What is the cost of Tracleer?
The cost for Tracleer oral tablet 62.5 mg is around $6,134 for a supply of 30, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
How do you get bosentan?
All patients must be enrolled in the Bosentan REMS and must comply with the Bosentan REMS requirements in order to receive bosentan: Patients must agree to complete liver tests and pregnancy tests based on the patient's reproductive potential classification prior to receiving bosentan.
Who makes TRACLEER?
SOUTH SAN FRANCISCO, Calif, September 6, 2017 – Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies 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 ...
How long can you take bosentan?
Adults—At first, 62.5 milligrams (mg) two times a day (morning and evening) for 4 weeks. Your doctor may increase your dose up to 125 mg two times a day. If you are also taking this medicine with ritonavir for at least 10 days, starting dose is 62.5 mg once a day or every other day as directed by your doctor.
What class of drug is Tracleer?
Tracleer belongs to a class of drugs called PAH, Endothelin Antagonists.
What is Tracleer used for?
Tracleer (bosentan) is an endothelin receptor antagonist, which works to help decrease blood pressure in the lungs, used to treat pulmonary arterial hypertension (PAH). Tracleer improves your ability to exercise and prevents your condition from getting worse.
Is there a generic for Tracleer?
Hikma is introducing bosentan tablets, in dosage strengths of 62.5 mg and 125 mg. The product is the generic of Actelion's Tracleer. Bosentan is indicated for the treatment of pulmonary arterial hypertension in adults to improve exercise ability and to decrease clinical worsening.
Is Tracleer available generic?
May 9, 2019 - Amneal and Par/Endo launched AB-rated generic versions of Actelion's Tracleer (bosentan) 62.5 mg and 125 mg tablets.
What is the use of bosentan tablet?
Bosentan is used to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs) in adults and children 3 years of age and older. Bosentan may improve the ability to exercise and slow the worsening of symptoms in patients with PAH.
What is the mechanism of action of bosentan?
The mechanism of action of bosentan is competitive inhibition of endothelin-1 receptors. Endothelin-1 is a potent vasoconstrictor, which also mediates cell proliferation, fibrosis and inflammation.
Why should you not use Tracleer?
Use of TRACLEER® should generally be avoided in patients with elevated aminotransferases (>3 x ULN) at baseline because monitoring for hepatotoxicity may be more difficult. It is important to adhere strictly to the monthly monitoring schedule for the duration of treatment.
What is the metabolite of Tracleer?
TRACLEER ® is metabolized by CYP2C9 and CYP3A.
What are the reactions to Tracleer?
Observed reactions include Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), anaphylaxis, rash and angioedema.
What is Tracleer metabolized by?
TRACLEER® is metabolized by CYP2C9 and CYP3A. Co-administration with agents that are metabolized by these pathways may affect plasma concentrations of one or both agents. Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable when TRACLEER® is co-administered.
What is Janssen Carepath?
Janssen CarePath is your one source for access, affordability, and treatment support for your patients. Janssen CarePath helps verify insurance coverage for your patients, helps find financial assistance options for eligible patients, and provides ongoing support to help patients start and stay on prescribed Janssen medications.
Does a specialty pharmacy supply refills?
The specialty pharmacy will supply refills as long as the prescriber verifies the continued prescription and the patient complies with the Bosentan REMS Program requirements.
Can Tracleer cause birth defects?
Based on animal data, TRACLEER® is likely to cause major birth defects if used during pregnancy. Exclude pregnancy before and during treatment. To prevent pregnancy, females of reproductive potential must use 2 reliable forms of contraception during treatment and for 1 month after stopping TRACLEER® unless the patient has an intrauterine device (IUD) or tubal sterilization, in which case no other contraception is needed. Obtain monthly pregnancy tests.
Summary
Actelion Pharmaceuticals was founded in 1997 by Jean-Paul Clozel, Walter Fischli, Thomas Widmann, Martine Clozel, and Andre Mueller in Allschwill, Switzerland.
Eligibility
Tracleer Access Program, a patient assistance program provided by Actelion Pharmaceuticals, offers Tracleer at no cost for up to 30 days to those who are eligible for the program. Eligibility is based off of the following requirements:
Other Tips
If you have any questions please call the Actelion Pharmaceuticals program directly.
Important Note
The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.
Uses
Bosentan is used to treat a condition of high blood pressure in the lungs (pulmonary arterial hypertension). It works by causing the blood vessels (arteries) in the lungs to relax and expand, thus decreasing the pressure.
How To Use
Before using, review the bosentan Medication Guide for information on the safe use of this medicine. Take this medication by mouth usually twice daily in the morning and evening with or without food; or as directed by your doctor. The dosage is based on your medical condition and response to therapy.
Side Effects
Headache, nose/throat irritation, itching, flushing, or stomach upset may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: irregular heartbeat, unusual tiredness and weakness, swelling of the legs, dizziness or lightheadedness.
Precautions
Tell your doctor your medical history, especially of: liver problems, blood disorders (e.g., anemia), any allergies. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. This medication must not be used during pregnancy because it may cause fetal harm.
Drug Interactions
This drug is not recommended for use with: cyclosporine, glyburide. Ask your doctor or pharmacist for more details.
Overdose
If overdose is suspected, contact your local poison control center or emergency room immediately.
What is a Tracleer?
TRACLEER ® is a prescription medicine indicated for patients with certain types of pulmonary arterial hypertension (PAH, WHO Group 1), which is high blood pressure in the vessels of the lungs . TRACLEER ® can improve your ability to exercise as measured by 6-minute walk test and can slow the worsening of your physical condition and symptoms.
How to report a Tracleer side effect?
These are not all the possible side effects of TRACLEER ®. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or by calling Actelion at 1-866-228-3546.
Why do you need a blood test before taking Tracleer?
So you must have your blood tested to check your liver function before you start TRACLEER® and each month after that. Your healthcare professional will order these tests. Regular blood tests are important because they will help your healthcare professional adjust or stop your treatment before there is permanent damage.
Can you take Tracleer with Bosentan?
Before you begin taking TRACLEER ®, you must read and agree to all of the instructions in the Bosentan REMS Program. Because of potential liver damage and in an effort to make the chance of fetal exposure to TRACLEER ® as small as possible, TRACLEER ® may be prescribed only through the Bosentan REMS Program.
Is Tracleer good for PAH?
TRACLEER ® is also indicated in pediatric patients 3 years and older with PAH caused by unidentified or hereditary factors to improve a certain kind of blood flow to the heart called peripheral vascular resistance (PVR). Studies showing TRACLEER ® is effective in pediatric patients included mainly patients with WHO Functional Class II-III.
Can Tracleer cause liver failure?
TRACLEER® can cause serious liver damage, including in rare cases liver failure. Even in situations with regular liver testing, rare cases of unexplained liver cirrhosis (scar tissue in the liver) have developed in patients with other medical conditions and taking other medications in addition to TRACLEER® for over 12 months.
What is a Tracleer?
TRACLEER ® is a prescription medicine indicated for patients with certain types of pulmonary arterial hypertension (PAH, WHO Group 1), which is high blood pressure in the vessels of the lungs . TRACLEER ® can improve your ability to exercise as measured by 6-minute walk test and can slow the worsening of your physical condition and symptoms.
How to report a Tracleer side effect?
These are not all the possible side effects of TRACLEER ®. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or by calling Actelion at 1-866-228-3546.
Why do you need a blood test before taking Tracleer?
So you must have your blood tested to check your liver function before you start TRACLEER® and each month after that. Your healthcare professional will order these tests. Regular blood tests are important because they will help your healthcare professional adjust or stop your treatment before there is permanent damage.
Can you take Tracleer before your period?
Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant. If you are the parent or caregiver of a female child who started taking TRACLEER ® before reaching puberty, you should check your child regularly to see if she is developing signs of puberty.
Can Tracleer cause liver failure?
TRACLEER® can cause serious liver damage, including in rare cases liver failure. Even in situations with regular liver testing, rare cases of unexplained liver cirrhosis (scar tissue in the liver) have developed in patients with other medical conditions and taking other medications in addition to TRACLEER® for over 12 months.
Can you take Tracleer with Bosentan?
Before you begin taking TRACLEER ®, you must read and agree to all of the instructions in the Bosentan REMS Program. Because of potential liver damage and in an effort to make the chance of fetal exposure to TRACLEER ® as small as possible, TRACLEER ® may be prescribed only through the Bosentan REMS Program.
Can Tracleer cause low sperm count?
Your healthcare professional will look for the cause of this. Lower sperm count. Some men who take TRACLEER® may have lower sperm counts. This may affect your ability to father a child. Tell your healthcare professional if fertility is a concern for you. Low red blood cell levels (anemia).
What is tracler used for?
Tracleer (bosentan) is a member of the agents for pulmonary hypertension drug class and is commonly used for Pulmonary Hypertension.
How much does a free drug card save?
The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.
Is Tracleer generic?
A generic version of Tracleer is available, see bosentan prices.
How do I apply for the Tracleer patient assistance program?
Our process makes it as easy as possible to apply for the Tracleer patient assistance program. Begin by completing the enrollment application form on our website. Tell us about any medications that you are taking, including Tracleer, your healthcare provider, your insurance plan, and your household income. This information is required by the pharmaceutical manufacturers who will supply the medication, so it is important to make sure this information is accurate and up to date.
What doses of Tracleer are available?
Tracleer is available in tablet form, in the following doses: 62.5 mg and 125 mg. Or oral suspension form, in the following doses: 32 mg.
What is Tracleer?
Tracleer is an FDA (U.S. Food and Drug Administration) approved medication manufactured by Janssen-Cilag Pty Ltd.
Is NiceRx a Tracleer coupons provider?
NiceRx is not a Tracleer coupon, Tracleer discount card, or Tracle er copay card provider. We do not offer Tracleer manufacturer coupons, Tracleer discounts, rebates, Tracleer savings cards, trial offers, or free Tracleer samples. We are a service provider that helps eligible individuals access their medication directly from the U.S. pharmaceutical company.
Important Note
Uses
- Tracleer Access Program, a patient assistance program provided by Actelion Pharmaceuticals, offers Tracleer at no cost for up to 30 days to those who are eligible for the program. Eligibility is based off of the following requirements: - You must not be covered by any private, public, or Medicare Part D prescription coverage programs. - You must no...
How to Use
Side Effects
Precautions
- The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug. BOSENTAN - ORAL (boh-...
Drug Interactions
- Bosentan is used to treat a condition of high blood pressure in the lungs (pulmonary arterial hypertension). It works by causing the blood vessels (arteries) in the lungs to relax and expand, thus decreasing the pressure.
Notes
- Before using, review the bosentan Medication Guide for information on the safe use of this medicine. Take this medication by mouth usually twice daily in the morning and evening with or without food; or as directed by your doctor. The dosage is based on your medical condition and response to therapy. Your doctor may recommend to gradually increase your dose over time so …
Missed Dose
- Headache, nose/throat irritation, itching, flushing, or stomach upset may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: irregular heartbeat, unusual tiredness and weakness, swelling of the legs, dizziness or lightheadedness. If you notice any of the following very serious …
Storage
- Tell your doctor your medical history, especially of: liver problems, blood disorders (e.g., anemia), any allergies. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. This medication must not be used during pregnancy because it may cause fetal harm. If you are pregnant or think you may be pregnant, do not take this medi…
Medical Alert
- This drug is not recommended for use with: cyclosporine, glyburide. Ask your doctor or pharmacist for more details. Tell your doctor of all prescription and nonprescription medication you may use, especially: azole antifungals (e.g., itraconazole, ketoconazole), statins for high cholesterol (e.g., lovastatin, simvastatin), birth control pills, HIV protease inhibitors (e.g., indinavi…