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For HCPs

Letairis (ambrisentan) is a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of the lungs.


PAH and Swelling

Why PAH can cause swelling

Important: Along with your treatment regimen, good nutrition is important for helping to manage PAH.

Have the rings on your fingers become tight? Or have you noticed your shoes feeling more snug than usual? You’re not imagining things—PAH and PAH medications like Letairis may cause swelling.

Swelling can occur when you have too much fluid in your body. The hearts of people with PAH cannot pump as much blood as usual, which can cause fluid to collect, leading to swelling.

Swelling can be a major problem for people with PAH, especially in the hands, legs, ankles, and feet. If swelling becomes uncomfortable or severe, it’s important to see your doctor right away.

Ways to help manage mild swelling

Reduce your salt intake

One way to help manage swelling associated with PAH is to make changes to the amount of salt in your diet.

Having too much salt is one of the major causes of swelling, because salt helps regulate the balance of fluids in your body. When you have too many fluids in your body, swelling can occur. While it can be very difficult to avoid salt altogether, you can make a big difference by cutting back as much as possible.

Here are ways you can limit your salt intake:

  • Read the labels on all the food you buy and opt for food with less salt: The American Heart Association recommends you have less than 1500 mg of salt a day
  • Don’t add salt when you cook: Instead, use alternatives to salt such as lemon juice, garlic, and fresh herbs when seasoning cooked meals
  • Avoid salty snack foods: Chips, pretzels, pickled foods, and condiments such as ketchup and soy sauce are high in sodium
  • Avoid packaged food: Be aware that many packaged meats, sauces, and frozen foods are high in salt, so check the labels before you buy them

Limit your fluid intake

Another way to help manage swelling associated with PAH is to limit your fluid intake. Many people with PAH are put on fluid restriction, so check with your PAH doctor to find out what is right for you.

One of the best ways to limit your fluid intake is to keep track of all the liquids you drink during the day. And keep in mind that foods such as soup, sherbet, and Jell-O® count as fluids, so take that into account when you are planning your day.

If you find yourself thirsty, eating fresh fruit like oranges or melon—anything with water in it—may help curb thirst while limiting your actual fluid intake. Talk to your doctor about eating fruit when you’re thirsty.

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Important Safety Information
and Indication

What is the most important information I should know about Letairis?

Letairis can cause serious birth defects if taken during pregnancy.

  • Females must not be pregnant when they start taking Letairis or become pregnant while taking Letairis
  • Females who are able to get pregnant must have a negative pregnancy test before starting Letairis, every month while taking Letairis, and 1 month after stopping Letairis. Your doctor will decide when to do the tests, and order the tests for you depending on your menstrual cycle
    • Females who are able to get pregnant are females who have entered puberty (even if they have not started their period), and have a uterus, and have not gone through menopause (menopause means that you have not had a period for at least 12 months for natural reasons, or that you have had your ovaries removed)

Females who are able to get pregnant must use two acceptable forms of birth control while taking Letairis and for 1 month after stopping Letairis because the medicine may still be in the body. See the Letairis Medication Guide for acceptable birth control options.

  • 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 to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during treatment with Letairis
  • If you decide that you want to change the form of birth control, talk with your doctor to be sure that you choose another acceptable form of birth control
  • 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

If you are the parent or caregiver of a female child who started taking Letairis 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 any pubic hair. Your child may reach puberty before having her first menstrual period.

Females can only receive Letairis through a restricted program called the Letairis Risk Evaluation and Mitigation (REMS) program. If you are a female who can get pregnant, you must talk to your doctor, understand the benefits and risks of Letairis, and agree to all of the instructions in the Letairis REMS program.

Who should not take Letairis?

Do not take Letairis if:

  • You are pregnant, plan to become pregnant, or become pregnant while taking Letairis. Letairis can cause serious birth defects. (See "What is the most important information I should know about Letairis?")
  • You have Idiopathic Pulmonary Fibrosis (IPF)

What should I avoid while taking Letairis?

  • Do not get pregnant. If you miss a menstrual period, or think you might be pregnant, call your doctor right away
  • Do not breastfeed. It is not known if Letairis passes into your breast milk

What are the other possible side effects of Letairis?

Serious side effects of Letairis can include:

  • Swelling all over the body (fluid retention) can happen within weeks after starting Letairis. Tell your doctor right away if you have any unusual weight gain, tiredness, or trouble breathing while taking Letairis. 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 counts have happened in some men taking a medicine that is like Letairis, which may affect your 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 Letairis. If this happens, you may need a blood transfusion. Your doctor will do blood tests to check your red blood cells before starting Letairis. Your doctor may also do these tests while you are taking Letairis

The most common side effects of Letairis are 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). Tell your doctor if you have any side effect that bothers you or does not go away.

The most common side effects of Letairis when taken with tadalafil are swelling of hands, legs, ankles and feet (peripheral edema), headache, stuffy nose (nasal congestion), cough, low red blood cell levels (anemia), indigestion (dyspepsia) or upper respiratory tract infection (bronchitis).

Some medicines that are like Letairis can cause liver problems. Tell your doctor if you get any of these symptoms while taking Letairis: loss of appetite, nausea or vomiting, fever, achiness, generally do not feel well, pain in the upper right stomach (abdominal) area, yellowing of your skin or the whites of your eyes, dark urine, itching.

What should I tell my doctor before taking Letairis?

  • All your medical conditions. Be sure to tell your doctor if you have a low red blood cell level (anemia) or liver problems
  • All the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Letairis 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 cyclosporine (Gengraf, Neoral, Sandimmune). Your doctor may need to change your dose of Letairis

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

What is Letairis?

Letairis is a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of the lungs.

  • Letairis can improve your ability to exercise and it can help slow down the worsening of your physical condition and symptoms
  • When taken with tadalafil, Letairis is used to reduce the risks of your disease progressing and hospitalization due to worsening PAH, and to improve your ability to exercise

Please see full Prescribing Information, including Medication Guide, with important warnings.