Description and Brand Names

Información sobre medicamentos proporcionada por: IBM Micromedex

US Brand Name

  1. Dalvance

Descriptions


Dalbavancin injection is used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults. It belongs to the family of medicines called antibiotics. Dalbavancin works by killing bacteria or preventing their growth. Dalbavancin will not work for colds, flu, or other virus infections.

This medicine is to be given only or under the direct supervision of your doctor.

This product is available in the following dosage forms:

  • Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of dalbavancin injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dalbavancin injection in the elderly. However, elderly patients are more likely to have unwanted side effects and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving dalbavancin injection.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cholera Vaccine, Live

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to glycopeptide, history of—Use with caution. May increase risk of having an allergic reaction to occur again.
  • Diarrhea or
  • Liver disease—Use with caution. May make these conditions worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 minutes.

To help clear up your infection completely, dalbavancin must be given for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, dalbavancin must be given on a regular schedule.

Precautions

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including skin reactions and anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause infusion-related reactions. This can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a cough, difficulty with swallowing, dizziness, fast heartbeat, trouble breathing, swelling in your face or hands, fever, chills, itching or hives, or feeling of warmth or redness on your upper body while you are receiving this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Side Effects

Along with its needed effects, a medicine 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:

Less common or rare

  1. Abdominal or stomach pain or tenderness
  2. back pain
  3. black, tarry stools
  4. bleeding gums
  5. blood in the urine or stools
  6. chest pain or tightness
  7. chills
  8. clay colored stools
  9. cough
  10. dark urine
  11. decreased appetite
  12. difficulty swallowing
  13. dizziness
  14. fast heartbeat
  15. feeling of warmth
  16. fever
  17. headache
  18. hives, welts, itching, or rash
  19. loss of appetite
  20. painful or difficult urination
  21. pale skin
  22. pinpoint red spots on the skin
  23. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  24. redness of the face, neck, arms, and occasionally, upper chest
  25. redness of the skin
  26. severe abdominal or stomach cramps and pain
  27. sore mouth or tongue
  28. sore throat
  29. sores, ulcers, or white spots on the lips or in the mouth
  30. swelling of the feet or lower legs
  31. swollen glands
  32. tightness in the chest
  33. troubled breathing with exertion
  34. unusual bleeding or bruising
  35. unusual tiredness or weakness
  36. vomiting of blood or material that looks like coffee grounds
  37. watery and severe diarrhea, which may also be bloody
  38. yellow eyes or skin

Some side effects 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:

Less common

  1. Diarrhea

Less common or rare

  1. Anxiety
  2. blurred vision
  3. cold sweats
  4. coma
  5. confusion
  6. cool, pale skin
  7. depression
  8. increased hunger
  9. nightmares
  10. seizures
  11. shakiness
  12. slurred speech

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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