"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
Tyvaso Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
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. Common side effects of Tyvaso include:
- sore throat
- throat irritation or pain after use
- jaw/muscle/bone pain
- flushing (warmth, redness, or tingling)
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. 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. During pregnancy, Tyvaso should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Tyvaso in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin;
- feeling like you might pass out;
- fever, chills, cough with yellow or green mucus, stabbing chest pain, wheezing;
- unusual bleeding such as nosebleeds, bleeding gums, or any bleeding that will not stop;
- pale skin, weakness, easy bruising;
- unexpected vaginal bleeding;
- blood in your urine or stools, black or tarry stools;
- coughing up blood or vomit that looks like coffee grounds; or
- swelling of your ankles or feet.
Less serious side effects may include:
- cough, sore throat;
- pain or irritation in your throat after use;
- nausea, diarrhea;
- headache or jaw pain; or
- flushing (warmth, redness or tingling).
Read the entire detailed patient monograph for Tyvaso (Treprostinil Inhalation Solution)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Tyvaso Overview - Patient Information: Side Effects
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual bleeding/bruising.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Tyvaso (Treprostinil Inhalation Solution)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tyvaso FDA Prescribing Information: Side Effects
The following potential adverse reactions are described in WARNINGS AND PRECAUTIONS:
- Decrease in systemic blood pressure [see WARNINGS AND PRECAUTIONS].
- Bleeding [see WARNINGS AND PRECAUTIONS].
Adverse Reactions Identified In Clinical Trials
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.
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, 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 Frequent ≥ than Placebo
n = 115
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)|
|*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 (89%) percent of patients achieved the target dose of nine breaths, four times daily. Forty-two (42%) percent achieved a dose of 12 breaths four times daily. The adverse events during this chronic dosing study were qualitatively similar to those observed in the 12-week placebo controlled trial.
Adverse Events Associated with Route of Administration
Adverse events in the treated group during the double-blind and open-label phase reflecting irritation to the respiratory tract included: cough, throat irritation, pharyngeal pain, epistaxis, hemoptysis and wheezing. Serious adverse events during the open-label portion of the study included pneumonia in fifteen subjects. There were three serious episodes of hemoptysis (one fatal) noted during the open-label experience.
Adverse Reactions Identified In Post-Marketing Experience
The following adverse reaction has been identified during the postapproval 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:
Read the entire FDA prescribing information for Tyvaso (Treprostinil Inhalation Solution)
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