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Details for: ZEVTERA

Company: AVIR PHARMA INC.

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02446685ZEVTERACEFTOBIPROLE (CEFTOBIPROLE MEDOCARIL SODIUM)500 MG / VIALPOWDER FOR SOLUTIONINTRAVENOUS
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Summary Reports

Regulatory Decision Summary

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:

If you think you, or a person you are caring for, have taken too much ZEVTERA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

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

Serious side effects and what to do about them
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:

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

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.

Date modified: