For US Healthcare Professionals

Full Prescribing
Information

FAQs

Frequently Asked
Questions

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

FREQUENTLY ASKED QUESTIONS ABOUT TYVASO

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

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 lung disease, such as asthma or chronic obstructive pulmonary disease (COPD)
  • Have a lung infection
  • Have liver or kidney problems
  • 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 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 during treatment with TYVASO.

See Important Safety Information, Patient Package Insert, 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 in people who take blood thinners (anticoagulants).

The most common side effects seen with TYVASO are coughing, 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, Patient Package Insert, 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, Patient Package Insert, 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:

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