epoprostenol (Veletri)

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Trade Name: Veletri

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

Manufacturer: Actelion Pharmaceuticals US, Inc.

Presentation: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 0.5 mg/10mL

Storage and handling

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

Disclaimer:

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.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

No data

VELETRI is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class IIIu2013IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.
VELETRI is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class IIIu2013IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases. ()

Important Note: Reconstitute VELETRI only as directed with Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not dilute reconstituted solutions of VELETRI or administer it with other parenteral solutions or medications .

Dosagen
Administrationn
Reconstitutionn

VELETRI contains epoprostenol sodium equivalent to 0.5 mg (500,000 ng) or 1.5 mg (1,500,000 ng) epoprostenol and is supplied as a sterile lyophilized material in a 10 mL vial.
Injection: 10 mL single-dose vial with 0.5 mg (500,000 ng) or 1.5 mg (1,500,000 ng) VELETRI. ()

A large study evaluating the effect of epoprostenol on survival in NYHA Class III and IV patients with congestive heart failure due to severe left ventricular systolic dysfunction was terminated after an interim analysis of 471 patients revealed a higher mortality in patients receiving epoprostenol plus conventional therapy than in those receiving conventional therapy alone. The chronic use of VELETRI in patients with congestive heart failure due to severe left ventricular systolic dysfunction is therefore contraindicated.
Some patients with pulmonary hypertension have developed pulmonary edema during dose initiation, which may be associated with pulmonary veno-occlusive disease. VELETRI should not be used chronically in patients who develop pulmonary edema during dose initiation.
VELETRI is also contraindicated in patients with known hypersensitivity to the drug or to structurally related compounds.

Congestive heart failure due to severe left ventricular systolic dysfunction ()
Pulmonary edema ()
Hypersensitivity to the drug or to structurally related compounds ()

No data

Do not abruptly lower the dose or withdraw dosing. All dosing initiation and changes should be closely monitored. (, )

To report SUSPECTED ADVERSE REACTIONS, please contact: ACTELION at 1-866-228-3546 or FDA at 1-800-FDA-1088, or http://www.fda.gov/medwatch

Most common adverse reactions during:n

Additional reductions in blood pressure may occur when VELETRI is administered with diuretics, antihypertensive agents, or other vasodilators. When other antiplatelet agents or anticoagulants are used concomitantly, there is the potential for VELETRI to increase the risk of bleeding. However, patients receiving infusions of epoprostenol in clinical trials were maintained on anticoagulants without evidence of increased bleeding. In clinical trials, epoprostenol was used with digoxin, diuretics, anticoagulants, oral vasodilators, and supplemental oxygen.
In a pharmacokinetic substudy in patients with congestive heart failure receiving furosemide or digoxin in whom therapy with epoprostenol was initiated, apparent oral clearance values for furosemide (n = 23) and digoxin (n = 30) were decreased by 13% and 15%, respectively, on the second day of therapy and had returned to baseline values by day 87. The change in furosemide clearance value is not likely to be clinically significant. However, patients on digoxin may show elevations of digoxin concentrations after initiation of therapy with epoprostenol, which may be clinically significant in patients prone to digoxin toxicity.

Diuretics, antihypertensive agents, or other vasodilators: reduction in blood pressure ()
Antiplatelet agents or anticoagulants: increase the risk of bleeding ()
Patients on digoxin: elevations of digoxin concentrations clinically significant in patients prone to digoxin toxicity ()

No data

Signs and symptoms of excessive doses of epoprostenol during clinical trials are the expected dose-limiting pharmacologic effects of epoprostenol, including flushing, headache, hypotension, tachycardia, nausea, vomiting, and diarrhea. Treatment will ordinarily require dose reduction of epoprostenol.
One patient with secondary pulmonary hypertension accidentally received 50 mL of an unspecified concentration of epoprostenol. The patient vomited and became unconscious with an initially unrecordable blood pressure. Epoprostenol was discontinued and the patient regained consciousness within seconds. In clinical practice, fatal occurrences of hypoxemia, hypotension, and respiratory arrest have been reported following overdosage of epoprostenol.
Single intravenous doses of epoprostenol at 10 and 50 mg/kg (2,703 and 27,027 times the recommended acute phase human dose based on body surface area) were lethal to mice and rats, respectively. Symptoms of acute toxicity were hypoactivity, ataxia, loss of righting reflex, deep slow breathing, and hypothermia.

Epoprostenol sodium is the sodium salt of epoprostenol, formulated as a sterile lyophilized powder for intravenous (IV) administration. Each vial of VELETRI contains epoprostenol sodium equivalent to either 0.5 mg (500,000 ng) or 1.5 mg (1,500,000 ng) epoprostenol, 50 mg arginine and 100 mg sucrose. Sodium hydroxide is added to adjust pH.
Epoprostenol (PGI, PGX, prostacyclin), a metabolite of arachidonic acid, is a naturally occurring prostaglandin with potent vasodilatory activity and inhibitory activity of platelet aggregation.
Epoprostenol is (5,9a,11a,13,15)-6,9-epoxy-11,15-dihydroxyprosta-5,13-dien-1-oic acid. Epoprostenol sodium has a molecular weight of 374.45 and a molecular formula of CHNaO. The structural formula is:
VELETRI is a white to off-white lyophilized powder material. It is reconstituted with Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP.
The reconstituted solution of VELETRI has a pH ranging from 11 to 13 and is increasingly unstable at a lower pH.

No data

Long-term studies in animals have not been performed to evaluate carcinogenic potential. A micronucleus test in rats revealed no evidence of mutagenicity. The Ames test and DNA elution tests were also negative, although the instability of epoprostenol makes the significance of these tests uncertain. Fertility was not impaired in rats given epoprostenol by subcutaneous injection at doses up to 100 mcg/kg/day (600 mcg/m/day, 2.5 times the recommended human dose [4.6 ng/kg/min or 245.1 mcg/m/day, IV] based on body surface area).

No data

No data

Patients receiving VELETRI should receive the following information.
VELETRI must be reconstituted as directed using only Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. VELETRI is infused continuously through a permanent indwelling central venous catheter via a small, portable infusion pump. Thus, therapy with VELETRI requires commitment by the patient to drug reconstitution, drug administration, and care of the permanent central venous catheter. Patients must adhere to sterile technique in preparing the drug and in the care of the catheter, and even brief interruptions in the delivery of VELETRI may result in rapid symptomatic deterioration. A patient's decision to receive VELETRI should be based upon the understanding that there is a high likelihood that therapy with VELETRI will be needed for prolonged periods, possibly years. The patient's ability to accept and care for a permanent intravenous catheter and infusion pump should also be carefully considered.

Made in Czech Republic
Manufactured for:ttttttActelion Pharmaceuticals US, Inc.ttttttSouth San Francisco, CA 94080, USA
u00a9 2008 u2013 2019 Actelion Pharmaceuticals US, Inc.
ACT20200930

NDC 66215-403-01
VELETRI
0.5 mg (500,000 ng)/vial
Sterile, Lyophilized ProductFor Intravenous Infusion Only
Rx OnlyACTELION

NDC 66215-402-01
VELETRI
1.5 mg (1,500,000 ng)/vial
Sterile, Lyophilized ProductFor Intravenous Infusion Only
Rx OnlyACTELION

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of epoprostenol (Veletri) which is also known as Veletri and Manufactured by Actelion Pharmaceuticals US, Inc.. It is available in strength of 0.5 mg/10mL.

epoprostenol (Veletri) 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.