- June 26, 2015
- Taiho Pharmaceutical Co., Ltd.
ZOSYN® Receives Approval for the Additional Indication of Febrile Neutropenia
Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) announced today that it had received approval for the additional indication of febrile neutropenia for ZOSYN 2.25 and ZOSYN 4.5, and ZOSYN 4.5 for I.V. infusion bag in Japan. ZOSYN is an injectable antibiotic combined with β-lactamase inhibitor (generic name: tazobactam and piperacillin).
Japan's Ministry of Health, Labour and Welfare's (MHLW) Study Group on Unapproved and Off-label Drugs of High Medical Need*1 received requests from a related medical society to develop this drug for the indication of febrile neutropenia, and the Study Group assessed that there was a strong medical need for this indication. As a result, in December 2010, the MHLW requested that Taiho develop ZOSYN for this indication. Phase III clinical studies were then conducted for this indication, and Taiho submitted an application to the MHLW for approval of this indication on July 2, 2014.
Its approval for this indication is based on the results of the above-mentioned clinical studies that assessed the drug’s defervescence and clinical efficacies, along with its safety when used on both adult and pediatric febrile neutropenic patients, as well as its pharmacokinetic profiles when used on children in the clinical studies. The results of these studies verified that when used on Japanese febrile neutropenic patients, ZOSYN is as effective and safe as drugs that have previously received approval for this indication in Japan.
Taiho remains committed to making further contributions to patients and medical practitioners engaged in the treatment of infectious diseases.
About ZOSYN
ZOSYN is an injectable antibacterial combination product consisting of the β-lactamase inhibitor tazobactam that Taiho discovered and the semisynthetic antibiotic piperacillin that Toyama Chemical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masuji Sugata) discovered in a ratio of 1:8 in potency for intravenous administration. Taiho holds the marketing authorization for ZOSYN in Japan, and Taisho Toyama Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Kenichi Fujita) is marketing the product.
In July 2008, ZOSYN was approved in Japan for the treatment of septicemia, pneumonia, pyelonephritis, and complicated cystitis in adults and children. In September 2012, it received approval for the indications of peritonitis, intra-abdominal abscess, cholecystitis, and cholangitis. ZOSYN is approved in 112 countries.*2 ZOSYN is recommended in the guidelines issued by the medical societies in the countries including the US and Europe for treatment of various infectious diseases, and is well recognized as a standard therapeutic agent for bacterial infections around the world.
About febrile neutropenia
Patients suffering from solid tumor or hematopoietic diseases such as acute leukemia are treated with a variety of chemotherapies and radiation therapies. Febrile neutropenia is a febrile disease that occurs when neutropenia (lower than normal neutrophils counts) accompanies bone marrow suppression caused by these treatments. It advances suddenly and becomes life threatening but is known to improve upon administration of broad-spectrum antibiotics.
*1: The Study Group was established for the purpose of assisting pharmaceutical companies in their efforts to develop drugs or indications that are not approved in Japan but are approved for use in the US and Europe. The Study Group evaluates medical needs for the drugs and indications, and assesses the suitability of the public knowledge-based application and the additional trials required for the approval application.
*2: As of August 2014
Product specifications
Newly approved indication is underlined.
| Brand name | ZOSYN® 2.25 for Intravenous Injection; ZOSYN® 4.5 for Intravenous Injection, ZOSYN® 4.5 for I.V. Infusion Bags |
|---|---|
| Generic name | Tazobactam piperacillin |
| Indication | 1. Septicemia, pneumonia, pyelonephritis, complicated cystitis, peritonitis, intra-abdominal abscess, cholecystitis, and cholangitis Indicated bacteria: Staphylococcus spp., Streptococcus spp., Streptococccus pneumoniae, Enterococcus spp., Moraxella (Branhamella) catarrhalis, Escherichia coli, Citrobacter spp., Klebsiella spp., Enterobacter spp., Serratia spp., Proteus spp., Providencia spp., Haemophilus influenzae, Pseudomonas aeruginosa, Acinetobacter spp., Peptostreptococcus spp., Clostridium spp. (except C. difficile), Bacteroides spp., Prevotella spp. 2. Febrile neutropenia |
| Dosage and administration | Dosage and Administration for ZOSYN 2.25 for Intravenous Injection; ZOSYN 4.5 for Intravenous Injection ・For septicemia and pneumonia, peritonitis, intra-abdominal abscess, cholecystitis, and cholangitis: The usual adult dosage of ZOSYN for intravenous infusion is a 4.5 g single dose, three times daily. In the case of pneumonia, the dosage may be increased to four times daily according to the symptoms and clinical condition. If necessary, the drug may be injected slowly as an intravenous bolus infusion. The usual pediatric dosage for intravenous infusion is a 112.5 mg/kg single dose, three times daily. If necessary, ZOSYN may be injected slowly as an intravenous bolus infusion. The single-dose amount may be adequately decreased according to the symptoms and clinical condition. However, the upper limit of the dosage is equal to the one for adults: 4.5 g. ・For pyelonephritis and complicated cystitis: The usual adult dosage of ZOSYN for drip infusion is a 4.5 g single dose, twice daily. The dosage may be increased to three times daily according to the symptoms and clinical condition. If necessary, ZOSYN may be injected slowly as an intravenous bolus infusion. The usual pediatric dosage for intravenous infusion is a 112.5 mg/kg single dose, twice daily. If necessary, ZOSYN may be injected slowly as an intravenous bolus infusion. The dosage may be adequately decreased according to the symptoms and clinical condition. The dosage may also be increased to three times per day in accordance with the symptoms and the patient's condition. However, the upper limit of the dosage is equal to the one for adults: 4.5g. ・For febrile neutropenia The usual adult dosage of ZOSYN for drip infusion is a 4.5 g single dose, four times daily. If necessary, ZOSYN may be injected slowly as an intravenous bolus infusion. The usual pediatric dosage for intravenous infusion is a 90 mg/kg single dose, four times daily. If necessary, ZOSYN may be injected slowly as an intravenous bolus infusion. However, the upper limit of the dosage is equal to the one for adults: 4.5 g. Dosage and administration for ZOSYN 4.5 for I.V. Infusion Bags ・For septicemia and pneumonia, peritonitis, intra-abdominal abscess, cholecystitis, and cholangitis: The usual adult dosage of ZOSYN for intravenous infusion is a 4.5 g single dose, three times daily. In the case of pneumonia, the dosage may be increased to four times daily according to the symptoms and clinical condition. The usual pediatric dosage for intravenous infusion is a 112.5 mg/kg single dose, three times daily. The dosage may be decreased according to the symptoms and clinical condition. ・For pyelonephritis and complicated cystitis: The usual adult dosage of ZOSYN for drip infusion is a 4.5 g single dose, twice daily. The dosage may be increased to three times daily according to the symptoms and clinical condition. The usual pediatric dosage for intravenous infusion is a 112.5 mg/kg single dose, twice daily. The dosage may be decreased according to the symptoms and clinical condition. It may also be increased to three times daily according to the symptoms and clinical condition. However, the upper limit of the dosage is equal to the one for adults: 4.5 g. ・For febrile neutropenia The usual adult dosage of ZOSYN for drip infusion is a 4.5 g single dose, four times daily. The usual pediatric dosage for intravenous infusion is a 90 mg/kg single dose, four times daily. However, the upper limit of the dosage is equal to the one for adults: 4.5 g. |
Information in this news release was current as of the original release date.
Taiho Pharmaceutical's news releases are intended to provide information to the media. It may contain information about ethical drugs or products under development, however information contained in the news releases are not intended to constitute promotion, advertisement, or medical advice.