What Cubicin is used for and how to use it
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Cubicin - Consumer Medicine Information

Manufacture: Sunovion Pharmaceuticals Inc.
Country: Canada
Condition: Bacteremia, Endocarditis, Methicillin-Resistant Staphylococcus Aureus Infection, Skin and Structure Infection, Skin or Soft Tissue Infection
Class: Miscellaneous antibiotics
Form: Liquid solution, Intravenous (IV)
Ingredients: daptomycin, sodium hydroxide

About This Medication

What the medication is used for

CUBICIN is used in adults (18 years and older) for the treatment of bacterial infections, including serious skin infections and certain heart valve infections. It is given intravenously (injected into a vein) and will be given to you when you are in a hospital or similar clinical setting.

What it does

CUBICIN kills certain bacteria (“germs”) which cause infections, including serious skin infections and certain heart valve infections.

When it should not be used

CUBICIN should not be given to you if you are allergic to daptomycin or any other similar drugs.

What the medicinal ingredient is

CUBICIN contains daptomycin.

What the important nonmedicinal ingredients are

CUBICIN contains sodium hydroxide.

What dosage forms it comes in

CUBICIN® is provided by the manufacturer as a solid. Your doctor or nurse will dissolve the solid in salt water so that it can be injected.

Warnings And Precautions

CUBICIN, like many antibiotics, can cause Clostridium difficile colitis (bowel inflammation caused by a bacterial infection). If you experience symptoms such as severe diarrhea, fever, abdominal pain or tenderness, you may have developed Clostridium difficile colitis. Contact your doctor immediately since your treatment may need to be changed.

CUBICIN can cause muscle pain and weakness, or unusual sensations in the hands and feet (e.g., burning, “pins and needles”, numbness). Your doctor will check you for these symptoms. While you are taking CUBICIN your doctor may stop other medications that you have been taking, for example, to lower your cholesterol.

CUBICIN has been associated with a condition called eosinophilic pneumonia. Eosinophilic pneumonia is a rare, but serious condition where a type of white blood cell (eosinophil) fills the lungs. Symptoms of eosinophilic pneumonia include fever, cough, shortness of breath, or difficulty breathing.

Talk to your doctor before taking CUBICIN if:

  • You have kidney, or severe liver problems
  • You are pregnant, or planning on becoming pregnant
  • You are breastfeeding or planning to breastfeed. Breastfeeding should be discontinued during treatment with CUBICIN.
  • You are allergic to any antibiotics or other drugs.
  • You are taking other medications (see INTERACTIONS WITH THIS MEDICINE)
  • You have any questions about your treatment, both before and during treatment

Talk to your doctor if the following occur while taking CUBICIN:

  • You notice any unusual muscle pain or weakness
  • You notice any unusual sensations in your hands or feet (e.g., burning, “pins and needles”, numbness)
  • You notice a new or worsening fever, cough, shortness of breath, or have difficulty breathing

Interactions With This Medication

Drugs that may interact with CUBICIN include:

  • Drugs that lower cholesterol (HMG-CoA reductase inhibitors also know as “statins” such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin)
  • Tobramycin (another antibiotic)
  • Blood thinners (warfarin)

Proper Use Of This Medication

CUBICIN is administered in a hospital or clinical setting, by a doctor or nurse.

Serious skin infections

The usual adult dose is 4 mg for every kg of body weight, given as a solution that is injected into a vein. It is given once a day over either a 30 minute period or a 2 minute period.

Bacterial infections including certain heart valve infections

The usual adult dose is 6 mg for every kg of body weight, given as a solution that is injected into a vein. It is given once a day either over a 30 minute period or a 2 minute period.

Use in children

CUBICIN is not recommended for use in patients under the age of 18 years.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional poison control centre, even if there are no symptoms.

Side Effects And What To Do About Them

Serious Side Effects, How Often They
happen And What To Do About Them
Symptom / effect Talk with your doctor or
pharmacist
Only if
severe
In all cases
Uncommon Serious allergic reaction including symptoms such as shortness of breath, difficulty swallowing, hives, or itching, drug rash and angioedema (swelling of the tissues such as mouth, throat, lips, hands, and extremities). +
Pain in the hands and feet (burning, “pins and needles”), numbness, muscle pain, weakness or tiredness. +
Irregular heartbeat +
Very Rare Eosinophilic Pneumonia (fever, cough, shortness of breath, difficulty breathing) +

Common side effects that may occur include: headache, nausea, diarrhea, constipation, vomiting, rash, itching, difficulty sleeping, dizziness, or rash. If you experience these symptoms and they become bothersome, consult your doctor

This is not a complete list of side effects. For any unexpected effects while taking CUBICIN, tell your doctor or nurse.

How To Store It

Vials containing lyophilized powder should be stored at 2 to 8°C.

Reconstituted solutions are to be used immediately or refrigerated (2 to 8°C) and used within 72 hours, then discarded. Health Care professionals should refer to the Product Monograph for more details.


Reporting Suspected 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: www.healthcanada.gc.ca/medeffect
  • Call toll-free fax: 1-866-234-2345
  • Complete a Canada Vigilance Reporting form and:
    • Fax toll-free to 1-866-678-6789 or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701C
      Ottawa, ON K1A 0K9
    Postage paid labels, the Canada Vigilance Reporting Form and the adverse drug reaction reporting guidelines are available on the MedEffect Canada website at www.healthcanada.gc.ca/medeffect.

Note: Should you require information related to the management of side effects, contact your health professional. 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.sunovion.ca or by contacting the sponsor, Sunovion Pharmaceuticals Canada Inc., at: 1-866-260-6291

This leaflet was prepared by Sunovion Pharmaceuticals Canada Inc.

Last revised: October 9, 2015