REMODULIN 10 MG

What is REMODULIN?

REMODULIN 10 MG contains TREPROSTINIL (TREPROSTINIL SODIUM) : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02246555, held by UNITED THERAPEUTICS CORPORATION, supplied as SOLUTION for INTRAVENOUS ; SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 07-Oct-2005. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is REMODULIN used for?

Remodulin (treprostinil) Injection is indicated for the long-term, subcutaneous or intravenous treatment of pulmonary arterial hypertension (PAH) in NYHA Class III and IV patients who did not respond adequately to conventional therapy. Remodulin should be used only by clinicians experienced in the diagnosis and treatment of PAH. Remodulin is a potent pulmonary and systemic vasodilator. Initiation of Remodulin must be performed in a setting with adequate personnel and equipment for physiological monitoring and emergency care. Remodulin is infused continuously through a subcutaneous or surgically placed indwelling central venous catheter. 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. In order to reduce the risk of infection, aseptic technique must be used in the preparation and administration of Remodulin.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Remodulin is administered by continuous subcutaneous or continuous intravenous infusion. Remodulin is preferably infused subcutaneously, but can be administered by a central intravenous line if the subcutaneous route is not tolerated, because of severe site pain or reaction. The infusion rate is initiated at 1.25 ng/kg/min. If this initial dose cannot be tolerated, because of systemic effects, reduce the infusion rate to 0.625 ng/kg/min. Dosage Adjustments: The goal of chronic dosage adjustments is to establish a dose at which PAH symptoms are improved, while minimizing excessive pharmacologic effects of Remodulin (headache, nausea, emesis, restlessness, anxiety and infusion site pain or reaction). The infusion rate should be increased in increments of 1.25 ng/kg/min per week for the first four weeks of treatment and then 2.5 ng/kg/min per week for the remaining duration of infusion depending on clinical response. Dosage adjustment may be undertaken more often if tolerated and adjusted based on PAH signs and symptoms and Remodulin side effects. Dose-related symptoms may necessitate a decrease in infusion rate; however, the event may resolve without dosage adjustment. Should an adverse event worsen and/or become intolerable, the infusion rate should be reduced, or infusion should be discontinued. Abrupt cessation of infusion should be avoided (See WARNINGS AND PRECAUTIONS). Restarting a Remodulin infusion within a few hours after interruption can be done using the same dose rate. Interruptions for longer periods may require the dose of Remodulin to be re-titrated. Remodulin can be administered without further dilution for subcutaneous administration, or diluted for intravenous infusion with 0.9% Sodium Chloride Injection or Sterile Water for Injection at concentrations as low as 0.004 mg/mL prior to administration.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Remodulin should be stored at room temperature at 15° to 30°C. A single vial of Remodulin should be used for no more than 30 days after the initial puncture of the rubber stopper. Remodulin can be administered without further dilution for subcutaneous administration, or diluted for intravenous infusion with Sterile Water for Injection, or 0.9% Sodium Chloride Injection prior to administration to concentrations as low as 0.004 mg/mL. For SC administration, undiluted Remodulin can be administered up to 72 hours at 37°C. For IV administration, diluted Remodulin is stable for up to 48 hours at 40°C or 24 hours refrigerated.

How is it supplied?

Remodulin Injection is supplied in 20 mL multi-use vials at concentrations of 1.0 mg/mL, 2.5 mg/mL, 5.0 mg/mL, and 10.0 mg/mL of treprostinil for subcutaneous or intravenous use.

Contraindications

Remodulin is contraindicated in patients with known hypersensitivity to the drug, any of its excipients, or to structurally related compounds. For a complete listing of Remodulin excipients, see the Dosage Forms, Composition and Packaging section of the product monograph.

Warnings and precautions

General Conditions of Use: Remodulin is a potent pulmonary and systemic vasodilator. Remodulin is indicated for subcutaneous or intravenous use only. Remodulin should be used only by clinicians experienced in the diagnosis and treatment of PAH. Dosage adjustments in clinical trials were based on the patient's signs and symptoms of PAH and side effects of Remodulin. Dosage of Remodulin should be adjusted at the first sign of recurrence or worsening of symptoms attributable to PAH or the occurrence of intolerable adverse events associated with Remodulin. The decision to initiate therapy with Remodulin should be based on the understanding that there is a high likelihood that subcutaneous or intravenous therapy with Remodulin will be needed for prolonged periods, possibly years, and the patient's ability to administer Remodulin and care for an infusion system should be carefully considered. As with any potent vasodilator, abrupt withdrawal or sudden large reductions in dosage of Remodulin may result in worsening of PAH symptoms. Avoid abrupt withdrawal of Remodulin if at all possible. Although in clinical trials, no patient death from discontinuation of Remodulin was judged directly attributable to the interruption of the drug, 2 of 11 patients who abruptly discontinued subcutaneous Remodulin therapy died within 24 hours. Although their death may have been related to their deteriorating clinical condition, it seems most appropriate to wean patients from Remodulin. Only 3 of 55 (5%) patients with abrupt disruption of Remodulin developed increased symptoms of PAH, and no patients developed hemodynamic instability. In addition, among patients who discontinued Remodulin abruptly, no relationship has been established between abrupt discontinuation and rebound pulmonary hypertension. Risk of Catheter-Related Blood Stream Infections: Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion (undiluted) is the preferred mode of administration.

What can be used instead?

Other Canadian products sharing ATC code B01AC21 TREPROSTINIL. 4 of 8 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies TREPROSTINIL worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. TREPROSTINIL appears in 105 registered pack listings across 12 markets, published on 9 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.