Orenitram
treprostinil · KIT · United Therapeutics Corporation
Orenitram is a kit containing treprostinil. Manufactured by United Therapeutics Corporation.
Key Facts
- Brand Name
- Orenitram
- Generic Name
- treprostinil
- NDC Code (Product)
66302-363- Manufacturer
- United Therapeutics Corporation
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA203496
- Drug Class
- Prostacycline Vasodilator [EPC]
- Marketing Start
- 02/14/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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%). ( 1.1 ) 1.1 Pulmonary Arterial Hypertension 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%).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Give with food. Swallow tablets whole; use only intact tablets. ( 2.1 ) Starting dose: 0.125 mg TID or 0.25 mg BID. ( 2.1 ) 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. The maximum daily dose is 120 mg. ( 2.1 ) If transitioning from intravenous (IV) or subcutaneous (SC) Remodulin ® , the Orenitram dose should be increased while simultaneously decreasing the IV/SC infusion rate. ( 2.2 ) 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. ( 2.3 ) Avoid use in patients with moderate hepatic impairment. ( 2.3 ) 2.1 Recommended Dosing Take Orenitram with food. Swallow Orenitram tablets whole; do not crush, split, or chew. The recommended starting dose of Orenitram is 0.125 mg three times daily (TID) with food, taken approximately 8 hours apart or 0.25 mg twice daily (BID) with food, taken approximately 12 hours apart. Titrate by 0.125 mg TID or 0.25 or 0.5 mg BID not more frequently than every 3 to 4 days. Increase the dose to the highest tolerated dose. The recommended maximum daily dose is 120 mg. If dose…
Contraindications
4 CONTRAINDICATIONS Severe hepatic impairment (Child Pugh Class C) [see Use In Specific Populations (8.6) and Clinical Pharmacology (12.3) ] . Severe hepatic impairment (Child Pugh Class C). ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 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. ( 2.4 , 7.1 ) 7.1 Effect of CYP2C8 Inhibitors on Treprostinil 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 [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3) ] .
Adverse Reactions
6 ADVERSE REACTIONS 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. ( 6.1 ) 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a 12-week, placebo-controlled, monotherapy study (Study 1; WHO Group 1; functional class II-III), and an event-driven, placebo-controlled, combination therapy study (Study 4; WHO Group 1; functional class I-III), the most commonly reported adverse reactions that occurred in patients receiving Orenitram included: headache, diarrhea, nausea, and flushing. Orenitram patients in Study 1 (N=151) had access to 0.25 mg tablets at randomization. Approximately 91% of such patients in Study 1 experienced an adverse reaction, but …
Frequently Asked Questions
What is Orenitram used for?
Orenitram contains treprostinil. It is a kit taken as directed. Consult your doctor for specific uses.
Is Orenitram a controlled substance?
Orenitram is not classified as a controlled substance by the DEA.
What is the generic name for Orenitram?
The generic name for Orenitram is treprostinil. There are 11 other brand versions of treprostinil.
What is the NDC code for Orenitram ?
The NDC (National Drug Code) for Orenitram is 66302-363, listed by United Therapeutics Corporation.