequently Asked
Questions

Get answers to some of the most commonly asked questions about PAH and TYVASO.

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FREQUENTLY ASKED QUESTIONS ABOUT TYVASO

Watch this video for answers to some of the most commonly asked questions about TYVASO.

FAQS ANSWERED BY A TYVASO PATIENT

[VIDEO DURATION 09:27]

VO=voiceover.

LA=live action.

VO:

Frequently asked questions about TYVASO.

LA/MARLA:

Hello, my name is Marla, and I’ve been on TYVASO therapy for a few years now.

Knowing firsthand what it's like living with PAH, I just want to share the perspective of someone who’s walked the same path.

VO:

As you know, PAH is high blood pressure in the arteries of the lungs. It’s caused by excess cells and platelets building up in the artery lining and decreasing blood flow from the heart to the lungs.

And it causes symptoms that make daily activities harder.

LA/MARLA:

Some people can be helped by adding TYVASO, and I’m one of them.

Let me share with you some frequently asked questions I often get about TYVASO.

The first question I get is: “What is TYVASO?”

VO/MARLA:

TYVASO is a prostacyclin analogue therapy that’s inhaled directly into the lungs. It’s for people already on a background oral therapy with an ERA or a PDE-5 inhibitor who need to improve their ability to exercise.

People living with PAH have too little prostacyclin in their bodies.

TYVASO mimics the effects of natural prosta­cyclin in the body, helping to keep the pulmonary arteries open and working properly.

VO:

What is TYVASO?

TYVASO (treprostinil) is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH; WHO Group I), which is high blood pressure in the arteries of your lungs. TYVASO can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO. It is not known if TYVASO is safe and effective in children under 18 years of age.

LA/MARLA:

People ask me: “How do I inhale TYVASO?”

TYVASO comes with a portable handheld device that delivers the medicine directly to your lungs.

VO/MARLA:

Once daily, you will set up the device. Your Specialty Pharmacy Services nurse will show you how, and they'll stay in touch with you during the first few weeks of treatment.

You’ll inhale TYVASO 4 times a day, so it helps to link treatments to daily activities.

During each session, you will take a series of breaths through the mouthpiece.

My doctor started me with 3 breaths and increased my dose based on how I tolerated TYVASO, until I reached a target dose of 9 breaths per treatment session.

Your doctor will determine the amount of breaths that are right for you. A typical session should take 2-3 minutes. And, remember, you'll do this 4 times a day.

LA/MARLA:

Once you get used to it, you’ll find it fits into your daily routine.

People also want to know: “What side effects are associated with TYVASO?”

VO/MARLA:

Some people do experience side effects. If you do have side effects, your doc­tor or Specialty Pharmacy Services nurse are there to help.

The most common side effects seen with TYVASO are coughing, headache, throat irritation and pain, nausea, reddening of your face and neck (flushing), fainting or loss of consciousness, dizziness, and diarrhea.

TYVASO increases the risk of bleeding, partic­ularly if you take blood thinners.

Or, if you have low blood pressure, TYVASO may lower your blood pressure further.

These are not all of the possible side effects with TYVASO.

If you have any side effects that bother you or don’t go away, speak to your doctor so you can get help.

He or she may want you to bring your device to your office visit, or have a Specialty Phar­macy Services nurse visit you to check that you are using the device correctly.

You’ll also find helpful suggestions on the TYVASO website.

LA/MARLA:

Of course, the main question for all of us is: “I just want to see an improvement; will TYVASO help me?”

VO/MARLA:

Well, in a clinical trial, patients who added TYVASO to their background oral therapy (bosentan or sildenafil) increased their exercise ability by an average of 71 feet or about 21-and-a-half meters.

Some people find they’re able to walk a bit further, do a little more.

LA/MARLA:

That’s how it’s helped me.

VO/MARLA:

What support will I receive once I have been prescribed TYVASO?

Once your healthcare provider has put you on TYVASO, you will be contact­ed by a Specialty Pharmacy.

The Specialty Pharmacy will let you know when to expect your TYVASO shipment to arrive and make an appointment for a Specialty Pharmacy Services nurse to come to your house to show you how to use it.

The nurse will set up a schedule of visits and follow-up phone calls to make sure you are comfortable using TYVASO.

Also, check the TYVASO website for other programs sponsored by United Therapeutics that you may find useful.

LA/MARLA:

Another important question is: “How often do you take it?”

Of course you want to know how TYVASO will fit into your life.

VO/MARLA:

TYVASO is taken 4 times a day.

An easy way to remember is to link these sessions to other things you do every day.

Your doctor will prescribe the number of breaths that you will take during each of your 4 treatment sessions.

If you are at home for the day, you only have to set up your unit once in the morning. But if you are traveling or on the go, it is easy to disassemble and reassemble.

LA/MARLA:

Last question: “How do I care for the Inhalation System?”

VO/MARLA:

At the end of each day, you'll need to go through a process of taking apart the unit and washing the various accessories.

Once you get used to it, this usually takes about 5 minutes.

Once a week, use a lint-free cloth to wipe out the inside of the inhalation device chamber.

And once a month, you’ll get a set of new ac­cessories, along with your TYVASO Refill Kit.

LA/MARLA:

If you’re like me, you’ll soon get into a routine.

And, remember, if you have any questions, call your doctor or Specialty Pharmacy and they will be happy to help you!

I hope TYVASO will help you…as it’s helped me!

VO:

What is TYVASO?

TYVASO (treprostinil) is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH; WHO Group I), which is high blood pressure in the arteries of your lungs. TYVASO can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO. It is not known if TYVASO is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

Before you take TYVASO, tell your healthcare provider about all your medical conditions, including if you have lung disease or infection, liver or kidney problems, low blood pressure, or bleeding problems. If you are pregnant, plan to become pregnant, or breast-feeding, tell your doctor. It is not known if TYVASO will harm your unborn baby or if it passes into breast milk.

Tell your healthcare provider about all the medicines you take, as TYVASO and other medicines may affect each other: Especially medicines used to treat high blood pressure or heart disease, or that decrease blood clotting (anticoagulants), water pills (diuretics), gemfibrozil (Lopid) or rifampin (Rimactane, Rifadin, Rifamate, Rifater).

TYVASO can cause serious side effects, including low blood pressure (symptomatic hypotension) and bleeding problems, especially in people who take blood thinners (anticoagulants).

The most common side effects of TYVASO are cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, and diarrhea. These are not all the possible side effects of TYVASO. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

The risk information provided here is not comprehensive. To learn more about TYVASO, talk with your healthcare provider. Please seeFull Prescribing Information,Patient Product Information, and the TD-100 and TD-300TYVASO Inhalation System Instructions for Use manuals at www.TYVASO.com or call 1-877-UNITHER (1-877-864-8437).

STARTING TYVASO

People living with PAH may not produce enough natural prostacyclin. TYVASO is a man-made form of prostacyclin, called a prostacyclin analogue. It mimics some of the effects of the natural prostacyclin in the body, helping to keep the blood vessels in the lungs open and working properly.

Adding TYVASO to your background oral medication, like bosentan (an ERA) or sildenafil (a PDE-5 inhibitor), could help improve your ability to exercise. Adding TYVASO may help you do more in your day—go for a stroll, walk your kids to the bus stop, or walk to a mailbox.

In a clinical study, people who added TYVASO to their PAH background therapy walked farther—improving their 6MWD by 19 m in as soon as 6 weeks.

Individual results may vary.

6-minute walk distance (6MWD) is a test to see how far you can walk in 6 minutes.

In the 12-week clinical study of TYVASO, people taking an oral PAH medicine (bosentan or sildenafil) completed a 6-minute walk test at the beginning and end of the study.

If you and your doctor agree that TYVASO could help you, a referral for your TYVASO prescription will go to a Specialty Pharmacy (SP) provider. Once approved, an SP nurse will come to your home or your doctor’s office to show you how to use the TYVASO Inhalation System and will support you as you begin therapy.

Before you take TYVASO, tell your healthcare provider about all of your medical conditions, including if you:

  • Have low blood pressure
  • Have bleeding problems
  • Are pregnant or plan to become pregnant. It is not known if TYVASO will harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if TYVASO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with TYVASO.

See Important Safety Information and Full Prescribing Information for more information about TYVASO.

TYVASO and the TYVASO Inhalation System are available only through the following Specialty Pharmacy providers:

Accredo Specialty Pharmacy

PHONE

1-866-344-4874

FAX

1-800-711-3526

WEBSITE

www.accredo.com

PHONE

1-877-242-2738

FAX

1-877-943-1000

WEBSITE

www.cvsspecialty.com

Dosing

You can take TYVASO with you throughout your day. The portable TYVASO device allows for dosing at home or on the go.

  • Set up device once a day
  • Each treatment sessions takes about 2 to 3 minutes
  • Plan for treatment sessions approximately every 4 waking hours
  • Clean device once a night

TYVASO comes in plastic ampules packaged in a light-protective foil pouch and are good until the date shown, when stored in the unopened pouch at the temperature range indicated on the pouch. TYVASO ampules do not need to be refrigerated, and should be stored away from light.

TYVASO ampules can be used until the expiration date printed on the pouch. Do not use TYVASO ampules past the expiration date printed on the pouch.

  • TYVASO ampules should be used within 7 days after opening the foil pouch.
  • TYVASO can be kept in the TYVASO Inhalation System medicine cup for no more than 1 day.

Throw away any remaining TYVASO that is left in the medicine cup at the end of the day.

The Instructions for Use manual will tell you all you need to know to properly assemble, use, care for, and troubleshoot your TYVASO Inhalation System. You can also watch this Instructional Video for more information.

The Instructions for Use manual will tell you all you need to know to properly assemble, use, care for, and troubleshoot your TYVASO Inhalation System. Watch this Overview Video or download Instructions for Use manual.

Key things to remember:

  • At the end of each day, you’ll need to go through a short process of taking apart the unit and washing the various accessories. Once you get used to this, it usually takes about 5 minutes.
  • Once a week, use a lint-free cloth to wipe out the inside of the inhalation device chamber
  • Once a month, you’ll get a set of new accessories, along with your TYVASO Refill Kit

Side Effects

TYVASO can cause serious side effects, including:

  • Low blood pressure (symptomatic hypotension). If you have low blood pressure, TYVASO may lower your blood pressure more.
  • Bleeding problems. TYVASO may increase the risk of bleeding, especially in people who take blood thinners (anticoagulants).

The most common side effects of TYVASO are cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, and diarrhea.

Tell your doctor about any side effect that bothers you or does not go away.

See Important Safety Information and Full Prescribing Information for more information about TYVASO.

TYVASO was studied as a therapy that is added to treatment with bosentan (an endothelin receptor antagonist [ERA]) or sildenafil (a phosphodiesterase type 5 [PDE-5] inhibitor).

TYVASO may interact with certain other medications, so tell your doctor if you’re taking any of the following:

  • Medicines used to treat high blood pressure or heart disease
  • Medicines that decrease blood clotting (anticoagulants)
  • Water pills (diuretics)
  • Gemfibrozil (Lopid®) or rifampin (Rimactane®, Rifadin®, Rifamate®, Rifater®)

Be sure to make a list of all the medicines (prescription and over the counter), vitamins, and herbal supplements you take routinely or even occasionally. Update the list as needed, keep it with you, and show it to your doctor and Specialty Pharmacy provider.

See Important Safety Information and Full Prescribing Information for more information about TYVASO.

Access and Patient Support

Once your doctor has prescribed the TYVASO Inhalation System, your kit will be delivered to your home, and a Specialty Pharmacy (SP) nurse will contact you to schedule a virtual or in-person appointment to teach you how to use it. You can receive additional visits and phone calls to be sure you are comfortable using TYVASO, and you can call for help 24/7.

Watch videos and download the TYVASO Information Brochure, as well as other tools, on the TYVASO RESOURCES page.

Your healthcare team and doctor are always available to answer questions about your TYVASO treatment.

Each month, your Specialty Pharmacy (SP) provider will automatically send you a 28-day supply of TYVASO, along with a kit containing a new set of accessories for your TYVASO Inhalation System. Don’t hesitate to contact your SP provider if you have any questions about taking TYVASO, operating the TYVASO Inhalation System, or if you need more medication.

Your Specialty Pharmacy (SP) provider will replace your device automatically every 2 years. If you need a replacement before then, just contact your SP provider.

TYVASO and the TYVASO Inhalation System are available only through the following Specialty Pharmacy providers:

Accredo Specialty Pharmacy

PHONE

1-866-344-4874

FAX

1-800-711-3526

WEBSITE

www.accredo.com

PHONE

1-877-242-2738

FAX

1-877-943-1000

WEBSITE

www.cvsspecialty.com