Tyvaso® is the most widely prescribed inhalable prostanoid therapy for PAH.1 Tyvaso is 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%).
Count on Tyvaso
What You Should Know
When choosing a treatment option for your patients with PAH, it is important to evaluate the benefits and risks. There are several reasons why you may choose Tyvaso, including:
Benefits of Tyvaso
The ONLY inhalable prostanoid therapy approved as add-on to monotherapy
Improvement in 6MWD
After 1.7 years (mean) on oral monotherapy, adding Tyvaso for 12 weeks improved median 6 MWD by 20m (P<0.001)
4x Daily Dosing
Four times daily dosing that can be adjusted for planned activities
Individualized Titration for Patients
Administer between 3 to 9 breaths of Tyvaso per treatment session, four times daily.
If starting dose of 3 breaths is not tolerated, reduce to 1 to 2 breaths and subsequentaly increase to 3 breaths as tolerated
Warnings and Precautions
Patients with Pulmonary Disease or Pulmonary Infections The safety and efficacy of Tyvaso have not been established in patients with
significant underlying lung disease (eg, 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
Risk of Symptomatic Hypotension Treprostinil is a pulmonary and systemic vasodilator. In patients with low systemic arterial
pressure, treatment with Tyvaso may produce symptomatic hypotension
Patients with Hepatic or Renal Insufficiency Tyvaso should be titrated slowly in patients with hepatic or renal insufficiency,
because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function
Risk of Bleeding Since Tyvaso inhibits platelet aggregation, there may be an increased risk of bleeding, particularly among patients
receiving anticoagulant therapy
Effect of Other Drugs on Treprostinil Coadministration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (eg, gemfibrozil) may increase
exposure (both Cmax and AUC) to treprostinil. Coadministration of a CYP2C8 enzyme inducer (eg, rifampin) may decrease exposure to treprostinil. Increased
exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness
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
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