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Details for: PRAXBIND

Company: BOEHRINGER INGELHEIM (CANADA) LTD LTEE

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02454343PRAXBINDIDARUCIZUMAB50 MG / MLSOLUTIONINTRAVENOUS
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Summary Reports

Summary Basis of Decision
Regulatory Decision Summary

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

PRAXBIND should only be given to adult patients who are taking a blood-thinning drug called Pradaxa® (dabigatran etexilate).

PRAXBIND is used in emergency situations where a doctor decides that rapid reversal of the effect of Pradaxa® is required:

  • For emergency surgery/urgent procedures;
  • In life-threatening or uncontrolled bleeding.
What it does

PRAXBIND contains idarucizumab, which is a special type of protein called a monoclonal antibody.

PRAXBIND must be administered into your vein by your healthcare provider in order to work. Once in your bloodstream, PRAXBIND immediately and tightly binds to Pradaxa®, reversing its anti-clotting effect. The PRAXBIND - Pradaxa® complex is then removed via your kidneys.

When it should not be used

Do not use PRAXBIND if
- You are allergic (hypersensitive) to idarucizumab or to any of the other non-medicinal ingredients of PRAXBIND (see section “What are the ingredients in PRAXBIND” above).

What the medicinal ingredient is

idarucizumab

What the non-medicinal ingredients are

acetic acid glacial, polysorbate 20, sodium acetate trihydrate, sorbitol, water for injection

What dosage form it comes in

PRAXBIND is supplied as a sterile solution for injection into your vein and is administered in two 50 mL vials, each containing 2.5 g of idarucizumab. Two vials equal one dose

Warnings and precautions

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

  • Have a genetic disease called hereditary fructose intolerance or allergy to sorbitol as the sorbitol contained in this medicine may cause serious adverse reactions.
Other warnings you should know about:
PRAXBIND will only work for reversal of Pradaxa®. It will not reverse other medicines used to prevent the formation of blood clots.

Tell your healthcare professional about all the medicines you take, including any prescription or non-prescription drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication

Preclinical studies have shown no interactions of PRAXBIND with volume expanders, coagulation factor concentrates and anticoagulants other than Pradaxa®.

Based on the properties and the high specificity in binding to dabigatran, clinically relevant interactions with other medicinal products are considered unlikely.

Pregnancy
There is no information about the use of PRAXBIND in pregnant women. Tell your doctor if you are pregnant or planning to become pregnant (planning to have a baby). The doctor will weigh the benefits against the risks of taking PRAXBIND while you're pregnant.

Breast-feeding
It is not known whether the ingredients of PRAXBIND can pass into human milk. If you are breast-feeding, tell the doctor.

Proper use of this medication

How PRAXBIND is administered:
PRAXBIND must be administered into your vein by your healthcare provider. PRAXBIND will be prepared in a hospital as an infusion (a drip) over several minutes or an injection (with a syringe).

Usual Dose

The usual dose of PRAXBIND is 5 g which is supplied as two 50 mL vials of 2.5 g each. Two vials is equivalent to one dose.

Overdose

There is no clinical experience with overdoses of PRAXBIND.

Side effects and what to do about them

If you experience any side effects such as hypersensitivity or allergic reaction symptoms, after PRAXBIND administration, inform your healthcare professional.

If you have a troublesome symptom or side effect after PRAXBIND administration which becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

In studies of very sick patients, worsening of ongoing conditions such as shock, organ failure or bleeding into the brain have occurred. These are not related to treatment with PRAXBIND. Treatment methods may include administration of fluids, blood transfusion or even surgery.

Symptoms of anaphylactic shock (sudden drop in blood pressure) and other potential hypersensitivity (fever, difficulty in breathing or wheezing, increased frequency of rapid breathing, rash or itching) were also reported in patients. Adverse events reported in greater than or equal to 5% of patients were difficulty passing stools (7%). These were reported in a clinical trial, but may not be directly related to PRAXBIND.

After treatment with PRAXBIND, a temporary excess of protein in the urine has been observed.

Stopping treatment with the blood-thinning drug Pradaxa® , may lead to increased risk of a blood clot in major blood vessels in your lungs or heart. This could potentially lead to a heart attack or stroke. You may need to resume treatment with drugs which dissolve the blood clots as soon as medically appropriate.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases
Hypersensitivity:
Fever  
Difficulty in breathing or wheezing  
Increased frequency of rapid breathing  
Rash  
Itching  

* These were reported in a clinical trial, but may not be directly related to PRAXBIND.

Re-administration of Pradaxa® (dabigatran etexilate)
24 hours after administering PRAXBIND, re-administration of Pradaxa® may be considered by your doctor.

How to store

PRAXBIND will be stored at 2-8°C in a hospital.

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 three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

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 PRAXBIND:

This leaflet was prepared by Boehringer Ingelheim (Canada) Ltd. The information in this leaflet is current up to the time of the last revision date shown below, but more current information may be available from the manufacturer.

Last Revised: April 18, 2019

Date modified: