Letermovir

What is Letermovir?

Letermovir (PREVYMIS) is a CMV DNA terminase complex inhibitor used as prophylaxis of cytomegalovirus (CMV) infection and disease in adults who have received an allogeneic hematopoietic stem cell (bone marrow) transplant.

What are the uses of this medicine?

This medicine is used to prevent cytomegalovirus (CMV) infection and disease in adults who have received an allogeneic hematopoietic stem cell (bone marrow) transplant.

How does this medicine work?

• An orally bioavailable, non-nucleoside, 3,4-dihydroquinazolinyl acetic acid and inhibitor of the pUL56 subunit of the viral terminase complex of cytomegalovirus (CMV), with potential CMV-specific antiviral activity.
• Upon oral administration, letermovir binds to the pUL56 subunit of the viral terminase complex of CMV and prevents the cleavage of concatemeric DNA into monomeric genome length DNA.
• As this agent interferes with viral DNA processing and subsequent viral DNA packaging into procapsids, CMV replication is blocked and CMV infection is prevented.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• receiving pimozide or ergot alkaloids
• are taking PREVYMIS with cyclosporine, do not take:

Pitavastatin or simvastatin

What drug interactions can this medicine cause?

• Co-administration of PREVYMIS with inducers of transporters (e.g. P-gp) and/or enzymes (e.g. UGTs) is not recommended due to the potential for a decrease in letermovir plasma concentrations.
• Co-administration of PREVYMIS with midazolam results in increased midazolam plasma concentrations, indicating that letermovir is a moderate inhibitor of CYP3A.
• Co-administration of PREVYMIS with drugs that are substrates of OATP1B1/3 transporters may result in a clinically relevant increase in plasma concentrations of co-administered OATP1B1/3 substrates.
• If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

Recommended Dosageː

• The recommended dosage of PREVYMIS is 480 mg administered orally or intravenously once daily.
• Initiate PREVYMIS between Day 0 and Day 28 post-transplantation (before or after engraftment), and continue through Day 100 post-transplantation.

Dosage Adjustment When Co-administered with Cyclosporineː If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily.

Administration PREVYMIS comes as a tablet or can be given by your doctor through an IV line (intravenously).

If you take PREVYMIS tablets:

• Take PREVYMIS exactly as your doctor tells you to take it.
• Do not stop taking PREVYMIS without talking to your doctor first.
• Take 1 PREVYMIS tablet once a day.
• Take PREVYMIS with or without food.
• Swallow PREVYMIS tablets whole.
• It is important that you do not miss or skip doses of PREVYMIS.
• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and take your dose at the next scheduled time. Do not take 2 doses of PREVYMIS at the same time to make up for a missed dose.
• If you take too much PREVYMIS, call your doctor right away.

If you receive PREVYMIS through an IV line (intravenously):

• PREVYMIS injection must be administered through a sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter.
• You will receive PREVYMIS 1 time each day given over 1 hour.
• If you miss or skip your dose of PREVYMIS, call your doctor right away.
• Do not use PREVYMIS injection with IV bags and infusion set materials containing the plasticizer diethylhexyl phthalate (DEHP).

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablet: 240 mg; 480 mg.
• Injection: 240 mg/12 mL (20 mg/mL) or 480 mg/24 mL (20 mg/mL) in a single-dose vial.

This medicine is available in fallowing brand namesː

• PREVYMIS

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• diarrhea
• vomiting
• swelling in your arms and legs
• cough
• headache
• tiredness
• stomach (abdominal) pain

What special precautions should I follow?

The concomitant use of PREVYMIS with certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions (PREVYMIS or concomitant drugs) or reduced therapeutic effect of PREVYMIS or the concomitant drug.

What to do in case of emergency/overdose?

• There is no specific antidote for overdose with PREVYMIS.
• In case of overdose, it is recommended that the patient be monitored for adverse reactions and appropriate symptomatic treatment be instituted.
• It is unknown whether dialysis will result in meaningful removal of PREVYMIS from systemic circulation.

Can this medicine be used in pregnancy?

• No adequate human data are available to establish whether PREVYMIS poses a risk to pregnancy outcomes.

Can this medicine be used in children?

• Safety and efficacy of PREVYMIS in patients below 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient: letermovir Inactive ingredients:

• Tablets: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone 25. Film coating: hypromellose 2910, iron oxide red (only for 480 mg tablets), iron oxide yellow, lactose monohydrate, titanium dioxide, triacetin. Carnauba wax is added as a polishing agent.
• Injection: hydroxypropyl betadex, sodium chloride, sodium hydroxide, and Water for Injection, USP.

Who manufactures and distributes this medicine?

• Distributed by: Merck Sharp & Dohme Corp., a subsidiary of

MERCK & CO.,INC., Whitehouse Station, NJ 08889, USA

What should I know about storage and disposal of this medication?

Tablets:

• Store PREVYMIS tablets in the original package until use.
• Store PREVYMIS tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Injection:

• Store PREVYMIS injection vials at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
• Store in the original carton to protect from exposure to light.

• Dailymed label info on Letermovir
• FDA Letermovir

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