Xenleta Side Effects Center

Last updated on RxList: 11/8/2021
Xenleta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Xenleta?

Xenleta (lefamulin) is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms.

What Are Side Effects of Xenleta?

Common side effects of Xenleta include:

  • injection site reactions,
  • elevated liver enzymes,
  • nausea,
  • low blood potassium,
  • insomnia,
  • headache,
  • diarrhea,
  • nausea, and
  • vomiting

Dosage for Xenleta

The recommended dosage of Xenleta is 150 mg every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days or 600 mg orally every 12 hours for 5 days.

What Drugs, Substances, or Supplements Interact with Xenleta?

Xenleta may interact with strong CYP3A4 inducers or P-gp inducers, strong CYP3A inhibitors or P-gp inhibitors, alprazolam, diltiazem, verapamil, simvastatin, vardenafil, antiarrhythmics, antipsychotics, erythromycin, moxifloxacin, and tricyclic antidepressants. Tell your doctor all medications and supplements you use.

Xenleta During Pregnancy and Breastfeeding

Xenleta is not recommended for use during pregnancy; it may harm a fetus. Females of reproductive potential are advised to use effective contraception during treatment with Xenleta and for 2 days after the final dose. It is unknown if Xenleta passes into breast milk. Because of the potential for adverse reactions in nursing infants, breastfeeding is not recommended while using Xenleta. Women should pump and discard breast milk for the duration of treatment with Xenleta and for 2 days after the final dose.

Additional Information

Our Xenleta (lefamulin) Injection, for Intravenous Use and Xenleta (Lefamulin) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Bowel regularity means a bowel movement every day. See Answer
Xenleta Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose); or
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • nausea, vomiting, diarrhea;
  • sleep problems (insomnia);
  • low potassium;
  • headache;
  • abnormal liver function tests; or
  • pain, bruising, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xenleta (Lefamulin Injection)

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Xenleta Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • QT Prolongation [see WARNINGS AND PRECAUTIONS].
  • Clostridioides difficile-associated Diarrhea [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

XENLETA was evaluated in two clinical trials in CABP patients (Trial 1 and Trial 2). Across the two trials, a total of 641 patients were treated with XENLETA. Trial 1 (intravenous [IV] to oral dosing switch trial) enrolled 551 adult patients, 276 randomized to XENLETA (273 received at least one dose of XENLETA) and 275 randomized to moxifloxacin (273 received at least one dose of moxifloxacin). Trial 2 (oral dosing only trial) enrolled 738 adult patients, 370 randomized to XENLETA (368 received at least one dose of XENLETA) and 368 randomized to moxifloxacin (all 368 received at least one dose of moxifloxacin).

Trial 1 enrolled patients with Pneumonia Outcomes Research Team (PORT) Risk Class III-V. The mean duration of intravenous treatment was 6 days; the mean total duration of treatment was 7 days. Trial 2 enrolled patients with PORT Risk Class II-IV. The mean duration of treatment was 5 days for XENLETA and 7 days for moxifloxacin.

In Trial 1 and Trial 2 (pooled), the median age of patients treated with XENLETA was 61 (range 19-97) years; 42% of patients were 65 years or older and 18% were 75 years or older. Patients were predominantly male (58%) and white (79%) and had a median body mass index (BMI) of 26.0 (range 13.0-56.8) kg/m². Approximately 52% of XENLETA-treated patients had creatinine clearance (CrCl) <90 mL/min.

Serious Adverse Reactions And Adverse Reactions Leading To Discontinuation

In Trial 1 and Trial 2 (pooled), serious adverse reactions occurred in 36/641 (5.6%) patients treated with XENLETA and 31/641 (4.8%) patients treated with moxifloxacin. Treatment was discontinued due to an adverse reaction in 21/641 (3.3%) patients treated with XENLETA and 21/641 (3.3%) patients treated with moxifloxacin. Death within 28 days occurred in 8/641 (1.2%) patients treated with XENLETA and 7/641 (1.1%) patients treated with moxifloxacin.

Most Common Adverse Reactions

Table 2 and Table 3 include adverse reactions occurring in ≥2% of patients receiving XENLETA in Trials 1 and 2.

Table 2: Adverse Reactions Occurring in ≥2% of Patients Receiving XENLETA in Trial 1

Adverse Reaction Trial 1 IV ± Oral Dosing
XENLETA
N=273
Moxifloxacin
N=273
Administration site reactions* 7% 3%
Hepatic enzyme elevation** 3% 3%
Nausea 3% 2%
Hypokalemia 3% 2%
Insomnia 3% 2%
Headache 2% 2%
*Administration site reactions include infusion site pain, infusion site phlebitis, and injection site reaction.
**Hepatic enzyme elevation includes alanine aminotransferase increased, aspartate aminotransferase increased, and liver function test increased.

Table 3: Adverse Reactions Occurring in ≥2% of Patients Receiving XENLETA in Trial 2

Adverse Reaction Trial 2 Oral Dosing
XENLETA
N=368
Moxifloxacin
N=368
Diarrhea 12% 1%
Nausea 5% 2%
Vomiting 3% 1%
Hepatic enzyme elevation** 2% 2%
**Hepatic enzyme elevation includes alanine aminotransferase increased, aspartate aminotransferase increased, and liver function test increased.

Selected Adverse Reactions Occurring In Less Than 2% of Patients Receiving XENLETA In Trials 1 And 2

Blood and Lymphatic System Disorders: anemia, thrombocytopenia

Cardiac Disorders: atrial fibrillation, palpitations

Gastrointestinal Disorders: abdominal pain, constipation, dyspepsia, epigastric discomfort, erosive gastritis

Infections and Infestations: Clostridioides difficile colitis, oropharyngeal candidiasis, vulvovaginal candidiasis

Investigations: alkaline phosphatase increased, creatine phosphokinase increased, electrocardiogram QT prolonged, gamma-glutamyl transferase increased

Nervous System Disorders: somnolence

Psychiatric Disorders: anxiety

Renal and Urinary Disorders: urinary retention

DRUG INTERACTIONS

Effect Of Other Drugs On XENLETA

Strong And Moderate CYP3A Inducers Or P-gp Inducers

Concomitant use of oral or intravenous XENLETA with strong CYP3A4 inducers or P-gp inducers decreases lefamulin AUC and Cmax [see CLINICAL PHARMACOLOGY], which may reduce the efficacy of XENLETA. Avoid concomitant use of XENLETA Injection and XENLETA Tablets with strong and moderate CYP3A4 inducers or P-gp inducers unless the benefit outweighs the risks.

Strong And Moderate CYP3A Inhibitors Or P-gp Inhibitors

Concomitant use of XENLETA Tablets with strong CYP3A inhibitors or P-gp inhibitors increases lefamulin AUC [see CLINICAL PHARMACOLOGY], which may increase the risk of adverse reactions with XENLETA Tablets. Avoid concomitant use of XENLETA Tablets with strong CYP3A inhibitors or P-gp inhibitors. Monitor for adverse effects of XENLETA Tablets when administered concomitantly with moderate CYP3A inhibitors or P-gp inhibitors.

Effect Of XENLETA On Other Drugs

CYP3A4 Substrates

Concomitant use of XENLETA Tablets with sensitive CYP3A4 substrates increases the AUC and Cmax of CYP3A4 substrates [see CLINICAL PHARMACOLOGY] , which may increase the risk of toxicities associated with cardiac conduction. Concomitant use with CYP3A substrates known to prolong the QT interval is contraindicated [see CONTRAINDICATIONS]. Concomitant use of sensitive CYP3A substrates with XENLETA Tablets requires close monitoring for adverse effects of these drugs (for example, alprazolam, diltiazem, verapamil, simvastatin, vardenafil). Concomitant use of XENLETA Injection with CYP3A4 substrates does not affect the exposure of CYP3A4 substrates.

Drugs That Prolong QT

The pharmacodynamic interaction potential to prolong the QT interval of the electrocardiogram between XENLETA and other drugs that effect cardiac conduction is unknown. Therefore, avoid concomitant use of XENLETA Injection and XENLETA Tablets with such drugs (for example, Class IA and III antiarrhythmics, antipsychotics, erythromycin, moxifloxacin, tricyclic antidepressants).

Read the entire FDA prescribing information for Xenleta (Lefamulin Injection)

© Xenleta Patient Information is supplied by Cerner Multum, Inc. and Xenleta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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