TYVASO is a prostacyclin vasodilator indicated for the treatment of PAH (WHO Group 1) to improve exercise ability. For the full TYVASO indication, see below.1
Frequently Asked Questions
What is Tyvaso?
How was Tyvaso studied?
TYVASO was studied in TRIUMPH, a combination trial in PAH. TRIUMPH I was a 12-week, multicenter, randomized, double-blind, placebo-controlled trial of an inhaled prostacyclin (TYVASO) and a single oral PAH agent (bosentan or sildenafil). The primary efficacy endpoint of the trial was the change in 6-minute walk distance (6MWD) relative to baseline at 12 weeks.1,2
TYVASO was also studied in an open-label extension study, TRIUMPH OLE, to evaluate the efficacy, safety, and dosing of TYVASO over time. Patients (N=206) from the placebo-controlled study initiated TYVASO after completing the 12-week TRIUMPH study, entering the long-term, uncontrolled OLE study.1,3
What are the most common adverse events?
TRIUMPH I STUDY: Adverse events (AEs) observed in the 12-week placebo-controlled study TRIUMPH I (N=235) at a rate of at least 4% and were more frequent in patients treated with TYVASO than placebo include1*†:
|Treatment n (%)|
|Adverse Event||TYVASO (n=115)||Placebo (n=120)|
|Cough||62 (54%)||35 (29%)|
|Headache||47 (41%)||27 (23%)|
|29 (25%)||17 (14%)|
|Nausea||22 (19%)||13 (11%)|
|Flushing||17 (15%)||1 (<1%)|
|Syncope||7 (6%)||1 (<1%)|
- Of the 23 total discontinuations, 7 patients discontinued in
the Tyvaso group due to adverse events, compared with 4
in the placebo group2
- In addition, adverse events occurring in ≥10% of patients were dizziness and diarrhea1
†More than 3% greater than placebo.
TRIUMPH OLE STUDY: AEs observed during the chronic dosing study—in which 206 patients were dosed for a mean duration of 2.3 years, with a maximum exposure of 5.4 years—were qualitatively similar to those observed in the 12-week, placebo-controlled trial. Serious adverse events included pneumonia (n=15) and hemoptysis (n=3).1
You may consider the following management approaches for common adverse events.
The following approaches to managing adverse reactions are based on anecdotal evidence cited in Poms et al (2011)4 and should not be construed as medical advice. United Therapeutics does not recommend or endorse using healthcare products other than as directed or prescribed.
|Adverse Event||Management Approaches4|
• Before treatment, drink very cold water for numbing effect or warm water to soothe and relax
• Review proper administration technique. Incorrect technique has been associated with cough and can be corrected with
• Reduce the number of breaths per treatment and/or titrate more slowly (eg, by 1 breath, 4x per day)
• Inhaled anticholinergics
• Inhaled steroids
• OTC or prescription cough medicines
• OTC pain relievers (acetaminophen, short-term ibuprofen, aspirin)
• Temporary dose reductions (eg, by 1 breath, 4x per day)
• Oral phenol-based analgesic sprays to numb throat before treatment
• Swish and spit after treatment
• Eat a small meal before next treatment
• Temporary dose reductions (eg, by 1 breath, 4x per day)
• If severe, decrease by 1 breath, 4x per day, and increase when symptom improves
Remind patients to talk to you or your staff about any adverse reactions and not to discontinue treatment without your direction.
Can Tyvaso be used during pregnancy?
There are no adequate and well-controlled studies with TYVASO in pregnant women. It is not known whether treprostinil is excreted in human milk.1
Are there any data on long-term treatment with Tyvaso?
The long-term use and safety of TYVASO have been studied in an open-label extension of the pivotal TRIUMPH I study, with a mean duration of 2.3 years and maximum exposure of 5.4 years (N=206).1
Safety and dosing were evaluated:
• 89% of patients achieved the target dose of 9 breaths, 4x daily1
• 42% of patients achieved a dose of 12 breaths, 4x daily1
• The maximum recommended dosage is 9 breaths, 4x daily1
The adverse events during this chronic dosing study were qualitatively similar to those observed in the 12-week, placebo-controlled trial. Additionally, serious adverse events included pneumonia (n=15) and hemoptysis (n=3).1
Kaplan-Meier estimates of survival were1:
• 97% at 1 year
• 91% at 2 years
• 82% at 3 years
These uncontrolled observations do not allow comparison with a control group not given TYVASO and cannot be used to determine the long-term effect of TYVASO on mortality.1
What is the Tyvaso Inhalation System?
The TYVASO Inhalation System is a lightweight, portable, handheld device approved for direct-to-the-lungs administration of TYVASO.1,5
How long does each dosing session take?
Each dosing session should take about 2 to 3 minutes and should be administered 4x daily, during waking hours.6
How do patients keep track of their treatments?
The Getting Started with TYVASO folder includes a TYVASO Treatment Tracker (written diary) to help patients keep track of their breaths during each treatment session. A new treatment tracker is provided monthly with each TYVASO prescription refill.
How long does it take to set up the Tyvaso Inhalation System?
Setting up the TYVASO Inhalation System for use takes about 5 minutes and must be done once each day prior to the day’s first treatment session.6
How is the Tyvaso Inhalation System cleaned?
The TYVASO Inhalation System requires once-daily cleaning with warm, mild, soapy water. Accessory parts should be washed by hand and allowed to air dry. The base of the device should not be immersed in water or placed in a dishwasher.5
Once a week, use a clean cloth to wipe the interior of the device chamber. For more instructions on cleaning and maintenance of the TYVASO Inhalation System, refer to the Cleaning and Storing section beginning on page 46 of the TD-300 Instructions for Use Manual.5
How do you order and replace the accessories?
For patient convenience, replacement accessory parts are delivered monthly with each TYVASO prescription refill.5 Call your Specialty Pharmacy Service provider with any additional questions. Patients will receive a replacement device every 2 years.
How is Tyvaso supplied?
TYVASO is supplied in 2.9-mL, clear, low-density polyethylene (plastic) ampules packaged as 4 ampules in a foil pouch. TYVASO is a clear, colorless to slightly yellow solution containing 1.74 mg of treprostinil per ampule at a concentration of 0.6 mg/mL.1
The TYVASO Inhalation System Starter Kit contains a 28-ampule carton of TYVASO (the 7 foil pouches each contain four 2.9-mL ampules. Each ampule contains 1.74 mg treprostinil [0.6 mg per mL]) and the TYVASO Inhalation System (NDC 66302-206-01).1
The TYVASO Inhalation System Rell Kit contains a 28-ampule carton of TYVASO (the 7 foil pouches each contain four 2.9-mL ampules. Each ampule contains 1.74 mg treprostinil [0.6 mg per mL]) and accessories. (NDC 66302-206-02).1
The TYVASO 4-Pack Carton with 1 foil pouch contains four 2.9-mL ampules. Each ampule contains 1.74 mg treprostinil (0.6 mg per mL). (NDC 66302-206-03).1
The TYVASO Inhalation System Institutional Starter Kit contains a 4-ampule carton of TYVASO (1 foil pouch contains four 2.9-mL ampules; each ampule contains 1.74 mg treprostinil [0.6 mg per mL]) and the TYVASO Inhalation System. (NDC 66302-206-04).1
How is Tyvaso stored?
Ampules of TYVASO are stable until the date indicated when stored in the unopened foil pouch at 25℃ (77℉), with excursions permitted to 15℃ to 30℃ (59℉ to 86℉) [see USP Controlled Room Temperature]. Once the foil pack is opened, ampules should be used within 7 days. Because TYVASO is light-sensitive, unopened ampules should be stored in the foil pouch.1,6
One ampule of TYVASO should be used each day in the TYVASO Inhalation System. After a TYVASO ampule is opened and transferred to the medicine cup, the solution should remain in the device for no more than 1 day (24 hours). Any remaining solution should be discarded at the end of the day.6
HOW ARE TYVASO AND THE TYVASO INHALATION SYSTEM DISTRIBUTED?
TYVASO is distributed by the following Specialty Pharmacies:
TYVASO can be prescribed by filling out the Patient Referral Form.
WHAT ADDITIONAL SUPPORT DOES THE SPECIALITY PHARMACY SERVICE PROVIDER OFFER YOUR PATIENTS?
The Specialty Pharmacy Service (SPS) providers are available to help initiate TYVASO therapy and provide continuous patient support with ongoing services and resources. Services offered to patients include one-step referral, reimbursement support, initial delivery of TYVASO and supplies, in-home device training, ongoing follow-up, and delivery of monthly refills.