批准日期：2018年10月4日 公司：Paratek Pharmaceuticals
感染 装载剂量 维持剂量
CABP 第1天：200毫克 静脉注射100毫克
ABSSSI 第1天：200毫克 静脉注射100毫克
ABSSSI 第1天和第2天： 每日口服300毫克
用于注射：100 mg omadacycline（相当于131 mgomadacycline tosylate）作为冻干粉末，在单剂量小瓶中重新配制并在静脉输注前进一步稀释
片剂：150 mg omadacycline（相当于196 mg omadacyclinetosylate）
注射用NUZYRA作为无菌冻干粉末在单剂量无色玻璃小瓶中提供，每个小瓶含有100mg NUZYRA（相当于131mg omadacycline甲苯磺酸盐）。
注射用NUZYRA和NUZYRA片剂应储存在20°C至25°C（68°F至77°F）;允许偏移15°C至30°C（59°F至86°F）[见USP Controlled 室温] [见剂量和管理]。 不要冻结。
FDA Approval of NUZYRA™ (Omadacycline)
NUZYRA™ (Omadacycline)First and only once-daily IV and oral antibiotic approved to treat both CABP and ABSSSI patients in nearly 20 Years
U.S. Food and Drug Administration (FDA) has approved NUZYRA™ (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). NUZYRA, a modernized tetracycline, is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug resistant strains.
“In the face of ever-increasing antibiotic resistance, the FDA approved NUZYRA with a label having full approval for both CABP and ABSSSI. We are excited to bring to physicians an effective, well-tolerated monotherapy option for patients,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “NUZYRA offers clinicians the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation. This potentially helps reduce hospitalizations and the costs associated with hospital stays.”
The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause 2 million illnesses and approximately 23,000 deaths each year in the United States. The main bacteria causing CABP, Streptococcus pneumoniae, is responsible for 1.2 million infections and 7,000 deaths, whereas ABSSSI is responsible for more than 750,000 hospitalizations. The increase of antibiotic resistance continues to drive the need for new, effective therapies.
“Treating pneumonia and skin infections has become increasingly complex as existing antibiotic therapies sometimes have reduced efficacy as resistance continues to grow. This reality makes it increasingly challenging to provide safe and effective treatments to patients,” said Keith Kaye, M.D., MPH, Director of Clinical Research, Division of Infectious Diseases, University of Michigan. “There continues to be a need for novel antibiotics with both IV and oral formulations, such as NUZYRA, to help physicians stay ahead of the evolving resistance landscape.”
NUZYRA (omadacycline) is a novel antibiotic with both once-daily intravenous (IV) and oral formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.
Indications and Usage
NUZYRA™ is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Important Safety Information
NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.
Warnings and Precautions
Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.
The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.
The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.
Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.
Prescribing NUZYRA 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.
The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.
Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.
Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.
Use in Specific Populations
Lactation: Breastfeeding is not recommended during treatment with NUZYRA.