Bacterial infections:

Indications for XENLETA INJECTION:

Susceptible community-acquired bacterial pneumonia (CABP).

Adult:

≥18yrs: Tabs: Swallow whole. Take with water at least 1hr before or 2hrs after a meal. 600mg every 12hrs for 5 days. Moderate or severe hepatic impairment: not recommended. Inj: 150mg IV over 60mins every 12hrs for 5–7 days; may switch to 600mg tabs every 12hrs to complete the treatment. Severe hepatic impairment: 150mg IV over 60mins every 24hrs. Do not exceed the recommended dose and infusion rate.

Children:

<18yrs: not established.

Contraindications:

Tabs: concomitant with CYP3A substrates that prolong the QT interval (eg, pimozide).

Warnings/Precautions:

Avoid in those with known QT prolongation, ventricular arrhythmias including torsades de pointes; if unavoidable, monitor ECG. Evaluate if diarrhea occurs; discontinue if C. difficile-associated diarrhea is suspected or confirmed. Renal failure with dialysis. Hepatic impairment: monitor (see Adults). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 2 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: pump/discard breast milk (during and for 2 days after the last dose).

See Also:

Pharmacologic Class:

Pleuromutilin.

Interactions:

See Contraindications. Tabs & Inj: Avoid concomitant with Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmics, antipsychotics, pimozide, erythromycin, moxifloxacin, TCAs, strong/moderate CYP3A4 inducers, or P-gp inducers. Tabs: Avoid concomitant strong CYP3A inhibitors or P-gp inhibitors. Concomitant with moderate CYP3A inhibitors or P-gp inhibitors; monitor. Concomitant with sensitive CYP3A substrates (eg, alprazolam, diltiazem, verapamil, simvastatin, vardenafil); monitor closely.

Adverse Reactions:

Tabs: diarrhea, nausea, vomiting, hepatic enzyme elevation; Inj: also administration site reactions, hypokalemia, insomnia, headache; C. difficile-associated diarrhea; QT prolongation.

Generic Availability:

NO

How Supplied:

Tabs—30; Single-dose vials (w. diluent bags)—6