Delafloxacin

Delafloxacin is a prescription medicine used for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CAMP) caused by susceptible bacteria.

• Delafloxacin is available under the following different brand names: Baxdela

Common side effects of Delafloxacin include:

• nausea
• diarrhea
• headache
• transaminase elevations
• vomiting

Serious side effects of Delafloxacin include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fast heartbeat
• headache
• hunger
• sweating
• irritability
• dizziness
• feeling anxious
• shaking
• numbness, weakness, tingling, burning pain, in the hands, arms, legs, or feet
• nervousness
• confusion
• agitation
• paranoia
• hallucinations
• memory problems
• trouble concentrating
• thoughts of self-harm
• sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of the joints
• severe and constant chest pain in the chest, stomach, or back
• severe stomach pain
• diarrhea that is watery or bloody
• seizure
• muscle weakness
• lightheadedness
• skin rash 
• severe headaches
• ringing in the ears
• vision problems
• pain behind the eyes

Rare side effects of Delafloxacin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to the FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 300 mg/vial (equivalent to 433 mg delafloxacin meglumine)

Tablet

• 450 mg (equivalent to 649 mg delafloxacin meglumine)

Skin and Skin Structure Infections

Adult dosage

• 300 mg IV every 12 hours for 5-14 days, or
• 300 mg IV every 12 hours, then switch to a 450 mg tablet orally every 12 hours for 5-14 days, or
• 450 mg orally every 12 hours for 5-14 days

Community-acquired Bacterial Pneumonia

Adult dosage

• 300 mg IV every 12 hours for 5-10 days, or
• 300 mg IV every 12 hours, then switch to a 450 mg tablet orally every 12 hours for 5-10 days, or
• 450 mg orally every 12 hours for 5-10 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Delafloxacin has severe interactions with no other drugs
• Delafloxacin has serious interactions with the following drugs:
  • fexinidazole
  • microbiota oral
  • selinexor
• Delafloxacin has moderate interactions with 28 other drugs
• Delafloxacin has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to delafloxacin or its components or other fluoroquinolones

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Delafloxacin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Delafloxacin?”

Cautions

• Prescribing an antibiotic in the absence of proven or strongly suspected bacterial infection is unlikely to provide benefit and increases the risk of developing drug-resistant bacteria
• Increased risk of aortic aneurysm and dissection within 2 months following fluoroquinolone use observed in epidemiologic studies, particularly in elderly patients; etiology has not been identified; reserve use in patients with known or at greater risk for aortic aneurysm only when there are no alternative antibacterial treatments available
• Blood glucose disturbances reported with fluoroquinolones, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (eg, glyburide) or with insulin; careful blood glucose monitoring recommended; severe cases of hypoglycemia resulting in coma or death reported with other fluoroquinolones; if a hypoglycemic reaction occurs in a patient being treated with this medication, discontinue therapy and initiate appropriate therapy immediately
• Disabling and potentially irreversible serious reactions
  • Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions from different body systems, including tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and CNS effects (eg, hallucinations, anxiety, depression, insomnia, severe headaches, confusion); patients of any age or without pre-existing risk factors have experienced these adverse reactions
  • Discontinue therapy immediately at first signs or symptoms of any serious adverse reaction; in addition, avoid the use of fluoroquinolones, including this drug, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones
• Tendinitis and tendon rupture
  • Risk of tendinitis and tendon rupture in all ages; the Achilles tendon is most frequently involved, but rupture is also reported with the rotator cuff, hand, biceps, 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 above 60 years of age, in patients taking corticosteroid drugs, and, in patients with kidney, heart, and lung transplants; 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
• Peripheral neuropathy
  • Fluoroquinolones are associated with an increased risk of peripheral neuropathy; sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported
  • Discontinue therapy 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 to minimize the development of an irreversible condition
  • Symptoms may occur soon after initiation of fluoroquinolones and may be irreversible in some patients; avoid therapy in patients who have previously experienced peripheral neuropathy
• 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 therapy in patients with known history of myasthenia gravis
• Hypersensitivity reactions
  • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, were 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 reported in patients receiving therapy; these reactions may occur after the first or subsequent doses of this drug; discontinue therapy at the first appearance of a skin rash or any other sign of hypersensitivity
• Clostridium difficile-associated diarrhea (CDAD)
  • CDAD is reported in users of nearly all systemic antibacterial drugs, including this medication, 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; hyper toxin-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
• Central nervous effects
  • If the following adverse effects occur, discontinue delafloxacin immediately and institute appropriate therapy
• Psychiatric effects
  • Associated with increased risk of psychiatric adverse reactions, including toxic psychosis, hallucinations, paranoia, depression, suicidal thoughts or acts, delirium, disorientation, confusion, disturbances in attention, anxiety, agitation, nervousness, insomnia, nightmares, or memory impairment; may occur after the first dose
  • If reactions occur, discontinue therapy and institute appropriate measures
• CNS effects
  • Associated with increased risk of seizures, increased intracranial pressure (including pseudotumor cerebri), dizziness, and tremors
  • Assess benefits and risks of use in patients with known or suspected CNS disorders (eg, severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold
  • If reactions occur, discontinue therapy and institute appropriate measures
• Drug interaction overview
• Do not coadminister IV delafloxacin in the same IV line with any solution containing multivalent cations (eg, magnesium)
• Chelation
  • Fluoroquinolones form chelates with alkaline earth and transition metal cations
  • Delafloxacin oral administration with antacids containing aluminum or magnesium, with sucralfate, with metal cations (eg, iron), or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations (eg, didanosine buffered tablets for oral suspension or the pediatric powder for oral solution), may substantially interfere with the absorption and decrease the systemic exposure
  • Administer delafloxacin at least 2 hours before or 6 hours after the aforementioned agents

Pregnancy and Lactation

• Data are limited regarding use in pregnant women and are insufficient to inform a drug-associated risk of major birth defects and miscarriages
• Lactation
  • Unknown if distributed in human breast milk
  • Excreted in the breast milk of rats
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition