Baxdela

General

Delafloxacin meglumine is available in the following dosage form(s) and strength(s):

• For Injection: 300 mg of delafloxacin (equivalent to 433 mg delafloxacin meglumine) as a lyophilized powder in a single-dose vial for reconstitution and further dilution before intravenous infusion.1

• Oral Tablets: 450 mg delafloxacin (equivalent to 649 mg delafloxacin meglumine).1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

• Intravenous: Administer 300 mg of delafloxacin by intravenous infusion over 60 minutes every 12 hours for 5–14 days.1 Alternatively, administer 300 mg of delafloxacin by intravenous infusion over 60 minutes every 12 hours and then, at clinician's discretion, switch to 450 mg of oral delafloxacin as tablets every 12 hours for total duration of 5–14 days.1

• Oral: Administer 450 mg of delafloxacin as tablets every 12 hours for 5–14 days.1

• Dosage for patients with renal impairment is based on the estimated glomerular filtration rate (eGFR).1

Estimate of GFR based on a Modification of Diet in Renal Disease (MDRD) equation.

For a total treatment duration of 5 to 14 days.

All intravenous doses of delafloxacin meglumine are administered over 60 minutes.

Not recommended due to insufficient information to provide dosing recommendations.

Advise the patient to read the FDA-approved patient labeling (Medication Guide).1

Serious Adverse Reactions

Advise patients to stop taking delafloxacin meglumine if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug.1

Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of fluoroquinolones and may occur together in the same patient. Inform patients to stop taking delafloxacin meglumine immediately if they experience an adverse reaction and to call their healthcare provider.1

Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue delafloxacin meglumine treatment. Symptoms may be irreversible. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants.1

Inform patients that peripheral neuropathies have been associated with delafloxacin meglumine use; symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness develop, immediately discontinue delafloxacin meglumine and contact their physician.1

Inform patients that convulsions have been reported in patients receiving fluoroquinolones. Instruct patients to notify their physician before taking this drug if they have a history of convulsions. Inform patients that they should know how they react to delafloxacin meglumine before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Instruct patients to notify their physician if persistent headache with or without blurred vision occurs.1

Instruct patients to inform their physician of any history of myasthenia gravis. Instruct patients to notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties.1

Inform patients that delafloxacin meglumine can cause hypersensitivity reactions, even following a single dose, and to discontinue delafloxacin meglumine at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.1

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, instruct patients to contact their physician as soon as possible.1

Inform patients that antibacterial drugs, including delafloxacin meglumine tablets and injection should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When delafloxacin meglumine tablets and delafloxacin meglumine injection are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by delafloxacin meglumine tablets and delafloxacin meglumine injection or other antibacterial drugs in the future.1

Administration with Food and Concomitant Medications

Inform patients that delafloxacin meglumine tablets may be taken with or without food and without any dietary restrictions.1

Inform patients that delafloxacin meglumine tablets should be taken at least 2 hours before or 6 hours after antacids containing magnesium or aluminum, sucralfate, metal cations such as iron, multivitamin preparations containing zinc or iron, or didanosine buffered tablets for oral suspension or didanosine pediatric powder for oral solution.1

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use in children is not recommended. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of delafloxacin in the elderly. However, elderly patients are more likely to have age-related kidney problems, or develop severe tendon disorders (including tendon rupture), especially in those who also take steroid medicines, which may require caution in patients receiving delafloxacin.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum
• Calcium
• Iron
• Magnesium
• Sucralfate
• Zinc

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain disease (eg, hardening of the arteries) or
• Kidney disease, severe or
• Organ transplant (eg, heart, kidney, or lung), history of or
• Tendon disorder (eg, rheumatoid arthritis), history of—Use with caution. May cause side effects to become worse.

• Diarrhea or
• Peripheral neuropathy (nerve problem), history of or
• Seizures (epilepsy), history of—Use with caution. May make these conditions worse.

• Myasthenia gravis (severe muscle weakness), or history of—Should not be used in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Diarrhea

• Anxiety
• bloody urine
• bluish color of the skin
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• changes in skin color
• chest pain or discomfort
• chills
• cold sweats
• coma
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• cool, pale skin
• cough or hoarseness
• decreased frequency or amount of urine
• depression
• difficulty in moving
• dizziness or lightheadedness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast, slow, irregular, pounding, or racing heartbeat or pulse
• feeling of constant movement of self or surroundings
• fever
• flushed, dry skin
• fruit-like breath odor
• headache
• hearing loss
• hives, itching, skin rash
• hoarseness
• increased blood pressure
• increased hunger
• increased thirst
• increased urination
• irritation
• joint pain, stiffness, or swelling
• loss of appetite
• loss of taste
• lower back or side pain
• muscle aches or cramps
• muscle pains or stiffness
• nausea
• nervousness
• painful or difficult urination
• pounding in the ears
• redness of the skin
• seizures
• sensation of spinning
• shakiness
• slurred speech
• stomach pain
• swelling of the eyelids, face, lips, hands, fingers, lower legs, or feet
• swollen joints
• tenderness, pain, swelling, warmth, skin discoloration, or prominent superficial veins over the affected area
• tightness in the chest
• troubled breathing or swallowing
• unexplained weight loss
• unusual tiredness or weakness
• vomiting
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abnormal dreams
• belching
• feeling of warmth
• heartburn
• indigestion
• pain or redness at the injection site
• redness of the face, neck, arms, and occasionally, the upper chest
• stomach discomfort, upset, or pain
• trouble sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Acute Bacterial Skin and Skin Structure Infections

Baxdela is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following:

Gram-positive organisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis.

Gram-negative organisms: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Baxdela and other antibacterial drugs, Baxdela should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. 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.

Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy and Central Nervous System Effects

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions could occur within hours to weeks after starting a fluoroquinolone. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions (5.2, 5.3 and 5.4)].

Discontinue Baxdela immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including Baxdela, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

Tendinitis and Tendon Rupture

Fluoroquinolones have been associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting a fluoroquinolone, or as long as several months after completion of fluoroquinolone therapy. Tendinitis and tendon rupture can occur bilaterally.

This risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over age 60 years of age, in patients taking corticosteroid drugs, and, in patients with kidney, heart, and lung transplant. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors.

Discontinue Baxdela immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking Baxdela, to avoid exercise and use of the affected area, and to promptly contact their healthcare provider about changing to a non-quinolone antimicrobial drug. Avoid Baxdela in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture.

Peripheral Neuropathy

Fluoroquinolones have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness have been reported in patients receiving fluoroquinolones, including Baxdela. Symptoms may occur soon after initiation of fluoroquinolones and may be irreversible in some patients [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Discontinue Baxdela immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation and/or motor strength in order to minimize the development of an irreversible condition. Avoid fluoroquinolones, including Baxdela in patients who have previously experienced peripheral neuropathy [see Adverse Reactions (6.1)].

Central Nervous System Effects

Fluoroquinolones have been associated with an increased risk of central nervous system (CNS) reactions, including: convulsions and increased intracranial pressure (including pseudotumor cerebri) and toxic psychosis. Fluoroquinolones, including Baxdela, may also cause CNS reactions of nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or acts. These adverse reactions may occur following the first dose. If these reactions occur in patients receiving Baxdela, discontinue Baxdela immediately and institute appropriate measures. As with all fluoroquinolones, use Baxdela when the benefits of treatment exceed the risks in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold.

Exacerbation of Myasthenia Gravis

Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Post-marketing serious adverse reactions, including death and requirement for ventilator support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid Baxdela in patients with known history of myasthenia gravis [see Patient Counseling Information (17)].

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Hypersensitivity reactions have been reported in patients receiving Baxdela. These reactions may occur after first or subsequent doses of Baxdela [see Adverse Reactions (6.1)]. Discontinue Baxdela at the first appearance of a skin rash or any other sign of hypersensitivity.

Clostridium difficile-Associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported in users of nearly all systemic antibacterial drugs, including Baxdela, with severity ranging from mild diarrhea to fatal colitis. Treatment with antibacterial agents can alter the normal flora of the colon, and may permit overgrowth of C. difficile.

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antibacterial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. 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, ongoing antibacterial use not directed against C. difficile should be discontinued, if possible. Appropriate measures such as fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated

Development of Drug-Resistant Bacteria

Prescribing Baxdela 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 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 (5.1)]
• Tendinitis and Tendon Rupture [see Warnings and Precautions (5.2)]
• Peripheral Neuropathy [see Warnings and Precautions (5.3)]
• Central Nervous System Effects [see Warnings and Precautions (5.4)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.6)]
• Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.7)]

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.

Baxdela was evaluated in two multicenter, multinational, randomized, double-blind, double-dummy, non-inferiority 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 3 lists selected adverse reactions occurring in ≥ 2 % of patients receiving Baxdela in the pooled adult Phase 3 clinical trials.

Adverse Reactions Occurring in Less Than 2% of Patients Receiving Baxdela in Phase 3 Clinical Trials

The following selected adverse reactions were reported in Baxdela-treated patients at a rate of less than 2% in these clinical trials.

Cardiac Disorders: sinus tachycardia, palpitations, bradycardia

Ear and Labyrinth Disorders: tinnitus, vertigo

Eye Disorders: vision blurred

General disorders and administration site conditions: infusion site extravasation, infusion site bruise, discomfort, edema, erythema, irritation, pain, phlebitis, swelling, or thrombosis

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: anxiety, insomnia, abnormal dreams

Renal and Urinary: renal impairment, renal failure

Skin and Subcutaneous Tissue Disorders: pruritus, urticaria, dermatitis, rash

Vascular Disorders: flushing, hypotension, hypertension, phlebitis

Advise the patient to read the FDA-approved patient labeling (Medication Guide)

Serious Adverse Reactions

Advise patients to stop taking Baxdela if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug.

Inform patients of the following serious adverse reactions that have been associated with Baxdela or other fluoroquinolone use:

• Disabling and Potentially Irreversible Serious Adverse Reactions that may occur together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of fluoroquinolones and may occur together in the same patient. Inform patients to stop taking Baxdela immediately if they experience an adverse reaction and to call their healthcare provider.
• Tendinitis and Tendon Rupture: Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Baxdela treatment. Symptoms may be irreversible. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
• Peripheral Neuropathy: Inform patients that peripheral neuropathies have been associated with Baxdela use, symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, immediately discontinue Baxdela and tell them to contact their physician.
• Central Nervous System Effects: (for example, convulsions, dizziness, lightheadedness, increased intracranial pressure): Inform patients that convulsions have been reported in patients receiving fluoroquinolones, Instruct patients to notify their physician before taking this drug if they have a history of convulsions. Inform patients that they should know how they react to Baxdela before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Instruct patients to notify their physician if persistent headache with or without blurred vision occurs.
• Exacerbation of Myasthenia Gravis: Instruct patients to inform their physician of any history of myasthenia gravis. Instruct patients to notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties.
• Hypersensitivity Reactions: Inform patients that Baxdela can cause hypersensitivity reactions, even following a single dose, and to discontinue Baxdela at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.
• Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, instruct patients to contact their physician as soon as possible.
• Antibacterial Resistance: Inform patients that antibacterial drugs including Baxdela Tablets and Injection should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When Baxdela Tablets and Baxdela Injection are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Baxdela Tablets and Baxdela Injection or other antibacterial drugs in the future.

Administration with Food and Concomitant Medications

• Inform patients that Baxdela Tablets may be taken with or without food and without any dietary restrictions [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)].
• Inform patients that Baxdela Tablets should be taken at least 2 hours before or 6 hours after antacids containing magnesium, or aluminum, with sucralfate, with metal cations such as iron, or with multivitamin preparations containing zinc or iron, or with didanosine buffered tablets for oral suspension or the pediatric powder for oral solution.

Distributed by:

Melinta Therapeutics, Inc.
300 Tri-State International
Lincolnshire, Illinois, USA

Trademarks depicted herein are the property of their respective owners.

©2017 Melinta Therapeutics, Inc. All rights reserved.

Baxdela™
(delafloxacin) for injection

300 mg per single-dose vial

Must be reconstituted and further diluted.
For intravenous infusion only.

Contains 10 Vials

Rx Only
Made in Italy
NDC 70842-102-03

Melinta
THERAPEUTICS
The
Antibiotics
Company

The manufacturer makes no recommendation regarding use during pregnancy. US FDA pregnancy category: Not assigned. Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of fetotoxicity but failed to reveal evidence of teratogenicity or fetolethality. After oral administration to rats during organogenesis, maternal toxicity and reduced fetal body weights were seen at the highest dose (1600 mg/kg/day) and delayed fetal ossification was observed at all doses; no malformations were observed up to the highest dose (about 7 times the estimated human plasma exposure [based on AUC]). At the highest IV dose (120 mg/kg/day; estimated about 5 times human plasma exposure [based on AUC]) in a pre-postnatal study, pregnant rats showed slightly lower body weights and slightly longer gestation length than controls; effects on pups included increased mortality during lactation, small stature, and lower body weights (learning, memory, sensory function, locomotor activity, developmental landmarks, and reproductive performance were not affected); the No Observed Adverse Effect Level (NOAEL) for maternal toxicity pup development was 60 mg/kg/day (about 580 mg/day IV for 60 kg patient [just below clinical IV dose]). There are no controlled data in human pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Before using delafloxacin injection,

• tell your doctor and pharmacist if you are allergic or have had a severe reaction to delafloxacin, any other quinolone or fluoroquinolone antibiotic such as ciprofloxacin (Cipro), gatifloxacin (Tequin; not available in the U.S.), gemifloxacin (Factive), levofloxacin (Levaquin), lomefloxacin (Maxaquin; not available in the U.S.), moxifloxacin (Avelox), nalidixic acid (NegGram), norfloxacin (Noroxin), ofloxacin (Floxin), and sparfloxacin (Zagam; not available in the U.S.), any other medications, or any of the ingredients in delafloxacin injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using delafloxacin injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

• Baxdela^®

Use in children is not recommended. Safety and efficacy have not been established.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum
• Calcium
• Iron
• Magnesium
• Sucralfate
• Zinc