Tracleer : Uses, Side Effects, Interactions & More

IMPORTANT WARNING:

For male and female patients:
Tracleer can cause liver damage. Tell your doctor if you have or have ever had liver disease. Your doctor will order a blood test to make sure your liver is working normally before you start taking Tracleer and every month during your treatment. Keep all appointments with your doctor and the laboratory. Tracleer can damage the liver before causing symptoms. Regular blood tests are the only way to detect liver damage before it becomes permanent and serious. If you experience any of the following symptoms, call your doctor immediately: nausea, vomiting, fever, stomach pain, yellowing of the skin or eyes, or extreme tiredness. Your doctor may reduce your dose or temporarily or permanently stop your treatment with Tracleer if you experience side effects or have abnormal laboratory results.

For female patients:
Do not take Tracleer if you are pregnant or plan to become pregnant. Tracleer can harm the fetus. If you are able to become pregnant, you will need to take a pregnancy test before starting treatment, every month during treatment, and for 1 month after your treatment to show that you are not pregnant. Your doctor will order pregnancy tests. You must use reliable birth control during your treatment and for 1 month after your treatment. Hormonal contraceptives (birth control pills, patches, rings, injections, implants, and intrauterine devices) may not work well when used with Tracleer and should not be used as your only method of birth control. Talk to your doctor about the birth control methods that will work for you. In most cases, you will be asked to use two forms of birth control.

Call your doctor right away if you have unprotected sex, think your birth control failed, miss a period, or think you may be pregnant while taking Tracleer. Don’t wait until your next appointment to discuss this with your doctor.

If you are the parent or guardian of a patient who has not yet reached puberty, check your child regularly for any signs of puberty (breast breakouts, pubic hair) and report any changes to your doctor.

Due to the risks of liver damage and birth defects, Tracleer is only available through a restricted program called the Tracleer Risk Assessment and Mitigation Strategy Program (Tracleer REMS). To receive Tracleer, you and your doctor must be registered with Tracleer REMS and follow program requirements, such as once a month liver function and pregnancy tests. Your doctor will enroll you in the program. Tracleer is only available at certain Tracleer REMS registered pharmacies. Ask your doctor or pharmacist if you have any questions about how to fill your prescription.

You will receive the manufacturer’s patient information sheet (Medication Guide) when you start treatment with Tracleer and each time you get a refill. Read the information carefully each time and ask your doctor or pharmacist if you have any questions. You can also get the FDA Medication Guide website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Talk to your doctor about the risks of taking Tracleer.

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Why is this medication prescribed?

Tracleer (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. Tracleer may improve the ability to exercise and delay the worsening of symptoms in PAH patients. Tracleer is in a class of medications called endothelin receptor antagonists. It works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have PAH.

How should this medicine be used?

Tracleer (Bosentan) comes as a tablet and a dispersible tablet (tablets that can be dissolved in liquid) to take by mouth. It is usually taken with or without food twice a day in the morning and in the evening. To remind you to take Tracleer, take it at around the same time every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any parts you do not understand. Take Tracleer exactly as directed. Do not take more or less or take it more often than prescribed by your doctor.

If you are taking the dispersible tablet, put it in a small amount of liquid just before taking it. If your doctor has told you to take half a tablet, carefully break the dispersible tablet on the line. Take half of the tablet as directed and put the other half back in the open blister pack. Use the other half of the tablet within 7 days. Do not quarter the dispersible tablet.

Your doctor will likely prescribe a low dose of Tracleer and increase it after 4 weeks.

Tracleer controls the symptoms of PAH but does not cure it. It may take 1 to 2 months or more before you feel the full benefit of Tracleer. Keep taking Tracleer even if you feel fine. Do not stop taking Tracleer without consulting your doctor. If you stop taking Tracleer suddenly, your symptoms may get worse. Your doctor may reduce your dose gradually.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking Tracleer,

  • Tell your doctor and pharmacist if you are allergic to Tracleer, any other medications, or any of the ingredients in Tracleer tablets or dispersible tablets.
  • Do not take cyclosporine (Gengraf, Neoral, Sandimmune) or glyburide (DiaBeta, Glynase) while taking Tracleer.
  • Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: amiodarone (Nexterone, Pacerone); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet), lovastatin (Altoprev), and simvastatin (Flolopid, Zocor, in Vytorin); diltiazem (Cardizem, Cartia, Diltzac, others); erythromycin (E.E.S., Eryc, PCE); fluconazole (Diflucan); gemfibrozil (Lopid); itraconazole (Onmel, Sporanox); ketoconazole; rifampicin (Rifadin, Rimactane, in Rifater, Rifamate); ritonavir (Norvir, in Kaletra, Viekira Pak, Technivie); voriconazole (Vfend); and warfarin (Coumadin, Jantoven). Many other medications can also interact with Tracleer, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you closely for side effects.
  • Tell your doctor if you have or have ever had heart failure (a condition in which the heart cannot pump enough blood to other parts of the body).
  • Tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor will probably tell you not to breastfeed while taking Tracleer.
  • If you have phenylketonuria (PKU, a hereditary disease in which a special diet must be followed to prevent mental retardation), you should know that the dispersible tablets are sweetened with aspartame, a source of phenylalanine.
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What special dietary instructions should I follow?

Talk to your doctor about drinking grapefruit juice while taking this medication.

What should I do if I forget a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for the one you forgot.

What side effects can this medication cause?

Tracleer may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • flushing
  • runny nose, sore throat, and other cold symptoms
  • joint pain

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

  • hives; rash; itching; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, and eyes; hoarseness; fever; swollen lymph nodes; tiredness
  • swelling of the feet, ankles, or lower legs, sudden weight gain, more trouble with breathing than normal
  • new or worsening shortness of breath; new or worsening cough with or without blood; chest pain; fast, pounding, or irregular heartbeat
  • fainting
  • dizziness; pale skin; shortness of breath; weakness; fast, pounding, or irregular heartbeat

Male laboratory animals that received Tracleer-like drugs developed problems with their testes and produced fewer sperm (male reproductive cells) than normal. It is not known whether Tracleer will damage the testicles or decrease the number of sperm produced in men. Talk to your doctor about the risks of taking Tracleer if you would like to have children in the future.

Tracleer can cause other side effects. Call your doctor if you have any unusual problems while taking this medicine.

If you experience a serious side effect, you or your doctor can submit a report online to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medicine in the container it came in, tightly closed, and out of the reach of children. Store at room temperature and away from excess heat and moisture (not in the bathroom).

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Unnecessary medications must be disposed of in special ways to ensure that pets, children, and others cannot consume them. However, you should not flush this medicine down the toilet. Instead, the best way to dispose of your medications is through a drug take-back program. Talk to your pharmacist or contact your local garbage / recycling department to find out about take-back programs in your community. Check out the FDA drug safe disposal website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medicines out of the sight and reach of children, as many containers (such as those containing weekly pills and those for eye drops, creams, patches and inhalers) are not child-resistant and small children can easily open them. To protect young children from poisoning, always close the safety caps and immediately place the medicine in a safe place, one that is upright and out of their sight and reach. http://www.upandaway.org

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim collapsed, had a seizure, is having trouble breathing, or is unable to wake up, immediately call 911 for emergency services.

Symptoms of overdose may include the following:

  • headache
  • nausea
  • vomiting
  • fast heartbeat
  • fainting
  • sweating
  • dizziness
  • blurred vision

What other information should I know?

Do not let anyone else take your medicine. Ask your doctor any questions you have about refilling your prescription.

It is important that you keep a written list of all prescription and over-the-counter (over-the-counter) medications you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should take this list with you every time you visit a doctor or if you go into hospital. It is also important information to take with you in case of emergencies.

Brand Names

  • Tracleer®

Disclaimer: DrLinex has made every effort to ensure that all information is factually accurate, comprehensive and up-to-date. However, this article should not be used as a licensed health care professional’s choice of knowledge and expertise. You should always consult your doctor or other health care professional before taking any medication. The information given here is subject to change and it has not been used to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions or adverse effects. The lack of warning or other information for any drug does not indicate that the combination of medicine or medication is safe, effective or appropriate for all patients or all specific uses.

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