Note: This document contains side effect information about treprostinil. Some dosage forms listed on this page may not apply to the brand name Tyvaso DPI.

Applies to treprostinil: oral tablet extended release. Other dosage forms:

• inhalation powder, inhalation solution
• injection solution

Serious side effects of Tyvaso DPI

Along with its needed effects, treprostinil (the active ingredient contained in Tyvaso DPI) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking treprostinil:

More common

• Decreased urine
• dry mouth
• increased thirst
• irregular heartbeat
• muscle pain or cramps
• nausea or vomiting
• pain in the jaw, arms, or legs
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking treprostinil:

Symptoms of overdose

• Blurred vision
• confusion
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• headache, severe
• sweating

Other side effects of Tyvaso DPI

Some side effects of treprostinil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach discomfort
• diarrhea
• feeling of warmth
• headache
• redness of the face, neck, arms, and occasionally, upper chest

For Healthcare Professionals

Applies to treprostinil: inhalation powder, inhalation solution, injectable solution, oral tablet extended release.

General

Oral tablets: The most frequently reported side effects were headache, diarrhea, nausea, and flushing.

Oral inhalation: The most frequently reported side effects were cough, headache, diarrhea, nausea, dizziness, throat irritation, pharyngolaryngeal pain, and flushing.

Parenteral: The most frequently reported side effects were subcutaneous infusion site pain and reaction, headache, diarrhea, nausea, jaw pain, vasodilation, edema, and hypotension.^[Ref]

Local

Very common (10% or more): Infusion site pain (up to 85%), infusion site reaction (up to 83%), Infusion site bleeding/bruising (33.5%)

Frequency not reported: Induration, erythema, infusion site infection

Postmarketing reports: Subcutaneous infusion site abscess^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 30%), nausea (up to 30%)

Common (1% to 10%): Abdominal discomfort, rectal hemorrhage, melena, vomiting, abdominal pain, dyspepsia

Frequency not reported: Gastrointestinal bleeding^[Ref]

Nervous system

Very common (10% or more): Headache (up to 63%)

Common (1% to 10%): Syncope, paresthesia, dizziness^[Ref]

Cardiovascular

Very common (10% or more): Flushing (15%), vasodilation (up to 11%)

Common (1% to 10%): Hypotension, tachycardia, palpitation, hypertension, heart failure, bradycardia, hemorrhage

Frequency not reported: Systemic blood pressure decreased, pallor, right ventricular heart failure, supraventricular tachycardia, hematoma

Postmarketing reports: Thrombophlebitis^[Ref]

Dermatologic

Very common (10% or more): Rash (up to 83.1%), pruritus (up to 13.6%)

Common (1% to 10%): Contact dermatitis, sweating, ecchymosis, cellulitis

Uncommon (0.1% to 1%): Skin ulcer

Postmarketing reports: Angioedema, macular rash, popular rash^[Ref]

Musculoskeletal

Very common (10% or more): Pain in extremity (14%), pain in jaw (up to 13.1%)

Common (1% to 10%): Myalgia, back pain

Uncommon (0.1% to 1%): Neck pain, arthralgia, leg cramp, muscle pain

Postmarketing reports: Bone pain, muscle spasm^[Ref]

Respiratory

Very common (10% or more): Cough (54%), throat irritation/pharyngolaryngeal pain (25%)

Common (1% to 10%): Hypoxia, epistaxis, pharyngitis, dyspnea, sinusitis, pulmonary hypertension, rhinitis, hemoptysis

Uncommon (0.1% to 1%): Bronchitis

Frequency not reported: Wheezing, pneumonia^[Ref]

Other

Very common (10% or more): Pain (11.9%)

Common (1% to 10%): Edema, infection, flu syndrome, asthenia, overdose, chest pain, fever, peripheral edema

Uncommon (0.1% to 1%): Viral infection, malaise

Frequency not reported: Infection, fatigue, BUN decreased, LDH decreased, bilirubin decreased, swelling arm^[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, anorexia, dehydration, gout^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection^[Ref]

Hematologic

Common (1% to 10%): Anemia

Frequency not reported: Bleeding, thrombocytopenia, WBC decreased, RBC decreased, hemoglobin decreased, hematocrit decreased, eosinophils increased, platelet count increased^[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety, depression

Uncommon (0.1% to 1%): Nervousness^[Ref]