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 US Healthcare Professionals Only

Tyvaso Inhalation System

Tyvaso is delivered noninvasively, directly to the lungs

Ultrasonic nebulizers deliver directly to distal airspaces that are in close proximity to pulmonary arterioles affected in PAH.1

TD-300—Redesigned with your patients in mind

In addition to the features found in the TD-100 device (eg, lightweight portability, 1 ampule per day, once-daily setup, end-of-day cleaning), the ergonomic TD-300 Tyvaso Inhalation System features user-friendly enhancements designed to simplify the dosing process for Tyvaso2-4:

  • Internal battery for cordless use during the day
    (8 hours until full charge when plugged in)2
  • Full-color display2
  • Volume adjuster2
Product image: TD-300 Tyvaso Inhalation System
Getting Started
How to Assemble
How to Use
How to Clean
How to Store

 

TD-100 Tyvaso Inhalation System

The TD-100 Tyvaso Inhalation System is a portable, lightweight nebulizer used to inhale and administer Tyvaso, a direct-to-the-lungs prostacyclin analogue.3,4

  • Once-daily set-up4
  • Only 1 plastic ampule needed per day regardless of dose4
  • Once-daily cleaning4
Product image: Tyvaso Inhalation System
Getting Started
How to Assemble
How to Use
How to Clean
How to Store

For complete, step-by-step instructions on proper assembly, use, and care of the TD-300 Tyvaso Inhalation System, patients should refer to the TD-300 Instructions for Use manual. For information about the TD-100 Tyvaso Inhalation System, patients should refer to the TD-100 Instructions for Use manual.

Transition Period

Beginning summer 2018, patients who receive a referral for Tyvaso will receive the TD-300 device. Beginning fall 2018, existing Tyvaso patients will be transitioned to the TD-300 device when they are eligible for their 2-year device replacement. Our goal is for all Tyvaso patients to be transitioned to the TD-300 device by mid-2019.

Your patient's specialty pharmacy will handle their transition to the new TD-300 device with no additional paperwork required from you or your office.

TD-300 Tyvaso Inhalation System Brochure

Photo of the TD-300 Tyvaso Inhalation System Brochure

This brochure has detailed information about the TD-300 device, including an in-depth
comparison with the previous TD-100 model.

Download

IMPORTANT SAFETY INFORMATION FOR TYVASO

WARNINGS AND PRECAUTIONS
DRUG INTERACTIONS / SPECIFIC POPULATIONS
ADVERSE REACTIONS

INDICATION

Tyvaso (treprostinil) 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.

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Please see the Full Prescribing Information, Patient Product Information, and the TD-100 and TD-300 Tyvaso Inhalation System Instructions for Use manuals.

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

References: 1. Channick RN, Voswinckel R, Rubin LJ. Inhaled treprostinil: a therapeutic review. Drug Des Devel Ther. 2012;6:19-28. 2. Tyvaso [instructions for use manual]. Research Triangle Park, NC: United Therapeutics Corporation; 2017. 3. Tyvaso [instructions for use manual]. Research Triangle Park, NC: United Therapeutics Corporation; 2014. 4. Tyvaso [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2017.

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
  • 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
  • Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production
  • Safety and effectiveness in pediatric patients have not been established
ADVERSE REACTIONS
  • The most common adverse reactions 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%). In addition, adverse reactions occurring in ≥10% of patients were dizziness and diarrhea

INDICATION

Tyvaso (treprostinil) 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.

TYVISIhcpOCT17

Please see the Full Prescribing Information, Patient Product Information, and the TD-100 and TD-300 Tyvaso Inhalation System Instructions for Use manuals.

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