Applies to dalbavancin: intravenous powder for solution.

Serious side effects of Dalbavancin

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:

Less common

• 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
• sore mouth or tongue
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach cramps, pain, or tenderness
• swelling of the feet or lower legs
• swollen glands
• trouble breathing
• 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

Other side effects of Dalbavancin

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:

Less common

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

For Healthcare Professionals

Applies to dalbavancin: intravenous powder for injection.

General

The most common adverse reactions in adult patients were nausea, headache, and diarrhea; these were generally of mild or moderate severity.^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Flushing, phlebitis

Frequency not reported: Wound hemorrhage^[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus

Uncommon (0.1% to 1%): Urticaria

Frequency not reported: Petechiae, skin reactions^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, vomiting

Uncommon (0.1% to 1%): Constipation, abdominal pain, dyspepsia, abdominal discomfort, Clostridioides difficile colitis, oral candidiasis

Frequency not reported: Gastrointestinal hemorrhage, melena, hematochezia, C difficile-associated diarrhea^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Vulvovaginal mycotic infection, urinary tract infection, vulvovaginal pruritus

Hematologic

Uncommon (0.1% to 1%): Anemia, thrombocytosis, eosinophilia, leukopenia, neutropenia, increased platelet count

Frequency not reported: Hemorrhagic anemia, thrombocytopenia, increased INR, spontaneous hematoma

Hepatic

Uncommon (0.1% to 1%): Increased ALT, increased AST, abnormal liver function test, increased transaminases, increased hepatic enzyme, increased GGT

Frequency not reported: Hepatotoxicity, increased hepatic transaminases^[Ref]

Among patients with normal baseline ALT levels treated with this drug, 17 (0.8%) had post-baseline ALT elevations greater than 3 times the upper limit of normal (3 x ULN), including 5 patients with post-baseline ALT values greater than 10 x ULN; among patients with normal baseline ALT levels treated with comparators, 2 (0.2%) had post-baseline ALT elevations greater than 3 x ULN, but not greater than 10 x ULN. Of the 17 patients treated with this drug, 15 had underlying conditions that could affect liver enzymes (including chronic viral hepatitis, history of alcohol abuse, metabolic syndrome). In 1 trial, 1 patient treated with this drug had post-baseline ALT elevations greater than 20 x ULN. ALT elevations were reversible in all patients with follow-up assessments.^[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylactoid reaction

Frequency not reported: Serious hypersensitivity (anaphylactic)^[Ref]

Metabolic

Uncommon (0.1% to 1%): Decreased appetite, increased blood uric acid

Frequency not reported: Hypoglycemia^[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Dizziness, dysgeusia^[Ref]

Other

Uncommon (0.1% to 1%): Infusion-related reactions, fungal infection, increased blood lactate dehydrogenase, increased blood alkaline phosphatase, increased body temperature

Frequency not reported: Pyrexia

Postmarketing reports: Back pain (as an infusion-related reaction)

Psychiatric

Uncommon (0.1% to 1%): Insomnia

Respiratory

Uncommon (0.1% to 1%): Cough

Rare (0.01% to 0.1%): Bronchospasm^[Ref]