Important Safety Information and Indication
Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
• To improve exercise ability and delay clinical worsening.
Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).
What is the most important information I should know about ambrisentan tablets?
Females who are able to get pregnant must use two acceptable forms of birth control during treatment with ambrisentan tablets, and for one month after stopping ambrisentan tablets because the medicine may still be in the body.
- If you have had a tubal sterilization or have an IUD (intrauterine device) or progesterone implant, these methods can be used alone and no other form of birth control is needed.
- Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during treatment with ambrisentan tablets./li>
- If you decide that you want to change the form of birth control that you use, talk with your doctor or gynecologist to be sure that you choose another acceptable form of birth control.
See the chart below for Acceptable Birth Control Options during treatment with ambrisentan tablets.
Acceptable Birth Control Options
- Do not have unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your doctor may tell you to use emergency birth control.
- Tell your doctor right away if you miss a menstrual period or think you may be pregnant for any reason.
If you are the parent or caregiver of a female child who started taking ambrisentan tablets before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your doctor right away if you notice that she is developing breast buds or pubic hair. Your doctor should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.
Females can only receive ambrisentan tablets through a restricted program called the Ambrisentan Risk Evaluation and Mitigation Strategy (REMS) program. If you are a female who can get pregnant, you must talk to your doctor, understand the benefits and risks of ambrisentan tablets, and agree to all of the instructions in the Ambrisentan REMS program.
Males can receive ambrisentan tablets without taking part in the Ambrisentan REMS program.
What are Ambrisentan Tablets?
- Ambrisentan tablets are a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
- Ambrisentan tablets can improve your ability to exercise and it can help slow down the worsening of your physical condition and symptoms.
- It is not known if ambrisentan tablets are safe and effective in children.
Who should not take ambrisentan tablets?
Do not take ambrisentan tablets if:
- you are pregnant, plan to become pregnant, or become pregnant during treatment with ambrisentan tablets. Ambrisentan tablets can cause serious birth defects. (See “What is the most important information I should know about ambrisentan tablets?”)
Serious birth defects from ambrisentan tablets happen early in pregnancy.
- you have a condition called Idiopathic Pulmonary Fibrosis (IPF)
What should I tell my doctor before taking ambrisentan tablets?
Before you take ambrisentan tablets, tell your doctor if you:
- have been told that you have a low red blood cell level (anemia)
- have liver problems
- have any other medical conditions
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ambrisentan tablets and other medicines may affect each other, causing side effects. Do not start any new medicines until you check with your doctor.
Especially tell your doctor if you take the medicine cyclosporine (Gengraf, Neoral, Sandimmune). Your doctor may need to change your dose of ambrisentan tablets.
How should I take Ambrisentan Tablets?
- Ambrisentan tablets will be mailed to you by a certified pharmacy. Your doctor will give you complete details.
- Take ambrisentan tablets exactly as your doctor tells you to take it. Do not stop taking ambrisentan tablets unless your doctor tells you to stop.
- You can take ambrisentan tablets with or without food.
- Do not split, crush or chew ambrisentan tablets.
- It will be easier to remember to take ambrisentan tablets if you take it at the same time each day.
- If you take more than your regular dose of ambrisentan tablets, call your doctor right away.
- If you miss a dose, take it as soon as you remember that day. Take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.
What should I avoid while taking Ambrisentan Tablets?
- Do not get pregnant while taking ambrisentan tablets. (See the serious birth defects section of the Medication Guide above called “What is the most important information I should know about ambrisentan tablets?”) If you miss a menstrual period, or think you might be pregnant, call your doctor right away./li>
- It is not known if ambrisentan passes into your breast milk. You should not breastfeed if you are taking ambrisentan tablets. Talk to your doctor about the best way to feed your baby if you take ambrisentan tablets.
What are the possible side effects of ambrisentan tablets?
Ambrisentan tablets can cause serious side effects including:
- See “What is the most important information I should know about ambrisentan tablets?”
- Swelling all over the body (fluid retention) can happen within weeks after starting ambrisentan tablets. Tell your doctor right away if you have any unusual weight gain, tiredness, or trouble breathing while taking ambrisentan tablets. These may be symptoms of a serious health problem. You may need to be treated with medicine or need to go to the hospital.
- Decreased sperm count. Decreased sperm counts have happened in some men taking a medicine that is like ambrisentan tablets. A decreased sperm count may affect the ability to father a child. Tell your doctor if being able to have children is important to you.
- Low red blood cell levels (anemia) can happen during the first weeks after starting ambrisentan tablets. If this happens, you may need a blood transfusion. Your doctor will do blood tests to check your red blood cells before starting ambrisentan tablets. Your doctor may also do these tests during treatment with ambrisentan tablets.
The most common side effects of ambrisentan tablets include:
- swelling of hands, legs, ankles and feet (peripheral edema)
- stuffy nose (nasal congestion)
- inflamed nasal passages (sinusitis)
- hot flashes or getting red in the face (flushing)
Some medicines that are like ambrisentan tablets can cause liver problems. Tell your doctor if you get any of these symptoms of a liver problem while taking ambrisentan tablets:
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of ambrisentan tablets. 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.
How should I store ambrisentan tablets?
Store ambrisentan tablets at room temperature between 68°F to 77°F (20°C to 25°C), in the package it comes in.
Keep ambrisentan tablets and all medicines out of the reach of children.
General information about the safe and effective use of ambrisentan tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ambrisentan tablets for a condition for which it was not prescribed. Do not give ambrisentan 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 ambrisentan tablets. If you would like more information, ask your doctor. You can ask your doctor or pharmacist for information about ambrisentan tablets that is written for health professionals.
What are the ingredients in ambrisentan tablets?
Active ingredient: ambrisentan
Inactive Ingredients: croscarmellose sodium, lactose monohydrate, lecithin, magnesium stearate, microcrystalline cellulose, partially hydrolyzed polyvinyl alcohol, polyethylene glycol, povidone, talc and titanium dioxide. Additionally, 5 mg tablet contains: FD&C red#40 aluminum lake.