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Teflaro (Ceftaroline Fosamil) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following serious events are described in greater detail in the Warnings and Precautions section

  • Hypersensitivity reactions[see Warnings and Precautions ]
  • Clostridium difficile-associated diarrhea[see Warnings and Precautions]
  • Direct Coombs' test seroconversion[see Warnings and Precautions]

Adverse Reactions from Clinical Trials

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.

Teflaro was evaluated in four controlled comparative Phase 3 clinical trials (two in ABSSSI and two in CABP) which included 1300 adult patients treated with Teflaro (600 mg administered by IV over 1 hour every 12h) and 1297 patients treated with comparator (vancomycin plus aztreonam or ceftriaxone) for a treatment period up to 21 days. The median age of patients treated with Teflaro was 54 years, ranging between 18 and 99 years old. Patients treated with Teflaro were predominantly male (63%) and Caucasian (82%).

Serious Adverse Events and Adverse Events Leading to Discontinuation

In the four pooled Phase 3 clinical trials, serious adverse events occurred in 98/1300 (7.5%) of patients receiving Teflaro and 100/1297 (7.7%) of patients receiving comparator drugs. The most common SAEs in both the Teflaro and comparator treatment groups were in the respiratory and infection system organ classes (SOC). Treatment discontinuation due to adverse events occurred in 35/1300 (2.7%) of patients receiving Teflaro and 48/1297 (3.7%) of patients receiving comparator drugs with the most common adverse events leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the Teflaro group and 0.5% in comparator group.

Most Common Adverse Reactions

No adverse reactions occurred in greater than 5% of patients receiving Teflaro. The most common adverse reactions occurring in > 2% of patients receiving Teflaro in the pooled phase 3 clinical trials were diarrhea, nausea, and rash.

Table 4 lists adverse reactions occurring in ≥ 2% of patients receiving Teflaro in the pooled Phase 3 clinical trials.

Table 4: Adverse Reactions Occurring in ≥ 2% of Patients Receiving Teflaro in the Pooled Phase 3 Clinical Trials
System Organ Class/
Preferred Term
Pooled Phase 3 Clinical Trials
(four trials, two in ABSSSI and two in CABP)
Teflaro
(N=1300)
Pooled Comparatorsa
(N=1297)

aComparators included vancomycin 1 gram IV every 12h plus aztreonam 1 gram IV every 12h in the Phase 3 ABSSSI trials, and ceftriaxone 1 gram IV every 24h in the Phase 3 CABP trials.

Gastrointestinal disorders
Diarrhea 5 % 3 %
Nausea 4 % 4 %
Constipation 2 % 2 %
Vomiting 2 % 2 %
Investigations
Increased transaminases 2% 3 %
Metabolism and nutrition disorders
Hypokalemia 2 % 3 %
Skin and subcutaneous tissue disorders
Rash 3% 2%
Vascular disorders
Phlebitis 2% 1%

Other Adverse Reactions Observed During Clinical Trials of Teflaro

Following is a list of additional adverse reactions reported by the 1740 patients who received Teflaro in any clinical trial with incidences less than 2%. Events are categorized by System Organ Class.

Blood and lymphatic system disorders- Anemia, Eosinophilia, Neutropenia, Thrombocytopenia

Cardiac disorders- Bradycardia, Palpitations

Gastrointestinal disorders- Abdominal pain

General disorders and administration site conditions- Pyrexia

Hepatobiliary disorders -Hepatitis

Immune system disorders- Hypersensitivity, Anaphylaxis

Infections and infestations-Clostridium difficilecolitis

Metabolism and nutrition disorders- Hyperglycemia, Hyperkalemia

Nervous system disorders- Dizziness, Convulsion

Renal and urinary disorders- Renal failure

Skin and subcutaneous tissue disorders- Urticaria



REPORTS OF SUSPECTED TEFLARO SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Teflaro. The information is not vetted and should not be considered as verified clinical evidence.

Possible Teflaro side effects / adverse reactions in 22 year old male

Reported by a physician from United States on 2011-11-25

Patient: 22 year old male weighing 93.4 kg (205.6 pounds)

Reactions: Blood Iron Decreased, Cellulitis, Anaemia, Condition Aggravated, Culture Wound Positive, Purulent Discharge, Staphylococcus Test Positive

Suspect drug(s):
Teflaro

Other drugs received by patient: Tylenol (Aceaminophen) (500 Milligram, Tablets) (Acetaminophen); Nicotine Patch (Nicotine) (21 Milligram, Poultice OR Patch) (Nicotine); Lortab (Acetaminophen and Hydrocodone) (7.5 Milligram, Tablets) (Aceta



Possible Teflaro side effects / adverse reactions in 36 year old male

Reported by a pharmacist from United States on 2011-12-14

Patient: 36 year old male

Reactions: Leukopenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Teflaro

Other drugs received by patient: Septra (Bactrim)(bactrim); Fluconazole



Possible Teflaro side effects / adverse reactions in 55 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-03

Patient: 55 year old female weighing 105.4 kg (231.9 pounds)

Reactions: Dyspnoea, Oedema Peripheral, Neutropenia

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Clindamycin
    Dosage: clindamycin 900mg every 12 hrs intravenous
    Indication: Cellulitis
    Start date: 2011-12-20
    End date: 2012-01-05

Teflaro
    Dosage: ceftaroline 600mg every 12 hrs intravenous
    Indication: Cellulitis
    Start date: 2011-12-20
    End date: 2012-01-05



See index of all Teflaro side effect reports >>

Drug label data at the top of this Page last updated: 2013-07-31

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