Letermovir


Concise Prescribing Info
Indications/Uses
Prophylaxis of CMV reactivation and disease in CMV-seropositive [R+] recipients of allogeneic HSCT.
Dosage/Direction for Use
Adult : PO/IV 480 mg once daily, start within 28 days post-transplant continue until 100 days post-transplantation.
Dosage Details
Intravenous
Cytomegaloviral infections
Adult: Prophylaxis of CMV reactivation and disease in CMV-seropositive recipients [R+] of allogeneic HSCT: 480 mg once daily via infusion over 1 hour, start within 28 days post-transplant continue until 100 days post-transplantation.

Oral
Cytomegaloviral infections
Adult: Prophylaxis of CMV reactivation and disease in CMV-seropositive [R+] recipients of allogeneic haematopoietic stem cell transplant (HSCT): 480 mg once daily, start within 28 days post-transplant continue until 100 days post-transplantation.
Special Patient Group
Patient taking ciclosporin: 240 mg once daily, may increase to 480 mg once daily if ciclosporin is discontinued.
Hepatic Impairment
Severe (Child-Pugh Class C): Not recommended.
Administration
Film-Coated Tab: May be taken with or without food.
Reconstitution
IV infusion: Add contents of a vial containing 20 mg/mL solution to 250 mL infusion bag or bottle containing 5% dextrose or 0.9% NaCl solution and mix bag gently. Do not shake.
Incompatibility
IV: Incompatible with amphotericin B (liposomal), amiodarone, aztreonam, cefepime, ciprofloxacin, ciclosporin, diltiazem, filgrastim, gentamicin, levofloxacin, linezolid, lorazepam, midazolam, mycophenolate mofetil, ondansetron, and palonosetron.
Contraindications
Hypersensitivity. Concomitant use with pimozide, ergot alkaloids, St. John’s wort, dabigatran; admin with simvastatin, rosuvastatin, pitavastatin when co-administered with ciclosporin.
Special Precautions
Pregnancy and lactation. Renal and severe hepatic impairment.
Adverse Reactions
Gastrointestinal disorders: Nausea, diarrhoea, vomiting, abdominal pain.
General disorders and admin site conditions: Fatigue.
Metabolism and nutrition disorders: Peripheral oedema.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Cough.
Patient Counseling Information
This drug may cause fatigue and vertigo, if affected do not drive or operate machinery.
MonitoringParameters
Monitor CMV DNA weekly until week 14 post-transplant then every 2 weeks until week 24. Monitor for CMV reactivation.
Drug Interactions
May increase serum concentration of ciclosporin, sirolimus, tacrolimus, amiodarone, glyburide. May decrease serum concentration of warfarin, phenytoin, voriconazole, omeprazole, pantoprazole. Decreased concentration with nafcillin, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, thioridazine, bosentan, efavirenz, etravirine.
Potentially Fatal: May increase serum concentrations of pimozide and ergot alkaloids (e.g. ergotamine, dihydroergotamine) leading to increased risk of tachycardia (e.g. QT interval prolongation, torsade de pointes) and ergotism, respectively. May increase serum concentrations of HMG-CoA reductase inhibitors (e.g. atorvastatin, simvastatin, rosuvastatin, pitavastatin) which may lead to myopathy or rhabdomyolysis. May decrease plasma concentrations and efficacy of medicines transported hepatically by P-gp (e.g. dabigatran).
Food Interaction
Decreased serum concentration and efficacy with St. John’s wort.
Action
Description: Letermovir inhibits cytomegalovirus (CMV) DNA terminase complex (pUL51, pUL56, pUL89), which is important for viral DNA cleavage and packaging. It also affects production of proper unit length genomes and interferes with virion maturation.
Pharmacokinetics:
Absorption: Rapidly absorbed. Bioavailability: Approx 35%. Time to peak plasma concentration: 1.5-3 hours.
Distribution: Volume of distribution: 45.5 L (IV). Plasma protein binding: 99%.
Metabolism: Metabolised in the liver by UGT1A1/1A3 (minor).
Excretion: Via faeces (93%; 70% as unchanged drug); urine (<2%). Elimination half-life: 12 hours.
Chemical Structure

Click on icon to see table/diagram/image
Storage
Tab: Store below 30°C. Solution for inj: Store below 30°C. Protect from light. Reconstituted soln: Store between 2-8°C for 48 hours or 24 hours at room temp.
MIMS Class
ATC Classification
J05AX18 - letermovir ; Belongs to the class of other antivirals. Used as a direct acting antiviral in the systemic treatment of viral infections.
Disclaimer: This information is independently developed by MIMS based on Letermovir from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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