Ruinier® is the commercial brand name of Treprostinil Injection, a synthetic prostacyclin analog developed by Zhaoke Pharmaceutical. It activates prostacyclin receptors to induce pulmonary and systemic vasodilation, inhibit platelet aggregation, reverse vascular remodeling, reduce pulmonary artery pressure and right heart load to improve exercise tolerance for pulmonary hypertension patients. This preparation is administered via subcutaneous injection or intravenous infusion only.
Main Indications
Long-term treatment for adult patients with pulmonary arterial hypertension (PAH, WHO Group 1) to improve exercise capacity;
For patients with moderate to severe pulmonary arterial hypertension to relieve dyspnea and fatigue during physical activity.
Clinical Research
Global multicenter Phase III pivotal trials verified that continuous treprostinil injection significantly improved 6-minute walking distance, hemodynamic parameters and long-term survival for patients with moderate-to-severe pulmonary arterial hypertension;
Bioequivalence clinical trials for domestic generic treprostinil injection demonstrated consistent pharmacokinetic characteristics, efficacy and safety compared with the original reference formulation Remodulin;
Long-term follow-up clinical studies confirmed sustained hemodynamic improvement and reduced clinical deterioration risk with prolonged parenteral treprostinil treatment.
Common Side Effects
Common adverse reactions at injection site: pain, erythema, induration, bruising for subcutaneous administration;
Systemic adverse reactions include headache, diarrhea, nausea, jaw pain, flushing, peripheral edema;
Severe rare adverse events involve hypotension, hemorrhage, right heart failure aggravation; most adverse reactions are dose-dependent and can be relieved by dose titration and symptomatic management.
Approval Status in China
Ruinier® (Treprostinil Injection, specification 20mL:20mg, 1 vial per box) has passed generic drug consistency evaluation and obtained marketing approval from the National Medical Products Administration (NMPA), serving as a domestic generic alternative for long-term parenteral treatment of pulmonary arterial hypertension.
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