Details for: PRAXBIND
Company: BOEHRINGER INGELHEIM (CANADA) LTD LTEE
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02454343 | PRAXBIND | IDARUCIZUMAB | 50 MG / ML | SOLUTION | INTRAVENOUS |
Summary Reports
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.
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.
| 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:
- 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/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (http://www.boehringer-ingelheim.ca), or by calling the manufacturer, Boehringer Ingelheim (Canada) Ltd., at: 1-800-263-5103, extension 84633.
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