Ambrisentan : Uses, Side Effects, Interactions & More

IMPORTANT WARNING:

Do not take ambrisentan if you are pregnant or plan to become pregnant. Ambrisentan can harm the fetus. If you are a woman and can become pregnant, you should not start taking ambrisentan until a pregnancy test has shown that you are not pregnant. You must use two reliable methods of birth control during treatment with this medicine and for 1 month after stopping treatment. Don’t have unprotected sex. Talk to your doctor about the birth control methods that will work for you. Call your doctor right away if you miss a menstrual period or think you may be pregnant while taking ambrisentan.

Due to the risk of birth defects, ambrisentan is available to women only through a special program of restricted distribution. A program called Ambrisentan REMS (Risk Assessment and Mitigation Strategy) has been established to ensure that patients undergo the proper laboratory tests before and while receiving ambrisentan. Women can get ambrisentan only if they are registered with this program. Your doctor must enroll you in this program. You can only receive the drug at a pharmacy that participates in the program. Ask your doctor if you have any questions about participating in the program or how to get your medicine.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests during your treatment with ambrisentan.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you start treatment with ambrisentan and each time you get a refill. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risks of taking ambrisentan.

Why is this medication prescribed?

Ambrisentan is used alone or in combination with tadalafil (Adcirca, Cialis) to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs). Ambrisentan can improve the ability to exercise and delay the worsening of symptoms in people with PAH. Ambrisentan belongs to a class of drugs called endothelin receptor antagonists. It works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have PAH.

How should this medicine be used?

Ambrisentan comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take ambrisentan at around the same times every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any parts you do not understand. Take ambrisentan exactly as directed. Do not take more or less, or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor may start you on a low dose of ambrisentan and gradually increase your dose.

Ambrisentan controls the symptoms of PAH but does not cure it. Keep taking ambrisentan even if you feel fine. Do not stop taking ambrisentan without consulting your doctor. If you suddenly stop taking ambrisentan, your condition may get worse.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking ambrisentan,

  • Tell your doctor and pharmacist if you are allergic to ambrisentan, any other medications, or any of the ingredients in ambrisentan tablets. Ask your pharmacist or see the Medication Guide for a list of ingredients.
  • Tell your doctor and pharmacist what other prescription and over-the-counter medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention if you are taking cyclosporine (Gengraf, Neoral, Sandimmune). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • Tell your doctor if you have idiopathic pulmonary fibrosis (scarring of the lungs of unknown cause). Your doctor will likely tell you not to take ambrisentan.
  • Tell your doctor if you have or have ever had anemia (a lower than normal number of red blood cells) or liver disease.
  • Tell your doctor if you are breastfeeding. Do not breastfeed if you are taking ambrisentan.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for the one you forgot.

What side effects can this medication cause?

Ambrisentan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • flushing
  • pale skin
  • fast heartbeat
  • headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • hoarseness
  • difficulty swallowing or breathing
  • rash
  • unusual weight gain
  • extreme tiredness
  • loss of appetite
  • lack of energy
  • nausea
  • vomiting
  • pain in the upper right stomach area
  • yellowing of the skin or eyes
  • flu-like symptoms
  • itching
  • dark colored urine

Some men taking a drug similar to ambrisentan developed a lower than normal sperm count (number of male reproductive cells); an effect that could affect your ability to father a child. Talk to your doctor about the risks of taking ambrisentan if you want to have children in the future.

Ambrisentan may cause other side effects. Call your doctor if you have any unusual problems while taking this medicine.

If you experience a serious side effect, you or your doctor can submit a report online to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medicine in the container it came in, tightly closed, and out of the reach of children. Store at room temperature and away from excess heat and moisture (not in the bathroom).

Unnecessary medications must be disposed of in special ways to ensure they cannot be consumed by pets, children, and others. However, you should not flush this medicine down the toilet. Instead, the best way to dispose of your medications is through a drug take-back program. Talk to your pharmacist or contact your local garbage / recycling department to find out about take-back programs in your community. See the FDA Safe Drug Disposal website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medicines out of the sight and reach of children, since many containers (such as those containing weekly pills and those for eye drops, creams, patches and inhalers) are not resistant to children and small children can easily open them. To protect young children from poisoning, always close the safety caps and immediately place the medicine in a safe place, one that is upright and out of their sight and reach. http://www.upandaway.org

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim collapsed, had a seizure, has trouble breathing, or cannot wake up, immediately call 911 for emergency services.

Symptoms of overdose may include the following:

  • headache
  • flushing
  • dizziness
  • nausea
  • nasal congestion

What other information should I know?

Do not let anyone else take your medicine.

It is important that you keep a written list of all prescription and over-the-counter (over-the-counter) medications you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should take this list with you each time you visit a doctor or if you go into hospital. It is also important information to take with you in case of emergencies.

Brand names

  • Letairis®

Disclaimer: We have made every effort to ensure that all information is factually accurate, comprehensive and up-to-date. However, this article should not be used as a licensed health care professional’s choice of knowledge and expertise. You should always consult your doctor or other health care professional before taking any medication. The information given here is subject to change and it has not been used to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions or adverse effects. The lack of warning or other information for any drug does not indicate that the combination of medicine or medication is safe, effective or appropriate for all patients or all specific uses.

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