treprostinil (Orenitram)

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Trade Name: Orenitram

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 Corp.

Presentation: TABLET, EXTENDED RELEASE, HUMAN PRESCRIPTION DRUG

Strength: 0.125 mg/1

Storage and handling

TREPROSTINIL 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.

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Orenitram is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression and to improve exercise capacity.
The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%).
Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):

To delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%). ()

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Give with food. Swallow tablets whole; use only intact tablets. ()
Starting dose: 0.125 mg TID or 0.25 mg BID. ()
Titrate by 0.125 mg TID or by 0.25 mg or 0.5 mg BID, not more frequently than every 3 to 4 days as tolerated. ()
If transitioning from intravenous (IV) or subcutaneous (SC) Remodulin, the Orenitram dose should be increased while simultaneously decreasing the IV/SC infusion rate. ()
Mild hepatic impairment (Child Pugh Class A): Initiate at 0.125 mg BID. Increment at 0.125 mg BID not more frequently than every 3 to 4 days. ()
Avoid use in patients with moderate hepatic impairment. ()

Orenitram (treprostinil) extended-release tablets are available in the following five strengths:
Extended-Release Tablets: 0.125 mg, 0.25 mg, 1 mg, 2.5 mg and 5 mg. ()

Severe hepatic impairment (Child Pugh Class C) .

Severe hepatic impairment (Child Pugh Class C). ()

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Do not abruptly discontinue dosing. (, )
In patients with diverticulosis, Orenitram tablets can become lodged in a diverticulum. ()

Most common adverse reactions (incidence >10%) reported in clinical studies in patients treated with Orenitram compared with placebo are headache, diarrhea, nausea, vomiting, jaw pain, and flushing. ()
To report SUSPECTED ADVERSE REACTIONS, contact United Therapeutics Corp. at 1-866-458-6479 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil in healthy adult volunteers increases exposure to treprostinil. Reduce the starting dose of Orenitram to 0.125 mg BID and use 0.125 mg BID increments not more frequently than every 3 to 4 days .

When co-administered with strong CYP2C8 inhibitors the initial dose is 0.125 mg BID with 0.125 mg BID dose increments not more frequently than every 3 to 4 days. (, )

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Signs and symptoms of overdose with Orenitram during clinical trials reflect its dose-limiting pharmacologic effects and include severe headache, nausea, vomiting, diarrhea, and hypotension. Treat supportively.

Orenitram is an extended-release osmotic tablet for oral administration. Orenitram is formulated as the diolamine salt of treprostinil, a tricyclic benzindene analogue of prostacyclin. The chemical name is Acetic acid, 2-[[(1,2,3a,9a)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3)-3-hydroxyoctyl]-1-benz[f]inden-5-yl]oxy]-, complexed with 2,2'-iminobis[ethanol] (1:1). The molecular formula is CHO.CHNO, the molecular weight is 495.65, and it has the following structural formula:
Orenitram tablets are formulated in five strengths, which contain 0.125 mg of treprostinil (equivalent to 0.159 mg treprostinil diolamine), 0.25 mg of treprostinil (equivalent to 0.317 mg treprostinil diolamine), 1 mg of treprostinil (equivalent to 1.27 mg treprostinil diolamine), 2.5 mg of treprostinil (equivalent to 3.17 mg treprostinil diolamine), or 5 mg of treprostinil (equivalent to 6.35 mg treprostinil diolamine). The formulations also contain xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol USP, iron oxide black, n-butyl alcohol, and propylene glycol.
Orenitram is designed to release treprostinil at a near zero-order rate using an osmotic tablet technology. The tablet core is coated with a semi-permeable membrane and has a laser-drilled aperture through the membrane. Upon contact with water (e.g., after ingestion), the core tablet absorbs water through the semi-permeable membrane. The water dissolves the water-soluble treprostinil diolamine and the water-soluble osmotic excipients, which creates hydrostatic pressure within the membrane, eventually forcing the drug across the membrane at a controlled rate.

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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. 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 13- and 18-fold, respectively, the human exposure at the dose of 3.5 mg BID on an AUC basis.
In vitro
in vivo
In rats, treatment with treprostinil diolamine had no effect on reproductive performance or sperm motility at doses up to 10 mg/kg/day. The exposures at this dose level are about 6- (male) to 11- (female) fold the human exposure at the dose of 3.5 mg BID on an AUC basis.

Four multicenter, randomized, double-blind studies were conducted and compared Orenitram to placebo in a total of 349 (Study 1), 350 (Study 2), 310 (Study 3), and 690 (Study 4) patients with PAH.

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United Therapeutics Corp.Research Triangle Park, NC 27709

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NDC 66302-300-01
100 Tablets
Orenitramn treprostinilExtended-ReleaseTablets
0.125 mg
Swallow whole.Do not split, chew, crushor break tablets.

Orenitramn (treprostinil)EXTENDED-RELEASE TABLETS
0.125 mgper tablet
Swallow whole.Do not split, chew, crush, or break tablets.
10 Tablets(1 x 10 tablet blister pack)
Pharmacist:Dispense the accompanying Patient Information Leaflet to each patient.
Rx Only NDC 66302-300-02

NDC 66302-302-01
100 Tablets
Orenitramn treprostinilExtended-ReleaseTablets
0.25 mg
Swallow whole.Do not split, chew, crushor break tablets.

Orenitramn (treprostinil)EXTENDED-RELEASE TABLETS
0.25 mgper tablet
Swallow whole.Do not split, chew, crush, or break tablets.
10 Tablets(1 x 10 tablet blister pack)
Pharmacist:Dispense the accompanying Patient Information Leaflet to each patient.
Rx Only NDC 66302-302-02

NDC 66302-310-01
100 Tablets
Orenitramn treprostinilExtended-ReleaseTablets
1 mg
Swallow whole.Do not split, chew, crushor break tablets.

Orenitramn (treprostinil)EXTENDED-RELEASE TABLETS
1 mgper tablet
Swallow whole.Do not split, chew, crush, or break tablets.
10 Tablets(1 x 10 tablet blister pack)
Pharmacist:Dispense the accompanying Patient Information Leaflet to each patient.
Rx Only NDC 66302-310-02

NDC 66302-325-01
100 Tablets
Orenitramn treprostinilExtended-ReleaseTablets
2.5 mg
Swallow whole.Do not split, chew, crushor break tablets.

Orenitramn (treprostinil)EXTENDED-RELEASE TABLETS
2.5 mgper tablet
Swallow whole.Do not split, chew, crush, or break tablets.
10 Tablets(1 x 10 tablet blister pack)
Pharmacist:Dispense the accompanying Patient Information Leaflet to each patient.
Rx Only NDC 66302-325-02

NDC 66302-350-01
100 Tablets
Orenitramn treprostinilExtended-ReleaseTablets
5 mg
Swallow whole.Do not split, chew, crushor break tablets.

Orenitramn (treprostinil)EXTENDED-RELEASE TABLETS
5 mgper tablet
Swallow whole.Do not split, chew, crush, or break tablets.
10 Tablets(1 x 10 tablet blister pack)
Pharmacist:Dispense the accompanying Patient Information Leaflet to each patient.
Rx Only NDC 66302-350-02

Select Strength and Packaging*

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of treprostinil (Orenitram) which is also known as Orenitram and Manufactured by United Therapeutics Corp.. It is available in strength of 0.125 mg/1.

treprostinil (Orenitram) 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.