LVANCE treated patients at a rate of less than 2% in these clinical trials:
Blood and lymphatic system disorders: anemia, hemorrhagic anemia, leucopenia, neutropenia, thrombocytopenia, petechiae, eosinophilia, thrombocytosis
Gastrointestinal disorders: gastrointestinal hemorrhage, melena, hematochezia, abdominal pain
General disorders and administration site conditions: infusion-related reactions
Hepatobiliary disorders: hepatotoxicity
Immune system disorders: anaphylactoid reaction
Infections and infestations: Clostridium difficile colitis, oral candidiasis, vulvovaginal mycotic infection
Investigations: hepatic transaminases increased, blood alkaline phosphatase increased, international normalized ratio increased
Metabolism and nutrition disorders: hypoglycemia
Nervous System disorders: dizziness
Respiratory, thoracic and mediastinal disorders: bronchospasm
Skin and Subcutaneous Tissue disorders: urticaria
Vascular disorders: flushing, phlebitis, wound hemorrhage, spontaneous hematoma
Alanine Aminotransferase (ALT) Elevations
Among patients with normal baseline ALT levels, more DALVANCE- than comparator-treated patients had post-baseline ALT elevations greater than 3 times the upper limit of normal (ULN), 12 (0.8%) vs. 2 (0.2%), respectively including three subjects with post-baseline ALT values greater than 10 times ULN. Eight of 12 patients treated with DALVANCE and one comparator patient had underlying conditions which could affect liver enzymes, including chronic viral hepatitis and a history of alcohol abuse. In addition, one DALVANCE-treated subject in a Phase 1 trial had post-baseline ALT elevations greater than 20 times ULN. ALT elevations were reversible in all subjects. No comparator-treated subject with normal baseline transaminases had post-baseline ALT elevation greater than 10 times ULN.
7 DRUG INTERACTIONS
7.1 Drug-Laboratory Test InteractionsDrug-laboratory test interactions have not been reported.
7.2 Drug-Drug InteractionsNo clinical drug-drug interaction studies have been conducted with DALVANCE. There is minimal potential for drug-drug interactions between DALVANCE and cytochrome P450 (CYP450) substrates, inhibitors, or inducers [see Clinical Pharmacology (12.3)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy: Category CThere have been no adequate and well-controlled studies with dalbavancin in pregnant women. DALVANCE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
No evidence of embryo or fetal toxicity was found in the rat or rabbit at a dose of 15 mg/kg/day (1.2 and 0.7 times the human dose on an exposure basis, respectively). Delayed fetal maturation was observed in the rat at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis).
In a rat prenatal and postnatal development study, increased embryo lethality and increased offspring deaths during the first week post-partum were observed at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis).
8.3 Nursing MothersDalbavancin is excreted in the milk of lactating rats. It is not known whether dalbavancin or its metabolite is excreted in human milk; therefore, caution should be exercised when DALVANCE is administered to a nursing woman.
8.4 Pediatric UseSafety and efficacy in pediatric patients have not been established.
8.5 Geriatric UseOf the 1778 patients |
