Remodulin

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

Treatment

20 Active Studies for Remodulin

What is Remodulin

Treprostinil

The Generic name of this drug

Treatment Summary

Treprostinil is a drug that mimics the effects of prostacyclin, a natural substance that helps regulate blood pressure. It is used to treat pulmonary hypertension, a condition characterized by abnormally high blood pressure in the arteries of the lungs.

Remodulin

is the brand name

image of different drug pills on a surface

Remodulin Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Remodulin

Treprostinil

2002

47

Effectiveness

How Remodulin Affects Patients

Treprostinil relaxes the blood vessels in the lungs and body, and stops platelets from clumping together. In animals, this leads to a decrease in the amount of pressure in the heart and an increase in how much blood it pumps. Treprostinil can also cause a decrease in heart rate and contraction, although no major effects on heart rhythm have been found. Taking treprostinil increases the risk of bleeding, and can cause symptoms like low blood pressure. People with asthma, COPD, or bronchial hyperreactivity may experience bronchospasms when inhaling treprostinil.

How Remodulin works in the body

Treprostinil is a medication used to treat pulmonary arterial hypertension. It works by opening potassium channels on cells and increasing levels of a molecule called cAMP, which both stimulates vasodilation in the arteries and prevents platelet aggregation. It also has anti-inflammatory properties.

When to interrupt dosage

The prescribed dosage of Remodulin depends upon the established condition, including refractory to traditional therapy, Pulmonary Arterial Hypertension and NYHA class IV. The measure of dosage deviates, depending on the method of delivery (e.g. Solution or Inhalant) specified 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

Remodulin Contraindications

Condition

Risk Level

Notes

Severe Hepatic Impairment

Do Not Combine

There are 20 known major drug interactions with Remodulin.

Common Remodulin 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.

Remodulin Toxicity & Overdose Risk

Symptoms of a treprostinil overdose can include flushing, headache, nausea, vomiting, diarrhea, low blood pressure, and seizures. Two cases of serious hemodynamic issues have been reported, one of which involved a child who received an accidental dose of 7.5 mg. In animal studies, treprostinil did not increase cancer risk, affect fertility or mating performance, or cause mutagenic or clastogenic effects. Additionally, no significant increases in tumors were found in rats given up to 10 mg/kg/day of oral treprostinil diolamine.

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

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

54 active clinical trials are currently investigating the potential of Remodulin to mitigate Pulmonary Arterial Hypertension, NYHA Functional Class III and Pulmonary Arterial Hypertension.

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

Remodulin Reviews: What are patients saying about Remodulin?

5

Patient Review

2/17/2016

Remodulin for Pulmonary Arterial Hypertension

Remodulin unfortunately caused me some heart trouble in the form of arythmia. My cardiologist has since taken me off the medication. In addition to that, I experienced awful pain in my face and legs while taking it.

5

Patient Review

8/4/2009

Remodulin for Pulmonary Arterial Hypertension

Even though there are some less-than-ideal side effects, this medication has really worked well for me.

4.3

Patient Review

4/30/2016

Remodulin for Pulmonary Arterial Hypertension

I've been using this treatment since July and I'm feeling much healthier now. The initial pain was uncomfortable, but it's worth it for the results. I'm hoping to switch to the pill form soon - has anyone else done that?

4

Patient Review

8/12/2009

Remodulin for Pulmonary Arterial Hypertension

Remodulin has been a total lifesaver for me. I started using it in 2007 and have had few side effects--(just a little diarrhea and leg pain.) Once you get used to the process, it is simple to use and even easier once you are stable and can use the smaller pump. It is wonderful to be able to breathe again!

3

Patient Review

6/13/2010

Remodulin for Pulmonary Arterial Hypertension

This drug has been a godsend for our daughter. When she was first diagnosed with PAH, the prognosis wasn't good. We were told that she might only have six to ten months left. Thanks to this medication, she's still here and going strong nearly five years later.

3

Patient Review

6/19/2010

Remodulin for Pulmonary Arterial Hypertension

At first, this medication is quite painful. However, after using it for three years, I've found that the pain decreases significantly. I hope this helps others who are considering this treatment!

2.7

Patient Review

8/18/2010

Remodulin for Pulmonary Arterial Hypertension

As I increased my dosage, I found that this medication caused more pain in my extremities. Sometimes the pain was almost unbearable, despite also taking Gabapentin and a strong pain medication.

1.7

Patient Review

1/10/2013

Remodulin for Pulmonary Arterial Hypertension

The pain at the site is unbearable. I usually have to change the site after just six days because the pain is so intense.

1

Patient Review

1/7/2011

Remodulin for Pulmonary Arterial Hypertension

I've been on remodulin for 1 1/2 yrs site pain is painful up to 2 wks ,nausia at times. pain in legs & hands.It has lowered right venticle pressure from 110 down to 61,so ikeep doing it and try to stay positive! Good luck to all .Geno
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about remodulin

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

What type of medication is Remodulin?

"Remodulin is a medication used to treat pulmonary arterial hypertension, which is high blood pressure in the arteries of your lungs. Remodulin can reduce symptoms associated with exercise."

Answered by AI

What is the drug Remodulin used for?

"This helps to decrease the number of hospital visits and improve your ability to exercise.

This medication is used to treat pulmonary arterial hypertension, a type of high blood pressure in the lungs. Treprostinil helps to improve symptoms such as shortness of breath and tiredness. This helps to decrease the number of hospital visits and improve your ability to exercise."

Answered by AI

What happens if you stop Remodulin?

"If you stop taking treprostinil suddenly, or if you decrease your dose too quickly, you may experience symptoms of pulmonary hypertension such as pain when breathing, dizziness, weakness, and fatigue."

Answered by AI

Is Remodulin a continuous infusion?

"Remodulin may be diluted with either 5% Dextrose Injection or 0.9% Sodium Chloride Injection, USP to a total volume not to exceed 20 mL.

Remodulin is a medication that is indicated to be given as a continuous infusion through either a subcutaneous line or an intravenous line. Remodulin is typically given through a subcutaneous line, but can be given intravenously if the subcutaneous route is not tolerated because of severe site pain or reaction. Remodulin can be diluted with either 5% Dextrose Injection or 0.9% Sodium Chloride Injection, USP to a total volume not to exceed 20 mL."

Answered by AI

Clinical Trials for Remodulin

Image of UPMC Presybeterian in Pittsburgh, United States.

Telaglenastat for Pulmonary Hypertension

18 - 75
All Sexes
Pittsburgh, PA

The research study is being conducted to evaluate the effectiveness of a drug called Telaglenastat in adults diagnosed with Pulmonary Hypertension (PH). PH is a progressive condition that affects the arteries in the lungs, specifically the pulmonary arteries, which carry blood from the right side of the heart to the lungs. Telaglenastat is not currently approved by the Food and Drug Administration for the treatment of PH. However, the study investigators believe that Telaglenastat may help lower blood pressure in the lungs and improve both heart and lung function. It is important to note that the drug will not be available to participants once the study concludes.

Phase 1 & 2
Waitlist Available

UPMC Presybeterian

Michael Risbano, MD

Have you considered Remodulin clinical trials?

We made a collection of clinical trials featuring Remodulin, we think they might fit your search criteria.
Go to Trials
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 (+6 Sites)

Pfizer CT.gov Call Center

Pfizer

Image of University of Oklahoma health sciences Center in Oklahoma City, United States.

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

Have you considered Remodulin clinical trials?

We made a collection of clinical trials featuring Remodulin, we think they might fit your search criteria.
Go to Trials

Have you considered Remodulin clinical trials?

We made a collection of clinical trials featuring Remodulin, we think they might fit your search criteria.
Go to Trials