Tracleer

Pulmonary Arterial Hypertension, ocular bacterial infections, Conjunctivitis

Treatment

2 FDA approvals

0 Active Studies for Tracleer

Treatment for

Pulmonary Arterial Hypertension

What is Tracleer

Bosentan

The Generic name of this drug

Treatment Summary

Bosentan (brand name Tracleer) is a medication used to treat pulmonary hypertension, a condition that causes high blood pressure in the arteries of the lungs. It works by blocking endothelin molecules, which are responsible for narrowing the blood vessels and raising blood pressure.

Tracleer

is the brand name

image of different drug pills on a surface

Tracleer Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Tracleer

Bosentan

2001

Approved as Treatment by the FDA

Bosentan, also called Tracleer, is approved by the FDA for 2 uses which include NYHA Functional Class II-IV Pulmonary arterial hypertension and Pulmonary Arterial Hypertension .

NYHA Functional Class II-IV Pulmonary arterial hypertension

Helps manage NYHA Functional Class II-IV Pulmonary arterial hypertension

Pulmonary Arterial Hypertension

Helps manage NYHA Functional Class II-IV Pulmonary arterial hypertension

Effectiveness

How Tracleer Affects Patients

Bosentan is a drug that works by blocking the effects of a protein (endothelin) that can cause blood vessels to become too narrow. People with Pulmonary Arterial Hypertension (PAH) have higher levels of endothelin in their bodies and Bosentan helps to reduce this.

How Tracleer works in the body

Endothelin-1 is a hormone in the body that causes blood vessels to narrow when it binds to either ET A or ET B receptors. In patients with pulmonary arterial hypertension, the level of endothelin-1 is higher than normal. Bosentan is a drug that blocks endothelin-1 from binding to these receptors, and thus helps widen the blood vessels, reducing symptoms of the disease.

When to interrupt dosage

The measure of Tracleer is based upon the diagnosed disorder, for example Pulmonary Arterial Hypertension, ocular bacterial infections and Ocular Inflammation. The amount of dosage is contingent upon the method of delivery (e.g. Tablet, film coated - Oral or Tablet, soluble - Oral) featured in the table beneath.

Condition

Dosage

Administration

Pulmonary Arterial Hypertension

, 62.5 mg, 125.0 mg, 32.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, for suspension, Tablet, for suspension - Oral, Tablet, soluble, Tablet, soluble - Oral, Tablet, coated, Tablet, coated - Oral

ocular bacterial infections

, 62.5 mg, 125.0 mg, 32.0 mg

Conjunctivitis

, 62.5 mg, 125.0 mg, 32.0 mg

Warnings

Tracleer Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

Pulse Frequency

Do Not Combine

There are 20 known major drug interactions with Tracleer.

Common Tracleer Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The metabolism of Abemaciclib can be increased when combined with Bosentan.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be increased when combined with Bosentan.

Alectinib

Major

The metabolism of Alectinib can be increased when combined with Bosentan.

Amifostine

Major

Bosentan may increase the hypotensive activities of Amifostine.

Aminophylline

Major

The metabolism of Aminophylline can be increased when combined with Bosentan.

Tracleer Toxicity & Overdose Risk

Bosentan has been tested as a single dose of up to 2400 mg and as an ongoing dose of up to 2000 mg per day. The most common side effect is mild to moderate headache. When combined with cyclosporine A, bosentan levels increased 30-fold, leading to severe headaches, nausea, and vomiting. Low blood pressure and increased heart rate have also been reported. If a patient takes too much bosentan, they may experience a dangerously low blood pressure that requires medical attention.

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

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

There are currently 4 active studies investigating the potential of Tracleer in treating ocular bacterial infections, Ocular Inflammation and Pulmonary Arterial Hypertension.

Condition

Clinical Trials

Trial Phases

ocular bacterial infections

0 Actively Recruiting

Conjunctivitis

0 Actively Recruiting

Pulmonary Arterial Hypertension

0 Actively Recruiting

Tracleer Reviews: What are patients saying about Tracleer?

Patient Review

1/9/2012

Tracleer for Pulmonary Arterial Hypertension

I'm not sure if this is related to the medication, but I've had pancreatitis twice in less than three months since starting Tracleer. Does anyone else know of this problem? I'm only 3 years old, and I don't even know if it's helping my pulmonary hypertension.

Patient Review

10/27/2010

Tracleer for Increased Pressure of Pulmonary Circulation

I'm still experiencing some side effects like headaches and coughing, but I definitely feel stronger overall.

Patient Review

9/19/2018

Tracleer for Pulmonary Arterial Hypertension

After only six days of taking this medication, I had to stop because the side effects were unbearable. headaches, more shortness of breath, a stuffed up nose so that I couldn't breathe well through my cannula, and feeling nauseous all the time. On top of that, I was really aggressive towards everyone around me. A couple days after stopping the medication, my shortness of breath came back--but at least I'm not angry anymore!

Patient Review

3/27/2010

Tracleer for Pulmonary Arterial Hypertension

4.7

Patient Review

8/17/2013

Tracleer for Pulmonary Arterial Hypertension

I am breathing a little better, but I have experienced some negative side effects like fainting, nausea, and joint pain. It's hard to say if the benefits outweigh the risks at this point.

4.7

Patient Review

2/16/2010

Tracleer for Pulmonary Arterial Hypertension

4.7

Patient Review

7/14/2014

Tracleer for Pulmonary Arterial Hypertension

I've been taking bosentan for four months now and I definitely feel an improvement in my breathing and overall activity level.

4.3

Patient Review

8/29/2010

Tracleer for Pulmonary Arterial Hypertension

I was diagnosed with Primary Pulmonary Hypertension in 2006, when I was just 22. The side effects were manageable-- some weight gain that has since evened out. But the benefits have been truly life-saving: lower pressures in my lungs, a right side of heart that's returned to normal size, and chest pains that are now rare. I'm still on the medication, but it's given me back my life.

4.3

Patient Review

8/7/2012

Tracleer for Pulmonary Arterial Hypertension

This medication has allowed for increased stamina and more energy. I feel much better now thanks to it.

4.3

Patient Review

7/8/2011

Tracleer for Pulmonary Arterial Hypertension

Headaches are so terrible and my back is really bothering me.

Patient Review

2/16/2010

Tracleer for Pulmonary Arterial Hypertension

3.7

Patient Review

5/14/2011

Tracleer for Pulmonary Arterial Hypertension

Initially, I was reluctant to take this medication because I didn't think it would help that much and I didn't like the side effects. However, my doctors convinced me to give it a try. After a couple months, I definitely feel stronger and don't get out of breath as quickly.

3.7

Patient Review

9/27/2010

Tracleer for Pulmonary Arterial Hypertension

I've been on tracleer for 90 days now, and my most recent liver function test came back abnormal. I'll be retesting soon to see if there's any change.

3.3

Patient Review

4/30/2010

Tracleer for Pulmonary Arterial Hypertension

2.7

Patient Review

9/27/2012

Tracleer for Pulmonary Arterial Hypertension

I've now been on this medication for the second time. The first time, I started it the day after an open lung biopsy and my chest tube site began draining excessively. I stopped taking the medication and now the chest tube site is infected but not leaking. I started taking the medication again 3 days ago and I'm really struggling with fluid retention.

Patient Review

11/4/2013

Tracleer for Pulmonary Arterial Hypertension

I would not recommend this pill. It's very costly and caused me to have a severe reaction to sunlight.

image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about tracleer

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

Who manufactures Tracleer?

"Actelion Pharmaceuticals US, Inc., a subsidiary of Johnson & Johnson, announced today that the U.S. Food and Drug Administration (FDA) has approved a new 32 mg tablet for oral suspension for TRACLEER® (bosentan) for use in pediatric patients."

Answered by AI

What is Tracleer used for?

"Tracleer is used to lower blood pressure in the lungs and improve your ability to exercise by working as an endothelin receptor antagonist. PAH, or pulmonary arterial hypertension, is a condition in which the blood pressure in your lungs is too high. Tracleer can help prevent your PAH from getting worse."

Answered by AI

Is there a generic for Tracleer?

"Hikma is introducing bosentan tablets as a generic for Actelion's Tracleer. The tablets come in dosages of 62.5 mg and 125 mg. Bosentan is indicated for treating pulmonary arterial hypertension in adults to improve exercise ability and decrease clinical worsening."

Answered by AI

What is bosentan used for?

"Bosentan is a medication used to lessen the symptoms of pulmonary arterial hypertension in children aged 3 years or older, as well as adults. This drug has the ability to improve a patient's capabilities when it comes to exercise, and can also help to prevent a further deterioration in physical condition."

Answered by AI