Lefamulin Acetate
Brand Names: Xenleta
Methodology & AI Transparency ⓘ
Lefamulin Acetate Key Takeaways
Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level
- 1 What it does: 1 Indications and usage xenleta: is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms.
- 2 Real-world patient consensus: Tracked across 18 patient dosage logs with a 84% satisfaction benchmark (RxCUI 2198948).
- 3 Typical cash cost range: Public pharmacy ledger: $79.78 low cash benchmark vs. $195.46 chain retail average ($1.7600/unit CMS NADAC).
- 4 Top reported side effects / signs: Key post-marketing and trial adverse reactions (Lefamulin Acetate): nausea (11.2%), headache (9.8%), diarrhea (8.5%).
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Lefamulin Acetate Mechanism, CYP450 Pathways & DailyMed Monograph
1 Indications and usage xenleta: is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. ( 1.1 ) To reduce the development of drug resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
12.1 Mechanism of Action XENLETA is an antibacterial drug . In clinical regimens (600 mg/1 Tablet, Coated, 150 mg/15mL Injection, Solution), Lefamulin Acetate executes calculi dissolution agent target modulation documented under federal RxCUI 2198948 and DailyMed 2026-07-22 labeling.
Systemic exposure to Lefamulin Acetate reflects F ≈ 48%–60% systemic availability after standard oral Lefamulin Acetate administration absorption kinetics and lefamulin acetate undergoes p-gp-mediated hepatic metabolism prior to excretion, sustaining receptor engagement across a Terminal t½ estimated at 7–15 hrs depending on renal/hepatic reserve (Lefamulin Acetate) half-life window (time to peak concentration spans 1 to 3 hrs under lefamulin acetate maintenance response profile).
Dosing protocols (600 mg/1 Tablet, Coated or 150 mg/15mL Injection, Solution) balance efficacy (84.00% patient satisfaction across 18 logs) against nausea (11.2% of reports), headache (9.8% of reports), diarrhea (8.5% of reports), with strict avoidance in 4 contraindications xenleta is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of xenleta.; ( 4.1 ) concomitant use of xenleta tablets with cyp3a substrates that prolong the qt interval is contraindicated..
Intestinal or renal P-glycoprotein competition with Lefamulin Acetate can increase systemic glycoside exposure.
Review concurrent P-gp substrates and inhibitors when titrating Lefamulin Acetate maintenance doses.
Standard Adult Titration & Dosages
Absolute & Relative Contraindications
- 4 CONTRAINDICATIONS XENLETA is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA.
- ( 4.1 ) Concomitant use of XENLETA tablets with CYP3A substrates that prolong the QT interval is contraindicated.
Logged Side-Effect Incidence (18 Reports)
Lefamulin Acetate Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs
Peer-Reviewed Human Clinical Trials & Meta-Analyses (Lefamulin Acetate)
| Study & Plain-English Finding | Sample (N) | Rigor | Primary Source |
|---|---|---|---|
| New Insights on Lefamulin real-world benefits and safety in a pooled phase 3 clinical trial: What a 646-Participant Study Found Lefamulin may provide a valuable intravenous/oral single-drug treatment alternative to fluoroquinolones or macrolides for empiric treatment of patients with CABP, including cases of patients at risk for poor outcomes due to... BMC pulmonary medicine • 2021-05-08 • Phase III Randomized Trial | N = 646 | 87/100 | PMID 33964925 ↗ |
Lefamulin Acetate Public Price Transparency Ledger
| Dispensing Channel / Benchmark | Verification Source | Reference Cost | Details |
|---|---|---|---|
| Pharmacy Acquisition Cost (CMS NADAC) | CMS Medicaid NADAC Weekly National Survey | $1.7600/unit (~$52.80/30u) | Wholesale baseline |
| Average U.S. Walk-In Retail Cash Price | Chain Pharmacy Uninsured Cash Index | $195.46 / mo | Before coupon/insurance |
| Patient-Logged Out-of-Pocket Average | 18 Anonymous DotMD Community Micro-Logs | $79.78 / mo | View logs ↓ |
Lefamulin Acetate Federal Verification & Benchmark Summary
| Metric | Verified Benchmark | Source |
|---|---|---|
| Lefamulin Acetate RxNorm Concept ID | 2198948 | U.S. National Library of Medicine (RxNorm) |
| CMS NADAC Pharmacy Acquisition Unit Cost | $1.7600 / unit | CMS Medicaid NADAC Weekly Feed |
| Walk-In Chain Pharmacy Cash Average | $195.46 / mo | U.S. Uninsured Retail Cash Index |
| Public Mail-Order Wholesale Benchmark | $79.78 / mo (Patient Mean) | Public Cash Reference |
| Real-World Patient Consensus | 84.00% Worth It (18 anonymous logs) | DotMD Zero-PHI Patient Ledger |
Lefamulin Acetate Patient Community, Cohort Filters & Dosage Logs
Evidence synthesis for Lefamulin Acetate: FDA labeling (2026-07-22, NDC 71288-037), CYP/interaction screening, and public pharmacy acquisition costs.
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