BAXDELA INJECTION Rx
Generic Name and Formulations:
Delafloxacin 300mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution.
Indications for BAXDELA INJECTION:
Susceptible acute bacterial skin and skin structure infections (ABSSSI).
Infuse over 60mins. ≥18yrs: 300mg every 12hrs for 5–14 days; or, 300mg every 12hrs then switch to oral tabs 450mg every 12hrs as clinically indicated for a total of 5–14 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.
<18yrs: not recommended.
Serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, CNS effects, and exacerbation of myasthenia gravis.
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 effects); discontinue immediately if signs/symptoms occur. History of tendon disorders, peripheral neuropathy, or myasthenia gravis: avoid. CNS disorders (eg, cerebral arteriosclerosis, epilepsy) that increase seizure risk. Discontinue at 1st sign of skin rash, or any other hypersensitivity. 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. Pregnancy. Nursing mothers.
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. For IV: avoid concomitant solution containing multivalent cations (eg, calcium, magnesium) through same IV line.
Nausea, diarrhea, headache, transaminase elevations, vomiting, other CNS, cardiac, GI, metabolic, musculoskeletal, injection reactions (see full labeling); tendinitis/tendon rupture, peripheral neuropathy, hypersensitivity reactions, C. difficile-associated diarrhea.
Tabs—20; Blister packs—20 (2x10 tabs); Single-dose vials—10