Details for: ZEVTERA
Company: AVIR PHARMA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02446685 | ZEVTERA | CEFTOBIPROLE (CEFTOBIPROLE MEDOCARIL SODIUM) | 500 MG / VIAL | POWDER FOR 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
ZEVTERA is used for the treatment of bacterial infections. Your doctor prescribed ZEVTERA because you
have a serious lung infection referred to as Hospital-acquired pneumonia (HAP) or Community-acquired
pneumonia (CAP).
Antibacterial drugs, including ZEVTERA, should only be used to treat bacterial infection. They do not
treat viral infections (e.g. the common cold). Your doctor will make this decision. Although it is common
to feel better early in the course of antibacterial therapy, the medication should be taken exactly as
directed and should not be shared. Misuse or overuse of ZEVTERA could lead to the growth of bacteria
that will not be killed by ZEVTERA (resistance). This means that ZEVTERA may not work for you in the
future. Do not share your medicine.
What it does
ZEVTERA is an antibiotic medicine containing the active substance ceftobiprole, which belongs to an established group of medicines called ‘cephalosporin antibiotics’. ZEVTERA works by killing certain bacteria which can cause serious lung infections, including those which have developed resistance to other drugs.
When it should not be used
- you are hypersensitive (allergic) to ZEVTERA or to citric acid monohydrate or sodium hydroxide.
- you are hypersensitive to cephalosporin antibiotics.
- you have immediate and severe hypersensitivity (e.g., an anaphylactic (severe allergic) reaction) to any other type of beta-lactam antibiotic, such as penicillins or carbapenems.
What the medicinal ingredient is
Medicinal ingredient: ceftobiprole, as ceftobiprole medocaril
What the non-medicinal ingredients are
Non-medicinal ingredients: citric acid monohydrate, sodium hydroxide
What dosage form it comes in
ZEVTERA comes as a powder for solution in clear glass vials, each vial containing 500 mg of the active substance ceftobiprole. The powder is made up into a concentrate by a doctor or nurse, then diluted for intravenous administration.
Warnings and precautions
Serious Warnings and Precautions
Serious and occasionally fatal allergic (hypersensitivity) reactions have been reported in patients receiving β-lactam antibiotics (same class as ZEVTERA). Allergic reactions have also been observed with ZEVTERA use. Talk to your doctor if you have had any previous allergic reactions to penicillins, cephalosporins or other allergens (See What are possible side effects from using ZEVTERA).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ZEVTERA. Talk about any health conditions or problems you may have, including if you:
- have other infections. While antibiotics including ZEVTERA kill certain bacteria, other bacteria and fungi may continue to grow more than normal. This is called overgrowth. Your doctor will monitor you for overgrowth and treat you if necessary
- are pregnant or planning to become pregnant.
- have kidney problems.
- are breast-feeding or if you intend to breast-feed.
- are taking or have recently taken any other medicines, including medicines you get without a prescription.
- are under 18 years of age. ZEVTERA should not be given to children or adolescents as there is no experience with the use of ZEVTERA in children.
- have any allergies to any medicines, including antibiotics.
- are on a controlled sodium diet.
- have diarrhea during after being given ZEVTERA.
- have a history of severe hypersensitivity reactions to antibiotics.
- have a history of seizures.
- are HIV positive.
- have a severely weakened immune system.
- have very low white blood counts.
- have a lowered bone marrow function.
Interactions with this medication
The following may interact with ZEVTERA:
statins (pitavastin, pravastatin, rosuvastatin), glyburide, and bosentan
Proper use of this medication
How to take ZEVTERA:
- ZEVTERA will be given to you by a doctor or nurse
Usual Dose:
The pharmacist or healthcare professional will prepare the product for use.
The recommended dose is 500 mg ceftobiprole every 8 hours given as a drip into a vein over a period
of 2 hours. Treatment usually lasts 4-14 days for CAP and 7-14 days for HAP. Your doctor will decide on
the duration of treatment. You may need a lower dose if you have kidney problems.
Overdose:
There is no information available on overdosing of ZEVTERA.
Missed Dose
If you think you have missed a dose of ZEVTERA, discuss this with your healthcare professional as soon as possible.
Side effects and what to do about them
These are not all the possible side effects you may have when taking ZEVTERA. If you experience any
side effects not listed here, tell your healthcare professional. Please also see 7 WARNINGS AND
PRECAUTIONS.
If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever,
abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this
occurs, stop taking ZEVTERA and contact your healthcare professional immediately.
The following side effects may happen with this medicine. The frequency category is based on
reporting of the side effect, whether or not the side effect was caused by the drug.
Common: may affect between 1% and 10% of people
Headache, drowsiness (somnolence)
Feeling dizzy
Unusual taste (dysgeusia)
Rash, itching or hives - Contact your doctor if these symptoms persist
Feeling sick (nausea), being sick (vomiting) - Contact your doctor if these symptoms persist
Redness, pain or swelling were the injection was given - Contact your doctor if these symptoms
persist
Uncommon: may affect between 0.1% and 1% of people
Stomach pain (abdominal pain), indigestion or “heartburn” (dyspepsia)
Muscle cramps
| 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 | |||
| Sudden swelling of your lips, face, throat or tongue; a severe rash; and, swallowing or breathing problems. These may be signs of a severe allergic reaction (anaphylaxis) and may be life threatening. | ✔ | ||
| Hypersensitivity including skin reddening | ✔ | ||
| Diarrhea. Tell your doctor straight away if you get diarrhea. | ✔ | ||
| Diarrhea that becomes severe or does not go away or stool that contains blood or mucus during or after treatment with ZEVTERA. In this situation, you should not take medicines that stop or slow bowel movement. | ✔ | ||
| Low levels of the mineral 'sodium' in your blood | ✔ | ||
| Increase in the level of some liver enzymes in your blood. | ✔ | ||
| Fungal infections in different parts of your body | ✔ | ||
| Convulsions, seizures, or fits | ✔ | ||
| UNCOMMON | |||
| Temporarily decreased or increased numbers of certain types of blood cells | ✔ | ||
| Shortness of breath or difficulty breathing, asthma | ✔ | ||
| Swelling, particularly of the ankles and legs | ✔ | ||
| Kidney problems | ✔ | ||
| Blood testing showing temporarily increased levels of triglycerides, blood sugar, or creatinine | ✔ | ||
| Blood testing showing decreased levels of potassium | ✔ | ||
| Sleeplessness and sleep disturbances, maybe including anxiety, panic attacks and nightmares | ✔ | ||
| Not known: frequency cannot be estimated from the available data A more severe decrease in a specific type of white blood cells (agranulocytosis) | ✔ | ||
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.
How to store
Keep in a safe place out of reach and sight of children.
The healthcare professional will store the product under refrigeration (2°C - 8°C) in the carton to
protect from light, before reconstitution.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website http://www.avirpharma.com/, or by calling 1-800-363-7988.
This information is current up to the time of the last revision date shown below, but more current
information may be available from the manufacturer.
This leaflet was prepared by:
AVIR Pharma Inc.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.avirpharma.com
Last Revised: April 29, 2021
ZEVTERA is a registered trademark of Basilea Pharmaceutica International AG; used under license by
AVIR Pharma Inc.