Auro-Ambrisentan: Uses, Side Effects and Dosage

What Auro-Ambrisentan is used for:

Auro-Ambrisentan is used in adults to treat high blood pressure in the pulmonary arteries. They are blood vessels that carry blood away from the heart to the lungs.

How Auro-Ambrisentan works:

Auro-Ambrisentan is an endothelin receptor antagonist (ERA).

It reduces high blood pressure by relaxing the pulmonary arteries. This makes it easier for the heart to pump blood to the lungs.

The ingredients in Auro-Ambrisentan are:

Medicinal ingredient: ambrisentan

Non-medicinal ingredients: Cellulose microcrystalline, Croscarmellose sodium, FD&C Red #40 Aluminum Lake, Lactose monohydrate, Lecithin (soya), Macrogol, Magnesium Stearate, polyvinyl alcohol, Talc, Titanium dioxide.

Auro-Ambrisentan comes in the following dosage form:

Tablets: 5 mg and 10 mg

Do not use Auro-Ambrisentan if:

• you are pregnant, are planning to become pregnant, or could become pregnant because you are not using reliable birth control.
• you are breastfeeding or plan to breastfeed your baby.
• you are allergic to ambrisentan or to any of the other ingredients in Auro-Ambrisentan. Auro-Ambrisentan contains lactose, lecithin (soya) and FD&C Red #40 Aluminum Lake (a colouring agent).
• you have liver disease or abnormal liver test results.

• have a lung condition called Idiopathic Pulmonary Fibrosis (IPF). The symptoms of this condition include:

  • Shortness of breath
  • Dry cough
  • Fatigue
  • Joint or muscle pain

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Auro-Ambrisentan. Talk about any health conditions or problems you may have, including if you:

• have swelling.
• have a low amount of red blood cells (anemia).
• have or ever had liver problems.

Other warnings you should know about:

Auro-Ambrisentan can cause serious side effects, including:

• Peripheral edema (swelling of the legs or hands caused by fluid retention) : This may happen within weeks after starting Auro-Ambrisentan. You are at a higher risk of experiencing it if you:

  • take high doses of Auro-Ambrisentan
  • are 65 years of age or older

Tell your healthcare professional if you experience swelling in your hands or legs while taking Auro-Ambrisentan.

• Anemia (decreased number of red blood cells): This may happen within weeks after starting Auro-Ambrisentan. Tell your healthcare professional if you experience signs of anemia while taking Auro-Ambrisentan.

• Liver problems: Stop taking Auro-Ambrisentan and tell your healthcare professional right away if you experience:

  • signs and symptoms of liver problems
  • Worsening of liver disease.
• Allergic reactions: Auro-Ambrisentan contains FD&C Red#40 Aluminum Lake, a colouring agent that may cause allergic reactions. If you experience signs of an allergic reaction while taking Auro-Ambrisentan, stop taking it and tell your healthcare professional right away.

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

Driving and operating machinery:

• It is not known whether Auro-Ambrisentan affects your ability to drive or use machines.
• You should not drive or use machines until you know how Auro-Ambrisentan affects you.
• If you ever feel sleepy or unwell, do not drive or use machines, and tell your healthcare professional.

Male fertility: During animal studies, reduced fertility was observed in male rats taking ambrisentan, the active ingredient in Auro-Ambrisentan. If you are a man taking Auro-Ambrisentan, it is possible that Auro-Ambrisentan may lower your sperm count. Talk to your healthcare professional if you wish to father a child, or have any questions or concerns about this.

Pregnancy:

• Auro-Ambrisentan should not be used during pregnancy. Taking it during pregnancy may cause injury to your baby.
• If you are a woman who could become pregnant, your healthcare professional will ask you to take a pregnancy test before you start taking Auro-Ambrisentan and regularly while you are taking Auro-Ambrisentan.
• Use a highly effective birth control method while taking Auro-Ambrisentan. If you discover that you are pregnant while taking Auro-Ambrisentan, contact your healthcare professional as soon as possible.

Breastfeeding: It is not known whether Auro-Ambrisentan can pass into breastmilk. Auro-Ambrisentan should not be used during breastfeeding.

Children and adolescents (under 18 years of age): Auro-Ambrisentan is not to be used in children and adolescents under 18 years of age.

Laboratory tests and monitoring: Your healthcare professional will do tests, including blood tests, before you start Auro-Ambrisentan and regularly during treatment. These tests will check:

• The amount of red blood cells in your body.
• That your liver is working properly.
• If you are pregnant.

Depending on your test results, your healthcare professional may adjust your dose, stop or discontinue your treatment with Auro-Ambrisentan.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Auro-Ambrisentan:

• Cyclosporine A – used to treat certain autoimmune diseases and to prevent rejection of organ transplants
• Sildenafil, tadalafil – used to treat erectile dysfunction or high blood pressure in the lungs
• Ketoconazole – used to treat fungal skin infections
• Digoxin – used to treat heart conditions

How to take Auro-Ambrisentan:

Take Auro-Ambrisentan:

• exactly as your healthcare professional tells you.

• with or without food.

Instructions on how to remove a tablet from the blister packaging

1. 1. Tear along the cutting lines to separate one “pocket” from the strip.

1. 2. Starting at the arrow corner, lift the outer layer and peel it back over the pocket.

1. 3.

   Gently push one end of the tablet out through the foil layer.

   

Usual dose:

• The initial dose of Auro-Ambrisentan is 5 mg, once a day. Your healthcare professional may decide to increase your dose to 10 mg, once a day.
• The maximum recommended daily dose is 10 mg.
• If you take cyclosporine A, do not take more than 5 mg of Auro-Ambrisentan, once per day.

Overdose:

Missed dose:

If you forget to take Auro-Ambrisentan, take the missed dose as soon as you remember, then continue with the next dose at your usual time. Do not take a double dose to make up for the one that you missed.

Possible side effects from using Auro-Ambrisentan:

These are not all the possible side effects you may have when taking Auro-Ambrisentan. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with Auro-Ambrisentan may include:

• Headache
• Stuffy nose
• Sore throat
• Constipation
• Pain in the abdomen
• Problems with sinuses
• Feeling sick
• Vomiting
• Feeling weak or tired
• Skin rash
• Hot flashes
• Ringing in the ears
• Changes in vision, including blurry vision

If any of these affects you severely, tell your healthcare professional.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

Storage:

Store between 15 - 30°C.

Keep out of reach and sight of children.

If you want more information about Auro-Ambrisentan:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-

  product-database.html); the manufacturer’s website http://www.auropharma.ca; or by calling 1- 855-648-6681.

Date of Authorization: 2026-07-16