Applies to oritavancin: intravenous powder for solution.

Serious side effects of Oritavancin

Along with its needed effects, oritavancin 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 or nurse immediately if any of the following side effects occur while taking oritavancin:

Less common

• Accumulation of pus
• changes in skin color
• dry, red, hot, or irritated skin
• fast, pounding, or irregular heartbeat or pulse
• fever
• pain, swelling, or tenderness in the skin
• swollen, red, tender area of infection

Less common

• Anxiety
• black, tarry stools
• blistering, peeling, or loosening of the skin
• blurred vision
• chest pain or tightness
• chills
• cold sweats
• confusion
• cool, pale skin
• cough
• difficulty in moving
• dizziness
• headache
• hives, itching skin, or rash
• increase in bone pain
• increased hunger
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lower back, side, or stomach pain
• muscle aches, cramps, pains, or stiffness
• nervousness
• nightmares
• noisy breathing
• painful or difficult urination
• pale skin
• red, irritated eyes
• redness or soreness of the skin
• seizures
• shakiness
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the eyelids, face, lips, hands, feet, ankles, or lower legs
• swollen glands
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness

Incidence not known

• Stomach cramps or tenderness
• watery and severe diarrhea, which may also be bloody

Other side effects of Oritavancin

Some side effects of oritavancin 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

• Hard lump, pain, redness, or pale skin at the site of injection
• nausea or vomiting

For Healthcare Professionals

Applies to oritavancin: intravenous powder for injection.

General

In pooled clinical trials, serious side effects were reported in 5.8% of patients treated with this drug (compared to 5.9% treated with vancomycin). Cellulitis was the serious side effect reported most often with both drugs.

This drug was discontinued due to side effects in 3.7% of patients, most often due to cellulitis and osteomyelitis.

The most commonly reported side effects included nausea, headache, vomiting, limb and subcutaneous abscesses, and diarrhea.^[Ref]

Dermatologic

Common (1% to 10%): Cellulitis, limb abscess, pruritus, rash, subcutaneous abscess, urticaria

Uncommon (0.1% to 1%): Erythema multiforme, leukocytoclastic vasculitis^[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea, nausea, vomiting

Frequency not reported: Clostridium difficile associated diarrhea^[Ref]

Hepatic

Common (1% to 10%): Abnormal liver function tests, increased ALT, increased AST

Uncommon (0.1% to 1%): Blood bilirubin increased

Frequency not reported: Increased total bilirubin^[Ref]

Local

Common (1% to 10%): Infusion site erythema, infusion site phlebitis, infusion site reactions^[Ref]

Infusion site reactions included extravasation, induration, infusion site erythema, infusion site phlebitis, peripheral edema, pruritus, and rash.^[Ref]

Other

Common (1% to 10%): Extravasation, induration

Frequency not reported: Infusion related reactions^[Ref]

Cardiovascular

Common (1% to 10%): Peripheral edema, tachycardia

Uncommon (0.1% to 1%): Flushing^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache^[Ref]

Hematologic

Common (1% to 10%): Anemia

Uncommon (0.1% to 1%): Eosinophilia, thrombocytopenia^[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia

Uncommon (0.1% to 1%): Osteomyelitis, tenosynovitis^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Angioedema, hypersensitivity/hypersensitivity reactions^[Ref]

Respiratory

Uncommon (0.1% to 1%): Bronchospasm, wheezing^[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperuricemia, hypoglycemia^[Ref]