Dalbavancin

Approved Uses

Dalbavancin is primarily used to treat acute bacterial skin and skin structure infections (ABSSSI). These are serious infections that affect the skin and the tissues just beneath the skin. Common examples of these infections include:

• Cellulitis (a deep skin infection)
• Major skin abscesses
• Wound infections

This medication is effective against specific types of Gram-positive bacteria. It is often used to treat infections caused by Staphylococcus aureus, including methicillin-resistant strains (MRSA), as well as various types of Streptococcus bacteria.

Patient Population

Dalbavancin is approved for use in both adults and pediatric patients, including newborns. It is typically administered in a healthcare setting when a healthcare provider determines that an intravenous antibiotic is necessary to manage a severe bacterial infection.

It is important to note that dalbavancin only treats bacterial infections. It will not work for viral infections, such as the common cold or flu.

How Dalbavancin Fights Infection

Dalbavancin belongs to a class of medications known as lipoglycopeptide antibiotics. It is specifically designed to treat acute bacterial skin and skin structure infections caused by certain types of Gram-positive bacteria.

Inhibiting Cell Wall Synthesis

Bacteria require a strong, rigid outer layer called a cell wall to survive, maintain their shape, and protect themselves from their environment. Dalbavancin works by interfering with the process bacteria use to build these walls. It binds to specific building blocks within the bacterial cell, preventing them from being linked together to form a stable structure.

Bacterial Death

When the construction of the cell wall is interrupted, the bacteria can no longer maintain their integrity. This process results in:

• Cellular breakdown: Without a functional cell wall, the bacterial cell eventually bursts and dies.
• Bactericidal action: Because dalbavancin actively kills the bacteria rather than just slowing their growth, it is classified as a bactericidal antibiotic.
• Stopping the spread: By killing the bacteria at the site of the infection, the medication prevents the bacteria from multiplying and spreading to other parts of the body.

Dalbavancin is known for having a long half-life, which means it stays active in the body for an extended period to continue fighting the infection. It is important to note that this medication only works against bacterial infections and is not effective against viral infections, such as the common cold or the flu.

Common Side Effects

The most frequently reported side effects of dalbavancin include:

• Nausea
• Headache
• Diarrhea
• Vomiting
• Rash
• Itching

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Allergic Reactions: Signs include hives, swelling of the face or throat, and difficulty breathing.
• Infusion Reactions: Symptoms such as flushing of the upper body, hives, or intense itching may occur if the medication is administered too quickly.
• Liver Issues: Although rare, changes in liver enzyme levels may occur during or after treatment.
• Severe Intestinal Conditions: Like many antibiotics, dalbavancin can cause Clostridioides difficile-associated diarrhea. This may present as severe watery or bloody diarrhea and stomach cramps, potentially occurring weeks or months after the last dose.

Serious Allergic Reactions

Serious and sometimes fatal hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving dalbavancin. If an allergic reaction occurs, the medication must be discontinued immediately. Patients with a known history of hypersensitivity to other glycopeptides should use this medication with caution, as cross-sensitivity may occur.

Infusion-Related Reactions

Administering dalbavancin too rapidly through an intravenous infusion can cause reactions similar to Red Man Syndrome. These symptoms may include:

• Flushing of the upper body
• Urticaria (hives)
• Pruritus (itching)
• Rash

To minimize the risk of these reactions, the infusion should be administered slowly over a period of 30 minutes.

Liver Health

Elevations in liver enzymes, specifically alanine aminotransferase (ALT), have been observed in clinical trials. While these elevations were generally mild, healthcare providers may monitor liver function, particularly in patients with pre-existing hepatic impairment.

Diarrhea and Colitis

Like most antibacterial agents, dalbavancin can alter the normal bacteria in the colon, leading to the overgrowth of Clostridioides difficile. This can result in Clostridioides difficile-associated diarrhea (CDAD), ranging in severity from mild diarrhea to fatal colitis. This condition can occur during treatment or more than two months after the last dose.

Renal Impairment

In patients with chronic renal impairment whose creatinine clearance is less than 30 mL/min and who are not receiving regular hemodialysis, dosage adjustments are necessary. The medication is not effectively removed by hemodialysis.

Development of Drug-Resistant Bacteria

Using dalbavancin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit and increases the risk of developing drug-resistant bacteria.

Pregnancy

There are no adequate and well-controlled studies regarding the use of dalbavancin in pregnant women. Animal studies have indicated that high doses of the medication may cause developmental issues, but these findings do not always predict human response. Healthcare providers typically only recommend dalbavancin during pregnancy when the clinical need is clear and the potential benefits outweigh the risks to the fetus.

Breastfeeding

It is not known if dalbavancin is present in human breast milk. While animal studies have shown that the drug is excreted in the milk of lactating rats, there is no specific data on its effects on nursing human infants. Individuals who are breastfeeding should discuss the potential risks and benefits with their doctor before starting treatment.

Available Forms

Dalbavancin is supplied as a sterile, lyophilized powder. It is contained in a single-dose vial and must be reconstituted and diluted by a healthcare professional before use.

Administration Method

This medication is administered only as an intravenous infusion. It is typically given by a healthcare provider in a clinical setting, such as a hospital or infusion center.

FDA Approval History

Dalbavancin was approved by the U.S. Food and Drug Administration (FDA) in May 2014. It was the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval under the Generating Antibiotic Incentives Now (GAIN) Act, which was designed to encourage the development of new antibacterial drugs.

Approved Indications

The medication is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:

• Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains)
• Streptococcus pyogenes
• Streptococcus agalactiae
• Streptococcus dysgalactiae
• The Streptococcus anginosus group (including S. anginosus, S. intermedius, and S. constellatus)

Pediatric Use

In 2021, the FDA expanded the approval of dalbavancin to include pediatric patients from birth. This allows for the treatment of ABSSSI in infants, children, and adolescents using weight-based dosing regimens.

Regulatory Status

Dalbavancin is a prescription-only medication that must be administered by a healthcare professional via intravenous infusion. There are currently no boxed warnings or Risk Evaluation and Mitigation Strategy (REMS) requirements associated with this drug.

Administration and Billing

Dalbavancin is an intravenous medication administered by healthcare professionals in clinical settings, such as hospitals or outpatient infusion centers. Because it is not typically dispensed through retail pharmacies, the cost is often billed as part of a medical procedure. The total price may include the medication itself along with fees for the infusion equipment and professional services.

Insurance Coverage

Most private insurance plans and government programs like Medicare cover dalbavancin when it is used for FDA-approved indications. Because it is administered in a clinic or hospital, it is usually covered under a patient's medical benefit rather than a standard prescription drug benefit. Out-of-pocket costs, such as deductibles or co-insurance, will vary depending on the specific terms of the individual's insurance policy.

Financial Assistance

Financial assistance programs may be available for patients who have difficulty covering the cost of treatment. These programs are often provided by the manufacturer or through the healthcare facility where the infusion is performed. Patients are encouraged to speak with their healthcare provider or the billing department at their treatment center to learn about available support options or payment plans.