Mulina
Generic Name: Lefamulin 600mg and Lefamulin 150 mg/15ml
Dosage Form: Tablet and IV Injection
TG Name: Anti-infectives
1. What is Mulina®?
Mulina® is a preparation of Lefamulin, a semi-synthetic antibacterial agent for oral and intravenous administration. Lefamulin features a novel mechanism of action that shows benefit against resistant bacteria that cause pneumonia.
2. How does Mulina® work in our body?
Mulina® is a systemic pleuromutilin antibacterial. It inhibits bacterial protein synthesis through interactions (hydrogen bonds, hydrophobic interactions, and Van der Waals forces) with the A-and P-sites of the peptidyl transferase center (PTC) in domain V of the 23s rRNA of the 50S subunit.
3. What are the indications of Mulina®?
Mulina® is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
4. What is the dosage & administration of Mulina®?
Dosage of Mulina® in Adult CABP Patients
Mulina® 150 mg injection every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days (With the option to switch to Mulina® Tablets 600 mg every 12 hours to complete the treatment course).
Mulina® tablet 600 mg orally every 12 hours for 5 days. For patients with severe hepatic impairment, dosage adjustment is required.
Dosage Adjustment for Patients with Hepatic Impairment
Mulina® Injection: Reduce the dosage of Mulina® Injection to 150 mg infused intravenously over 60 minutes every 24 hours for patients with severe hepatic impairment. No dosage adjustment of Mulina® Injection is needed for patients with mild or moderate hepatic impairment.
Mulina® Tablets: Mulina® Tablets have not been studied in and are not recommended for patients with moderate or severe hepatic impairment. No dosage adjustment of Mulina® Tablets is needed for patients with mild hepatic impairment.
Important Administration instruction
Mulina® Injection: Administer Mulina® Injection by intravenous infusion over 60 minutes. Must dilute in a 250 ml solution of citrate buffered 0.9% sodium chloride for injection supplied with Mulina® Injection before use. Mulina® Tablets: Take Mulina® Tablets at least 1 hour before a meal or 2 hours after a meal. Do not crush or divide Mulina® Tablet. Missed Dose: If a dose is missed, the patient should take the dose as soon as possible and anytime up to 8 hours prior to the next scheduled dose. If less than 8 hours remain before the next scheduled dose, do not take the missed dose, and resume dosing at the next scheduled dose.
Preparation of Mulina® Injection for Intravenous Infusion
- Dilute the entire 15 ml vial of Mulina® Injection into the diluent bottle supplied with Mulina® injection that contains 250 ml citrate buffered 0.9% sodium chloride solution.
- Use aseptic technique when adding Mulina® Injection into the diluent bottle. Mix thoroughly.
- Use the diluent bottle only if the solution is clear and the container is undamaged.
- Do not use the diluent bottle in series connections.
- Do not add other additives to the diluent bottle because their compatibilities with Mulina® Injection have not been established.
5. What are the contraindications of Mulina®?
Mulina® is contraindicated in patients with known hypersensitivity to Mulina®, pleuromutilin class drugs, or any of the components of Mulina® and also contraindicated for use with CYP3A4 substrates that prolong the QT interval. Mulina® is not recommended for pregnant women and pediatric patients age below 18 years old.
6. What are the adverse effects of Mulina®?
Mulina® has the potential to prolong the QT interval. Avoid Mulina® in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval. Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including Mulina®, with severity ranging from mild diarrhea to fatal colitis.
7. What would be the storage condition of Mulina®?
Mulina Injection for IV Infusion: Store in a refrigerator at 2ºC to 8ºC. Do not freeze and protect from light. Keep out of the reach of children.
Mulina® tablet: Do not store above 30ºC. Do not refrigerate or freeze. Keep in a dry place. Protect from light & keep out of the reach of children.
