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In August, FDA approved lefamulin (Xenleta—Nabriva Therapeutics), a pleuromutilin antibacterial for treatment of adults with community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, or Chlamydophila pneumoniae. Each year, this serious disease leads to 1 million hospitalizations and 50,000 deaths in the United States, according to CDC data.
The new drug is available in two formulations: as an I.V. injection and as 600-mg tablets. When the drug is administered by I.V. infusion, patients receive a dosage of 150 mg every 12 hours over 60 minutes for 5 to 7 days, with the option to switch to lefamulin 600-mg tablets every 12 hours to complete the treatment course.
The recommended dosage for the oral formulation is 600 mg every 12 hours for 5 days.
Efficacy and adverse effects
Lefamulin’s safety and efficacy, taken either orally or intravenously, were evaluated in two clinical trials with 1,289 patients who had CABP. Treatment with lefamulin was compared with treatment using another antibiotic, moxifloxacin, with or without linezolid.
The trials showed that patients treated with lefamulin had similar rates of clinical success as those treated with moxifloxacin with or without linezolid.
The drug’s most common adverse reactions via injection include administration-site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache. Adverse effects of the oral formulation include diarrhea, nausea, vomiting, and hepatic enzyme elevation. Patients who develop diarrhea should be evaluated for Clostridium difficile–associated diarrhea.
Warnings, precautions, contraindications
Lefamulin may also cause prolonged QT interval. Patients with prolonged QT interval, certain arrhythmias, receiving antiarrhythmic agents for certain irregular heart rhythms, or receiving other drugs that prolong the QT interval should avoid lefamulin. Patients should not use the drug if they have a known hypersensitivity to lefamulin or any of its components or to any other members of the pleuromutilin antibiotic class. Concomitant use with CYP3A substrates that prolong the QT interval is contraindicated.
Instruct patients who are using the oral formulation to take the tablets at least 1 hour before or 2 hours after a meal and to swallow the tablets whole with 6 to 8 oz. of water. Warn patients that they may develop watery stools (with or without stomach cramps and fever) during treatment and as late as 2 or more months after taking the last dose, and that this may be a sign of a more serious intestinal infection. Instruct patients to contact their prescriber as soon as possible if this symptom occurs.
Ask patients if they are currently taking any medications, including herbal or nutritional supplements, or are prescribed new medications during treatment. Explain that potential interactions with other medications may result in decreased effectiveness or increased toxicities of either lefamulin or the other medications. Also inform patients that allergic reactions could occur and that serious ones require immediate treatment.
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Manufacturer: Nabriva Therapeutics
Drug class: Pleuromutilin antibacterial
Indication: Treatment of adults with community-acquired bacterial pneumonia caused by susceptible microorganisms
Dosage: Injection—150 mg every 12 hours by I.V. infusion over 60 minutes for 5 to 7 days. Tablets—600 mg every 12 hours for 5 days.
Of note: In patients with severe hepatic impairment (Child-Pugh Class C), the injection dosage should be reduced to 150 mg infused over 60 minutes every 24 hours. Use of the oral formulation has not been studied in and is not recommended for patients with moderate (Child-Pugh Class B) or severe hepatic impairment.
Advise pregnant women and women who could become pregnant of the potential risks to a fetus and to use effective contraception during treatment and for 2 days after the final dose. Women who are breastfeeding should pump and discard their milk during treatment and for 2 days after the final dose.
FDA granted lefamulin priority review as part of the agency’s qualified infectious disease product (QIDP) designation under the Generating Antibiotic Incentives Now of the FDA Safety and Innovation Act. This designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections.
To reduce the development of drug-resistant bacteria and to maintain effectiveness of lefamulin and other antibacterial drugs, FDA urges that lefamulin be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Cara Aldridge Young, senior production editor
Continue at: https://www.pharmacytoday.org/article/S1042-0991(19)31143-0/fulltext
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