DALVANCE® (Dalbavancin)

DALVANCE®

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Important Safety Information

DALVANCE® (dalbavancin)‎ is a prescription infusion medication used to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI). To reduce the risk of developing drug-resistant bacteria, DALVANCE® should only be used to treat infections that are caused by the following microorganisms:

  • Staphylococcus aureus
  • Streptococcus pyogenes
  • Streptococcus agalactiae
  • Streptococcus dysgalactiae
  • Streptococcus anginosus
  • Enterococcus faecalis

Talk to your doctor about your medical history. You may need additional monitoring during treatment if you have moderate or severe liver or kidney disease. Tell your healthcare professional about all medications you’re currently taking — whether they’re prescription, over-the-counter, vitamins, or herbal supplements.

DALVANCE® is only effective when treating bacterial infections. It has no effect on viral infections. The medication is not recommended in patients who are allergic to dalbavancin.

What is the most important information I should know about DALVANCE®?

Serious allergic reactions have been reported in some patients. Tell your doctor immediately if you experience symptoms of anaphylaxis — including dizziness, itching, hives, flushed skin, low blood pressure, breathing difficulties, wheezing, nausea, vomiting, diarrhea, and/or fainting — as the condition could be life-threatening.

It is unknown whether DALVANCE® could have a harmful effect on pregnant or nursing women. Tell your doctor if you’re pregnant, planning on becoming pregnant, or breastfeeding.

Side Effects of DALVANCE®

As with any prescription medication, DALVANCE® carries the risk of side effects. The most common ones include:

  • Headaches
  • Back pain
  • Nausea
  • Diarrhea

In some cases, side effects may be more serious, including clostridium difficile (C. diff) and colitis that may result in fatal complications. Seek emergency care immediately if you experience severe abdominal pain and/or swelling, fever, chills, rapid heart rate, and/or frequent or bloody diarrhea.

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

DALVANCE® is indicated for adult patients with ABSSSI. Dosage for patients with normal renal function should be about 1500 mg, administered in a single dose, or split into two infusion therapies. For patients with renal impairment, the dosage should be reduced to 1125mg.

Please refer to the full prescribing information.