SUPPORTABLE

Important Safety Information Full Prescribing Information Patient Package Insert Instructions For Use

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Patient Assistance

ASSISTThere are a number of assistance programs available to help your patients obtain their medication, if they qualify. To find the program that best meets their needs, we have created ASSIST, your Access Solutions and Support Team. Now, there is one number to call to get answers to questions regarding how your patients can obtain their medications and supplies.

One Number for All Product Access Needs: 1-877-UNITHER (1-877-864-8437)

At 1-877-UNITHER (1-877-864-8437), our ASSIST Advisors will talk with your office staff, or directly with your patients, to help resolve issues and manage cases until completion.

All patients can utilize the ASSIST Program:

  • Patients with insurance
    Patients with either private or governmental insurance coverage may qualify for one of the available co-pay assistance options.
  • Patients without insurance
    We may be able to help obtain medication and supplies for eligible patients who cannot afford therapy, are not adequately insured, or are close to the lifetime limit of their current insurance policy.*
  • Patients with interrupted coverage
    We may be able to assist eligible patients in obtaining continued medication coverage, at a reasonable cost or no cost at all, if they experience a temporary interruption of therapy caused by a gap in their insurance coverage.*

By calling 1-877-UNITHER (1-877-864-8437), our ASSIST Advisors can also help verify insurance benefits, assist with submissions of prior authorization documentation, provide guidance for pharmacy claim denials and appeals, collaborate with Specialty Pharmacy Service Providers, and much more.

ASSIST your patients with financial solutions and support.

* Patients must meet certain eligibility criteria to qualify for assistance.

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).

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