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Details for: CUBICIN RF

Company: CUBIST PHARMACEUTICALS LLC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02465493CUBICIN RFDAPTOMYCIN500 MG / VIALPOWDER FOR SOLUTIONINTRAVENOUS
Search Reported Side Effects Report a Side Effect

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

CUBICIN®/CUBICIN® RF is used to treat bacterial infections:

  • of the skin and soft tissues (patients 1 year and older)
  • in the blood (patients 1 year and older)
  • certain heart valve infections (patients 18 years and older)

Antibacterial drugs like CUBICIN®/CUBICIN® RF treat only infections caused by bacteria. They do not treat viral infections. Although you may feel better early in treatment, CUBICIN®/CUBICIN® RF should be used exactly as directed. Misuse or overuse of CUBICIN®/CUBICIN® RF could lead to growth of bacteria that will not be killed by CUBICIN®/CUBICIN® RF (resistance). This means that CUBICIN®/CUBICIN® RF may not work for you in the future.

What it does

CUBICIN®/CUBICIN® RF are antibiotics. They work by killing certain bacteria that cause your infection.

When it should not be used

Do not use CUBICIN®/CUBICIN® RF if:

  • you are allergic to daptomycin.
What the medicinal ingredient is

Medicinal ingredients: Daptomycin

What the non-medicinal ingredients are

CUBICIN®

Non-medicinal ingredients: Sodium hydroxide

CUBICIN® RF

Sodium hydroxide and sucrose

What dosage form it comes in

Lyophilized powder for solution available as 500 mg/10 mL vial

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CUBICIN®/CUBICIN® RF. Talk about any health conditions or problems you may have, including if you:

  • have kidney or severe liver problems.
  • have high blood levels of creatine phosphokinase (CPK).
  • are pregnant, or planning on becoming pregnant.
  • are breastfeeding or plan to breastfeed. Breastfeeding should be stopped during treatment with CUBICIN®/CUBICIN® RF.
  • are allergic to any antibiotics or other drugs.
  • are taking other medications (see The following may interact with CUBICIN®/CUBICIN® RF).
  • have any questions about your treatment, both before and during treatment.

Other warnings you should know about:

Stop taking CUBICIN®/CUBICIN® RF and contact your doctor right away if you:

  • have severe or lasting diarrhea (bloody or watery) with or without
    • fever.
    • stomach pain or tenderness.

You may have Clostridium difficile colitis (bowel inflammation).

Interactions with this medication

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 CUBICIN®/CUBICIN® RF:

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

CUBICIN®/CUBICIN® RF will be given intravenously (injected into a vein) by a doctor or nurse in a hospital or clinical setting.

Usual Dose

Adults

Serious skin infections: The usual adult dose is 4 mg for every kg of body weight. Your dose will be given either as an injection over a 2-minute period or by infusion over a 30-minute period every 24 hours for 7 to 14 days.

Bacterial infections in the blood, including certain heart valve infections: The usual adult dose is 6 mg for every kg of body weight. Your dose will be given either as an injection over a 2-minute period or by infusion over a 30-minute period every 24 hours for 10 to 56 days.

Children

Your doctor will decide how much CUBICIN® / CUBICIN® RF to give your child based on their age, weight and type of infection.

Serious skin infections
Age Group Dosage* Duration of Therapy
12 to 17 years 5 mg/kg once every 24 hours infused over 30 minutes Up to 14 days
7 to 11 years 7 mg/kg once every 24 hours infused over 30 minutes
2 to 6 years 9 mg/kg once every 24 hours infused over 30 minutes
1 to less than 2 years 10 mg/kg once every 24 hours infused over 30 minutes
Bacterial infections in the blood
Age Group Dosage Duration of Therapy
12 to 17 years 7 mg/kg once every 24 hours infused over 30 minutes Up to 42 days
7 to 11 years 9 mg/kg once every 24 hours infused over 30 minutes
1 to 6 years 12 mg/kg once every 24 hours infused over 30 minutes

Overdose

If you think you have taken too much CUBICIN®/CUBICIN® RF, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking CUBICIN®/CUBICIN® RF. If you experience any side effects not listed here, contact your healthcare professional.

Common side effects may include:

  • headache or dizziness.
  • diarrhea or constipation.
  • nausea or vomiting.
  • rash or itching.
  • difficulty sleeping.
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
Uncommon
A serious allergic reaction with symptoms such as:
  • shortness of breath, difficulty swallowing.
  • hives, itching, drug rash, blister-like sores.
  • swelling of the mouth, throat, lips and limbs (angioedema).
   ✔  
Pain in the hands and feet with symptoms such as:
  • burning, "pins and needles", numbness.
  • muscle pain, weakness or tiredness (myopathy).
   ✔  
Irregular heartbeat   ✔  
Kidney problems with symptoms such as:
  • reduced kidney function, kidney failure.
  • increased urination, bloody urine.
  • lower back pain, pressure in the bladder.
  • fatigue and nausea.
  • Fever or rash
   ✔  
Very Rare
Respiratory problems with symptoms such as:
  • fever, cough, shortness of breath or difficulty breathing (eosinophilic pneumonia).
  • Inflammation of the lungs (organizing pneumonia)
   ✔  

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

CUBICIN® vials containing lyophilized powder should be stored at 2ºC to 8ºC.

CUBICIN® RF vials containing lyophilized powder should be stored at 15ºC to 30ºC.

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

Keep out of reach and sight of children.

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

If you want more information about CUBICIN®/CUBICIN® RF:

  • Talk to your healthcare professional
  • Find this document plus the full product monograph, prepared for health professionals at: http://www.sunovion.ca or by contacting the sponsor, Sunovion Pharmaceuticals Canada Inc., at: 1-866-260-6291 or by visiting the Health Canada website at: https://www.canada.ca/en/health-canada.html.

This leaflet was prepared by Sunovion Pharmaceuticals Canada Inc.

Last Revised: May 15, 2020

Date modified: