Details for: BRINAVESS
Company: CIPHER PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02462400 | BRINAVESS | VERNAKALANT HYDROCHLORIDE | 20 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
BRINAVESS is for the treatment of a fast, irregular heart rate called atrial fibrillation. You will only receive BRINAVESS if your irregular heart rate started in the last:
- days and you have not had surgery recently.
- 3 days following heart surgery.
Most likely, you will receive BRINAVESS when you are in a hospital or emergency room setting.
What it does
BRINAVESS works mainly on the atria of your heart. The atria are the top two chambers of the heart. BRINAVESS may help make your heart rate more regular.
When it should not be used
- you are allergic to vernakalant hydrochloride or any of the other ingredients of this medicine
- you have a heart condition such as:
- heart attack or acute heart failure in the last 30 days
- problems with the rhythm of your heart or the electrical system in your heart
- very slow heart rate
- longer than normal QT interval
- congenital / acquired long QT syndrome
- sick sinus syndrome
- second or third degree atrioventricular block without a pacemaker
- serious narrowing of the aortic heart valve
- (systolic) blood pressure less than 100 mm Hg
- advanced heart failure with symptoms at minimal physical activity or at rest
- you take certain intravenous medicines to help your abnormal heart rhythm:
- amiodarone
- procainamide
- ibutilide
- flecainide
BRINAVESS is not intended for use in patients younger than 18 years old.
What the medicinal ingredient is
vernakalant hydrochloride
What the non-medicinal ingredients are
citric acid, sodium chloride, sodium hydroxide and water for injection
What dosage form it comes in
Concentrated solution, 20 mg/mL
Warnings and precautions
To help avoid side effects and ensure proper use, your health care professional will complete a pre-infusion checklist before you take BRINAVESS. Health conditions or problems that may prevent you from taking BRINAVESS include:
- heart failure
- problems with the rhythm of your heart or the electrical system in your heart
- enlarged heart muscles or heart muscle disease
- swelling of the lining of the heart
- heart valve disease or narrowing of the heart valves
- liver problems
- having a pacemaker installed.
Other warnings you should know about:
Monitoring
You will be monitored during and after treatment with BRINAVESS. Your breathing, heart rate, blood pressure and the electrical activity of your heart will be checked.
Changes in blood pressure
You may develop low blood pressure during and after treatment with BRINAVESS. It may be serious and you may need treatment. This may be more likely to happen to you if you:
- have a history of heart failure.
- use medications, known as beta-blockers.
Very slow heart rate
BRINAVESS may lower your heart rate too much. You may need to be treated with medicine to help your heart rate. Rarely, you may even need to have a pacemaker installed to help you.
Blood tests
Before treatment with BRINAVESS, your doctor may test your blood to:
- see how well it clots.
- learn about your potassium level.
Pregnancy and breast-feeding
- BRINAVESS should not be used during pregnancy.
- It is not known whether BRINAVESS passes into breast milk.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
Your doctor will make sure you haven’t used these medications 4 hours before or after treatment with BRINAVESS:
- Intravenous medications to control your heart rhythm such as:
- Amiodarone
- Procainamide
- Flecainide
- Ibutilide
Proper use of this medication
- You will be treated with BRINAVESS in a hospital or emergency room setting.
- During treatment, your breathing, heart rate, blood pressure and the electrical activity of your heart will be checked. Treatment with BRINAVESS will be stopped if you develop:
- blood pressure that is too low.
- a slow heart rate.
- certain changes in your electrocardiogram (ECG).
- 2 hours after giving you BRINAVESS, your doctor will consider if you need to take other medications to help the beating of your heart.
Usual dose
- BRINAVESS dosing is based on weight, up to a certain maximum amount.
- You will receive an infusion of BRINAVESS into your vein for about 10 minutes.
- You may receive a second dose if the beating of your heart has not returned to normal 15 minutes after your first dose. You will only receive the second dose if it is safe to do so.
Overdose
Side effects and what to do about them
These are not all the possible side effects you may feel when taking BRINAVESS. If you experience any side effects not listed here, contact your healthcare professional.
Very common
- taste disturbances
- sneezing
If you experience any or all of side effects above, it will be within 2 hours of treatment with BRINAVESS. They usually pass quickly. If they do not, consult your doctor.
Common:
- a sensation of burning, numbness, tingling, or prickling
- low blood pressure
- slow heart rate
- tingling or numbness of the hands or feet
- nausea (feeling sick), vomiting (being sick), diarrhea
- numbness or tingling in the mouth
- feeling dizzy or weak
- feeling tired
- headache
- feeling hot
- excessive sweating
- itching
- coughing
- nasal discomfort
- pain at the infusion site
| 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 |
|---|---|---|---|
| COMMON | |||
| Slow heart rate, or a missed beat, or a short pause in the normal activity of your heart | ✔ | ||
| Low blood pressure causing dizziness, fainting, or weakness | ✔ | ||
| Unusual or irregular beats of your heart | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
BRINAVESS will be stored at room temperature (15-30°C) in the hospital.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 1908C
Ottawa, ON
K1A 0K9
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
- 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 (hc-sc.gc.ca); the manufacturer’s website http://www.cardiome.com/, or by calling 1-866-992-2749.
This leaflet was prepared by Cipher Pharmaceuticals Inc.
Last Revised July 24, 2018