Letairis (Ambrisentan Tablets) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

Letairis

Pulmonary Hypertension »

What are pulmonary arteries?

The human body has two major sets of blood vessels that distribute blood from the heart to the body. One set pumps blood from the right heart to the lungs and the other from the left heart to the rest of the body.

The portion of the circulation that distributes oxygen-rich blood from the left side of the heart, throughout the body, is referred to as the systemic circulation.
The blood then returns from the body to the right side of the heart and passes through the lungs to replenish oxygen.
It then returns to the left side of the heart for another round through the systemic circulation.
The portion of the circulation that distributes the blood from the right side of the heart to the lungs is referred to as the pulmonary (lung) circulation.
The pulmonary arteries are the major blood vessels that carry blood from the rig...

Read the Pulmonary Hypertension article »

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LETAIRIS
(ambrisentan) Tablets

WARNING

CONTRAINDICATED IN PREGNANCY

LETAIRIS (ambrisentan tablets) is very likely to produce serious birth defects if used by pregnant women, as this effect has been seen consistently when it is administered to animals [see CONTRAINDICATIONS]. Pregnancy must therefore be excluded before the initiation of treatment with LETAIRIS (ambrisentan tablets) and prevented during treatment and for one month after stopping treatment by the use of two acceptable methods of contraception unless the patient has had a tubal sterilization or chooses to use a Copper T 380A IUD or LNg 20 IUS, in which case no additional contraception is needed. Obtain monthly pregnancy tests.

Because of the risk of birth defects, LETAIRIS (ambrisentan tablets) is available only through a special restricted distribution program called the LETAIRIS (ambrisentan tablets) Education and Access Program (LEAP), by calling 1-866-664-LEAP (5327). Only prescribers and pharmacies registered with LEAP may prescribe and distribute LETAIRIS (ambrisentan tablets) . In addition, LETAIRIS (ambrisentan tablets) may be dispensed only to patients who are enrolled in and meet all conditions of LEAP [see WARNINGS AND PRECAUTIONS].

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 (ambrisentan tablets) 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 (ambrisentan tablets) 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 »

Last reviewed on RxList: 4/22/2011
This monograph has been modified to include the generic and brand name in many instances.