Letairis

DRUG DESCRIPTION

LETAIRIS is the brand name for ambrisentan, an endothelin receptor antagonist that is selective for the endothelin type-A (ETA) receptor. The chemical name of ambrisentan is (+)-(2S)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid. It has a molecular formula of C22H22N2O4 and a molecular weight of 378.42. It contains a single chiral center determined to be the (S) configuration and has the following structural formula:

Figure 1 : Ambrisentan Structural Formula

LETAIRIS (ambrisentan) Structural Formula Illustration

Ambrisentan is a white to off-white, crystalline solid. It is a carboxylic acid with a pKa of 4.0. Ambrisentan is practically insoluble in water and in aqueous solutions at low pH. Solubility increases in aqueous solutions at higher pH. In the solid state ambrisentan is very stable, is not hygroscopic, and is not light sensitive.

LETAIRIS is available as 5 mg and 10 mg film-coated tablets for once daily oral administration. The tablets include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablets are film-coated with a coating material containing FD&C Red #40 aluminum lake, lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Each square, pale pink LETAIRIS tablet contains 5 mg of ambrisentan. Each oval, deep pink LETAIRIS tablet contains 10 mg of ambrisentan. LETAIRIS tablets are unscored.

What are the possible side effects of ambrisentan (Letairis)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling short of breath;
  • fast or pounding heartbeats;
  • swelling of the feet, ankles, or legs;
  • nausea, stomach pain, loss of appetite, low fever, itching;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Letairis

What are the precautions when taking ambrisentan tablets (Letairis)?

Before taking ambrisentan, tell your doctor or pharmacist if you are allergic to it; or to other endothelin receptor blockers (e.g., bosentan); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, anemia.

Older adults may be at greater risk for swelling ankles/feet while using this drug.

This medication must not be used during pregnancy. It may harm an unborn baby. If you are planning pregnancy, become pregnant, or think you may be pregnant, tell your doctor immediately. Women who may become pregnant must have a negative pregnancy...

Read All Potential Precautions of Letairis


Letairis Consumer (continued)

SIDE EFFECTS: Stuffy nose, runny nose, headache, flushing, abdominal pain, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding heartbeat, extreme tiredness, swelling ankles/feet, sudden/unexplained weight gain, trouble breathing.

Other medications that are like ambrisentan may rarely cause very serious liver problems. Tell your doctor immediately if you develop symptoms of liver disease, including: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

This medication can decrease sperm production in some men, an effect that may lower male fertility. Consult your doctor for more details.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ambrisentan, tell your doctor or pharmacist if you are allergic to it; or to other endothelin receptor blockers (e.g., bosentan); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, anemia.

Older adults may be at greater risk for swelling ankles/feet while using this drug.

This medication must not be used during pregnancy. It may harm an unborn baby. If you are planning pregnancy, become pregnant, or think you may be pregnant, tell your doctor immediately. Women who may become pregnant must have a negative pregnancy test before starting this medication and once a month while taking it. Consult your doctor for more details and to discuss reliable forms of birth control. Unless otherwise directed by your doctor, it is recommended that at least 2 reliable forms of birth control (e.g., birth control pills, condoms) be used while taking this medication and for 1 month after stopping the medication.

It is not known whether this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.


Letairis Patient Information Including Side Effects

Brand Names: Letairis

Generic Name: ambrisentan (Pronunciation: am bri SEN tan)

  • What is ambrisentan (Letairis)?
  • What are the possible side effects of ambrisentan (Letairis)?
  • What is the most important information I should know about ambrisentan (Letairis)?
  • What should I discuss with my healthcare provider before taking ambrisentan (Letairis)?
  • How should I take ambrisentan (Letairis)?
  • What happens if I miss a dose (Letairis)?
  • What happens if I overdose (Letairis)?
  • What should I avoid while using ambrisentan (Letairis)?
  • What other drugs will affect ambrisentan (Letairis)?
  • Where can I get more information?

What is ambrisentan (Letairis)?

Ambrisentan prevents thickening of the blood vessels, especially those in the lungs and heart. Ambrisentan also lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Ambrisentan is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

Ambrisentan may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ambrisentan (Letairis)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling short of breath;
  • fast or pounding heartbeats;
  • swelling of the feet, ankles, or legs;
  • nausea, stomach pain, loss of appetite, low fever, itching;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache;
  • stomach pain, constipation;
  • stuffy nose, sinus pain, sore throat; or
  • warmth, redness, or tingly feeling under your skin.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you miss a menstrual period during treatment with ambrisentan. Use two reliable forms of birth control together while you are taking the medication and for at least 1 month after your treatment ends.

You will probably be required to take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.

Ambrisentan can cause severe liver problems. Symptoms include nausea, stomach pain, itching, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking ambrisentan, and again each month during your treatment.

Do not stop taking ambrisentan without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Ambrisentan is available only under a special program called LEAP (Letairis Education and Access Program). You must be registered in the program and sign agreements to use birth control and undergo pregnancy and blood testing as required by the program. Read all program brochures and agreements carefully.

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