美国FDA于2010年10月29日批准新型注射用头孢菌素类抗菌药ceftaroline fosamil（Teflaro）用于治疗成人社区获得性细菌性肺炎（CABP）和急性细菌性皮肤及皮肤组织感染（ABSSSI），包括甲氧西林耐药金黄色葡萄球菌（MRSA）感染。
本品由日本武田制药（Takeda）原研，在美国由Forest Laboratories公司上市销售。
作为头孢菌素类药物，本品通过干扰细菌细胞壁合成发挥抗菌作用。
4项在18岁及以上成人患者中进行的Ⅲ期临床研究对本品的安全性和疗效进行了评价，其中2项研究在CABP患者中进行，另2项在ABSSSI患者中进行。CABP研究使用的对照药品为头孢曲松（ceftriaxone，Rocephin）；ABSSSI研究使用的对照药品为万古霉素（vancomycin，Vancocin）+氨曲南（aztreonam，Azactam）。
在CABP研究中，共有1231例患者接受本品或头孢曲松治疗。研究的主要分析终点为治疗4天后基于肺炎体征和症状改善情况的临床应答。研究结果证明，本品与头孢曲松的疗效相当。
在ABSSSI研究中，共有1396例患者接受本品或万古霉素+氨曲南治疗。研究的主要分析终点为治疗3天后的临床应答情况，包括阻止感染蔓延的情况和退热情况等。研究结果显示，本品疗效与对照药品相当。
研究中，本品最常见的不良反应为腹泻、恶心和皮疹。

TEFLARO for injection is supplied as a sterile powder, in single-use, clear glass vials for reconstitution1

—TEFLARO is indicated for the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.
—TEFLARO is also indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.
—To reduce the development of drug-resistant bacteria and maintain the effectiveness of TEFLARO and other antibacterial drugs, TEFLARO should be used to treat only ABSSSI or CABP that are proven or strongly suspected to be caused by susceptible bacteria. Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
IMPORTANT SAFETY INFORMATION
Contraindications
—TEFLARO is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis and anaphylactoid reactions have been reported with ceftaroline.
Warnings and Precautions
Hypersensitivity Reactions
—Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported with beta-lactam antibacterials. Before therapy with TEFLARO is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. If this product is to be given to a penicillin- or other beta-lactam-allergic patient, caution should be exercised because cross sensitivity among beta-lactam antibacterial agents has been clearly established.
—If an allergic reaction to TEFLARO occurs, the drug should be discontinued. Serious acute hypersensitivity (anaphylactic) reactions require emergency treatment with epinephrine and other emergency measures that may include airway management, oxygen, intravenous fluids, antihistamines, corticosteroids, and vasopressors as clinically indicated.
Clostridium difficile-associated Diarrhea
—Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including TEFLARO, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible.
Direct Coombs' Test Seroconversion
—Seroconversion from a negative to a positive direct Coombs’ test result occurred in 120/1114 (10.8%) of patients receiving TEFLARO and 49/1116 (4.4%) of patients receiving comparator drugs in the four pooled Phase 3 trials. No adverse reactions representing hemolytic anemia were reported in any treatment group. If anemia develops during or after treatment with TEFLARO, drug-induced hemolytic anemia should be considered. If drug-induced hemolytic anemia is suspected, discontinuation of TEFLARO should be considered and supportive care should be administered to the patient if clinically indicated.
Development of Drug-Resistant Bacteria
—Prescribing TEFLARO in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Adverse Reactions
—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. 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 the comparator group.
—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.
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.
Use in Specific Populations
—TEFLARO has not been studied in pregnant women. Therefore, TEFLARO should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
—It is not known whether ceftaroline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TEFLARO is administered to a nursing woman.
—Safety and effectiveness in pediatric patients have not been established.
—Because elderly patients, those ≥65 years of age, are more likely to have decreased renal function and ceftaroline is excreted primarily by the kidney, care should be taken in dose selection in this age group and it may be useful to monitor renal function. Dosage adjustment for elderly patients should therefore be based on renal function.
—Dosage adjustment is required in patients with moderate (CrCl >30 to ≤50 mL/min) or severe (CrCl ≥15 to ≤30 mL/min) renal impairment and in patients with end-stage renal disease (CrCl <15 mL/min).
—The pharmacokinetics of ceftaroline in patients with hepatic impairment have not been established.
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原产地英文商品名:
TEFLARO 400mg/20ml/vial 10vials/box
原产地英文药品名:
CEFTAROLINE FOSAMIL ACETATE
中文参考商品译名:
TEFLARO 400毫克/20毫升/瓶 10瓶/盒
中文参考药品译名:
醋酸头孢洛林酯
生产厂家中文参考译名:
CEREXA
生产厂家英文名:
CEREXA
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原产地英文商品名:
TEFLARO 600mg/20ml/vial 10vials/box
原产地英文药品名:
CEFTAROLINE FOSAMIL ACETATE
中文参考商品译名:
TEFLARO 600毫克/20毫升/瓶 10瓶/盒
中文参考药品译名:
醋酸头孢洛林酯
生产厂家中文参考译名:
CEREXA
生产厂家英文名:
CEREXA
------------------------------------------------------------------
原产地英文商品名:
TEFLARO 600mg/20ml/vial
原产地英文药品名:
CEFTAROLINE FOSAMIL ACETATE
中文参考商品译名:
TEFLARO 600毫克/20毫升/瓶
中文参考药品译名:
醋酸头孢洛林酯
生产厂家中文参考译名:
CEREXA
生产厂家英文名:
CEREXA
------------------------------------------------------------------
原产地英文商品名:
TEFLARO 400mg/20ml/vial
原产地英文药品名:
CEFTAROLINE FOSAMIL ACETATE
中文参考商品译名:
TEFLARO 400毫克/20毫升/瓶
中文参考药品译名:
醋酸头孢洛林酯
生产厂家中文参考译名:
CEREXA
生产厂家英文名:
CEREX