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Full Prescribing
Information

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DIRECT-TO-LUNG DELIVERY

DIRECT-TO-LUNG
DELIVERY

Breathe It In...
TYVASO Is Inhaled
Directly Into the Lungs

TYVASO works to open up blood vessels and help keep the blood flowing through your lungs.

TYVASO Delivery: Inhaled medicine targets the lungs.TYVASO Delivery: Inhaled medicine targets the lungs.
TYVASO Delivery: Inhaled medicine targets the lungs.

HOW TYVASO WORKS

The TYVASO Inhalation System is a hand-held, portable device that allows you to inhale TYVASO through your mouth and into your lungs.

HOW TYVASO WORKS

[VIDEO DURATION 06:48]

DOCTOR:

OK, Amy. Let’s discuss what’s going on with you, and what might help.

PATIENT/AMY:

Thanks, Doctor. I’ll take all the help I can get.

DOCTOR:

As you know, you have a condition called pulmonary arterial hypertension, PAH for short, which means you have high blood pressure in the lungs.

Now, it’s been a few years. There are 4 functional classes of PAH, and the symptoms increase with each class.

PATIENT/AMY:

Yes, it has been harder to walk to the mailbox, and climbing stairs has been more difficult.

DOCTOR:

Well, based on your increased symptoms and the tests we did, you are currently in Functional Class 3.

PATIENT/AMY:

Hmmm… so what are my options?

DOCTOR:

For people like you who are already taking an oral medication, such as an ERA, which blocks excess endothelin, or a PDE5i, which increases blood flow to the arteries, I suggest adding another medicine that works differently—TYVASO, an inhaled prosta­cyclin analogue.

PATIENT/AMY:

What is that and how does it work?

DOCTOR:

Prostacyclin is a natural substance found in the body. It works on one of three pathways that help keep your blood vessels open. If any of these pathways are imbalanced, the arteries in your lungs can narrow, which may be the cause of your PAH symptoms.

Because your body doesn’t make enough prostacyclin, TYVASO may help. It mimics some of the natural effects of prostacyclin helping to keep the blood vessels in the lungs open and working properly.

PATIENT/AMY:

And how would I take TYVASO?

DOCTOR:

You take it by using a device to inhale it into your lungs to help open up the blood vessels and allow more blood to flow into your lungs.

VOICEOVER:

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.

DOCTOR:

Everyone is different. But, in a 12-week clini­cal trial, patients who added TYVASO to either bosentan or sildenafil walked an average of 71 feet or about 21-and-a-half meters more than before adding TYVASO.

In the clinical trial, some of the most common side effects were cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, and diarrhea.

Shall we get you started on TYVASO?

PATIENT/AMY:

Sounds good, Doctor...tell me how!

DOCTOR:

Well, first I’ll send in a referral to a Specialty Pharmacy that will work with your insurance company.

Once approved, you’ll get a call from the Specialty Pharmacy to arrange for TYVASO to be delivered to your home.

They will also make an appointment for a nurse to teach you how to use the TYVASO inhalation device.

[Phone rings]

PATIENT/AMY:

Hello.

SPECIALTY PHARMACY WORKER:

Hi, this is the Specialty Pharmacy calling. Your TYVASO kit should arrive any day now. We can have a nurse come by and train you on Thursday.

PATIENT/AMY:

That works great for me!

VOICEOVER:

Remember to wait for your SPS nurse to walk you through the process before starting TYVASO.

[Doorbell rings]

SPECIALTY PHARMACY NURSE:

Hi Amy, I’m Beth, your Specialty Pharmacy nurse.

PATIENT/AMY:

Hi Beth. Come in.

SPECIALTY PHARMACY NURSE:

Thank you.

PATIENT/AMY:

I'm a bit nervous.

SPECIALTY PHARMACY NURSE:

Most people are at first, but you'll soon get the hang of it.

PATIENT/AMY:

You think so?

SPECIALTY PHARMACY NURSE:

Of course...and keep in mind, I'll be coming back a few times as you get started. And you'll receive follow up calls.

PATIENT/AMY:

That’s a relief!

SPECIALTY PHARMACY NURSE:

Yes, don't worry. We're here to help.

PATIENT/AMY:

I've been taking TYVASO for about a month, and it fits right into my daily schedule.

DELIVERY MAN/CARLOS:

Hello!

PATIENT:

Oh, hi Carlos!

DELIVERY MAN/CARLOS:

How are you doing?

PATIENT/AMY:

I'm doing well.

VOICEOVER:

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 see Full Prescribing Information, Patient Product Information, and the TD-100 and TD-300 TYVASO Inhalation System Instructions for Use manuals at www.TYVASO.com or call 1-877-UNITHER (1-877-864-8437).

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