Description
Remodulin (treprostinil) is a prostacyclin analogue indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to diminish symptoms associated with exercise. It works by dilating pulmonary and systemic blood vessels, thereby reducing pulmonary vascular resistance and improving blood flow. Remodulin is administered either subcutaneously or intravenously and is typically used in patients who are intolerant of or whose condition is inadequately managed by oral therapies. It may also be used as a bridge to lung transplantation.
| Fact Table |
| Formula | C23H34O5 |
| License | US FDA |
| Bioavailability | 100% (subcutaneous and intravenous) |
| Legal status | Rx-only |
| Chemical Name | Treprostinil |
| Elimination half-life | 4.5 hours |
| Dosage (Strength) | 1 mg/mL, 2.5 mg/mL, 5 mg/mL, 10 mg/mL (continuous IV or SC infusion) |
| Pregnancy | Consult a doctor (Category B) |
| Brands | Remodulin, Tyvaso (inhaled), Orenitram (oral), Treprostinil Injection |
| Protein binding | 91% |
| PubChem CID | 6606184 |
| MedlinePlus | a608032 |
| ChEBI | 73675 |
| ATC code | B01AC21 |
| DrugBank | DB00374 |
| KEGG | D06042 |
| Routes of administration | Intravenous, Subcutaneous, Inhalation, Oral (extended-release) |
Directions
Remodulin should be initiated under the supervision of a healthcare provider experienced in the treatment of PAH. It is administered as a continuous subcutaneous or intravenous infusion via an infusion pump. Initial dosing generally starts at 1.25 ng/kg/min, with gradual titration based on clinical response and tolerability. The dose may be increased in increments of 1.25 ng/kg/min per week for the first four weeks, then 2.5 ng/kg/min per week thereafter. Transition from subcutaneous to intravenous delivery, or vice versa, must be done cautiously to avoid interruption of therapy.
Ingredients
Each mL of Remodulin contains:
- Treprostinil sodium (equivalent to 1, 2.5, 5, or 10 mg of treprostinil)
- Metacresol (preservative)
pH is adjusted with hydrochloric acid and/or sodium hydroxide.
Contraindications
Remodulin is contraindicated in patients with known hypersensitivity to treprostinil or any of the excipients in the formulation. Intravenous administration is contraindicated in patients with a history of pulmonary edema from congestive heart failure.
Cautions
Caution is advised in patients with hepatic or renal impairment, as treprostinil clearance may be reduced. Use with caution in patients with bleeding disorders or those taking anticoagulants due to an increased risk of bleeding. Abrupt discontinuation or sudden large dose reductions may lead to rebound PAH symptoms. Infections related to infusion site or catheter use are possible, particularly with intravenous administration. Proper aseptic technique must be strictly followed.
Side Effects
Common side effects of Remodulin include:
- Infusion site pain and reaction (especially with subcutaneous use)
Serious adverse effects may include bloodstream infections (particularly with IV administration), thrombocytopenia, and dose-related hypotension. Monitoring is required to mitigate risks.
IMPORTANT NOTE:
The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.
Product Code : 14619
Prescription Required