Baxdela
- Generic Name: delafloxacin injection, tablets
- Brand Name: Baxdela
- Drug Class: Fluoroquinolones
Baxdela (Delafloxacin Injection, Tablets) side effects drug center
Baxdela Side Effects Center
What Is Baxdela?
Baxdela (delafloxacin) is a fluoroquinolone antibacterial indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
What Are Side Effects of Baxdela?
Common side effects of Baxdela include:
- nausea,
- diarrhea,
- headache,
- transaminase elevations, and
- vomiting
Dosage for Baxdela
Administer Baxdela for injection at a dose of 300 mg by intravenous infusion over 60 minutes, every 12 hours, or a 450-mg Baxdela tablet orally every 12 hours for 5 to 14 days total duration.
What Drugs, Substances, or Supplements Interact with Baxdela?
Baxdela may interact with
- antacids containing aluminum or magnesium,
- metal cations such as iron,
- sucralfate, or
- multivitamins containing iron or zinc
Tell your doctor all medications and supplements you use.
Baxdela During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Baxdela; it is unknown how it may affect a fetus. It is unknown if Baxdela passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Baxdela (delafloxacin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Baxdela Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives, or the first sign of a skin rash; fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.
Delafloxacin can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).
Stop using this medicine and call your doctor at once if you have:
- low blood sugar--headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;
- nerve symptoms in your hands, arms, legs, or feet--numbness, weakness, tingling, burning pain;
- serious mood or behavior changes--nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or
- signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).
In rare cases, delafloxacin may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.
Also, stop using delafloxacin and call your doctor at once if you have:
- severe stomach pain, diarrhea that is watery or bloody;
- a seizure;
- muscle weakness or trouble breathing;
- a light-headed feeling, like you might pass out;
- the first sign of any skin rash, no matter how mild; or
- increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.
Common side effects may include:
- nausea, vomiting, diarrhea;
- headache; or
- abnormal liver function tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Baxdela (Delafloxacin Injection, Tablets)
Baxdela Professional Information
SIDE EFFECTS
The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling:
- Disabling and Potentially Irreversible Serious Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Tendinitis and Tendon Rupture [see WARNINGS AND PRECAUTIONS]
- Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
- Central Nervous System Effects [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
- Blood Glucose Disturbances [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of BAXDELA cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.
Overview Of The Safety Evaluation Of BAXDELA
BAXDELA was evaluated in three Phase 3 multicenter, multinational, randomized, double-blind clinical trials. These trials included two trials in ABSSSI patients (Trial 1 and Trial 2) and one trial in CABP (Trial 3). A total of 1170 patients were treated with BAXDELA across all Phase 3 trials (741 patients in the two ABSSSI trials and 429 patients in the CABP trial).
Acute Bacterial Skin And Skin Structure Infections (ABSSSI)
BAXDELA was evaluated in two multicenter, multinational, randomized, double-blind, double-dummy, noninferiority trials (Trial 1 and Trial 2) in adults with ABSSSI. In Trial 1 patients received BAXDELA 300 mg by intravenous infusion every 12 hours and in Trial 2 the patients received BAXDELA 300 mg by intravenous infusion every 12 hours for 6 doses then were switched to BAXDELA 450 mg tablets every 12 hours. The total treatment duration was 5 to 14 days. Adverse reactions were evaluated for 741 patients treated with BAXDELA and 751 patients treated with comparator antibacterial drugs. The median age of patients treated with BAXDELA was 49 years, ranging between 18 and 94 years old; 15% were age 65 years and older. Patients treated with BAXDELA were predominantly male (62%) and Caucasian (86%). The BAXDELA treated population included 44% obese patients (BMI ≥ 30 kg/m²), 11% with diabetes, and 16% with baseline renal impairment (calculated creatinine clearance less than 90 mL/min).
Serious Adverse Reactions And Adverse Reactions Leading To Discontinuation
Serious adverse reactions occurred in 3/741 (0.4%) of patients treated with BAXDELA and in 6/751 (0.8%) of patients treated with the comparator.
BAXDELA was discontinued due to an adverse reaction in 7/741 (0.9%) patients and the comparator was discontinued due to an adverse reaction in 21/751 (2.8%) patients. The most commonly reported adverse reactions leading to study discontinuation in the BAXDELA arm included urticaria (2/741; 0.3%) and hypersensitivity (2/741; 0.3%); whereas, the most commonly reported adverse reactions leading to study discontinuation in the comparator arm included urticaria (5/751; 0.7%), rash (4/751; 0.5%), hypersensitivity and infusion site extravasation (2/751; 0.3%).
Most Common Adverse Reactions
The most common adverse reactions in patients treated with BAXDELA were nausea (8%), diarrhea (8%), headache (3%), transaminase elevations (3%), and vomiting (2%). Table 4 lists selected adverse reactions occurring in ≥ 2% of patients receiving BAXDELA in the pooled adult Phase 3 clinical trials.
Table 4 : Selected Adverse Reactions Occurring in ≥ 2% of Patients Receiving BAXDELA in the Pooled Adult Phase 3 ABSSSI Clinical Trials
| Adverse Reactions | BAXDELA N = 741 (%) | Vancomycin /aztreonam N = 751 (%) |
| Nausea | 8% | 6% |
| Diarrhea | 8% | 3% |
| Headache# | 3% | 6% |
| Transaminase Elevations* | 3% | 4% |
| Vomiting | 2% | 2% |
| # The data are not an adequate basis for comparison of rates between the study drug and the active control. *Pooled reports include hypertransaminasaemia, increased transaminases, and increased ALT and AST. | ||
Community-Acquired Bacterial Pneumonia
BAXDELA was evaluated in one multicenter, multinational, randomized, double-blind trial in adults with CABP (Trial 3). Patients received BAXDELA 300 mg over 60 minutes every 12 hours for a minimum of 6 doses with an option to switch to oral BAXDELA tablet 450 mg every 12 hours for the remaining doses (total of 10 to 20 doses of intravenous infusion and oral combined). Adverse reactions were evaluated for 429 patients treated with BAXDELA and 427 patients treated with moxifloxacin. The median age of patients treated with BAXDELA was 63 years, ranging between 18 and 89 years; 47.1% were 65 years of age and older and 19.6% were 75 years of age and older. Patients treated with BAXDELA were predominantly male (58.3%) and white (92.3%). The BAXDELA-treated population included patients with obesity (BMI greater than or equal to 30) (24.0%), COPD/asthma (14.2%), cardiac disease (24.2%), diabetes (16.3%), and baseline renal impairment including 36.4% with moderate renal impairment (CrCl less than 30-59 mL/min), and 4.0% with severe renal impairment (CrCl less than 29 mL/min). Overall, approximately 12.4% of patients were in PORT Risk Class II, 60.1% were in PORT Risk Class III, 26.6% were in PORT Risk Class IV, and 0.9% were in PORT Risk Class V.
Serious Adverse Reactions And Adverse Reactions Leading To Discontinuation
Serious adverse reactions occurred in 2/429 (0.5%) of patients treated with BAXDELA and in 1/427 (0.2%) of patients treated with moxifloxacin. Discontinuation due to an adverse reaction occurred in 9/429 (2.1%) patients treated with BAXDELA and in 4/427 (0.9%) treated with moxifloxacin. The most commonly reported adverse reactions leading to study drug discontinuation in the BAXDELA arm were transaminase elevations (2/429; 0.5%). The most commonly reported adverse reactions leading to study drug discontinuation in the comparator arm were infusion site reactions (1/427; 0.2%).
Most Common Adverse Reactions
The most common adverse reactions in patients treated with BAXDELA were diarrhea (5%) and transaminase elevations (5%). Table 5 lists selected adverse reactions occurring in ≥ 2% of patients receiving BAXDELA in the adult Phase 3 CABP clinical trial.
Table 5 : Selected Adverse Reactions Occurring in ≥ 2% of Patients Receiving BAXDELA in the Adult Phase 3 CABP Clinical Trial
| Adverse Reactions | BAXDELA N = 429 | Moxifloxacin N = 427 |
| Diarrhea | 5% | 3% |
| Transaminase elevations* | 5% | 3% |
| * Includes hepatic enzyme increased, transaminases increased and alanine aminotransferase (ALT) increased. | ||
Adverse Reactions Occurring In Less Than 2% Of Patients Receiving BAXDELA In The ABSSSI (Trials 1 And 2) And CABP (Trial 3) Clinical Trials
The following selected adverse reactions were reported in BAXDELA-treated patients at a rate of less than 2% in the ABSSSI (Trials 1 and 2) and CABP (Trial 3) clinical trials:
Blood and Lymphatic System Disorders: agranulocytosis, anemia, leukopenia, neutropenia, pancytopenia
Cardiac Disorders: sinus tachycardia, palpitations, bradycardia, ventricular extrasystoles
Ear and Labyrinth Disorders: tinnitus, vertigo, vestibular disorder
Eye Disorders: vision blurred
General disorders and administration site conditions: infusion related reactions
Gastrointestinal Disorders: abdominal pain, dyspepsia
Immune System Disorders: hypersensitivity
Infections and Infestations: Clostridium difficile infection, fungal infection, oral candidiasis, vulvovaginal candidiasis
Laboratory Investigations: blood alkaline phosphatase increased, blood creatinine increased, blood creatine phosphokinase increased
Metabolism and Nutrition Disorders: hyperglycemia, hypoglycemia
Musculoskeletal and Connective Tissue Disorders: myalgia
Nervous System Disorders: dizziness, hypoesthesia, paraesthesia, dysgeusia, presyncope, syncope
Psychiatric Disorders: agitation, anxiety, confusional state, insomnia, abnormal dreams
Renal and Urinary: renal impairment, renal failure
Skin and Subcutaneous Tissue Disorders: pruritus, urticaria, dermatitis, rash
Vascular Disorders: flushing, hypotension, hypertension
Read the entire FDA prescribing information for Baxdela (Delafloxacin Injection, Tablets)
© Baxdela Patient Information is supplied by Cerner Multum, Inc. and Baxdela Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.