Details for: TRACLEER
Company: JANSSEN INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02244981 | TRACLEER | BOSENTAN (BOSENTAN MONOHYDRATE) | 62.5 MG | TABLET | ORAL |
| 02244982 | TRACLEER | BOSENTAN (BOSENTAN MONOHYDRATE) | 125 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
TRACLEER® (bosentan) tablets are prescribed for the treatment of pulmonary arterial hypertension (high blood pressure in the blood vessels between the heart and the lungs).
What it does
TRACLEER® reduces abnormally high blood pressure by relaxing these blood vessels. TRACLEER® tablets belong to the class of medicines known as endothelin receptor antagonists.
When it should not be used
Before you take TRACLEER®: Tests your doctor will do before treatment:
- a blood test for liver function;
- a blood test for anemia (reduction in red blood cells);
- a pregnancy test.
Do not use TRACLEER if you
- are hypersensitive (allergic) to bosentan or any other ingredients in the tablet (See What the important nonmedicinal ingredients are);
- have liver problems;
- are pregnant or planning to become pregnant (hormonal contraceptives alone are not effective when you take TRACLEER®);
- are a woman of childbearing age and not using adequate contraceptive methods;
- are being treated with cyclosporine A, or glyburide.
Tell your doctor immediately if you are pregnant or plan to become pregnant in the near future. This is because TRACLEER® may harm your unborn baby and you must not take TRACLEER® if you are pregnant. You must also not become pregnant while taking TRACLEER®.
If you are a woman of childbearing age, your doctor or gynecologist will advise you about adequate contraceptive methods while taking TRACLEER®. Because TRACLEER® may make hormonal contraception (e.g., oral, injection, implant or skin patches) ineffective, this method on its own is not reliable. Therefore, if you use hormonal contraceptives you must also use a barrier method (e.g., female condom, diaphragm, contraceptive sponge or your partner must also use a condom). Monthly pregnancy tests are recommended while you are taking TRACLEER® and you are of childbearing age.
Tell your doctor immediately if you are breastfeeding. You are advised to stop breastfeeding if TRACLEER® is prescribed for you because it is not known if this drug passes into the milk in women who are taking TRACLEER®.
If you are a man taking TRACLEER®, it is possible that this medicine may lower your sperm count. It cannot be excluded that this may affect your ability to father a child. Talk to your doctor if you have any questions or concerns about this.
If you feel dizzy while taking TRACLEER®, do not drive or operate any tools or machines. TRACLEER® is not recommended for children.
What the medicinal ingredient is
Bosentan monohydrate.
What the non-medicinal ingredients are
Corn starch, glyceryl behenate, magnesium stearate, povidone, pregelatinized starch, and sodium starch glycolate. The filmcoating is composed of ethylcellulose, hydroxypropylmethylcellulose, iron oxide red, iron oxide yellow, talc, titanium dioxide and triacetin.
What dosage form it comes in
TRACLEER® 62.5 mg film-coated bosentan (from bosentan monohydrate) tablets are orange-white, round and embossed with '62,5' on one side. TRACLEER® is also available as orange-white, oval, film-coated tablets containing 125 mg bosentan and embossed with '125' on one side.
Warnings and precautions
Serious Warnings and Precautions
Warnings and Precautions Before you use TRACLEER® talk to your doctor or pharmacist if you are:
- known to have liver problems;
- pregnant or thinking of becoming pregnant;
- a woman of childbearing age and not using adequate contraceptive methods;
- breastfeeding;
- hypersensitive (allergic) to bosentan or any other ingredients of TRACLEER®.
Before starting TRACLEER® treatment, tell your doctor and your pharmacist if you are taking or have recently taken any other medicines, even those you have bought yourself. It is especially important to tell your doctor if you are taking:
- hormonal contraceptives (as these may not be effective as the sole method of contraception when you take TRACLEER®);
- glyburide (for diabetes);
- cyclosporine A (a medicine used after transplants and to treat psoriasis), or any other drugs used to prevent rejection of transplanted organs;
- fluconazole (to treat fungal infections);
- rifampicin (to treat tuberculosis);
- vasodilators (drugs used to treat high blood pressure)
Tests during treatment: Some patients taking TRACLEER® were found to have abnormal liver function values (increase in liver enzymes) and some patients developed anemia (reduction in red blood cells). Because these findings may not cause symptoms you can feel or observe yourself, your doctor will do regular blood tests to assess any changes in your liver function and hemoglobin level.
Liver function: This blood test will be done: every month or more frequently, if needed. If you develop abnormal liver function, your doctor may decide to reduce your dose or stop treatment with TRACLEER®. When your blood test results for liver function return to normal, your doctor may decide to restart treatment with TRACLEER®.
Anemia: This blood test will be done:
- after 1 month and after 3 months of treatment;
- every 3 months during treatment thereafter.
Pregnancy tests for women of childbearing age: Due to the risk of failure of hormonal contraception when taking TRACLEER® and the risk in patients with pulmonary hypertension of rapid and severe deterioration of the disease, monthly pregnancy tests are recommended before and during treatment with TRACLEER®.
Interactions with this medication
Drugs that may interact with TRACLEER® include: warfarin, simvastatin and other statins, glyburide, ketoconazole, cyclosporine A, tacrolimus, sirolimus and hormonal contraceptives.
Proper use of this medication
Always take TRACLEER® exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are
Usual Dose
The usual dose is one tablet, swallowed twice daily (morning and evening), consistently with or without food. Swallow the tablet with water. For the first 4 weeks, you will take a 62.5 mg tablet twice daily, from then on, your doctor will advise you to take a 125 mg tablet twice daily, depending on how you react to TRACLEER®.
Overdose
If you take more tablets than you have been told to take, see a doctor or go to a hospital immediately.
Missed Dose
If you forget to take TRACLEER®, take a dose as soon as you remember, then continue to take your tablets at the usual time. Do not take a double dose to make up for forgotten tablets.
Stopping treatment:
Suddenly stopping your treatment with TRACLEER® may lead to a worsening of your symptoms. Do not stop taking TRACLEER® unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely.
Side effects and what to do about them
If you notice yellowing of the skin or eyes (jaundice) or other symptoms such as nausea, vomiting, fever, abdominal pain or unusual tiredness, see your doctor immediately because this may be related to abnormal liver function.
Headaches were the most common side effect in clinical studies. You may also notice one or more of the following side effects
- flushed appearance, inflammation of the throat and nasal passages, swelling of the legs and ankles, or other signs of fluid retention, low blood pressure, irregular heartbeat, heartburn, tiredness, itching, nasal congestion, nausea. If these side effects become bothersome, contact your doctor.
- vomiting, abdominal pain, diarrhea, skin rash.
If you notice any other side effects or signs of allergic reaction (e.g. swelling of the face or tongue, rash, pruritus) while you are taking TRACLEER® or if any of the side effects mentioned above worries you, please inform your doctor or pharmacist.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Abdominal pain | ✔ | ||
| Swelling of the legs and ankles | ✔ | ||
| Vomiting | ✔ | ||
| Itching | ✔ | ||
| Nausea | ✔ | ||
| Other signs of fluid retention | ✔ | ||
| Tiredness | ✔ | ||
| Uncommon | |||
| Rash | ✔ | ||
| Swelling of the face, throat or tongue | ✔ | ||
| Rare | |||
| Asthma like symptoms (wheezing) | ✔ | ||
| Yellowing of the skin and eyes (jaundice) | ✔ Call your doctor immediately | ||
This is not a complete list of side effects. For any unexpected effects while taking TRACLEER®, contact your doctor or pharmacist.
How to store
Keep out of the sight and reach of children. Store at room temperature between 15ºC and 30ºC. Do not use after the expiry date stated on the blister.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at MedEffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your doctor or pharmacist.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website ***
This document plus the full product monograph, prepared for health professionals can be found at: www.janssen.com/canada or by contacting the sponsor, Janssen Inc., at: 1-800-567-3331 or 1- 800-387-8781.
This leaflet was prepared by Janssen Inc., Toronto, Ontario, M3C 1L9.
All trademarks used under license. All other third party trademarks are trademarks of their respective owners.