Cubicin is an antibiotic that fights bacteria in the body.

Cubicin is used to treat bacterial infections of the skin and underlying tissues, and infections that have entered the bloodstream.

Cubicin is used for complicated infections, including MRSA or "super bug" infections. MRSA stands for methicillin-resistant Staphylococcus aureus.

To be sure Cubicin is helping your condition, your blood may need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

If you are using Cubicin at home, be sure you understand how to properly mix and store the medication.

Call your doctor at once if you have a new or worsening cough, fever, trouble breathing, diarrhea that is watery or bloody, muscle pain or weakness, tingly feeling, fever or flu symptoms, dark colored urine, mouth sores, pain or burning when you urinate, urinating less than usual or not at all, pale skin, or feeling light-headed.

Cubicin is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Cubicin if you do not understand how to use the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine. Ask your doctor or pharmacist if you have questions.

Cubicin must be given slowly, and the IV infusion can take 2 to 30 minutes to complete. When giving this medicine to a child or teenager, the infusion is even slower (30 to 60 minutes).

Cubicin must be mixed with a liquid (diluent) before using it. Prepare your injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Do not shake the medication bottle or you may ruin the medicine. Gently swirl the medicine when mixing. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

You may need frequent blood and urine tests.

This medicine may cause false results with certain medical tests. Tell any doctor who treats you that you are using Cubicin.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Some infections must be treated for up to 6 weeks. Skipping doses can increase your risk of infection that is resistant to medication. Daptomycin will not treat a viral infection such as the flu or a common cold.

Each single-use vial (bottle) of Cubicin is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using daptomycin.

Store Cubicin in the refrigerator. Do not freeze. After mixing with a diluent, store in the refrigerator and use it within 48 hours.

You may also store mixed Cubicin vials for up to 12 hours at room temperature.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose of Cubicin for Skin and Structure Infection:

4 mg/kg IV every 24 hours for 7 to 14 days

Use: For the treatment of complicated skin and skin structure infections (cSSSI) due to susceptible isolates of Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, S agalactiae, S dysgalactiae subspecies equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only)

Usual Adult Dose of Cubicin for Bacteremia:

6 mg/kg IV every 24 hours for 2 to 6 weeks

Comments:
-This drug should not be used for the treatment of left-sided infective endocarditis due to S aureus; in the clinical trial, outcomes were poor.
-This drug has not been studied in patients with prosthetic valve endocarditis.
-Limited safety data regarding use of this drug beyond 28 days

Uses: For the treatment of patients with S aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, due to methicillin-susceptible and methicillin-resistant isolates

Usual Adult Dose for Endocarditis:

6 mg/kg IV every 24 hours for 2 to 6 weeks

Comments:
-This drug should not be used for the treatment of left-sided infective endocarditis due to S aureus; in the clinical trial, outcomes were poor.
-This drug has not been studied in patients with prosthetic valve endocarditis.
-Limited safety data regarding use of this drug beyond 28 days

Uses: For the treatment of patients with S aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, due to methicillin-susceptible and methicillin-resistant isolates

Usual Pediatric Dose for Skin and Structure Infection:

1 to less than 2 years: 10 mg/kg IV every 24 hours
2 to 6 years: 9 mg/kg IV every 24 hours
7 to 11 years: 7 mg/kg IV every 24 hours
12 to 17 years: 5 mg/kg IV every 24 hours

Duration of therapy: Up to 14 days

Use: For the treatment of cSSSI due to susceptible isolates of S aureus (including methicillin-resistant isolates), S pyogenes, S agalactiae, S dysgalactiae subspecies equisimilis, and E faecalis (vancomycin-susceptible isolates only)

Usual Pediatric Dose for Bacteremia:

1 to 6 years: 12 mg/kg IV every 24 hours
7 to 11 years: 9 mg/kg IV every 24 hours
12 to 17 years: 7 mg/kg IV every 24 hours

Duration of therapy: Up to 42 days

Use: For the treatment of S aureus bloodstream infections (bacteremia)

You should not use Cubicin if you are allergic to daptomycin.

To make sure Cubicin is safe for you, tell your doctor if you have ever had:

• kidney disease; or

• a nerve or muscle disorder.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using Cubicin. Ask your doctor about any risk.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Get emergency medical help if you have signs of an allergic reaction to Cubicin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);

• fever, flu symptoms, mouth and throat ulcers, rapid heart rate, shallow breathing;

• pain or burning when you urinate;

• numbness, tingling, or burning pain in your hands or feet;

• easy bruising, unusual bleeding;

• new or worsening cough, fever, trouble breathing; or

• unexplained muscle pain, tenderness, or weakness.

Common Cubicin side effects may include:

• chest pain, trouble breathing;

• headache, dizziness;

• stomach pain, vomiting;

• swelling;

• abnormal liver function tests;

• rash, itching, sweating;

• trouble sleeping;

• sore throat; or

• increased blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially a "statin" cholesterol medicine such as:

• atorvastatin (Lipitor, Caduet);

• fluvastatin (Lescol);

• lovastatin (Mevacor, Altoprev, Advicor);

• pitavastatin (Livalo);

• pravastatin (Pravachol);

• rosuvastatin (Crestor); or

• simvastatin (Zocor, Simcor, Vytorin);

This list is not complete. Other drugs may interact with daptomycin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.