Trade Name: Remodulin

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: United Therapeutics Corporation

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 20 mg/20mL

Storage and handling

TREPROSTINIL Prostacycline Vasodilator [EPC],Prostaglandins I [CS],Vasodilation [PE]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • No data
  • Remodulin is a prostacyclin vasodilator indicated for:
  • Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). ()
  • Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. ()
  • PAH WHO Group 1 in patients with NYHA Class II-IV symptoms
  • Transition from Epoprostenol
  • Increase the Remodulin dose gradually as the epoprostenol dose is decreased, based on constant observation of response. ()
  • Administration
  • Continuous subcutaneous infusion is the preferred mode. Use intravenous (IV) infusion if subcutaneous infusion is not tolerated. (, )
  • Initial dose for patients new to prostacyclin infusion therapy: 1.25 ng/kg/min; increase based on clinical response (increments of 1.25 ng/kg/min per week for the first 4 weeks of treatment, later 2.5 ng/kg/min per week). Avoid abrupt cessation. (, )
  • Mild to moderate hepatic insufficiency: Decrease initial dose to 0.625 ng/kg/min.Severe hepatic insufficiency: No studies performed. ()
  • 20-mL vial containing 20 mg treprostinil (1 mg per mL).
  • 20-mL vial containing 50 mg treprostinil (2.5 mg per mL).
  • 20-mL vial containing 100 mg treprostinil (5 mg per mL).
  • 20-mL vial containing 200 mg treprostinil (10 mg per mL).
  • Remodulin is supplied in 20 mL vials containing 20, 50, 100, or 200 mg of treprostinil (1, 2.5, 5 or 10 mg/mL). ()
  • None
  • None
  • No data
  • Chronic intravenous infusions delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal. ()
  • Do not abruptly lower the dose or withdraw dosing. ()
  • Remodulin may cause symptomatic hypotension. ()
  • Remodulin inhibits platelet aggregation and increases the risk of bleeding. ()
  • The following adverse reactions are discussed elsewhere in labeling: Infections associated with intravenous administration .
  • Most common adverse reactions (incidence >3%) reported in clinical studies with Remodulin: subcutaneous infusion site pain and reaction, headache, diarrhea, nausea, jaw pain, vasodilatation, edema, and hypotension. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact United Therapeutics Corp. at 1-866-458-6479 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Dose adjustment of treprostinil may be necessary when co-administered with CYP2C8 inducers or inhibitors. Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor gemfibrozil increases exposure (both C and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer rifampin decreases exposure to treprostinil. It has not been determined if the changes in exposure of treprostinil with inhibitors or inducers of CYP2C8 observed for the oral administration of treprostinil would be similar for treprostinil administered via the parenteral route n
  • Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. ()
  • No data
  • Signs and symptoms of overdose with Remodulin during clinical trials are extensions of its dose-limiting pharmacologic effects and include flushing, headache, hypotension, nausea, vomiting, and diarrhea. Most events were self-limiting and resolved with reduction or withholding of Remodulin.
  • In controlled clinical trials using an external infusion pump, seven patients received some level of overdose and in open-label follow-on treatment seven additional patients received an overdose; these occurrences resulted from accidental bolus administration of Remodulin, errors in pump programmed rate of administration, and prescription of an incorrect dose. In only two cases did excess delivery of Remodulin produce an event of substantial hemodynamic concern (hypotension, near-syncope).
  • One pediatric patient was accidentally administered 7.5 mg of Remodulin via a central venous catheter. Symptoms included flushing, headache, nausea, vomiting, hypotension and seizure-like activity with loss of consciousness lasting several minutes. The patient subsequently recovered.
  • Remodulin (treprostinil) Injection is a sterile solution of treprostinil formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20 mL multidose vials in four strengths, containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL strength which contains 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2.
  • Treprostinil is chemically stable at room temperature and neutral pH.
  • Treprostinil is (1,2,3a,9a)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3)-3-hydroxyoctyl]-1-benz[]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of CHO.
  • The structural formula of treprostinil is:
  • Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50 mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection.
  • No data
  • A two-year rat carcinogenicity study was performed with treprostinil inhalation at target doses of 5.26, 10.6, and 34.1 mcg/kg/day. There was no evidence for carcinogenic potential associated with treprostinil inhalation in rats at systemic exposure levels up to about 34 and 1 times the human exposure, when based on C and AUC of the average subcutaneous infusion rate achieved in clinical trials, respectively. and genetic toxicology studies did not demonstrate any mutagenic or clastogenic effects of treprostinil. Treprostinil sodium did not affect fertility or mating performance of male or female rats given continuous subcutaneous (sc) infusions at rates of up to 450 ng treprostinil/kg/min [about 59 times the recommended starting human sc infusion rate (1.25 ng/kg/min) and 8 times the average rate (9.3 ng/kg/min) achieved in clinical trials, on a ng/m basis]. In this study, males were dosed from 10 weeks prior to mating and through the 2-week mating period. Females were dosed from 2 weeks prior to mating until gestational day 6.
  • Treprostinil diolamine did not demonstrate any carcinogenic effects in mouse or rat carcinogenicity studies. Oral administration of treprostinil diolamine to Tg.rasH2 mice at 0, 5, 10 and 20 mg/kg/day in males and 0, 3, 7.5 and 15 mg/kg/day in females daily for 26 weeks did not significantly increase the incidence of tumors. The exposures, when based on AUC, obtained at the highest dose levels used in males and females are about 7- and 15-fold, respectively, the human exposure of the average subcutaneous infusion rate achieved in clinical trials. Oral administration of treprostinil diolamine to Sprague Dawley rats at 0, 1, 3 and 10 mg/kg/day daily for 104 weeks did not significantly increase the incidence of tumors. The exposures obtained at the highest dose levels used in males and females are about 18- and 26-fold, respectively, the human exposure of the average subcutaneous infusion rate achieved in clinical trials.
  • Treprostinil diolamine was tested in a rat micronucleus assay and did not induce an increased incidence of micronucleated polychromatic erythrocytes.
  • No data
  • Remodulin is supplied in 20-mL multidose vials as sterile solutions in water for injection, individually packaged in cartons. Unopened vials of Remodulin are stable until the date indicated when stored at 25u00b0C (77u00b0F), with excursions permitted to 2-30u00b0C (36-86u00b0F). A single vial of Remodulin should be used for no more than 30 days after the initial introduction into the vial.
  • Remodulin Injection is supplied as:
  • Sterile Diluent for Remodulin is supplied separately as:
  • 50 mL vial, carton of 1 (NDC 66302-150-50).
  • No data
  • REMODULIN manufactured for:
  • United Therapeutics Corp.Research Triangle Park, NC 27709
  • REMODULINn (treprostinil) Injection
  • 20 mg/20 mL(1 mg/mL)
  • For Subcutaneous orIntravenous Infusion Only
  • 20 mL multidose vial
  • UnitedTherapeutics CORPORATION
  • REMODULINn (treprostinil) Injection
  • 50 mg/20 mL(2.5 mg/mL)
  • For Subcutaneous or Intravenous Infusion Only
  • 20 mL multidose vial
  • United Therapeutics CORPORATION
  • REMODULINn (treprostinil) Injection
  • 100 mg/20 mL (5 mg/mL)
  • For Subcutaneous or Intravenous Infusion Only
  • 20 mL multidose vial
  • United Therapeutics CORPORATION
  • REMODULINn (treprostinil) Injection
  • 200 mg/20 mL (10 mg/mL)
  • For Subcutaneous or Intravenous Infusion Only
  • 20 mL multidose vial
  • United Therapeutics CORPORATION
  • NDC 66302-150-50
  • STERILE DILUENTFOR REMODULINn 1 x 50mLVIAL
  • Contains drug diluent for use only with intravenousinfusion of REMODULIN (treprostinil) Injection
  • Each vial contains 94 mg glycine, 73.3 mgsodium chloride, sodium hydroxide (addedto adjust pH), and Water for Injection.
  • For dilution information see package insertfor REMODULIN (treprostinil) Injection.
  • Store at 20 - 25u00b0C (68 - 77u00b0F), excursions permittedto 15 - 30u00b0C (59 - 86u00b0F)[See USP Controlled Room Temperature]DO NOT FREEZE

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of treprostinil (Remodulin) which is also known as Remodulin and Manufactured by United Therapeutics Corporation. It is available in strength of 20 mg/20mL.

treprostinil (Remodulin) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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