Pronunciation:

dela-FLOX-a-sin

Brand Names:

• Baxdela

Dosage Forms:

• Powder for Solution

Warnings:

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects. Discontinue delafloxacin immediately and avoid the use of fluoroquinolones, including delafloxacin, in patients who experience any of these serious adverse reactions. Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid delafloxacin in patients with known history of myasthenia gravis .

Classifications:

Therapeutic—

Antibiotic

Chemical—

Fluoroquinolone

Uses of This Medicine:

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

Delafloxacin belongs to the class of drugs, known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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.

Children—

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

Older adults—

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

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.

Other 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 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 is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the 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 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

Other interactions—

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:

• Aortic aneurysm (bulge in the wall of the largest artery) or
• Diabetes or
• Diarrhea or
• Mental illness, history of or
• Peripheral neuropathy (nerve problem), history of or
• Seizures (epilepsy), history of—Use with caution. May make these conditions worse.

• Brain problems (eg, hardening of the arteries in the brain, change in brain structure) 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.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are receiving this medicine to make sure 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 occur while you are receiving the medicine or after you finish receiving it. The risk of having tendon problems may be increased if you are over 60 years of age, are using steroid medicines (eg, dexamethasone, prednisolone, prednisone, Medrol®), have severe kidney problems, have a history of tendon problems (eg, rheumatoid arthritis), or if you have received an organ transplant (eg, heart, kidney, or lung). Check with your doctor right away if you have sudden pain or swelling in a tendon (eg, ankle, back of the knee or leg, shoulder, elbow, or wrist), bruise more easily after an injury, or are unable to bear weight or move the affected area. Refrain from exercise until your doctor says otherwise.

Tell your doctor right away if you start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.

Tell your doctor right away if you have any of the following symptoms while receiving 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 worsen myasthenia gravis (severe muscle weakness) in people who already have this condition. Talk to your doctor if you have concerns.

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 have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

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

Delafloxacin injection may cause diarrhea, and in some cases it can be severe. It may occur 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 make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Delafloxacin injection may cause some people to become dizzy or lightheaded than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

If you are a diabetic patient taking diabetes medicine by mouth: 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 feel different symptoms of low blood sugar. If you experience symptoms of low blood sugar, check with your doctor right away.

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

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

Side Effects of This Medicine:

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.