Tyvaso Side Effects Center

Last updated on RxList: 11/1/2021
Tyvaso Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Tyvaso?

Tyvaso (treprostinil) Inhalation Solution is a vasodilator used to treat pulmonary arterial hypertension (PAH). Tyvaso improves your ability to exercise and prevents your condition from getting worse.

What Are Side Effects of Tyvaso?

Common side effects of Tyvaso include:

  • cough
  • headache
  • sore throat
  • throat irritation or pain after use
  • nausea
  • flushing
  • dizziness
  • diarrhea
  • jaw/muscle/bone pain
  • flushing (warmth, redness, or tingling)
Fainting is another common side effect of Tyvaso. If fainting occurs after taking Tyvaso, get medical help right away.

Dosage for Tyvaso

The initial adult dosage of Tyvaso therapy should begin with 3 breaths of Tyvaso (18 mcg of treprostinil), per treatment session, 4 times daily. If 3 breaths are not tolerated, reduce to 1 or 2 breaths and subsequently increase to 3 breaths, as tolerated.

What Drugs, Substances, or Supplements Interact with Tyvaso?

Tyvaso may interact with gemfibrozil, delavirdine, nicardipine, pioglitazone, tolbutamide, antibiotics, antifungals, blood pressure medications, blood thinners, diuretics, medications to treat congestive heart failure, NSAIDs (non-steroidal anti-inflammatory drugs), seizure medications, or sulfa drugs. Tell your doctor all medications and supplements you use.

Tyvaso During Pregnancy and Breastfeeding

During pregnancy, Tyvaso should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Tyvaso (treprostinil) Inhalation Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Salt and sodium are the same. See Answer
Tyvaso Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • easy bruising or bleeding (nosebleeds, bleeding gums), or any bleeding that will not stop;
  • unexpected vaginal bleeding;
  • coughing up blood or vomit that looks like coffee grounds; or
  • blood in your urine or stools, black or tarry stools.

Common side effects may include:

  • cough, sore throat;
  • pain or irritation in your throat after use;
  • dizziness or feeling light-headed;
  • nausea, diarrhea;
  • headache; or
  • flushing (warmth, redness or tingling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tyvaso (Treprostinil Inhalation Solution)

SLIDESHOW

How to Lower Blood Pressure: Exercise Tips See Slideshow
Tyvaso Professional Information

SIDE EFFECTSThe following potential adverse reactions are described in WARNINGS AND PRECAUTIONS:

  • Decrease in systemic blood pressure [see WARNINGS AND PRECAUTIONS].
  • Bleeding [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Pulmonary Arterial Hypertension

In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most commonly reported adverse reactions on Tyvaso included cough and throat irritation, headache, gastrointestinal effects, muscle, jaw or bone pain, dizziness, flushing, and syncope. Table 1 lists the adverse reactions that occurred at a rate of at least 4% and were more frequent in patients treated with Tyvaso than with placebo.

Table 1: Adverse Events in ≥4% of PAH Patients Receiving Tyvaso and More Frequenta than Placebo in TRIUMPH I

Adverse Event Treatment n (%)
Tyvaso
n=115
Placebo
n=120
Cough 62 (54) 35 (29)
Headache 47 (41) 27 (23)
Throat Irritation / Pharyngolaryngeal Pain 29 (25) 17 (14)
Nausea 22 (19) 13 (11)
Flushing 17 (15) 1 (<1)
Syncope 7 (6) 1 (<1)
a More than 3% greater than placebo

The safety of Tyvaso was also studied in a long-term, open-label extension study in which 206 patients were dosed for a mean duration of 2.3 years, with a maximum exposure of 5.4 years. Eighty-nine percent (89%) of patients achieved the target dose of 9 breaths, 4 times daily. Forty-two percent (42%) achieved a dose of 12 breaths, 4 times daily. The adverse events during this chronic dosing study were qualitatively similar to those observed in the 12-week placebo-controlled trial.

In a prospective, observational study comparing patients taking Tyvaso (958 patient-years of exposure) and a control group (treatment with other approved therapies for PAH; 1094 patient-years), Tyvaso was associated with a higher rate of cough (16.2 vs. 10.9 per 100 patient-years), throat irritation (4.5 vs. 1.2 per 100 pt-years), nasal discomfort (2.6 vs. 1.3 per 100 pt-years), and hemoptysis (2.5 vs. 1.3 per 100 pt-years) compared to the control group.

Pulmonary Hypertension Associated With ILD

In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (WHO Group 3), adverse reactions were similar to the experience in studies of PAH.

Post-Marketing Experience

The adverse reaction of angioedema has been identified during the post-approval use of Tyvaso. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

DRUG INTERACTIONS

Bosentan

In a human pharmacokinetic study conducted with bosentan (250 mg/day) and an oral formulation of treprostinil (treprostinil diolamine), no pharmacokinetic interactions between treprostinil and bosentan were observed.

Sildenafil

In a human pharmacokinetic study conducted with sildenafil (60 mg/day) and an oral formulation of treprostinil (treprostinil diolamine), no pharmacokinetic interactions between treprostinil and sildenafil were observed.

Effect Of Cytochrome P450 Inhibitors And Inducers

In vitro studies of human hepatic microsomes showed that treprostinil does not inhibit cytochrome P450 (CYP) isoenzymes CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A. Additionally, treprostinil does not induce cytochrome P450 isoenzymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A.

Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both Cmax and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8 [see WARNINGS AND PRECAUTIONS].

Effect Of Other Drugs On Treprostinil

Drug interaction studies have been carried out with treprostinil (oral or subcutaneous) co-administered with acetaminophen (4 g/day), warfarin (25 mg/day), and fluconazole (200 mg/day), respectively, in healthy volunteers. These studies did not show a clinically significant effect on the pharmacokinetics of treprostinil. Treprostinil does not affect the pharmacokinetics or pharmacodynamics of warfarin. The pharmacokinetics of R-and S-warfarin and the international normalized ratio (INR) in healthy subjects given a single 25 mg dose of warfarin were unaffected by continuous subcutaneous infusion of treprostinil at an infusion rate of 10 ng/kg/min.

Read the entire FDA prescribing information for Tyvaso (Treprostinil Inhalation Solution)

© Tyvaso Patient Information is supplied by Cerner Multum, Inc. and Tyvaso Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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