Classes
DEA Class; Rx
Common Brand Names; Remodulin, Orenitram
- PAH, Prostacyclin Analogs
treprostinil inhaled (Rx)
- Classes: PAH, Prostacyclin Analogs
Description
Analog of epoprostenol (prostacyclin) for treatment of pulmonary hypertension and pulmonary hypertension associated with interstitial lung disease
Given by inhalation (nebulizer solution or dry powder oral inhaler), continuous subcutaneous or IV infusion, and an oral extended-release tablet
Major advantage over IV epoprostenol is ease of use and less potential for serious infections
Indications
Indicated for the treatment of pulmonary hypertension and pulmonary hypertension-associated interstitial lung disease.
Indicated for treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability
Indicated for treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability
Contraindications
Extended-release tablets: Severe hepatic impairment (Child Pugh Class C)
Injectable: None
Adverse Effects
- Infusion site reaction, pain (80-85%)
- Headache (27-41%)
- Nausea (19-22%)
- Diarrhea (20-30%)
- Vasodilation (10-20%)
- Jaw pain (13%)
- Rash (10-20%)
- Dizziness 9%)
- Edema (9%)
- Pruritis (8%)
- Hypotension (4%)
Warnings
Hepatic/renal impairment (titrate up slowly); such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function
Use caution in patients with low arterial blood pressure (may produce symptomatic hypotension)
Do not take oral tablets with alcohol; faster release of treprostinil from the tablet may occur
The tablet shell does not dissolve and can lodge in a diverticulum in patients with diverticulosis
Abrupt withdrawal may worsen pulmonary arterial hypertension symptoms
Inhibits platelet aggregation and increases risk of bleeding; use caution in patients receiving concurrent anticoagulant/antiplatelet therapy
Indwelling central venous catherer associated with serious blood stream infections; use this method only in patients intolerant to the SC therapy
Experienced personnel required to administer therapy
Pregnancy and Lactation
Limited case reports of treprostinil insufficient to inform a drug-associated risk of adverse developmental outcomes; however, there are risks to mother and fetus associated with pulmonary arterial hypertension associated with an increased risk of maternal and fetal mortality; in animal studies, no adverse reproductive and developmental effects observed
There are no data on presence of treprostinil in human milk, effects on breastfed infant, or on milk production
Maximum Dosage
Titrate parenteral dose to patient response, doses up to 290 ng/kg/min have been studied; 12 breaths of solution for inhalation via oral inhalation/treatment session, given 4 times daily; titrate powder for inhalation to clinical response and tolerability, maximum dose not specified by manufacturer; titrate oral tablets to clinical response and tolerability, doses up to 21 mg PO twice daily have been studied.
Titrate parenteral dose to patient response, doses up to 290 ng/kg/min have been studied; 12 breaths of solution for inhalation via oral inhalation/treatment session, given 4 times daily; titrate powder for inhalation to clinical response and tolerability, maximum dose not specified by manufacturer; titrate oral tablets to clinical response and tolerability, doses up to 21 mg PO twice daily have been studied.
17 years and older: Titrate parenteral dose to patient response, doses up to 290 ng/kg/min have been studied; safe and effective use of the oral inhalation and tablets have not been established.
16 years and younger: Safe and effective use has not been not been established; however, mean doses of injectable treprostinil up to 86 ng/kg/min for chronic patients have been reported.
Safety and efficacy have not been established; however, mean doses of injectable treprostinil up to 86 ng/kg/min for chronic patients have been reported.
Safety and efficacy have not been established.
Safety and efficacy have not been established.