Important Patient Considerations

Before prescribing Tyvaso^®, you will need to know of all other medical conditions of your patient, including:

Lung disease, such as asthma or chronic obstructive pulmonary disease (COPD)
Lung infection
Liver problems or kidney problems
Low blood pressure
Pregnant or plan to become pregnant. It is not known if Tyvaso will harm an unborn baby. Women who can become pregnant should use effective birth control while taking Tyvaso.
Patients that are breast-feeding or plan to breast-feed. It is not known if Tyvaso passes into breast milk. Talk to your patients about the best way to feed their baby while taking Tyvaso

Tyvaso and other medicines may affect each other, so know of all of your patients prescriptions and non-prescription medicines, vitamins, and herbal supplements.

Make sure to ask patients if they take any of these medicines:

Anticoagulants
Diuretics
Antihypertensives or other drugs for heart disease
Gemfibrozil or other CYP2C8 inhibitors
Rifampin or other CYP2C8 inducers

It is not known if Tyvaso is safe or effective in people under 18 years of age.

What Are the Possible Adverse Events of Tyvaso?

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%).

Tyvaso can cause serious adverse events, including:

Increased risk of bleeding in people who take anticoagulants
A further drop in blood pressure in people who are hypotensive

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.

Important Safety Information for Tyvaso

Tyvaso is intended for oral inhalation only. Tyvaso is approved for use only with the Tyvaso Inhalation System
The safety and efficacy of Tyvaso have not been established in patients with significant underlying lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age. Patients with acute pulmonary infections should be carefully monitored to detect any worsening of lung disease and loss of drug effect
Tyvaso may increase the risk of bleeding, particularly in patients receiving anticoagulants
In patients with low systemic arterial pressure, Tyvaso may cause symptomatic hypotension. The concomitant use of Tyvaso with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension
Hepatic or renal insufficiency may increase exposure to Tyvaso and decrease tolerability. Tyvaso dosage adjustments may be necessary if inhibitors of CYP2C8 such as gemfibrozil or inducers such as rifampin are added or withdrawn
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%)
Tyvaso should be used in pregnancy only if clearly needed. Caution should be exercised when Tyvaso is administered to nursing women

For more information about Tyvaso, please see the Full Prescribing Information, Patient Package Insert, and the Tyvaso Inhalation System Instructions for Use Manual. Questions? Call the Customer Service Line at 1-877-UNITHER (1-877-864-8437).

Important Patient Considerations

What Are the Possible Adverse Events of Tyvaso?

Indication

Important Safety Information for Tyvaso

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