BAXDELA (delafloxacin meglumine)

There are 7 contraindications. Absolute contraindication.

Contraindication List
Aortic aneurysm
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Dissection of aorta
Ehlers-danlos syndrome
Loeys-dietz syndrome
Marfan syndrome
Myasthenia gravis

There are 9 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Clostridioides difficile infection
Depression
Idiopathic intracranial hypertension
Intracranial hypertension
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Peripheral neuropathy
Suicidal ideation
Tendon rupture

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Diabetes mellitus
Hypoglycemic disorder
Lower seizure threshold
Seizure disorder

There are 29 severe adverse reactions.

More Frequent	Less Frequent
Abnormal hepatic function tests	None.

Rare/Very Rare

Anaphylaxis Aortic aneurysm Arterial dissection Bradycardia Clostridioides difficile infection Delirium Dissection of aorta Drug-induced psychosis Extravasation injury Hallucinations Hypertension Hypoglycemic disorder Hypotension Idiopathic intracranial hypertension Injection site sequelae Kidney disease with reduction in glomerular filtration rate (GFr) Muscle weakness Neuromuscular blockade Peripheral neuropathy Renal failure Rhabdomyolysis Seizure disorder Sinus tachycardia Suicidal Suicidal ideation Tendon rupture Tendonitis Valvular regurgitation

There are 39 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea Headache disorder Nausea Vomiting	Dizziness

Rare/Very Rare

Acute abdominal pain Acute cognitive impairment Agitation Arthralgia Arthritis Blurred vision Depression Disturbance of attention Dream disorder Dysesthesia Dysgeusia Dyspepsia Facial edema Flushing Fungal infection Hyperglycemia Insomnia Memory impairment Myalgia Nervousness Nightmares Oral candidiasis Palpitations Paranoid disorder Paresthesia Phlebitis after infusion Pruritus of skin Skin rash Symptoms of anxiety Tinnitus Tremor Urticaria Vertigo Vulvovaginal candidiasis

Available data regarding use of delafloxacin in pregnant women are insufficient to inform any drug-associated risk for miscarriages or major birth defects. When delafloxacin (as the N-methyl glucamine salt) was administered orally to pregnant rats during organogenesis, no malformations or fetal deaths were observed at delafloxacin concentrations up to 7 times the estimated clinical exposure. Maternal toxicity and reduced fetal body weight were observed at the highest dosage (1.6 g/kg daily); fetal ossification delays were observed at all doses. When IV delafloxacin was administered to rats in late pregnancy through lactation, no adverse effects on offspring were observed at clinically relevant concentrations.

It is not known whether delafloxacin is distributed into human milk, affects the breast-fed infant, or affects milk production. Delafloxacin is distributed into milk in lactating rats. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for delafloxacin and potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Approximately 15% of patients receiving delafloxacin in clinical studies were 65 years of age or older. The clinical response rate at 48-72 hours after initiation of delafloxacin was 75.7% in patients 65 years of age or older compared with 82.3%

in those younger than 65 years of age. In the comparator group, the clinical response rate in patients 65 years of age or older was 71.3% compared with 82.1%

in those younger than 65 years of age. The risk of developing severe tendon disorders, including tendon rupture, is increased in older adults (usually those older than 60 years of age). This risk is further increased in those receiving concomitant corticosteroids.

(See Tendinitis and Tendon Rupture under Warnings/Precautions: Warnings, in Cautions.) Caution is advised if delafloxacin is used in geriatric adults, especially those receiving concomitant corticosteroids. The risk of aortic aneurysm and dissection may be increased in geriatric patients. (See Risk of Aortic Aneurysm and Dissection under Warnings/Precautions: Other Warnings and Precautions, in Cautions.) Pharmacokinetic data indicate that mean peak plasma concentration and area under the plasma concentration-time curve (AUC) of delafloxacin reported in geriatric individuals 65 years of age or older are about 35% higher than those reported in younger adults (18-40 years of age); this difference is not considered clinically important.