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Letairis

Generic name Ambrisentan (AM-briSEN-tan)
Agents to treat pulmonary hypertension

What is Letairis?

Letairis helps prevent thickening in blood vessels, particularly those of the heart and lungs. Ambrisentan lowers your blood pressure and helps your heart pump more blood.Letairis is used in the treatment of adults with pulmonary artery hypertension. It increases your ability to exercise and helps prevent your condition from worsening.Letairis can be used in conjunction with a medication called tadalafil.Letairis for women is only available from a pharmacy certified under a special programme. To be eligible for the programme, you must sign up and agree to take birth control, undergo pregnancy testing, and use blood tests.

Warnings

Letairis may harm an unborn child or cause birth defects. Ambrisentan should not be used if you're pregnant.You will need to use two methods of birth control during treatment and for one month afterwards if you are a woman with childbearing capacity.Letairis should not be used if you suffer from idiopathic lung fibrosis.

Before you take this drug

Letairis should not be used if you have an ambrisentan allergy or idiopathic lung fibrosis.Do not consume Letairis while pregnant or suspect you might be. Letairis can cause birth defects. If you think you might be pregnant or have missed a period, tell your doctor immediately.Before starting the treatment, you will need a negative pregnancy result. Every month you will be tested, as well as 1 month after the last dose.

Even if you don't plan to get pregnant, you can still become pregnant if:

  • You have reached puberty, even if your period has not yet begun.
  • You have not had a hysterectomy or had your ovaries taken out.
  • You have not experienced menopause. (You have never missed a period for 12 consecutive months.)

You must use two highly effective methods of birth control for 30 days following your last Letairis dose.

The following are recommended forms of birth control:

  • A tubal ligation, an IUD (intrauterine device) made of copper, or a progesterone implant
  • One hormone form (birth-control pill or skin patch) plus one barrier form (condom or diaphragm combined with spermicide or cervical caps with the spermicide);
  • A female barrier and a male condom (diaphragm or cervical cap) can be used together.
  • A partner's ovarian vasectomy, plus one hormone or barrier form

Letairis includes patient instructions on acceptable birth control methods to use when taking this medication. Please follow the instructions carefully. If you are experiencing unprotected sexual activity or believe that your contraception is failing, ask your doctor for emergency contraception.

Tell your doctor about any of the following to ensure that Letairis will be safe for you:

  • Liver disease
  • Anaemia (low red cell count)

Ambrisentan should not be used while breastfeeding.

Ambrisentan can lower a male's sperm counts and affect fertility.

Similar/related drugs

Sildenafil, Tadalafil, Adcirca, Revatio, Ambrisentan, and Opsumit

How to take Letairis?

Letairis should be taken once a day. Please follow all the instructions on the prescription label. Take this medication only as prescribed. Do not exceed the recommended dosage or take it for longer.Your doctor may conduct blood tests before you begin treatment with Letairis to ensure that you are safe to take the medicine. Your blood will be tested regularly during treatment.Letairis is taken with or without food. Take Letairis at the same time every day.The tablet should not be crushed, chewed, or divided. Avoid chewing, crushing or splitting the tablet.Store away from moisture or heat at room temperature. Store this medication in the original container.

Details on dosage

Adult dose for pulmonary hypertension:

Initial dose: oral, 5 mg once daily.
Comments:
If 5 mg is well tolerated, consider increasing the dose orally to 10 mg once daily.
When used in conjunction with tadalafil, the dose can be increased to suit your needs and tolerated every 4 weeks.
Uses:
-For treatment of pulmonary arterial hypotension (WHO Group 1) to improve exercise capacity and delay clinical deterioration.
For the treatment of pulmonary hypertension (WHO Group 1 in combination with Tadalafil) to reduce the risk of disease progression, hospitalisations for worsening of pulmonary hypertension, and improve exercise capacity

What happens if I miss the dose?

If you are almost due for your next dose, skip the missed one. Never take two doses of the same medicine at once.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.

Side effects of Letairis

If you experience any of the following symptoms of an allergic reaction: hives, difficulty breathing, swelling of the face, lips, or throat, and/or difficulty breathing, seek emergency medical attention.

If you experience:

  • Chest pain, severe shortness of breath, coughing up foamy mucus;
  • Swelling, tiredness, and rapid weight gain;
  • Anaemia (low red blood cells), pale skin, unusual fatigue, feeling lightheaded or hort of breath,, cold hands or feet;
  • Liver problem: loss of appetite and stomach pain on the upper right side; nausea; vomiting; fever; itching; or dark urine.

Common Letairis side effects may include:

  • You may experience swelling of your legs, feet, hands, or ankles.
  • Stuffy nose, sinus pain,
  • Hot flashes: redness on your face

There may be other side effects. For medical advice on side effects, call your doctor. Reaching out to the FDA with concerns can be done at 1-800-FDA-1088.

Interaction with other drug

Tell your doctor about your other medications, including:

  • Cyclosporine.

This list is incomplete. Ambrisentan may interact with other drugs, such as prescription and over-the-counter medicines, vitamins, and herbal products. This list does not encompass all drug interactions.

 

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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