Dalbavancin

Dalbavancin is used as a prescription medication for treating skin and skin structure infections.

• Dalbavancin is available under the following different brand names: Dalvance

Adult and pediatric dosage

Lyophilized powder for reconstitution

• 500mg/vial (20mg/mL after reconstitution)

Skin & Skin Structure Infections

Adult dosage

• 1-dose regimen of 1500 mg IV, or
• 2-dose regimen of 1000 mg IV followed 1 week later by 500 mg IV
• Infuse IV over 30 minutes

Pediatric dosage

• Birth to 5 years: 22.5 mg/kg IV as a single dose
• 6 to 17 years: 18 mg/kg IV as a single dose
• Not to exceed 1500 mg/dose
• Infuse IV over 30 minutes

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Dalbavancin include:

• nausea,
• vomiting,
• headache,
• diarrhea,
• rash, and
• itching.

Serious side effects of the Dalbavancin include:

• hives,
• difficult breathing,
• swelling of the face, lips, tongue, or throat,
• severe stomach pain, and
• watery or bloody diarrhea

Rare side effects of the Dalbavancin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Dalbavancin has no noted severe interactions with any other drugs.
• Dalbavancin has no noted serious interactions with any other drugs.
• Dalbavancin has no noted moderate interactions with any other drugs.
• Dalbavancin has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dalbavancin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dalbavancin?”

Cautions

• Administer via intravenous infusion, using a total infusion time of 30 minutes to minimize the risk of infusion-related reaction; rapid IV infusion of glycopeptide antibacterial agents can cause reactions, including upper body flushing, urticaria, pruritus, back pain, and rash; stopping or slowing infusion may result in cessation of these reactions
• ALT elevations above 3x ULN reported
• Prescribing antibiotics in the absence of a proven or strongly suspected bacterial infection, or a prophylactic indication is unlikely to provide benefit and increases the risk of the development of drug-resistant bacteria
• Clostridioides difficile-associated diarrhea (CDAD)
  • CDAD is reported with severity ranging from mild diarrhea to fatal colitis; treatment with antibacterial agents can alter the normal flora of the colon and may permit overgrowth of C. difficile
  • C. difficile produces toxins A and B which contribute to the development of CDAD; hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antibacterial therapy and may require colectomy
  • CDAD must be considered in all patients who present with diarrhea following antibacterial use; careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents
  • If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile should be discontinued, if possible appropriate measures such as fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated
• Hypersensitivity reactions
  • Serious hypersensitivity (anaphylactic) and skin reactions were reported with glycopeptide antibacterial agents, including dalbavancin
  • If an allergic reaction occurs, discontinue treatment and institute appropriate therapy for the allergic reaction; before using the product, inquire carefully about previous hypersensitivity reactions to other glycopeptides
  • Due to the possibility of cross-sensitivity, carefully monitor for signs of hypersensitivity during treatment in patients with a history of glycopeptide allergy

Pregnancy and Lactation

• There are no adequate and well-controlled studies with use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse developmental outcomes
• No treatment-related malformations or embryo-fetal toxicity were observed in pregnant rats or rabbits at clinically relevant exposures to dalbavancin
• Treatment of pregnant rats with dalbavancin at 3.5 times the human dose on an exposure basis during early embryonic development and from implantation to the end of lactation resulted in delayed fetal maturation and increased fetal loss, respectively
• Lactation
  • There are no data on the presence of dalbavancin or its metabolite in human milk, its effects on breastfed children, or milk production
  • Dalbavancin is excreted in the milk of lactating rats; when a drug is present in animal milk, the drug will likely be present in human milk
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breast-fed child from the drug or the underlying maternal condition