Details for: CUBICIN RF
Company: CUBIST PHARMACEUTICALS LLC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02465493 | CUBICIN RF | DAPTOMYCIN | 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
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.
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 |
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.
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:
|
✔ | ||
Pain in the hands and feet with symptoms such as:
|
✔ | ||
Irregular heartbeat | ✔ | ||
Kidney problems with symptoms such as:
|
✔ | ||
Very Rare | |||
Respiratory problems with symptoms such as:
|
✔ |
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:
- Visiting the Web page on Adverse Reaction Reporting: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
- 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
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