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Teflaro

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Teflaro

Teflaro

SIDE EFFECTS

The following serious events are described in greater detail in the WARNINGS AND PRECAUTIONS section

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. TEFLARO® (ceftaroline fosamil) injection for intravenous (IV) use Page 8 of 23

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)
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%
a Comparators 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.

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 difficile colitis

Metabolism and nutrition disorders - Hyperglycemia, Hyperkalemia

Nervous system disorders - Dizziness, Convulsion

Renal and urinary disorders - Renal failure

Skin and subcutaneous tissue disorders - Urticaria

Read the Teflaro (ceftaroline fosamil injection for intravenous (iv) use) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No clinical drug-drug interaction studies have been conducted with Teflaro. There is minimal potential for drug-drug interactions between Teflaro and CYP450 substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; and drugs that may alter renal blood flow [see CLINICAL PHARMACOLOGY].

Read the Teflaro Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 6/17/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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