Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are also discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infusion Related Reactions [see Warnings and Precautions ( 5.2 )] Hepatic Effects [see Warnings and Precautions ( 5.3 )] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring in >4% of adult patients treated with dalbavancin for injection were nausea, headache, and diarrhea.
The most common adverse reaction that occurred in >1% of pediatric patients was pyrexia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of dalbavancin for injection cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.
Clinical Trials Experience in Adult Patients Adverse reactions were evaluated for 2,473 patients treated with dalbavancin for injection: 1,778 patients were treated with dalbavancin for injection in seven Phase 2/3 trials comparing dalbavancin for injection to comparator antibacterial drugs and 695 patients were treated with dalbavancin for injection in one Phase 3 trial comparing dalbavancin for injection single-dose and another dalbavancin dosing regimen.
The median age of patients treated with dalbavancin for injection was 48 years, ranging between 16 and 93 years.
Patients treated with dalbavancin for injection were predominantly male (59.5%) and White (81.2%).
Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation Serious adverse reactions occurred in 121/2,473 (4.9%) of patients treated with any regimen of dalbavancin for injection.
In the Phase 2/3 trials comparing dalbavancin for injection to comparator, serious adverse reactions occurred in 109/1,778 (6.1%) of patients in the dalbavancin for injection group and 80/1,224 (6.5%) of patients in the comparator group.
In a Phase 3 trial comparing dalbavancin for injection single-dose and another dalbavancin dosing regimen, serious adverse reactions occurred in 7/349 (2.0%) of patients in the dalbavancin for injection single dose group and 5/346 (1.4%) of patients in another dalbavancin dosing regimen group.
5 WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with dalbavancin for injection.
If an allergic reaction occurs, discontinue treatment with dalbavancin for injection and institute appropriate therapy for the allergic reaction.
Carefully monitor patients with known hypersensitivity to glycopeptides.
( 5.1 ) Rapid intravenous infusion of dalbavancin for injection can cause flushing of the upper body, urticaria, pruritus, rash, and/or back pain.
Stopping or slowing the infusion may result in cessation of these reactions.
Like all medications, Dalbavancin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: