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BOSENTAN tablet, film coated


  1. Patient Information
  2. Instruct Patients That The Risks Associated With Bosentan Tablets Include:
  3. Instruct Patients That The Risks Associated With Bosentan Tablets Also Include The Following:
  4. Instruct Patients That The Risks Associated With Bosentan Include:
  5. Bosentan Tablets Can Cause Serious Side Effects Including:
  6. Call Your Healthcare Provider Right Away If You Have Any Of These Symptoms Of Liver Problems While Taking Bosentan Tablets:
  7. What Are Bosentan Tablets?
  8. Bosentan Tablets Are Only:
  9. Do Not Take Bosentan Tablets If You:
  10. What Is The Most Important Information I Should Know About Bosentan Tablets?
  11. Bosentan Tablets May Not Be Right For You.tell Your Healthcare Provider About All Your Medical Conditions, Including If You:
  12. Especially Tell Your Healthcare Provider If You Take:
  13. How Should I Take Bosentan Tablets?
  14. Bosentan Tablets Can Cause Serious Side Effects, Including:
  15. What Are The Ingredients In Bosentan Tablets?

Patient Information ⮝

Advise the patient to read the FDA-approved patient labeling (Medication Guide)

Restricted access

Advise the patient that bosentan tablets are only available through a restricted access program called the Bosentan REMS Program.

As a component of the Bosentan REMS, prescribers must review the contents of the bosentan tablets Medication Guide with the patient before initiating bosentan tablets.

Instruct Patients That The Risks Associated With Bosentan Tablets Include: ⮝

  • Hepatotoxicity

Discuss with the patient the requirement to measure serum aminotransferases monthly.

  • Embryo-fetal toxicity

Educate and counsel female patients of reproductive potential about the need to use reliable methods of contraception during treatment with bosentan tablets and for one month after treatment discontinuation. Females of reproductive potential must have monthly pregnancy tests and must use two different forms of contraception while taking bosentan tablets and for one month after discontinuing bosentan tablets[seeUse in Specific Populations (8.1)].

Females who have intrauterine devices (IUD) or tubal sterilization can use these contraceptive methods alone. Patients should be instructed to immediately contact their physician if they suspect they may be pregnant. Patients should seek additional contraceptive advice from a gynecologist or similar expert as needed.

Educate and counsel females of reproductive potential on the use of emergency contraception in the event of unprotected sex or contraceptive failure.

Advise pre-pubertal females to report any changes in their reproductive status immediately to her prescriber.

Advise patients to contact their gynecologist or healthcare provider if they want to change the form of birth control which is used to ensure that another acceptable form of birth control is selected.

Advise the patient that bosentan tablets are available only from certified pharmacies that are enrolled in the Bosentan REMS Program.

Patients must sign the Bosentan REMS Program Patient Enrollment Form to confirm that they understand the risks of bosentan tablets.

  • Lactation

Advise women not to breastfeed during treatment with bosentan tablets[seeUse in Specific Populations (8.2)].

  • Infertility

Advise males of reproductive potential that bosentan tablets may impair fertility[seeWarnings and Precautions (5.6),Adverse Reactions (6.1),Use in Specific Populations (8.3)andNonclinical Toxicology (13.1)].

Other Risks Associated withBosentan Tablets

Instruct Patients That The Risks Associated With Bosentan Tablets Also Include The Following: ⮝

Decreases in hemoglobin and hematocrit advise patients of the importance of hemoglobin testing

Decreases in sperm count

Fluid retention

Instruct Patients That The Risks Associated With Bosentan Include: ⮝

  • Hepatotoxicity

    Discuss with the patient the requirement to measure serum aminotransferases monthly.

  • Embryo-fetal toxicity

    Educate and counsel female patients of reproductive potential about the need to use reliable methods of contraception during treatment with bosentan and for one month after treatment discontinuation. Females of reproductive potential must have monthly pregnancy tests and must use two different forms of contraception while taking bosentan and for one month after discontinuing bosentan[seeUse in Specific Populations (8.1)].

Females who have intrauterine devices (IUD) or tubal sterilization can use these contraceptive methods alone. Patients should be instructed to immediately contact their physician if they suspect they may be pregnant. Patients should seek additional contraceptive advice from a gynecologist or similar expert as needed.

Educate and counsel females of reproductive potential on the use of emergency contraception in the event of unprotected sex or contraceptive failure.

Advise pre-pubertal females to report any changes in their reproductive status immediately to her prescriber.

Advise patients to contact their gynecologist or healthcare provider if they want to change the form of birth control which is used to ensure that another acceptable form of birth control is selected.

Advise the patient that bosentan is available only from certified pharmacies that are enrolled in the Bosentan REMS Program.

Patients must sign the Bosentan REMS Program Patient Enrollment Form to confirm that they understand the risks of bosentan.

Other Risks Associated with Bosentan

Instruct patients that the risks associated with bosentan also include the following:
Decreases in hemoglobin and hematocrit advise patients of the importance of hemoglobin testing
Decreases in sperm count
Fluid retention

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit
Ahmedabad 382213, INDIA

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 06-2019-01

Bosentan Tablets Can Cause Serious Side Effects Including: ⮝

Liver damage.

  • Liver damage may not cause symptoms at first. Only a blood test can show if you have early liver damage. You must have your blood tested to check your liver function before you start bosentan tablets and each month after that. Your healthcare provider will order these tests. Regular blood tests are important because they will help your healthcare provider adjust or stop your treatment before there is permanent damage.
  • Tell your healthcare provider if you have had liver problems, including liver problems while taking other medicines.

Call Your Healthcare Provider Right Away If You Have Any Of These Symptoms Of Liver Problems While Taking Bosentan Tablets: ⮝

  • nausea
  • vomiting
  • fever
  • unusual tiredness
  • stomach area (abdominal) pain
  • yellowing of the skin or the whites of your eyes (jaundice)

Serious birth defects.

  • Bosentan tablets can cause serious birth defects if taken during pregnancy. You must not be pregnant when you start taking bosentan tablets or during bosentan tablets treatment. Serious birth defects from bosentan tablets can happen early in pregnancy. Females who are able to get pregnant must have a negative pregnancy test before starting treatment with bosentan tablets, each month during treatment with bosentan tablets, and 1 month after stopping treatment with bosentan tablets.
  • Talk to your healthcare provider about your menstrual cycle. Your healthcare provider will decide when to do a pregnancy test and will order a pregnancy test for you depending on your menstrual cycle.
  • Females whoare ableto get pregnant are females who:
  • have entered puberty, even if they have not started their menstrual period,and
  • have a uterus,and
  • have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.
  • Females whoare not ableto get pregnant are females who:
  • have not yet entered puberty,or
  • do not have a uterus,or
  • have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removedor
  • are infertile for other medical reasons and this infertility is permanent and cannot be reversed.
  • Females who are able to get pregnant must use two acceptable forms of birth control during treatment with bosentan tablets, and for one month after stopping bosentan tablets because the medicine may still be in the body.
  • If you have had a tubal sterilization or have an IUD (intrauterine device), these methods can be used alone and no other form of birth control is needed.
  • Talk with your healthcare provider or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable birth control that you may use to prevent pregnancy during treatment with bosentan tablets.
  • If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another acceptable form of birth control.

for more information about side effects.

What Are Bosentan Tablets? ⮝

Bosentan tablets are a prescription medicine used to treat people with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of the lungs.

Bosentan tablets can improve your ability to exercise and can slow the worsening of your physical condition and symptoms. Bosentan tablets lowers high blood pressure in your lungs and lets your heart pump blood more efficiently.

Bosentan Tablets Are Only: ⮝

Prescribed by healthcare providers who are enrolled in the Bosentan REMS Program. Available to people who understand and agree to enroll in the Bosentan REMS Program.

Do Not Take Bosentan Tablets If You: ⮝

  • are pregnant, plan to become pregnant, or become pregnant during bosentan tablets treatment. Bosentan tablets can cause serious birth defects.All females should read thebirth defectssection of

What Is The Most Important Information I Should Know About Bosentan Tablets? ⮝

  • take any of these medicines:
    • cyclosporine A used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of heart, liver, and kidney transplants
    • glyburide used to treat diabetes
    • are allergic to bosentan or any of the ingredients in bosentan tablets.

    Bosentan Tablets May Not Be Right For You.tell Your Healthcare Provider About All Your Medical Conditions, Including If You: ⮝

    • have liver problems.
    • are breast-feeding or plan to breast feed.It is not known if bosentan passes into your milk. You and your healthcare provider should decide if you will take bosentan tablets or breastfeed. You should not do both.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Bosentan tablets and other medicines may affect how each other works and cause side effects.

    Especially Tell Your Healthcare Provider If You Take: ⮝

    • hormone-based birth control, such as pills, shots, patches, and implants. These birth control methods may not work as well when taken with bosentan tablets.
    • simvastatin or other -statin medicines used to lower cholesterol
    • rifampin used for tuberculosis
    • ketoconazole, fluconazole, itraconazole, or voriconazole used for fungal infections
    • warfarin sodium used to prevent blood clots
    • ritonavir used to treat HIV

    There may be more than one brand name medicine. Ask your healthcare provider if you are not sure if your medicine is one that is listed above.

    Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine.

    How Should I Take Bosentan Tablets? ⮝

    Your healthcare provider will give you detailed information about the Bosentan REMS Program.

    • Bosentan tablets is only available through certified pharmacies. You will only receive a 30-day supply of bosentan tablets at one time.
    • Take bosentan tablets exactly as prescribed.
    • Your healthcare provider will tell you how much bosentan tablets to take and when to take it.
    • In most cases, you will take 1 tablet in the morning and 1 in the evening.
    • You can take bosentan tablets orally with or without food.
    • If you take more than the prescribed dose of bosentan tablets, call your healthcare provider right away.
    • If you miss a dose of bosentan tablets, take your tablet as soon as you remember. Do not take 2 doses at the same time. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time.
    • Do not stop taking bosentan tablets unless your healthcare provider tells you to. Suddenly stopping your treatment may cause your symptoms to get worse. If you need to stop taking bosentan tablets, speak with your healthcare provider about the right way to stop.

    Bosentan Tablets Can Cause Serious Side Effects, Including: ⮝

      • Store bosentan tablets at room temperature between 20 to 25 C (68 to 77 F).

      Keep bosentan tablets and all medicines out of the reach of children.

      General information about bosentan tablets

      Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bosentan tablets for a condition for which it was not prescribed. Do not give bosentan tablets to other people, even if they have the same symptoms that you have. It may harm them.

      This Medication Guide summarizes the most important information about bosentan tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about bosentan tablets that is written for health professionals. For more information, go to www.amneal.com or call Amneal Pharmaceuticals at 1-877-835-5472.

    What Are The Ingredients In Bosentan Tablets? ⮝

    Active ingredient: Bosentan

    Inactive ingredients: Corn starch, ethyl cellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, pregelatinized starch, povidone, sodium starch glycolate type A, titanium dioxide, triacetin and talc.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Manufactured by:
    Amneal Pharmaceuticals Pvt. Ltd.
    Oral Solid Dosage Unit
    Ahmedabad 382213, INDIA

    Distributed by:
    Amneal Pharmaceuticals LLC
    Bridgewater, NJ 08807

    Rev. 06-2019-01

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