Dalbavancin

Dalbavancin is a prescription medication used in adults to treat skin infections caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

Dalbavancin belongs to a group of drugs called lipoglycopeptide antibiotics. These work by killing bacteria that cause infections.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of dalbavancin include nausea, vomiting, diarrhea, and headache.

Dalbavancin is a prescription medication used in adults skin infections caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Dalbavancin may be found in some form under the following brand names:

• Dalvance

Serious side effects have been reported with dalbavacin. See the “Dalbavancin Precautions” section.

Common side effects of dalbavancin include the following:

• Nausea
• Vomiting
• Diarrhea
• Headache

This is not a complete list of dalbavancin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with dalbavancin including the following:

• Hives
• Rash
• Itching
• Difficulty breathing or swallowing
• Severe diarrhea

Some people may experience an allergic reaction while receiving the infusion of dalbavancin. Symptoms of an allergic reaction include:

• Sudden reddening of the face, neck, or upper chest
• Itching
• Rash
• Hives

Do not take dalbavancin if you are allergic to dalbavancin, vancomycin, any other medications, or any of the ingredients in dalbavancin injection.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of dalbavancin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking dalbavancin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to dalbavancin, vancomycin, any other medications, or any of the ingredients in dalbavancin injection have or have had condition B
• have liver problems
• have kidney problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Dalbavancin falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Dalbavancin has been detected in the breast milk of rats. It is not known if dalbavancin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using dalbavancin.

Take dalbavancin exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss an appointment to receive an infusion of dalbavancin, call your doctor right away.

This medication will be administered by a healthcare professional in a hospital setting.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• your kidney function

The recommended dose of dalbavancin for the treatment of skin and skin structure infections is 1500 mg as a single dose or 1000 mg followed by 500 mg one week later. The medication is administered as an infusion over 30 minutes.

Patients with kidney impairment, the recommended doses are as follows:

Estimated CrCl >= 30 mL/min or on regular hemodialysis:

• 1500 mg as a single dose OR 
• 1000 mg followed one week later by 500 mg 

Estimated CrcCl < 30 mL/min and not on regular hemodialysis 

• 1125 mg as a single dose OR
• 750 mg followed one week later by 375 mg 

If you take too much dalbavancin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If dalbavancin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.