Details for: ERAXIS
Company: PFIZER CANADA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02330695 | ERAXIS | ANIDULAFUNGIN | 100 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
ERAXIS belongs to a group of medicines called
echinocandins. These medicines are used to treat serious
fungal infections.
ERAXIS is prescribed to treat a type of fungal infection
called invasive candidiasis (including candidemia). The
infection is caused by fungal cells (yeasts) called Candida.
What it does
Fungal cells exposed to ERAXIS have incomplete or defective cell walls making them fragile or unable to grow, thereby killing the cells and reducing the infection.
When it should not be used
If you are allergic (hypersensitive) to anidulafungin, other echinocandins, or any of the other ingredients of ERAXIS (Fructose, Mannitol, Polysorbate 80, Tartaric acid, Sodium hydroxide or Hydrochloric acid).
What the medicinal ingredient is
The active ingredient is anidulafungin.
What the non-medicinal ingredients are
Fructose, Mannitol, Polysorbate 80, Tartaric acid, Sodium hydroxide (for pH-adjustment), Hydrochloric acid (for pHadjustment)
What dosage form it comes in
ERAXIS is marketed as a carton containing 1 vial of 100 mg powder for solution for infusion.
Warnings and precautions
BEFORE you use ERAXIS talk to your doctor or pharmacist:
- If you have been told by your doctor that you have an intolerance to some sugars. Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicinal product contains fructose.
- If you become pregnant while taking ERAXIS: ERAXIS should not be taken during pregnancy, unless indicated by your doctor. Effective contraception should be used in women of childbearing potential.
- If you are breast-feeding or planning to breast feed . You and you doctor will decide whether you should take this medication or not while breastfeeding or whether you should discontinue breastfeeding.
- If you have any allergies to this drug or its ingredients or components of the container.
- If you have liver problems.
Interactions with this medication
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
It is not expected that ERAXIS will interact with other medications or that any adjustments will be necessary to other medicines you may be taking. However, do not start or stop any other medications without your doctor or pharmacist’s approval.
Proper use of this medication
ERAXIS will always be prepared and given to you by a doctor or a healthcare professional.
Usual Dose
ERAXIS should be administered once a day, by slow infusion into your vein over approximately 1.5 to 3 hours. The treatment starts with a loading dose of 200 mg on the first day, then with subsequent daily maintenance dose of 100 mg.
ERAXIS should not be given to patients under 18 years of age. Your doctor will determine the duration of your treatment and how much anidulafungin you will receive each day, and will monitor your response and condition.
Overdose
Your doctor will monitor your response and condition to determine what ERAXIS treatment is needed. However, if you are concerned that you may have been given too much ERAXIS, tell your doctor or another healthcare professional immediately.
Missed Dose
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However tell your doctor or pharmacist if you think that a dose has been forgotten.
Side effects and what to do about them
Like all medicines, ERAXIS can cause side effects, although not everybody gets them.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Hypokalemia (low potassium levels) and symptoms such as muscle weakness, and cramping, irregular heart beat, frequent urination | ✔ | ||
| Uncommon | |||
| High blood pressure | ✔ | ||
| Liver problems (hepatitis) with symptoms such as persistent abdominal pain, nausea, Vomiting | ✔ | ✔ | |
| Anaphylactic (allergic) reactions with symptoms such as rash, hives, low blood pressure, fainting, swelling of mouth, throat and extremities, weakness, difficulty in breathing | ✔ | ||
- A common effect is diarrhea.
- Uncommon side effects include headache, rash, itching, flushing, eye pain, infusion site reaction
If these reactions become troublesome, contact your doctor
This is not a complete list of side effects. For any unexpected effects while taking ERAXIS, contact your doctor or pharmacist.
How to store
Unreconstituted vials of ERAXIS are stored in a refrigerator
(2-8°C). Do not freeze.
Keep out of the reach and sight of children.
Do not use ERAXIS after the expiry date which is stated on the
label.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at MedEffect (www.healthcanada.gc.ca/medeffect);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and
sending it by:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 1908C
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect
Reporting Form are available at MedEffect.
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 document plus the full product monograph, prepared for
health professionals can be found at:
http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada
ULC, at 1-800-463-6001 (Medical Information).
This leaflet was prepared by Pfizer Canada ULC
Last revised: October 28, 2020
ERAXIS® Vicuron Holdings LLC
Pfizer Canada ULC, Licensee
© Pfizer Canada ULC, 2020