What are the most common side effects of TREPROSTINIL?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for TREPROSTINIL. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is TREPROSTINIL the same as Treprostinil?

Treprostinil is a brand name for TREPROSTINIL. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

TREPROSTINIL

Q: What is TREPROSTINIL used for?

TREPROSTINIL (brand name Treprostinil) is a Other indicated for 1 INDICATIONS AND USAGE Treprostinil injection is a prostacyclin mimetic indicated for: • Treatment of pulmonary arterial hypertension (PAH, PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). ( 1.1 ) • Patients who require transition from epoprostenol.

Q: How does TREPROSTINIL work?

TREPROSTINIL works through the following mechanism: 12.1 Mechanism of Action The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation..

Other

Brand names: Treprostinil, DILUENT

Intravenous, Subcutaneous

Mechanism of Action

12.1 Mechanism of Action The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation.

Indications

1 INDICATIONS AND USAGE Treprostinil injection is a prostacyclin mimetic indicated for: • Treatment of pulmonary arterial hypertension (PAH

PAH associated with congenital systemic-to-pulmonary shunts (23%)

or PAH associated with connective tissue diseases (19%). ( 1.1 ) • Patients who require transition from epoprostenol

PAH associated with congenital systemic-to-pulmonary shunts (23%)

treprostinil injection is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

Contraindications

• 4 CONTRAINDICATIONS None None

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Chronic intravenous infusions delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal
4 ) • Treprostinil injection inhibits platelet aggregation and increases the risk of bleeding
1 Risk of Catheter-Related Bloodstream Infection Chronic intravenous infusions of treprostinil injection are delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal
4 Risk of Symptomatic Hypotension Treprostinil is a pulmonary and systemic vasodilator

Known Side Effects

11 documented side effects by frequency

Shortness of Breath

>10%

Headache

>10%

Diarrhea

1-10%

Nausea

1-10%

Cough

1-10%

Dizziness

1-10%

Fatigue

1-10%

Vomiting

0.1-1%

Low Blood Pressure

0.1-1%

General Unwellness

0.1-1%

Limb Pain

0.1-1%

Community Discussions

No community discussions found for TREPROSTINIL yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → TREPROSTINIL openFDA label JSON → TREPROSTINIL FAERS adverse-event reports → TREPROSTINIL ClinicalTrials.gov → completed Phase 2+ trials of TREPROSTINIL

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Formulations

Dosage Forms

Tablet

Route

Intravenous, Subcutaneous