Treprostinil Side Effects

Some side effects of treprostinil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to treprostinil: inhalation solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking treprostinil: 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 of treprostinil may include:

• cough, sore throat;

• pain or irritation in your throat after use;

• dizziness;

• nausea, diarrhea;

• headache or jaw pain; 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.

For Healthcare Professionals

Applies to treprostinil: inhalation solution, injectable solution

General

In general, the most common adverse effects have included infusion site pain and reactions.

Local

Local adverse effects have included infusion site pain (85%) and infusion site reactions (83%) such as erythema, induration, or rash. These effects were classified as severe in 39% and 38% of patients, respectively.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (25%), nausea (22%), and vomiting.

Nervous system

Nervous system side effects have included headache (27%), dizziness (9%), and insomnia.

Cardiovascular

Cardiovascular side effects have included vasodilatation (11%), edema (9%), hypotension (4%), bradycardia, syncope, and flushing.

Dermatologic

Dermatologic reactions have included rash (14%) and pruritus (8%).

Musculoskeletal

Musculoskeletal side effects have included jaw pain (13%).

Other

Complications associated with infusion systems were related to the pump (93%) or to the infusion set (7%). Side effects were reported in 8 patients (4 treprostinil and 4 placebo), including nausea (due to excess drug) and dyspnea (due to return of pulmonary arterial hypertension symptoms).

The following adverse events may be attributable to the IV mode of infusion including arm swelling, paresthesias, hematoma and pain. Using an indwelling central venous catheter to deliver chronic intravenous infusions of treprostinil is associated with the risk of blood stream infections and sepsis, which may be fatal.

Other side effects have included jaw pain and foot pain.

Respiratory

Respiratory side effects of inhaled treprostinil have included cough, throat irritation, and pharyngolaryngeal pain.

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