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letermovir

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Letermovir is a cell proliferation virus terminal transferase inhibitor that blocks the DNA replication process of CMV and inhibits virus proliferation by inhibiting the activity of the CMV DNA terminase complex (including pUL51, pUL56 and pUL89).

1. Drug name

1. Generic name: Letermovir;

2. Trade name: PREVYMIS®.

2. Indications

1. Prevention of CMV infection after hematopoietic stem cell transplantation (HSCT): Applicable to CMV seropositive recipients (R+) aged 6 months and above and weighing ≥6kg.

2. Prevention of CMV disease after kidney transplantation: Applicable to high-risk (D+/R-) recipients aged 12 years and above and weighing ≥40kg.

3. Specifications and properties

Tablet : 240mg

4. Main ingredients

1. Active ingredients: Letermovir;

2. Excipients include: microcrystalline cellulose, croscarmellose sodium, etc. The injection contains hydroxypropyl betacyclodextrin.

5. Usage and dosage

1. HSCT recipient :

Adults and children ≥12 years old: 480 mg once daily by oral or intravenous infusion (1 hour) for 100 days after transplantation; for high-risk patients, the period can be extended to 200 days.

Children aged 6 months to <12 years old: adjust the dose according to body weight (for example, ≥30kg, use 480mg; 6-<7.5kg, use 80mg).

2. Kidney transplant recipient :

480 mg once daily for 200 days after transplantation.

VI. Dose adjustment of

1. Combined use of with cyclosporine:

The dose for adults and children ≥12 years old is reduced to 240mg/day; children <12 years old require individualized adjustment.

2. Renal/liver insufficiency :

Creatinine needs to be monitored during intravenous administration in patients with renal impairment (CLcr<50mL/min); it is contraindicated in severe liver impairment (Child-Pugh C grade).

7. Medication Precautions

1. Medication time : Tablets can be taken with food or on an empty stomach; oral granules must be mixed with room temperature soft food and taken within 10 minutes.

2. Treatment of missed doses : Take it immediately. If it is close to the next dose time, skip it. Do not double the dose.

3. Vomiting treatment : If you vomit after taking the medicine, there is no need to take a supplement, and you can continue with the next dose as originally planned.

4. Restrictions on injection : Only for use by those who cannot take it orally, intravenous administration is recommended within 4 weeks.

8. Medication for special groups

1. Children : It is available for HSCT recipients ≥6 months old or kidney transplant recipients ≥12 years old, and the dosage must be strictly based on body weight.

2. Pregnancy/lactation : No human data, animals show reproductive toxicity, the pros and cons need to be weighed.

3. Elderly : No need to adjust the dose.

9. Adverse reactions

1. HSCT receptor : Common nausea (27%), diarrhea (26%), vomiting (19%), and peripheral edema (14%).

2. Kidney transplant recipient : Diarrhea (32%) is the main adverse reaction.

10. Contraindications

1. It is prohibited to use pimozide and ergot alkaloids in combination.

2. Pitavastatin and simvastatin are prohibited when used in combination with cyclosporine.

11. Drug interactions

1. CYP3A inhibitor/inducer : For example, rifampicin and carbamazepine may reduce the efficacy of letermovir and should be avoided in combination.

2. Statin : When used in combination with cyclosporine, the dose of atorvastatin is ≤20 mg/day.

12. Storage method

Tablets: Store in original packaging away from moisture, at room temperature (20-25°C).