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Citric Buffered Normal Saline

ANHYDROUS CITRIC ACID

Manufacturer: Nabriva Therapeutics US, Inc.

Score: 141.0

Quick Summary

XENLETA is an antibacterial drug used for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. The recommended dosage is 150 mg every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days, with the option to switch to 600 mg orally every 12 hours. XENLETA is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA, and concomitant use with CYP3A substrates that prolong the QT interval is also contraindicated.

Key Clinical Findings and Indications

  • XENLETA is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae
  • XENLETA has been shown to be effective in treating CABP in clinical trials

Important Safety Information

Warning

XENLETA may cause QT prolongation, and concomitant use with CYP3A substrates that prolong the QT interval is contraindicated

Contraindications

  • Known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA
  • Concomitant use with CYP3A substrates that prolong the QT interval

Adverse Reactions

  • Administration site reactions
  • Hepatic enzyme elevation
  • Nausea
  • Hypokalemia
  • Insomnia
  • Headache

Dosing Recommendations

General Guidance

Reduce the dosage of XENLETA Injection to 150 mg infused intravenously over 60 minutes every 24 hours for patients with severe hepatic impairment (Child-Pugh Class C)

Community-acquired bacterial pneumonia (CABP)

Adult Dose

150 mg every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days, with the option to switch to 600 mg orally every 12 hours

Pediatric Dose

Special Population Considerations

Pregnancy

  • XENLETA may cause fetal harm when administered to pregnant women
  • There are no available data on the use of XENLETA in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

Nursing Mothers

Pediatric Use

  • The safety and effectiveness of XENLETA in patients less than 18 years of age has not yet been established

Geriatric Use

  • Of the 646 patients randomized to XENLETA in Trials 1 and 2, 268 (41.5%) were ≥65 years of age
  • Early clinical response (ECR) rates in the subgroup of patients ≥65 were similar to ECR rates in subjects <65 years of age and comparable across treatment groups (XENLETA versus moxifloxacin)

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