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Details for: APO-AMBRISENTAN

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02475375APO-AMBRISENTANAMBRISENTAN5 MGTABLETORAL
02475383APO-AMBRISENTANAMBRISENTAN10 MGTABLETORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

APO-AMBRISENTAN is used in adults to treat high blood pressure in the pulmonary arteries (pulmonary arterial hypertension).

What it does

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.

Tests your doctor will do before treatment:

  • a blood test to check that your liver is working properly and to check for anemia (reduction in red blood cells).
  • a pregnancy test.
When it should not be used

Do not take APO-AMBRISENTAN if you:

  • are allergic to ambrisentan or any ingredients in the tablet (see What the nonmedicinal ingredients are).
  • are pregnant, are planning to become pregnant, or could get pregnant because you are not using reliable birth control (contraception) (see WARNINGS AND PRECAUTIONS).
  • are breastfeeding
  • have liver disease or abnormal liver test results. Your doctor will decide if this medicine is suitable for you.
  • have a lung condition called idiopathic pulmonary fibrosis (IPF) that makes it hard to breathe, along with a dry cough, and sometimes, joint pain or swelling.
What the medicinal ingredient is

ambrisentan

What the non-medicinal ingredients are

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.

What dosage form it comes in

5 mg and 10 mg film-coated tablets

Warnings and precautions

Serious Warnings and Precautions

APO-AMBRISENTAN may harm your unborn baby if you take it while pregnant. Before you use APO-AMBRISENTAN talk to your doctor or pharmacist if you:

  • are pregnant or thinking of becoming pregnant.
  • could become pregnant because you are not using reliable birth control (contraceptive) methods.
  • are breastfeeding.

Before Treatment

BEFORE you use APO-AMBRISENTAN talk to your doctor or pharmacist if you:

  • have or ever had liver problems
  • have a low number of red blood cells (anemia)
  • have swelling (edema)
If you are a man taking APO-AMBRISENTAN, it is possible that APO-AMBRISENTAN may lower your sperm count. Talk to your doctor if you have any questions or concerns about this.

During treatment:

Some patients taking APO-AMBRISENTAN were found to have abnormal liver function (increase in liver enzymes) and some patients developed anemia (reduction in red blood cells). Because these findings may not cause symptoms you can feel or observe yourself, your doctor will do regular blood tests to check for any changes in your liver function and for anemia.

Liver function:
If your doctor decides it is needed this blood test will be done every month or more frequently.

If you develop abnormal liver function, your doctor may decide to stop treatment with APO-AMBRISENTAN. When your blood test results for liver function return to normal, your doctor may decide to restart treatment with APO-AMBRISENTAN.

Anemia:
This blood test will be done after 1 month and periodically after that.

If you develop anemia, your doctor may decide to perform further tests to investigate the cause.

Pediatrics (< 18 years of age): Safety and efficacy of APO-AMBRISENTAN under 18 years of age have not been established, and should therefore not be used in this age group.

Pregnancy:
If you become pregnant or think you may be pregnant while you’re taking APO-AMBRISENTAN, see your doctor immediately. APO-AMBRISENTAN may harm your unborn baby if you take it while you are pregnant. If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking APO-AMBRISENTAN and regularly while you are taking APO-AMBRISENTAN. You will also have to use a reliable method of birth control.

Driving and using machines:
It is not known whether APO-AMBRISENTAN affects your ability to drive or use machines. Don’t drive or operate machines if you’re feeling unwell.
Interactions with this medication

As with most medicines, interactions with other drugs are possible. Tell your doctor or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with APO-AMBRISENTAN:

  • cyclosporine A (an autoimmune drug typically used in organ transplants),
  • digoxin (a heart drug),
  • rifampin (an anti-bacterial drug typically used in lung infections),
  • ketoconazole (an anti-fungal drug typically used in skin infections),
  • warfarin (typically used to prevent clotting),
  • omeprazole (typically used to treat indigestion),
  • oral contraceptives (birth control).
Proper use of this medication

Do not stop taking APO-AMBRISENTAN without discussion with your doctor or your pharmacist.

Usual Dose

The usual dose of APO-AMBRISENTAN is 5 mg, once a day. Your doctor 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 a day.

You can take APO-AMBRISENTAN with or witho

Overdose

If you think you have taken too much APO-AMBRISENTAN contact your doctor, pharmacist, hospital emergency department or regional Poison Control Centre immediately even if there are no symptoms.

Missed Dose

If you forget to take a dose of APO-AMBRISENTAN, just take the tablet as soon as you remember, then continue with the next dose at your usual time. Don’t take two tablets at the same time to make up for a forgotten dose.

Side effects and what to do about them

Side effects may include:

  • headache
  • nasal congestion (runny or blocked nose), red and sore throat, sinusitis
  • constipation, abdominal pain, nausea, vomiting
  • flushing (redness of the skin),
  • fluid retention (edema)
  • feeling tired or weak
  • palpitations (fast or irregular heartbeat)
  • vision changes, (blurry or other changes to vision)
  • ringing in the ears (tinnitus)

Some patients taking APO-AMBRISENTAN may have symptoms related to low blood pressure, like dizziness or fainting.

If any of these affects you severely, tell your doctor or pharmacist.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Very Common
Swelling (edema), especially in the ankles and feet ✔    
Anemia: fatigue, loss of energy, weakness, shortness of breath   ✔  
Flushing (redness of the skin) ✔    
Worsening shortness of breath shortly after starting APO-AMBRISENTAN   ✔  
Dizziness ✔    
Palpitations: fast and/or irregular heart beat   ✔  
Common
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing     ✔
Rare
Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite     ✔
Not Known
Heart Failure: shortness of breath, extreme tiredness and swelling in the ankles and legs   ✔  
Chest pain and/or discomfort   ✔  

This is not a complete list of side effects. For any unexpected effects while taking APO-AMBRISENTAN, contact your doctor or pharmacist.

How to store

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

Keep out of reach and sight of children.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

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 this patient medication information by visiting the Health Canada website
    (https://www.canada.ca/en/healthcanada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website
    http://www.apotex.ca/products, or by calling 1- 800-667-4708.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last revised: December 18, 2018

Date modified: