Apo-Dabigatran: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-DABIGATRAN is a blood thinner (prevents blood clots from forming).

APO-DABIGATRAN is prescribed:

• After knee or hip replacement surgery to

  prevent the formation of blood clots in the vein of your leg(s) or in your lung(s);

• To treat blood clots and prevent them from re-

  occurring in the veins of your legs and/or lungs. If blood clots form in the veins of your legs you are at risk of a blood clot dislodging and traveling to the lungs causing serious health risks;

• To people who have irregular heartbeats (atrial

  fibrillation) to prevent a stroke (damage to part of the brain caused by an interruption of its blood supply), or sudden blocking of a blood vessel by a blood clot. People with atrial fibrillation have a part of their heart that does not beat the way it should. This can lead to formation of blood clots which increases the risk of stroke.

What it does:

APO-DABIGATRAN helps prevent the formation of blood clots by blocking the activity of a protein called thrombin.

When it should not be used:

Do not take APO-DABIGATRAN if you:

• Have severely reduced kidney function or your

  kidneys do not function;

• Have active bleeding or bleed excessively;

• Have a disease that increases your chances of

  bleeding, or bleeding in the brain (stroke) within the last 6 months or recent bleeding of a stomach ulcer;

  • Have an epidural or spinal catheter in place or within the first two hours after its removal. Your doctor will know what precautionary measures are required. APO-DABIGATRAN is not recommended for patients receiving epidural pain control after surgery;
  • Are taking oral ketoconazole, used to treat fungus infection;
  • Are taking oral glecaprevir/pibrentasvir, used to treat chronic hepatitis C virus infection;
  • Are already taking another blood thinner, including apixaban (ELIQUIS), bivalirudin, dalteparin, enoxaparin, fondaparinux, rivaroxaban (XARELTO), unfractionated heparin, warfarin (COUMADIN), unless your physician has decided to switch you to or from APO-DABIGATRAN;
  • Have an artificial heart valve;

  • Are breastfeeding. It is possible that APO-

    DABIGATRAN passes into breast milk;

  • Are allergic to dabigatran etexilate, dabigatran, or any other ingredient in the formulation.

What the medicinal ingredient is:

Dabigatran etexilate as dabigatran etexilate mesylate.

What the non-medicinal ingredients are: Colloidal silicon dioxide, croscarmellose sodium, fumaric acid, magnesium stearate, and mannitol.

HPMC capsule shell contains:

Black printing ink, FD&C Blue #1, hypromellose, iron oxide red, iron oxide yellow, and titanium dioxide.

Printing ink contains:

Iron oxide black, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

What dosage forms it comes in:

Capsules: 75 mg, 110 mg and 150 mg.

WARNINGS AND PRECAUTIONS

Stopping early any blood thinner, including APO-DABIGATRAN, increases the risk of having a sudden blocking of a blood vessel by a blood clot. This can lead to death or severe injury. If you need to stop APO-DABIGATRAN, your doctor may give you another blood thinner.

You may bleed very seriously or severely in any part of your body while you are taking APO-DABIGATRAN.

In order to help prevent serious bleeding with APO-DABIGATRAN, it is important to take APO-DABIGATRAN exactly as prescribed by your doctor.

In rare occasions, where you need emergency surgery or other urgent procedure or have obvious or hidden uncontrolled bleeding, you may have to discontinue taking APO-DABIGATRAN. In these situations, PRAXBIND (idarucizumab), a specific antidote for reversing the effect of APO-DABIGATRAN, can be used to immediately and completely reverse the blood-thinning effect of APO-DABIGATRAN.

Your doctor will tell you when it is appropriate for you to resume taking APO-DABIGATRAN.

Some cases of Anticoagulant-Related Nephropathy (ARN) were reported in patients taking APO-DABIGATRAN. It is a type of serious kidney damage caused by anticoagulant medicines. ARN causes bleeding in the kidneys, sometimes with the presence of blood in the urine. This leads to the kidneys being unable to function properly. Your healthcare professional may monitor the health of your kidneys during your treatment with APO-DABIGATRAN. If you are experiencing symptoms of ARN during your treatment, tell your healthcare professional right away.

BEFORE you use APO-DABIGATRAN talk to your doctor, nurse, or pharmacist if you:

• Have moderately reduced kidney function;
• Are dehydrated;

• Have a disease or have had an operation recently

  that increases your risk of bleeding. Examples are a blood clotting disease, a stomach ulcer, a biopsy, a very serious injury, or an inflammation of parts of your heart caused by bacteria;

• Are older than 75 years old;

• Have severe or life-threatening liver disease, or

  high liver enzymes;

• Are going to have a surgery, including a surgery

  on your brain, back, eye or other invasive or dental procedure. Your doctor may ask you to stop APO-DABIGATRAN temporarily for a few days before the surgery;

• Are pregnant or plan to become pregnant. The

  effects of APO-DABIGATRAN on pregnancy and the unborn child are not known;

• Are about to give birth;
• Are less than 18 years old;
• Weigh less than 50 kg;

• Know that you have a disease called

  antiphospholipid syndrome (a disorder of the

  immune system that causes an increased risk in blood clots).

INTERACTIONS WITH THIS MEDICATION

Tell your doctor about all the drugs you take. This includes prescription and non-prescription drugs, vitamins and herbal supplements. APO-DABIGATRAN may interact with other medications. This may cause serious side effects.

Know the medicines you take. Keep a list of your drugs and show it to your doctor and/or pharmacist each time you get a new drug.

The following may interact with APO-DABIGATRAN:

• Antacids, used to treat heartburns. If you need to take an antacid, take it at least two hours after taking APO-DABIGATRAN;
• Antibiotics, including rifampicin and clarithromycin;
• Antidepressants, in particular selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs);
• Antifungal drugs, including oral itraconazole and posaconazole;
• Antiretroviral drugs, used to treat HIV, including nelfinavir, ritonavir, saquinavir, and tipranavir;

• Blood thinners, including clopidogrel, prasugrel

  (EFFIENT) or ticagrelor (BRILINTA);

• Drugs used to prevent organ rejection after transplantation, including cyclosporine and tacrolimus;
• Drugs used to treat epilepsy, including carbamazepine;
• Drugs used to treat irregular heartbeats, including amiodarone (CORDARONE), dronedarone (MULTAQ) and quinidine;

• Nonsteroidal anti-inflammatory drugs

  (NSAIDs), used to reduce pain and swelling. Examples include aspirin (ASA), diclofenac, ibuprofen and naproxen;

• Proton pump inhibitors, used to treat heartburns;
• St. John’s Wort, an herbal medicine;
• Verapamil, used to lower blood pressure.

PROPER USE OF THIS MEDICATION

Before you start taking APO-DABIGATRAN and regularly after, your doctor will test your kidney function.

Take APO-DABIGATRAN exactly as prescribed.

APO-DABIGATRAN should be taken with a full glass of water and can be taken with or without food. If APO-DABIGATRAN upsets your stomach, take it with meals or within 30 minutes after meals. If APO-DABIGATRAN still upsets your stomach, consult your doctor or pharmacist. It is important to continue taking APO-DABIGATRAN as prescribed.

Swallow the capsule(s) whole. Do not chew or open the capsule. Do not sprinkle the pellets on food or mix with liquids.

Usual Adult Dose:

If your doctor has given you APO-DABIGATRAN to take twice a day, it is important to take it regularly at the same time each day at approximately 12 hour intervals.

• After knee or hip replacement surgery: 220

  mg once daily, taken as two (2) capsules of 110 mg at the same time.

Depending on your kidney function or other drugs you may be taking, your doctor may prescribe a lower dose of 150 mg once daily (taken as two (2) capsules of 75 mg at the same time).

Take APO-DABIGATRAN for as long as the doctor tells you.

• To treat blood clots and prevent them from re-

  occurring in the veins of your leg(s) or in your lung(s): 300 mg a day, taken as one (1) capsule of 150 mg twice daily.

You will start taking APO-DABIGATRAN following 5 to 10 days treatment with an injectable blood thinner.

The doctor will determine how long you should take APO-DABIGATRAN so take it until your doctor tells you to stop.

If you are 80 years and older and/or the doctor thinks you are more likely to bleed: 220 mg a day, taken as one (1) capsule of 110 mg, twice daily.

• For patients who have irregular heartbeats

  (atrial fibrillation): 300 mg a day, taken as one (1) capsule of 150 mg, twice daily.

  If you are 80 years and older and/or the doctor thinks you are more likely to bleed: 220 mg a day, taken as one (1) capsule of 110 mg, twice daily.

  Switching to APO-DABIGATRAN:

  If you are currently taking the blood thinner warfarin or receive a blood thinner given by injection, and your doctor has decided APO-DABIGATRAN is appropriate for you, make sure you ask your doctor when and how best to switch and start taking APO-DABIGATRAN.

Overdose:

If you think you, or a person you are caring for, have taken too much APO-DABIGATRAN, 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.

If you take more than the recommended dose of APO-DABIGATRAN, you may have an increased risk of bleeding. Your doctor can perform a blood test to assess the risk of bleeding.

For situations when rapid reversal of the blood-thinning effect of APO-DABIGATRAN is required, PRAXBIND (idarucizumab), a specific antidote for reversing the effect of APO-DABIGATRAN, can be available in hospitals and emergency rooms.

Missed Dose:

For all treatments, if you forget to take APO-DABIGATRAN, do not take a double dose to make up for the missed dose.

• After knee or hip replacement surgery: Take your next dose at the same time next day.
• To treat blood clots and prevent them from re-occuring in the veins of your leg(s) or in your lung(s): Take it as soon as you remember, but if it is almost time for your next dose (less than 6 hours before your next dose), take your next dose when you are supposed to.

• For patients who have irregular heartbeats

  (atrial fibrillation): Take it as soon as you remember, but if it is almost time for your next dose (less than 6 hours before your next dose), take your next dose when you are supposed to.

If you had knee or hip replacement surgery or are receiving treatment for prevention of blood clots in the veins of your legs and lungs and stop taking

APO-DABIGATRAN before your doctor told you to, you are at risk of developing a blood clot in a vein of your leg or in the lungs, which can be life-threatening.

If you have atrial fibrillation and stop taking APO-DABIGATRAN without talking to your doctor, you are at risk of suffering from a stroke or other complications due to blood clot formation, which can be fatal or lead to severe disability.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

You should be aware that prescription medicines carry some risks and that all possible risks may not be known at this stage.

As APO-DABIGATRAN acts on the blood clotting system, most side effects are related to signs of bruising or bleeding.

Although rare, APO-DABIGATRAN can cause very serious or severe bleeding that can occur in any part of your body. These bleedings may reduce your physical abilities or even lead to death.

Patients treated with APO-DABIGATRAN may experience the following side effects:

• abdominal pain, diarrhea, heartburn, nausea, reflux of gastric juice, upset stomach, vomiting;
• difficulty swallowing;
• bruising;
• hives, itching, rash
• hair loss;
• decrease in the number or even lack of white blood cells (which help to fight infections).

APO-DABIGATRAN can cause abnormal blood test results for kidney and liver function, number of platelets and number of red blood cells (anemia). Your doctor will ask for blood tests and will interpret the results.

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

HOW TO STORE IT

Keep out of the reach and sight of children and pets. Do not use APO-DABIGATRAN after the expiry date printed on the carton or blister.

Blister: Store at 15˚C - 30˚C. Store in original package to protect from moisture.

To remove a capsule from the blister, push the capsule through the blister foil.

Bottle: Store at 15˚C - 30˚C. Store in original package to protect from moisture. Once opened, the

product must be used within 4 months. Keep the bottle tightly closed.

When taking a capsule out of the bottle, please note the following instructions:

• The cap opens by pushing and turning.
• After removing the capsule, place the cap back on the bottle and tightly close the bottle right away.

Do not put the capsules in pill boxes or pill organizers, unless capsules can be maintained in the original package.

Any unused product or waste material should be disposed in accordance with local requirements.

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 (https://www.canada.ca/en/health-canada/services/drugs-health-

  products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

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

MORE INFORMATION

If you want more information about APO-DABIGATRAN:

• Talk to your healthcare professional

• Find the full product monograph that is

  prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada 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.

  All other trade-marks are the property of their respective owners.

Last revised: August 5, 2025