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.
ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in the Warnings and Precautions section Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Clostridioides difficile -Associated diarrhea [see Warnings and Precautions ( 5.2 )] Neurological Adverse Reactions [see Warnings and Precautions ( 5.3 )] Direct Coombs’ Test Seroconversion [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring in >2 % of adult patients and ≥3% of pediatric patients are diarrhea, nausea, and rash.
Additional adverse reactions that occurred in ≥3% of pediatric patients include vomiting and pyrexia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp.
at 1-800-706-5575 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 a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice.
Adult Patients Ceftaroline fosamil for injection was evaluated in four controlled comparative Phase 3 clinical trials (two in ABSSSI and two in CABP) which included 1,300 adult patients treated with ceftaroline fosamil for injection (600 mg administered by IV over 1 hour every 12h) and 1,297 patients treated with comparator (vancomycin plus aztreonam or ceftriaxone) for a treatment period up to 21 days.
The median age of patients treated with ceftaroline fosamil for injection was 54 years, ranging between 18 and 99 years old.
Patients treated with ceftaroline fosamil for injection were predominantly male (63%) and Caucasian (82%).
Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation In the four pooled adult Phase 3 clinical trials, serious adverse reactions (SARs) occurred in 98/1,300 (7.5%) of patients receiving ceftaroline fosamil for injection and 100/1,297 (7.7%) of patients receiving comparator drugs.
Treatment discontinuation due to adverse reactions occurred in 35/1,300 (2.7%) of patients receiving ceftaroline fosamil for injection and 48/1,297 (3.7%) of patients receiving comparator drugs with the most common adverse reactions leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the ceftaroline fosamil for injection group and 0.5% in comparator group.
WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs, including ceftaroline.
If a hypersensitivity reaction occurs, discontinue ceftaroline fosamil for injection.
( 5.1 ) Clostridiodes difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ceftaroline fosamil for injection.
Evaluate if diarrhea occurs.
( 5.2 ) Neurological adverse reactions have been reported in patients treated with cephalosporins, including ceftaroline.
Like all medications, Ceftaroline Fosamil 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: