Delafloxacin (Intravenous)

Delafloxacin injection is used to treat acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

Delafloxacin is a type of drug called a quinolone antibiotic. It works by killing bacteria or stopping them from growing. However, this medicine will not work for colds, flu, or other viral infections.

This medicine should only be given by your doctor or under their direct supervision.

It is very important for your doctor to check your progress while you are receiving this medicine to ensure it is working properly. Blood and urine tests may be needed to check for unwanted effects.

Delafloxacin injection may cause inflammation (tendinitis) or tearing of a tendon (the cord that attaches muscles to bones). This can happen while you are receiving the medicine or after you finish. The risk of tendon problems may be higher if you are over 60 years old, are using steroid medicines (e.g., dexamethasone, prednisolone, prednisone, Medrol®), have severe kidney problems, have a history of tendon issues (e.g., rheumatoid arthritis), or if you have received an organ transplant (e.g., heart, kidney, or lung). Contact your doctor immediately if you experience sudden pain or swelling in a tendon (e.g., ankle, back of the knee or leg, shoulder, elbow, or wrist), bruise more easily after an injury, or cannot bear weight or move the affected area. Avoid exercise until your doctor advises otherwise.

Notify your doctor right away if you begin to have numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be signs of a condition called peripheral neuropathy.

Inform your doctor immediately if you have any of the following symptoms while taking this medicine: seizures, feeling anxious, confused, or depressed, seeing, hearing, or feeling things that are not there, severe headache, trouble sleeping, or unusual thoughts or behaviors.

Delafloxacin injection may make myasthenia gravis (severe muscle weakness) worse in people who already have this condition. Discuss any concerns with your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you notice a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may increase your risk for aortic aneurysm (bulge in the wall of the largest artery). Contact your doctor immediately if you have sudden chest, stomach, or back pain, trouble breathing, cough, or hoarseness.

Delafloxacin injection may cause diarrhea, which can sometimes be severe. This may happen 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may worsen the diarrhea or make it last longer. If you have questions about this or if mild diarrhea continues or worsens, consult your doctor.

Delafloxacin injection may cause some people to feel more dizzy or lightheaded than usual. Avoid driving or doing anything dangerous until you know how this medicine affects you.

If you are a diabetic patient taking oral diabetes medicine: Delafloxacin may cause hypoglycemia (low blood sugar) in some patients. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may experience different symptoms of low blood sugar. If you have symptoms of low blood sugar, contact your doctor immediately.

• Symptoms of low blood sugar can include: anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty concentrating, drowsiness, excessive hunger, headache, nausea, nervousness, rapid heartbeat, shakiness, or unusual tiredness or weakness.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have allergies to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine is not recommended for children. Safety and effectiveness have not been proven.

Geriatric

Studies have not shown any specific problems for elderly patients that would limit the use of delafloxacin injection. However, older patients are more likely to have age-related kidney issues or develop aortic aneurysm or serious tendon problems (including tendon rupture), especially if they also take steroid medicines. Caution may be needed for older patients receiving delafloxacin injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together, even if an interaction could happen. In these cases, your doctor may want to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but not exhaustive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Acarbose
• Albiglutide
• Alogliptin
• Canagliflozin
• Chlorpropamide
• Dapagliflozin
• Dulaglutide
• Empagliflozin
• Ertugliflozin
• Exenatide
• Glimepiride
• Glipizide
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Linagliptin
• Liraglutide
• Lixisenatide
• Magnesium Sulfate
• Metformin
• Miglitol
• Nateglinide
• Pioglitazone
• Porfimer
• Pramlintide
• Repaglinide
• Rosiglitazone
• Saxagliptin
• Semaglutide
• Sitagliptin
• Tolazamide
• Tolbutamide
• Voglibose

Using this medicine with any of the following may increase the risk of certain side effects, but using both may be the best option for you. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used near mealtime or with specific foods because interactions may occur. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical conditions, especially:

• Aortic aneurysm (bulge in the wall of the largest artery) or
• Diabetes or
• Diarrhea or
• History of mental illness or
• History of peripheral neuropathy (nerve problem) or
• History of seizures (epilepsy)—Use with caution. May worsen these conditions.

• Brain issues (e.g., hardening of arteries in the brain, changes in brain structure) or
• Severe kidney disease or
• History of organ transplant (e.g., heart, kidney, or lung) or
• History of tendon disorders (e.g., rheumatoid arthritis)—Use with caution. May worsen side effects.

• End-stage kidney disease or
• History of myasthenia gravis (severe muscle weakness)—Should not be used in patients with these conditions.

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 or nurse immediately if any of the following side effects occur:

More common

• Diarrhea

Less common

• 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
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• cool, pale skin
• cough
• decreased frequency or amount of urine
• depression
• difficulty with 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 consciousness
• loss of taste
• lower back or side pain
• muscle cramps, pains, or stiffness
• nausea
• 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:

Less common

• 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Baxdela

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

Chemical Class: Fluoroquinolone

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. This medicine is given slowly, so the needle will have to remain in place for at least an hour.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Your doctor may give you a few doses of this medicine until your condition improves, and then be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

• What type of antibiotic is Baxdela?