Patient Medication Information: uses, side effects, how to take - Ivozfo
What is IVOZFO™ used for?
IVOZFO™ is used in adults, adolescents and children to treat bacterial infections of the:
- Urinary tract
- Heart – (a condition called endocarditis)
- Bones and joints
Lungs (a condition called pneumonia) caused by:
- Time spent in a hospital (hospital-acquired pneumonia)
- Use of a ventilator (ventilator-associated pneumonia)
- Skin and tissues below the skin
- Abdomen
- Brain and Spinal Cord (central nervous system)
- Blood, when caused by any of the infections listed above
Serious Warnings and Precautions
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It is used when other antibiotics cannot be used or have not worked.
This medicine is usually given in combination with other antibiotics.
Antibacterial drugs like IVOZFO™ treat only bacterial infections. They do not treat viral infections such as the common cold.
How does IVOZFO™ work?
IVOZFO™ belongs to a group of medicines called antibiotics. It works by killing a type of germ called bacteria that causes serious infections.
What are the ingredients in IVOZFO™?
Medicinal ingredients: Fosfomycin sodium
Non-medicinal ingredients: succinic acid
IVOZFO™ does not contain any preservatives.
IVOZFO™ comes in the following dosage forms:
As a powder for solution. It comes in vials containing 2g, 4 g or 8 g fosfomycin (as fosfomycin sodium).
Do not use IVOZFO™ if you are:
- allergic to fosfomycin
- allergic to succinic acid, which is the non-medicinal ingredient in IVOZFO™
- allergic to any part of the container
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IVOZFO™. Talk about any health conditions or problems you may have, including if you:
- have heart problems
- have high blood pressure
- have hyperaldosteronism which is a condition where you have too much of a hormone called aldosterone
- high levels of sodium in your blood
- have too much fluid in your lungs which is a condition called pulmonary edema
- have kidney problems since your healthcare professional may need to change the dose you receive
- have cirrhosis (scar tissue) of the liver
- have or have had diarrhea after taking antibiotics
- are pregnant or thinking of becoming pregnant
- are breastfeeding or are planning to breastfeed
Other warnings you should know about:
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your healthcare professional for advice before you receive this medicine. If you are pregnant, IVOZFO™ may pass to your baby in the womb. It may also pass to your baby through your breast milk. If you are pregnant or breastfeeding your healthcare professional will decide if you can receive this medicine.
Driving and using machines
When IVOZFO is given, there may be side effects such as confusion and weakness. If you experience these side effects, you should not drive or operate machinery.
Sodium content
Each gram of IVOZFO contains 320 mg sodium (salt). This is equal to 16 % of the recommended maximum daily dietary intake of sodium for an adult. Your healthcare professional will monitor the electrolytes in your blood, including your sodium levels, while you are receiving IVOZFO™. You should be on a low sodium diet while you are receiving IVOZFO™.
Gastrointestinal problems – Clostridium difficile-associated disease
IVOZFO may increase your risk of being infected with bacteria called C. difficile. Symptoms include watery diarrhea that happens three or more times per day or diarrhea associated with abdominal cramping.
Blood problems
When IVOZFO is given, there may be side effects associated with the blood such as neutropenia or agranulocytosis (conditions where you have too few or have a reduced amount of white blood cells). Your healthcare professional will monitor your white blood cell counts regularly.
Liver problems
Liver damage, including hepatitis have been seen with use of IVOZFO. If you have a condition called hepatic cirrhosis (scarring of the liver), your healthcare professional will monitor your sodium levels.
Allergic reactions
In rare cases, serious, life threatening allergic reactions may occur with the use of IVOZFO. If symptoms such as sweating, nausea or a change in the colour of the skin to a bluish-purple hue, your healthcare professional will stop giving you IVOZFO.
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 IVOZFO™:
- Medicines used to treat bacterial infections (antibiotics) such as penicillin, ampicillin, cefazolin, carbapenems, aminoglycosides and anti-staphylococcal agents may provide synergistic or additive effects.
How to take IVOZFO™:
- IVOZFO™ will be given to you by a healthcare professional.
- Your healthcare professional will reconstitute and further dilute IVOZFO™ before giving it to you.
- It is usually given 2, 3 or 4 times a day.
- It will be infused directly into your vein.
- It will be infused over a period of 15 – 60 minutes, depending on the dose you are given.
- If you are at risk for low levels of potassium in your blood, the infusion might take up to 4 hours.
- Follow all instructions given to you by your healthcare professional.
Usual dose:
- Your healthcare professional will decide how much IVOZFO™ you will be given and how often and for how long you will receive it.
- The dose you are given will depend on the type and severity of your infection.
- If you have kidney problems or require dialysis, your dose may be reduced.
- For children, the dose they are given depends on their weight and age.
Overdose:
| If you think you, or a person you are caring for, have taken too much IVOZFO™, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
IVOZFO™ is administered by a healthcare professional. If you suspect a missed dose, talk to your healthcare professional.
What are possible side effects from using IVOZFO™?
These are not all the possible side effects you may feel when taking IVOZFO™. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Nausea, vomiting or mild diarrhea
- Taste disturbances
- Rash
- Headache
- Tiredness
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 | |
| COMMON | ||
| Hypokalemia (low level of potassium in the blood): constipation, confusion, cramping, feeling of skipped heartbeat or | ||
| √ | ||
| palpitations, fatigue, trouble breathing, muscle weakness, muscle spasms or twitching. | |||
|---|---|---|---|
| Hypernatremia (high level of sodium in the blood): coma, confusion, thirst, muscle twitches, seizure. | √ | ||
| Pain, burning, redness or swelling along the vein being used for infusion of this medicine | √ | ||
| UNCOMMON | |||
| Liver problems: abdominal pain, dark urine, fatigue, light-coloured stool, loss of appetite, nausea, vomiting, yellowing of the skin or eyes (jaundice). | √ | ||
| VERY RARE | |||
| Allergic reaction: difficulty breathing, difficulty swallowing, fever, hives, itchy skin, rash, swelling of your tongue, throat or face. | √ | ||
| UNKNOWN | |||
| Clostridium difficile colitis (bowel inflammation): abdominal pain or tenderness, fever, severe diarrhea (bloody or watery). | √ | ||
| Heart failure: shortness of breath, wheezing or a tight feeling in the chest. | √ | ||
| Neutropenia (decreased white blood cells): aches, feeling tired, fever, flu-like symptoms, infections. | √ | ||
| Thrombocytopenia (decreased platelets in the blood): bleeding, bruising, fatigue, weakness. | √ | ||
| Hypophosphatemia (low level of phosphate in the blood): confusion, coma, fatigue, muscle weakness. | √ |
|---|
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:
- Keep out of the reach and sight of children.
- Store at 15-30°C.
- Do not use this medicine after the expiry date which is stated on the carton and label after “EXP”. The expiry date refers to the last day of that month.
- Following dilution, the product should be used immediately. If not used immediately, it should be protected from light and stored for no longer than 24 hours at 25°C in PVC bags and 48 hours at 2-8°C in the vial and in PVC bags.
If you want more information about IVOZFO™:
- 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.veritypharma.com, or by calling 1-888-877-4414.
Last Revised MAY 28, 2024
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