Dalbavancin

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

Call your doctor at once if you have:

• diarrhea that is watery or bloody.

Common side effects may include:

• headache;
• nausea; or
• diarrhea.

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.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using dalbavancin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Other drugs may interact with dalbavancin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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.

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

Usual Adult Dose for Skin and Structure Infection:

1000 mg IV, followed one week later by 500 mg IV

Comments: Infuse over 30 minutes.

Uses: Treatment of adult patients with 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 and Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus).

• It is used to treat skin infections.

• If you have an allergy to dalbavancin or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take dalbavancin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• BI 397
• Dalbavancin HCl
• Zeven

• Dalvance

Acute bacterial skin and skin structure infections: Treatment of adult patients with 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, S. dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus), and Enterococcus faecalis (vancomycin-susceptible strains)

Reconstitute with 25 mL of either SWFI or D5W for each 500 mg vial. To avoid foaming, alternate between gentle swirling and inversion of the vial until contents are completely dissolved. Do not shake. The reconstituted vial contains 20 mg/mL dalbavancin as a clear, colorless to yellow solution. Dilute for infusion in D5W (final solution concentration 1 to 5 mg/mL).

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Applies to dalbavancin: intravenous powder for solution

Along with its needed effects, dalbavancin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dalbavancin:

• Abdominal or stomach pain or tenderness
• back pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• chest pain or tightness
• chills
• clay colored stools
• cough
• dark urine
• decreased appetite
• difficulty swallowing
• dizziness
• fast heartbeat
• feeling of warmth
• fever
• headache
• hives, welts, itching, or rash
• loss of appetite
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the face, neck, arms, and occasionally, upper chest
• redness of the skin
• severe abdominal or stomach cramps and pain
• sore mouth or tongue
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the feet or lower legs
• swollen glands
• tightness in the chest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• watery and severe diarrhea, which may also be bloody
• yellow eyes or skin

Some side effects of dalbavancin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea

• Anxiety
• blurred vision
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• increased hunger
• nightmares
• seizures
• shakiness
• slurred speech