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REMODULIN (treprostinil sodium) Injection is approved as a continuous subcutaneous infusion for the treatment of pulmonary arterial hypertension (PAH) in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise.
The use of REMODULIN requires attention to the following:
- REMODULIN should be used only by doctors experienced in the diagnosis and treatment of PAH.
- REMODULIN therapy must be started in a setting with adequate personnel/equipment for monitoring and emergency care. REMODULIN is a potent pulmonary and systemic vasodilator, which causes the blood vessels to widen.
- Subcutaneous (or directly into the skin) therapy with REMODULIN may be used for prolonged periods, and the patient's ability to administer REMODULIN and care for an infusion system should be carefully considered.
- Abrupt withdrawal or sudden large reductions in dosage of REMODULIN may result in worsening of PAH symptoms and should be avoided.
- Reduction in blood pressure caused by REMODULIN may be aggravated by drugs that also reduce blood pressure, such as diuretics, antihypertensives, or vasodilators. There is also a potential for increased bleeding risk when REMODULIN is given to patients on anticoagulants (blood-thinning
agents) due to REMODULIN's ability to inhibit platelet aggregation (or blood clotting).