Prevymis

What Is Prevymis?

Prevymis (letermovir) is a CMV DNA terminase complex inhibitor indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

What Are Side Effects of Prevymis?

Common side effects of Prevymis include:

• nausea,
• diarrhea,
• vomiting,
• swelling of extremities,
• cough,
• headache,
• fatigue,
• and abdominal pain.

Dosage for Prevymis

The dose of Prevymis is 480 mg administered once daily orally or as an intravenous (IV) infusion over 1 hour through 100 days post-transplant.

What Drugs, Substances, or Supplements Interact with Prevymis?

Prevymis may interact with:

• amiodarone,
• warfarin,
• phenytoin,
• antidiabetic drugs,
• voriconazole,
• rifampin,
• pimozide,
• ergot alkaloids,
• HMG-CoA reductase inhibitors,
• immunosuppressants,
• proton pump inhibitors (PPIs),
• alfentanil,
• fentanyl,
• midazolam,
• and quinidine.

Prevymis During Pregnancy and Breastfeeding

Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Prevymis; it is unknown how it would affect a fetus. It is unknown if Prevymis passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Prevymis (letermovir) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Prevymis Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fast or irregular heartbeats.

Serious side effects may occur if you also use certain other medications.

Common side effects may include:

• nausea, diarrhea, vomiting, stomach pain;
• swelling in your arms or legs;
• cough;
• headache; or
• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Prevymis (Letermovir Tablets)

 

Prevymis Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult CMV-Seropositive Recipients [R+] Of An Allogeneic HSCT

The safety of PREVYMIS was evaluated in one Phase 3 randomized, double-blind, placebo-controlled trial (P001) in which 565 subjects were randomized and treated with PREVYMIS (N=373) or placebo (N=192) through Week 14 post-transplant. Adverse events were those reported while subjects were on study medication or within two weeks of study medication completion/discontinuation. The mean time for reporting adverse events and laboratory abnormalities was approximately 22% longer in the PREVYMIS arm compared to the placebo arm.

Cardiac Adverse Events

The cardiac adverse event rate (regardless of investigator-assessed causality) was higher in subjects receiving PREVYMIS (13%) compared to subjects receiving placebo (6%). The most common cardiac adverse events were tachycardia (reported in 4% of PREVYMIS subjects and in 2% of placebo subjects) and atrial fibrillation (reported in 3% of PREVYMIS subjects and in 1% of placebo subjects). Among those subjects who experienced one or more cardiac adverse events, 85% of PREVYMIS and 92% of placebo subjects had events reported as mild or moderate in severity.

Common Adverse Events

The rate of adverse events occurring in at least 10% of subjects in the PREVYMIS group and at a frequency at least 2% greater than placebo are outlined in Table 1.

Table 1: Trial P001 All Grade Adverse Events Reported in ≥ 10% of PREVYMIS-Treated HSCT Recipients at a Frequency at least 2% Greater than Placebo

Adverse Events	PREVYMIS (N=373)	Placebo (N=192)
nausea	27%	23%
diarrhea	26%	24%
vomiting	19%	14%
peripheral edema	14%	9%
cough	14%	10%
headache	14%	9%
fatigue	13%	11%
abdominal pain	12%	9%

Overall, similar proportions of subjects in each group discontinued study medication due to an adverse event (13% of PREVYMIS subjects vs. 12% of placebo subjects). The most frequently reported adverse event that led to study drug discontinuation was nausea, occurring in 2% of PREVYMIS subjects and 1% of placebo subjects. Hypersensitivity reaction, with associated moderate dyspnea, occurred in one subject following the first infusion of IV PREVYMIS after switching from oral PREVYMIS, leading to treatment discontinuation.

Laboratory Abnormalities

Selected laboratory abnormalities reported during treatment or within 2 weeks of stopping treatment are presented in the table below.

Table 2: Trial P001 Selected Laboratory Abnormalities

	PREVYMIS N=373	Placebo N=192
Absolute neutrophil count (cells/μL)
< 500	19%	19%
500 – < 750	4%	7%
750 – < 1000	8%	9%
Hemoglobin (g/dL)
< 6.5	2%	1%
6.5 – < 8.0	14%	15%
8.0 – < 9.5	41%	43%
Platelets (cells/μL)
< 25000	27%	21%
25000 – < 50000	17%	18%
50000 – < 100000	20%	30%
Serum creatinine (mg/dL)
> 2.5	2%	3%
> 1.5 – 2.5	17%	20%

The median time to engraftment (defined as absolute neutrophil count ≥ 500/mm³ on 3 consecutive days after transplantation) was 19 days in the PREVYMIS group and 18 days in the placebo group.

Read the entire FDA prescribing information for Prevymis (Letermovir Tablets)