Patient Medication Information: uses, side effects, how to take - Xfusor
What is XFusor used for?
XFusor is used in adults as an anaesthetic and for pain relief. It is used to provide pain relief after surgery:
- in the area of the nerves where the surgery was performed.
- into a surgical wound.
XFusor is not for use in children under 18 years of age.
How does XFusor work?
XFusor belongs to a group of medicines known as local anaesthetics. It acts by temporarily preventing the nerves in the area from transmitting sensations of pain, heat or cold. However, you may still experience sensations such as pressure and touch. In many cases, the nerves to the muscles in the area will also be blocked. This may cause temporary weakness or paralysis (loss of voluntary muscle function).
What are the ingredients in XFusor?
Medicinal ingredients: ropivacaine hydrochloride
Non-medicinal ingredients: sodium chloride, sodium hydroxide and/or hydrochloric acid for pH adjustment and water for injection.
XFusor comes in the following dosage forms:
Solution; 2 mg/mL
XFusor is available in an infusion pump (dispenser) containing 250 mL.
Do not use XFusor:
- if you are allergic to ropivacaine, other anaesthetics that end with “-caine”, or any of the other ingredients in XFusor. If you are unsure, ask your healthcare professional.
- to relieve pain during childbirth
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take XFusor. Talk about any health conditions or problems you may have, including if you:
- are taking any other medications, including other local anaesthetics or medicines used to treat abnormal heartbeat and heart rhythms
- have heart or blood circulation problems
- have liver or kidney disease
- have inflamed skin or a severe reaction to an infection (sepsis) at or near the proposed site where the XFusor dispenser is to be used
- have low blood pressure
- are dehydrated or suffer from excessive sweating, vomiting or diarrhea
- have a condition that affects your immune system, like diabetes
- are immunocompromised (your immune system does not work well)
are pregnant or planning to become pregnant. XFusor should only be used during
pregnancy if your healthcare professional has decided that the potential benefits outweigh the potential risks to your unborn child.
- are breastfeeding or planning to breastfeed. It is not known if XFusor passes into breast milk.
- have porphyria (a rare inherited or acquired disorder involved in making red blood pigment)
- are 65 years of age or older as you may be more likely to experience side effects
Other warnings you should know about:
XFusor can cause the following serious side effects:
- Allergic reactions
- Cardiovascular (heart) effects: this includes arrhythmias (abnormal heart rhythms) and cardiac arrest (heart suddenly stops beating).
See the Serious side effects and what to do about them table, below, for information on these and other serious side effects.
Neurologic effects: this can include an effect on mental function and coordination. Talk to your healthcare professional right away if you experience anxiety, dizziness, ringing in the ears, blurred vision, tremors, nausea, vomiting, chills or seizures (fits).
Risk of Fall: If you have had surgery on your lower limbs there is a risk of muscle weakness when XFusor is used. This can increase the risk of fall. Use caution when standing up, sitting or walking.
Driving and Using Machines: Do not drive or operate machinery while you are being treated with XFusor. Do not drive or operate machinery after you have stopped being treated with XFusor until your healthcare professional has confirmed that your motor functions, mental functions and coordination have returned to normal.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with XFusor:
- antiarrhythmics, medicines used to treat abnormal heartbeat and heart rhythms (e.g. mexiletine, amiodarone, procainamide, disopyramide, tocainide, flecainide)
- other local anaesthetics, medicines used to prevent pain during surgery (e.g. lidocaine, bupivacaine, mepivacaine, prilocaine)
- general anesthetics, used to put you to sleep during surgery
- sedatives, medicines that can increase drowsiness
- opioids, used to treat pain
if using XFusor for a long time:
- fluvoxamine or imipramine, used to treat depression
- enoxacin, an antibiotic
- theophylline, used to treat asthma and other lung problems
How to take XFusor:
- XFusor will be given to you by your healthcare professional in a hospital setting.
- XFusor will be given to you to reduce pain after surgery. It will be given to you either in the area of the nerves where the surgery was performed or into a surgical wound. Your healthcare professional will place a catheter during surgery, which can be connected to the XFusor dispenser.
- The dispenser is a non-electric device that contains the medicine. It has a tubing line with a connector permanently attached to it that can be connected to the catheter in the wound or port near the nerve.
- Your healthcare professional will activate the dispenser and connect it to the catheter/port. You will not need to do anything to the dispenser.
- After its activation, the dispenser will continuously give you the dose of medicine that was prescribed to relieve your pain.
Important Information:
- The dispenser will be placed in a carrying pouch. You will wear the carrying pouch either as a sling over your shoulder or around your waist as a belt. You must keep the carrying pouch with the dispenser on your shoulder/waist at all times to keep the catheter/port from being pulled out.
- Kinking of the tubing line must be avoided as this could result in you getting the wrong amount of medicine.
- Do not place tight wrappings around the tubing line.
- Do not use the dispenser if any part has been damaged or cracked, or if the connector on the tubing line appears broken, cracked or damaged in any way.
- The flow restrictor (clear rectangle) must remain taped to your skin. Removing the tape or allowing the flow restrictor to lose contact with your skin may result in you getting the wrong amount of medicine.
- Do not place hot or cold packs over the flow restrictor as this could result in you getting the wrong amount of medicine.
- Do not reconnect the dispenser if it is accidentally disconnected from the catheter/port during medication delivery, as this may cause an infection. Talk to your healthcare professional and let them know the dispenser has become disconnected.
- Do not bathe or shower with the dispenser, or while the catheter/port is still in place, as this could cause an infection.
- Do not tamper with the wound dressings or with the catheter/port as this could cause an infection.
Usual dose:
Your healthcare professional will decide on the dose that is right for you based on your condition.
Overdose:
Your healthcare professional will monitor you for signs and symptoms of an overdose. If an overdose is suspected, your healthcare professional will act accordingly to manage your side effects.
Symptoms of an overdose with XFusor include:
- feeling dizzy or light-headed
- numbness of the lips and around the mouth
- numbness of the tongue
- hearing problems
- tingling in the ears
- problems with your sight (vision)
- problems with speech
- twitching muscles or tremors (shaking)
- seizures (fits)
- loss of consciousness
- change in heart rhythm
- low blood pressure
- cardiac arrest (heart suddenly stops beating)
If you notice any of these symptoms, tell your healthcare professional right away.
| If you think you, or a person you are caring for, have taken too much XFusor, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
What are possible side effects from using XFusor?
These are not all the possible side effects you may feel when taking XFusor. If you experience any side effects not listed here, tell your healthcare professional.
Side effects with XFusor include:
- nausea or vomiting
- back pain
- headache
- sensation of tingling, numbness or burning in the skin
- feeling dizzy or anxious
- low body temperature
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | X | ||
| COMMON | |||
| Arrhythmias (abnormal heart rhythms): rapid (tachycardia), slow | X | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| (bradycardia), or irregular heartbeat | |||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse or heart palpitations | X | ||
| Urinary retention (inability to pass urine or to empty the bladder): hard to start the flow of urine, slow urine stream, or unable to completely empty your bladder when urinating | X | ||
| High temperature (fever) or chills | X | ||
| UNCOMMON | |||
| Fainting | X | ||
| Difficulty breathing | X | ||
| Toxicity symptoms: convulsions, seizures, feeling dizzy or light-headed, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems, problems with speech, stiff muscles, muscle twitching, and trembling | X | ||
| RARE | |||
| Cardiac arrest (heart suddenly stops beating): fatigue, loss of consciousness, dizziness, difficulty breathing, nausea, chest pain, or heart palpitations | X | ||
| Allergic reaction: difficulty swallowing, wheezing, drop in blood pressure, feeling sick to your stomach, vomiting, hives, rash, swelling of the face, lips, tongue or throat, itching, shortness of breath, difficulty breathing, skin redness, fast heart rate, sneezing, nausea, dizziness, or excessive sweating | X | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNKNOWN | |||
| Dyskinesia (uncontrolled, involuntary muscle movements): shakes, tics, tremors or spasms | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
Storage:
XFusor will be stored by your healthcare professional or the hospital as follows:
- The medicine should be stored between 15 to 30°C.
Your healthcare professional should not use this medicine if they see particles in the bottle within the dispenser, if the solution appears cloudy or discoloured, or if the product is leaking.
Keep out of reach and sight of children.
If you want more information about XFusor:
- 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 www.formativepharma.com, or by calling 1-855-808-9528.