ORENITRAM Treprostinil Application Scope

Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to delay disease progression and improve exercise capacity, particularly in patients with WHO functional class II–III symptoms, including idiopathic/heritable PAH (~66%) and PAH associated with connective tissue disease (~26%).

ORENITRAM Treprostinil Characteristics

Ingredients: Treprostinil
Properties: Sterile solution for subcutaneous or intravenous infusion
Packaging Specification:
- Available in 20 mL multi-dose vials
- Each vial contains 20 mg of treprostinil
Storage: Store at room temperature (20-25°C or 68-77°F), with excursions permitted between 15-30°C (59-86°F)
Expiry Date: Typically 24 months from the date of manufacture, but refer to the packaging for the exact expiration date
Executive Standard: Manufactured under FDA approval and complies with USP standards
Approval Number: NDA 203496
Date of Revision: Approved on December 20, 2019. Revisions may occur; refer to the latest prescribing information
Manufacturer: United Therapeutics Corporation

Guidelines for the Use of ORENITRAM Treprostinil

Dosage and Administration:
- Recommended Dose:
  - Initial dose: 1.25 ng/kg/min administered subcutaneously or intravenously
  - Titrate to effect, based on clinical response and tolerability
- Administration:
  - Administer via continuous subcutaneous or intravenous infusion
  - Dilute with sterile 0.9% sodium chloride solution or water for injection prior to intravenous use
- Missed Dose:
  - If a dose is missed, administer as soon as possible
  - Do not double the dose to make up for a missed dose
Adverse Reactions:
- Common Adverse Reactions: Arthralgia, pain, nausea, dizziness, headache, fatigue, depression
- Serious Adverse Reactions:
  - Abrupt discontinuation or large dose reductions may cause worsening of PAH symptoms
  - In patients with diverticulosis, tablet shells may lodge in diverticula
Contraindications: Severe hepatic impairment (Child–Pugh class C)
Precautions:
- Use with caution in patients with low blood pressure, liver impairment, or bleeding disorders
- Monitor for signs of hypotension and bleeding
- Avoid abrupt discontinuation; gradual dose reduction is recommended

ORENITRAM Interactions

Drug Interactions:
- Concomitant use with other vasodilators or antihypertensive agents may potentiate the hypotensive effect
- Increased risk of bleeding when used with anticoagulants
Food Interactions:
- Absorption may be increased when administered following a high-fat, high-calorie meal

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.