ated with increased risk for CMV reactivation (high risk stratum): Human Leukocyte Antigen (HLA)-related donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B or –DR; haploidentical donor; unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B, -C and -DRB1; use of umbilical cord blood as stem cell source; use of ex vivo T-cell-depleted grafts; Grade 2 or greater Graft-Versus-Host Disease (GVHD) requiring systemic corticosteroids. The remaining 70% of subjects did not meet any of these high risk stratum criteria and were therefore included in the low risk stratum. Additionally, 48% of subjects received a myeloablative regimen, 51% were receiving cyclosporine, and 43% were receiving tacrolimus. The most common primary reasons for transplant were acute myeloid leukemia (38%), myelodysplastic syndrome (16%), and lymphoma (12%).
Storage And Handling
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) [see USP Controlled Room Temperature].
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) [see USP Controlled Room Temperature].Store in the original carton to protect from exposure to light.
17 Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Spl Patient Package Insert
•Patient InformationPREVYMIS™ (PREH-vih-miss)(letermovir) tablets(letermovir) injection, for intravenous useWhat is PREVYMIS?PREVYMIS is a prescription medicine to help to prevent cytomegalovirus (CMV) infection and disease in adults who have received an allogeneic hematopoietic stem cell (bone marrow) transplant.It is not known if PREVYMIS is safe and effective in children under 18 years of age.Who should not take PREVYMIS?Do not take PREVYMIS if you take:PimozideErgot alkaloidsIf you are taking PREVYMIS with cyclosporine, do not take:Pitavastatin or simvastatinWhat should I tell my doctor before taking PREVYMIS?Tell your doctor about all your medical conditions, including if you:Have kidney or liver problems.Are pregnant or plan to become pregnant. It is not known if PREVYMIS will harm your unborn baby.Are breastfeeding or plan to breastfeed. It is not known if PREVYMIS passes into your breast milk. Talk to your doctor about the best way to feed your baby while taking PREVYMIS.Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. PREVYMIS may affect the way other medicines work, and other medicines may affect how PREVYMIS works and cause serious side effects.Know the medicines you take. Keep a list of medicines and show it to your doctor and pharmacist when you get a new medicine. Your doctor or pharmacist will tell you if it is safe to take PREVYMIS with other medicines. Do not start or stop taking another medicine without telling your doctor first.How should I take PREVYMIS?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 tab |
