Orenitram

NYHA Functional Class III, refractory to conventional therapy, NYHA class IV + 2 more

Treatment

20 Active Studies for Orenitram

What is Orenitram

Treprostinil

The Generic name of this drug

Treatment Summary

Treprostinil is a medication that mimics the effects of prostacyclin hormone to treat pulmonary hypertension.

Remodulin

is the brand name

image of different drug pills on a surface

Orenitram Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Remodulin

Treprostinil

2002

47

Effectiveness

How Orenitram Affects Patients

Treprostinil is a drug that works to widen blood vessels and reduce the risk of platelet clumping. In animals, this leads to lower pressure in the heart and an increase in blood flow. In humans, taking treprostinil can lead to a short-term change in the electrical activity of the heart. When taken orally, the effect on the heart has not been studied. Treprostinil can also cause low blood pressure, worsen symptoms of pulmonary arterial hypertension, and cause bronchospasms in those with asthma or COPD. Those taking treprostinil intravenously may experience infusion complications

How Orenitram works in the body

Treprostinil is a drug used to treat pulmonary arterial hypertension, a condition that causes high blood pressure in the arteries connecting the heart and lungs. Treprostinil works by activating receptors that increase levels of cAMP, a molecule that helps relax blood vessels and prevents blood clots. This promotes vasodilation and reduces inflammation, which helps lower blood pressure and improve heart function.

When to interrupt dosage

The prescribed dosage of Orenitram is subject to the declared condition, including refractory to conventional therapy, Pulmonary Arterial Hypertension and NYHA class IV. The amount of dosage is contingent upon the technique of delivery (e.g. Solution or Inhalant) detailed in the table below.

Condition

Dosage

Administration

refractory to conventional therapy

2.0 mg/mL, , 5.0 mg/mL, 10.0 mg/mL, 20.0 mg/mL, 2.5 mg, 1.0 mg, 5.0 mg, 1.74 mg/mL, 0.125 mg, 0.25 mg, 1.0 mg/mL, 2.5 mg/mL, 40.0 mg/mL, 0.048 mg, 0.064 mg, 0.016 mg, 0.032 mg

Intravenous; Subcutaneous, Injection, solution, , Injection, solution - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Inhalant, Respiratory (inhalation), Inhalant - Respiratory (inhalation), Tablet, extended release, Oral, Tablet, extended release - Oral, Inhalant - Oral, Injection, Injection - Intravenous; Subcutaneous, Subcutaneous, Injection, solution - Subcutaneous, Inhalant; Kit - Oral, Inhalant; Kit

Pulmonary Hypertension

2.0 mg/mL, , 5.0 mg/mL, 10.0 mg/mL, 20.0 mg/mL, 2.5 mg, 1.0 mg, 5.0 mg, 1.74 mg/mL, 0.125 mg, 0.25 mg, 1.0 mg/mL, 2.5 mg/mL, 40.0 mg/mL, 0.048 mg, 0.064 mg, 0.016 mg, 0.032 mg

Intravenous; Subcutaneous, Injection, solution, , Injection, solution - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Inhalant, Respiratory (inhalation), Inhalant - Respiratory (inhalation), Tablet, extended release, Oral, Tablet, extended release - Oral, Inhalant - Oral, Injection, Injection - Intravenous; Subcutaneous, Subcutaneous, Injection, solution - Subcutaneous, Inhalant; Kit - Oral, Inhalant; Kit

NYHA Functional Class III

2.0 mg/mL, , 5.0 mg/mL, 10.0 mg/mL, 20.0 mg/mL, 2.5 mg, 1.0 mg, 5.0 mg, 1.74 mg/mL, 0.125 mg, 0.25 mg, 1.0 mg/mL, 2.5 mg/mL, 40.0 mg/mL, 0.048 mg, 0.064 mg, 0.016 mg, 0.032 mg

Intravenous; Subcutaneous, Injection, solution, , Injection, solution - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Inhalant, Respiratory (inhalation), Inhalant - Respiratory (inhalation), Tablet, extended release, Oral, Tablet, extended release - Oral, Inhalant - Oral, Injection, Injection - Intravenous; Subcutaneous, Subcutaneous, Injection, solution - Subcutaneous, Inhalant; Kit - Oral, Inhalant; Kit

NYHA class IV

2.0 mg/mL, , 5.0 mg/mL, 10.0 mg/mL, 20.0 mg/mL, 2.5 mg, 1.0 mg, 5.0 mg, 1.74 mg/mL, 0.125 mg, 0.25 mg, 1.0 mg/mL, 2.5 mg/mL, 40.0 mg/mL, 0.048 mg, 0.064 mg, 0.016 mg, 0.032 mg

Intravenous; Subcutaneous, Injection, solution, , Injection, solution - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Inhalant, Respiratory (inhalation), Inhalant - Respiratory (inhalation), Tablet, extended release, Oral, Tablet, extended release - Oral, Inhalant - Oral, Injection, Injection - Intravenous; Subcutaneous, Subcutaneous, Injection, solution - Subcutaneous, Inhalant; Kit - Oral, Inhalant; Kit

Pulmonary Arterial Hypertension

2.0 mg/mL, , 5.0 mg/mL, 10.0 mg/mL, 20.0 mg/mL, 2.5 mg, 1.0 mg, 5.0 mg, 1.74 mg/mL, 0.125 mg, 0.25 mg, 1.0 mg/mL, 2.5 mg/mL, 40.0 mg/mL, 0.048 mg, 0.064 mg, 0.016 mg, 0.032 mg

Intravenous; Subcutaneous, Injection, solution, , Injection, solution - Intravenous; Subcutaneous, Solution, Solution - Intravenous; Subcutaneous, Inhalant, Respiratory (inhalation), Inhalant - Respiratory (inhalation), Tablet, extended release, Oral, Tablet, extended release - Oral, Inhalant - Oral, Injection, Injection - Intravenous; Subcutaneous, Subcutaneous, Injection, solution - Subcutaneous, Inhalant; Kit - Oral, Inhalant; Kit

Warnings

Orenitram Contraindications

Condition

Risk Level

Notes

Severe Hepatic Impairment

Do Not Combine

There are 20 known major drug interactions with Orenitram.

Common Orenitram Drug Interactions

Drug Name

Risk Level

Description

Amifostine

Major

Treprostinil may increase the hypotensive activities of Amifostine.

Amiodarone

Major

The metabolism of Amiodarone can be decreased when combined with Treprostinil.

Brigatinib

Major

The metabolism of Brigatinib can be decreased when combined with Treprostinil.

Cabazitaxel

Major

The metabolism of Cabazitaxel can be decreased when combined with Treprostinil.

Enasidenib

Major

The metabolism of Enasidenib can be decreased when combined with Treprostinil.

Orenitram Toxicity & Overdose Risk

Excessive treprostinil use can lead to side effects such as flushing, headaches, nausea, vomiting, diarrhea, and low blood pressure. In one case, a pediatric patient had a seizure-like activity and loss of consciousness after an accidental bolus administration. There is no evidence that treprostinil affects fertility or causes cancer in rats, but it has been linked to mutagenic and clastogenic effects in laboratory studies.

image of a doctor in a lab doing drug, clinical research

Orenitram Novel Uses: Which Conditions Have a Clinical Trial Featuring Orenitram?

54 active clinical trials are underway to assess the efficacy of Orenitram in providing relief for Pulmonary Arterial Hypertension, NYHA Functional Class III and Pulmonary Arterial Hypertension-related disorders.

Condition

Clinical Trials

Trial Phases

NYHA class IV

0 Actively Recruiting

NYHA Functional Class III

0 Actively Recruiting

refractory to conventional therapy

0 Actively Recruiting

Pulmonary Hypertension

30 Actively Recruiting

Phase 2, Phase 3, Not Applicable, Phase 1, Early Phase 1

Pulmonary Arterial Hypertension

3 Actively Recruiting

Phase 1, Not Applicable, Phase 4

Orenitram Reviews: What are patients saying about Orenitram?

4

Patient Review

11/17/2016

Orenitram for Pulmonary Arterial Hypertension

I've been on this medication for two years and have definitely seen an improvement in my stamina. The side effects have also lessened, which is great.

3.3

Patient Review

3/13/2022

Orenitram for Pulmonary Arterial Hypertension

So far, I've had very few side effects from Orenitram. I was diagnosed with PAH and told that I only have five years to live, but this medication has given me hope. I'm still getting tired easily, but hopefully that will improve with time.

2.3

Patient Review

2/3/2017

Orenitram for Pulmonary Arterial Hypertension

I've been taking this medicine for one and a half years now, and I'm really tired of it. It gives me ulcers and I often vomit blood. My doctor can see how exhausted I am and he wants me to change to a pump instead of the medication. I hate both options, but I've never tried the pump before so I'm not sure if that's what I'm going to do. Orenitram did kill me with its side effects.

1

Patient Review

6/19/2020

Orenitram for Pulmonary Arterial Hypertension

The side effects of this medication were awful. I lost my appetite and 16lbs in 3 weeks, had severe back pain and headaches, and felt totally exhausted all the time. I was able to get off of it eventually, but I wouldn't recommend it to anyone else.

1

Patient Review

3/17/2015

Orenitram for Pulmonary Arterial Hypertension

My brother passed away less than three months after starting orenitram. We are currently investigating the matter. Has anyone else had a similar experience? Please share if you have.

1

Patient Review

3/17/2016

Orenitram for Pulmonary Arterial Hypertension

I would not recommend this drug to anyone. It killed my husband who was only on it for six months. He is now on hospice care.

Patient Q&A Section about orenitram

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Orenitram have generic?

"If a generic version of Orenitram is not available in the United States, then it is likely that fraudulent online pharmacies will try to sell illegal versions of the drug. These versions of the drug may be counterfeit and potentially unsafe for patients."

Answered by AI

What is Orenitram used for?

"This medication helps to relax the blood vessels in your lungs which in turn decreases the pulmonary arterial hypertension and helps you to be more active."

Answered by AI

Does Orenitram lower blood pressure?

"Orenitram expands the arteries and decreases the amount of blood clotting platelets in your body. These effects lower blood pressure in the pulmonary artery that leads from the heart to the lungs."

Answered by AI

Is Orenitram a prostacyclin?

"Orenitram is a medication used to treat pulmonary arterial hypertension. It is designed to improve exercise capacity and delay disease progression."

Answered by AI

Clinical Trials for Orenitram

Image of Vanderbilt University Medical Center in Nashville, United States.

Nicotinamide Riboside for Pulmonary Hypertension

18 - 85
All Sexes
Nashville, TN

Pulmonary hypertension (PH) is a serious condition that puts strain on the heart and lungs and often leads to frequent hospital stays and shortened life expectancy. The most common cause is heart disease affecting the left side of the heart. A particularly high-risk form, called combined pre- and post-capillary pulmonary hypertension (CPH), occurs in about one in four people with heart failure. There are currently no approved treatments for CPH, and many patients develop right-sided heart failure and die earlier than expected. This study is based on a new approach that uses advanced computer methods to analyze a patient's unique biology and identify potential drug targets. Using this method, we identified nicotinamide riboside (NR) as a promising option for people with CPH. NR is a form of vitamin B3 that helps the body make NAD⁺, a substance essential for how cells produce energy and stay healthy. NAD⁺ plays an important role in how heart and blood vessel cells function. Previous research in animals suggests NR may help improve blood vessel changes in the lungs and support heart function. NR has also shown potential benefits in human studies related to cell energy, mitochondrial health, and reducing oxidative stress. In this study, NR is used only as a dietary supplement that supports normal body processes, not as a proven treatment. The investigators will conduct a small, carefully controlled study in which participants receive NR and a placebo at different times. The goal is to understand how NR affects biological and biochemical markers in the body, not to test whether it improves symptoms or outcomes. Any clinical measurements are included only to help interpret the biological effects.

Recruiting
New This Month

Vanderbilt University Medical Center

Evan L Brittain, MD

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Sotatercept for Pulmonary Arterial Hypertension

18+
All Sexes
Edmonton, Canada

The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension. Participants will be asked to: * Take Sotatercept every 21 days (±3 days) * Each participant will be enrolled in the study for 29 Weeks * Visit the clinic 18 times * Have a physical exam * Perform assessments of lung function and exercise tests * Have an ultrasound of their heart * Have blood draws done at regular intervals The main objectives of the study are: Primary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise. Secondary objective: To identify components of the diffusing capacity that respond to treatment with sotatercept in pulmonary arterial hypertension.

Phase 4
Recruiting

Clinical Physiology Laboratory

Michael Stickland, PhD

Merck Canada Inc.

Image of UCSF Health St. Mary's Hospital in San Francisco, United States.

PF-07868489 for Pulmonary Hypertension

18+
All Sexes
San Francisco, CA

The purpose of this study is to learn about the long-term safety, tolerability and effects of the study medicine (PF-07868489) for the possible treatment of PAH. PAH is a condition in which there is high blood pressure in the arteries that carry blood from the heart to the lungs. This high pressure makes it harder for the heart to pump blood through those lungs, potentially damaging the right side of the heart. This is an open-label study. Which means that both the healthcare providers and the study participants are aware of the medicine being given. This study is also an extension study with study medicine (PF-07868489). An extension study allows patients from an earlier clinical study (also called as qualifying study) to continue participating to assess long-term benefits and safety of the medicine.

Phase 2
Recruiting

UCSF Health St. Mary's Hospital (+13 Sites)

Pfizer CT.gov Call Center

Pfizer

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Neuromodulation for Pulmonary Arterial Hypertension

18 - 90
All Sexes
Oklahoma City, OK

Patients with Group 1 pulmonary hypertension will be enrolled in this study. Investigators will test the hypothesis of low-level tragal stimulation in patients with pulmonary hypertension. The study will be conducted over 4 weeks and patients will undergo low-level tragus stimulation for 1 hour every day for 4 weeks. At baseline the following tests will be conducted-6-minute walk distance, vascular function testing using noninvasive device and blood samples will be collected. Patient will also undergo a limited echocardiography to assess right ventricular function. After 4 weeks of stimulation patients will come back to undergo these tests again. Investigators hypothesized that low-level tragus stimulation (neuromodulation) will lead to improvement in vascular function, 6-minute walk distance and blood based biomarkers in patients with pulmonary hypertension.

Phase 1 & 2
Waitlist Available

University of Oklahoma health sciences Center

Tarun Dasari, MD

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We made a collection of clinical trials featuring Orenitram, we think they might fit your search criteria.
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