BAXDELA INJECTION Dosage & Rx Info

Baxdela Injection Generic Name & Formulations

Legal Class

General Description

Delafloxacin 300mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution.

Pharmacological Class

Quinolone.

How Supplied

Tabs—20; Blister packs—20 (2x10 tabs); Single-dose vials—10

Manufacturer

Melinta Therapeutics

Generic Availability

Mechanism of Action

The antibacterial activity of delafloxacin is due to the inhibition of both bacterial topoisomerase IV and DNA gyrase (topoisomerase II) enzymes which are required for bacterial DNA replication, transcription, repair, and recombination.

Baxdela Injection Indications

Indications

Susceptible acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

Baxdela Injection Dosage and Administration

Adult

Infuse over 60mins. ≥18yrs: 300mg every 12hrs; or, 300mg every 12hrs then switch to oral tabs 450mg every 12hrs as clinically indicated. ABSSSI: treat for 5–14 days. CABP: treat for 5–10 days. Renal impairment (eGFR 15–29mL/min/1.73m²): 200mg every 12hrs; may switch to oral form as clinically indicated. ESRD (eGFR <15mL/min/1.73m²) or hemodialysis: not recommended (insufficient data). See full labeling.

Children

<18yrs: not recommended.

Administration

Do not co-infuse with other medications.

Baxdela Injection Contraindications

Not Applicable

Baxdela Injection Boxed Warnings

Boxed Warning

Serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, CNS effects, and exacerbation of myasthenia gravis.

Baxdela Injection Warnings/Precautions

Warnings/Precautions

Increased risk of disabling and potentially irreversible adverse reactions (including tendinitis/tendon rupture [esp. in patients >60yrs, or those with kidney, heart or lung transplants], peripheral neuropathy, or CNS/psychiatric effects); discontinue immediately if signs/symptoms occur. CNS disorders (eg, cerebral arteriosclerosis, epilepsy) that increase seizure risk. History of myasthenia gravis; avoid. Increased risk of aortic aneurysm and dissection (esp. in elderly); reserve use only if no alternatives in patients with history or risk of. Discontinue at 1^st sign of skin rash, or any other hypersensitivity. Monitor blood glucose in diabetic patients; discontinue if hypoglycemia occurs. Severe renal impairment receiving IV form: monitor serum creatinine levels, eGFR closely; consider switching to oral form if serum creatinine level increases. Discontinue if eGFR falls <15mL/min/1.73m². Elderly. Pregnancy. Nursing mothers.

Baxdela Injection Pharmacokinetics

Absorption

Absolute bioavailability (450mg oral tab): 58.8%. Maximum concentration: within 1 hour after oral administration under fasting condition.

Distribution

Volume of distribution at steady state: 30–48 L. Plasma protein bound: ~84%.

Metabolism

Glucuronidation mediated mainly by UGT1A1, UGT1A3, and UGT2B15.

Elimination

Oral tabs:

Renal (50%), fecal (48%). Half-life: 4.2–8.5 hours.

IV:

Renal (65%), fecal (28%). Half-life: 3.7 hours.
Mean clearance: 16.3 L/h.

Baxdela Injection Interactions

Interactions

Separate dosing of oral form with magnesium- or aluminum-containing antacids, sucralfate, metal cations, multivitamins containing zinc or iron, or didanosine (buffered forms) by at least 2hrs before or 6hrs after these agents. Increased risk of tendinitis/tendon rupture with corticosteroids. Concomitant antidiabetics may increase blood glucose disturbances. For IV: avoid concomitant solution containing multivalent cations (eg, calcium, magnesium) through same IV line.

Baxdela Injection Adverse Reactions

Adverse Reactions

Nausea, diarrhea, headache, transaminase elevations, vomiting; tendinitis/tendon rupture, peripheral neuropathy, CNS/psychiatric effects, hypersensitivity reactions, C. difficile-associated diarrhea, dysglycemia, aortic aneurysm/dissection.

Baxdela Injection Clinical Trials

See Literature

Baxdela Injection Note