YOU ARE NOW LEAVING TYVASO

FOR US HEALTHCARE
PROFESSIONALS ONLY

For the treatment of pulmonary arterial hypertension
(PAH) (WHO Group 1) to improve exercise ability.
For the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.
For US Healthcare Professionals Only

Frequently Asked Questions (FAQs)

What is Tyvaso?

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

How was Tyvaso studied?

Tyvaso was studied in TRIUMPH I, a combination trial in PAH. TRIUMPH I was a 12-week, multicenter, randomized, double-blind, placebo-controlled trial of an inhalable prostacyclin (Tyvaso) and a single oral PAH agent (bosentan or sildenafil). The primary efficacy endpoint of the trial was the change in 6MWD relative to baseline at 12 weeks.1,2

What are the most common adverse events?

The most common adverse events seen with Tyvaso in ≥4% of PAH patients and >3% greater than placebo in the placebo-controlled clinical study were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%).1

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 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 daily

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 were evaluated1:

  • 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 the administration of Tyvaso.1,3

How long does each dosing session take?

Each dosing session should take about 2 to 3 minutes, 4x daily, during waking hours.4

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.4

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.3

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 pages 24 to 27 of the Instructions for Use manual.3

How do you order and replace the accessories?

For patient convenience, replacement accessory parts are delivered monthly with each Tyvaso prescription refill.3 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 Refill 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 containing 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).

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

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.1

How are Tyvaso and the Tyvaso Inhalation System distributed?

Tyvaso is distributed by the following Specialty Pharmacies:

accredo logo

Phone:1-866-344-4874
Fax: 1-800-711-3526
www.accredo.com

CVS Caremark Specialty Rx logo

Phone:1-877-242-2738
Fax: 1-877-943-1000
www.cvsspecialty.com

Tyvaso can be prescribed by filling out the Patient Referral Form.

What additional support does the Specialty 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.

Have additional questions? Request a rep to learn more.

IMPORTANT SAFETY INFORMATION FOR TYVASO

WARNINGS AND PRECAUTIONS
DRUG INTERACTIONS / SPECIFIC POPULATIONS
ADVERSE REACTIONS

INDICATION

Tyvaso is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. 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%).

The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.

While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration.

TYVISIhcpJUN16

Please see the Full Prescribing Information, Patient Package Insert, and the Tyvaso Inhalation System Instructions for Use manual.

For additional information about Tyvaso, visit www.tyvaso.com or call 1-877- UNITHER (1-877-864-8437).

6MWD=6-minute walk distance; TRIUMPH=TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension; WHO=World Health Organization.

References: 1. Tyvaso [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2016. 2. McLaughlin VV, Benza RL, Rubin LJ, et al. Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial. J Am Coll Cardiol. 2010;55(18):1915-1922. 3. Tyvaso [instructions for use manual]. Research Triangle Park, NC: United Therapeutics Corporation; 2013. 4. Tyvaso [patient prescribing information]. Research Triangle Park, NC: United Therapeutics Corporation; 2014.

IMPORTANT SAFETY INFORMATION FOR TYVASO

WARNINGS AND PRECAUTIONS
  • The efficacy of Tyvaso has not been established in patients with significant underlying lung disease (such as asthma or chronic obstructive pulmonary disease). Patients with acute pulmonary infections should be carefully monitored to detect any worsening of lung disease and loss of drug effect.
  • Tyvaso is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, Tyvaso may cause symptomatic hypotension.
  • Titrate slowly in patients with hepatic or renal insufficiency, as exposure to treprostinil may be increased in these patients.
  • Tyvaso inhibits platelet aggregation and increases the risk of bleeding, particularly in patients receiving anticoagulants.
  • Co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor gemfibrozil may increase exposure to treprostinil. Co-administration of the CYP2C8 enzyme inducer rifampin may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events, whereas decreased exposure is likely to reduce clinical effectiveness.
DRUG INTERACTIONS / SPECIFIC POPULATIONS
  • The concomitant use of Tyvaso with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension.
  • Co-administration of the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to oral treprostinil. Co-administration of the CYP2C8 enzyme inducer rifampin decreases exposure to oral treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8.
  • There are no adequate and well-controlled studies with Tyvaso in pregnant women. It is not known whether treprostinil is excreted in human milk.
ADVERSE REACTIONS
  • The most common adverse events seen with Tyvaso in ≥4% of PAH patients and more than 3% greater than placebo in the placebo-controlled clinical study were cough (54% vs 29%), headache (41% vs 23%), throat irritation/ pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%).

INDICATION

Tyvaso is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. 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%).

The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.

While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration.

TYVISIhcpJUN16

Please see the Full Prescribing Information, Patient Package Insert, and the Tyvaso Inhalation System Instructions for Use manual.

For additional information about Tyvaso, visit www.tyvaso.com or call 1-877- UNITHER (1-877-864-8437).