Patient Medication Information: uses, side effects, how to take - Apo-Ambrisentan

What APO-AMBRISENTAN is used for:

APO-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 APO-AMBRISENTAN works:

APO-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 APO-AMBRISENTAN are:

Medicinal ingredient: ambrisentan

Non-medicinal ingredients:

APO-AMBRISENTAN 5 mg: croscarmellose sodium, FD&C Red # 40, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sunset yellow aluminum lake 40%, talc and titanium dioxide.

APO-AMBRISENTAN 10 mg: croscarmellose sodium, FD&C Red # 40 aluminum lake 38-42%, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

APO-AMBRISENTAN comes in the following dosage form:

5 mg and 10 mg film-coated tablets

Do not use APO-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 APO-AMBRISENTAN. APO-AMBRISENTAN contains lactose 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 APO-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:

APO-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 APO-AMBRISENTAN. You are at a higher risk of experiencing it if you:
- take high doses of APO-AMBRISENTAN
- are 65 years of age or older

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

Anemia (decreased number of red blood cells): This may happen within weeks after starting APO-AMBRISENTAN. Tell your healthcare professional if you experience signs of anemia while taking APO-AMBRISENTAN.
Liver problems: Stop taking APO-AMBRISENTAN and tell your healthcare professional right away if you experience:
- signs and symptoms of liver problems
- worsening of liver disease.
Allergic reactions: APO-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 APO-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 APO-AMBRISENTAN affects your ability to drive or use machines.
You should not drive or use machines until you know how APO-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 APO-AMBRISENTAN. If you are a man taking APO-AMBRISENTAN, it is possible that APO-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:

APO-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 APO-AMBRISENTAN and regularly while you are taking APO-AMBRISENTAN.
Use a highly effective birth control method while taking APO-AMBRISENTAN. If you discover that you are pregnant while taking APO-AMBRISENTAN, contact your healthcare professional as soon as possible.

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

Children and adolescents (under 18 years of age): APO-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 APO-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 APO-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 APO-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 APO-AMBRISENTAN:

Take APO-AMBRISENTAN:

exactly as your healthcare professional tells you.
with or without food.

Usual dose:

The initial dose of APO-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 APO-AMBRISENTAN, once per day.

Overdose:

If you think you, or a person you are caring for, have taken too much APO-AMBRISENTAN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you forget to take APO-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 APO-AMBRISENTAN:

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

Side effects with APO-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

Frequency/Side Effect/Symptom	Talk to your healthcare professional		Stop taking this drug and get immediate medical help
Frequency/Side Effect/Symptom	Talk to your healthcare professional		Stop taking this drug and get immediate medical help
			Only if severe	In all cases
			Only if severe	In all cases
Very Common
Peripheral edema (swelling of the legs or hands caused by fluid retention): swollen or puffy legs or hands, feeling heavy, achy or stiff		√
Anemia (decreased number of red blood cells): fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness		√
Flushing (redness of the skin)		√
Dyspnea (shortness of breath)		√
Dizziness		√
Palpitations: fast and/or irregular heart beat		√
Common
Allergic reaction: difficulty swallowing or breathing, wheezing; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat		√
Rare
Liver problems: yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness, loss of appetite		√
Unknown
Heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise		√
Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up)		√

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

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at room temperature 15°C to 30°C.

Keep out of reach and sight of children.

If you want more information about APO-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.apotex.ca/products); or by calling 1-800-667-4708.

Date of Authorization: 2026-05-14

Apo-Ambrisentan: Uses, Side Effects and Dosage