What is PREVYMIS® (letermovir)?
Important Safety Information
PREVYMIS is a prescription medicine used to help prevent:
- Cytomegalovirus (CMV) infection and disease in adults and children 6 months and older weighing at least 13.2 pounds (lbs) or 6 kilograms (kg) who:
- have received an allogeneic hematopoietic stem cell (bone marrow) transplant, and
- have a high risk for getting CMV infection and disease.
- CMV disease in adults and children 12 years of age and older weighing at least 88.2 lbs (40 kg) who:
- have received a kidney transplant, and
- have a high risk for getting CMV disease.
It is not known if PREVYMIS is safe and effective in:
- children under 6 months of age or weighing less than 13.2 lbs (6 kg) who received a hematopoietic stem cell transplant, or
- children under 12 years of age or weighing less than 88.2 lbs (40 kg) who received a kidney transplant.
Important Safety Information
Do not take PREVYMIS if you take pimozide or ergot alkaloids.
If you are taking PREVYMIS with cyclosporine, do not take pitavastatin or simvastatin.
Before taking PREVYMIS, tell your healthcare provider about all your medical conditions, including if you have kidney or liver problems; are pregnant or plan to become pregnant, since it is not known if PREVYMIS will harm your unborn baby; and if you are breastfeeding or plan to breastfeed, since it is not known if PREVYMIS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking PREVYMIS.
Tell your healthcare provider 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 can cause serious side effects.
Know the medicines you take. Keep a list of medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider 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 healthcare provider first.
The most common side effects of PREVYMIS in adults who have received a hematopoietic stem cell transplant include: nausea, diarrhea, vomiting, swelling in your arms and legs, cough, headache, tiredness, and stomach (abdominal) pain.
The most common side effect of PREVYMIS in adults who have received a kidney transplant is diarrhea.
The side effects of PREVYMIS in children are similar to the side effects in adults.
These are not all the possible side effects of PREVYMIS.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please read the accompanying Patient Information and Instructions for Use for PREVYMIS, and discuss them with your doctor.
The Physician Prescribing Information also is available.
PREVYMIS is a prescription medicine used to help prevent:
- Cytomegalovirus (CMV) infection and disease in adults and children 6 months and older weighing at least 13.2 pounds (lbs) or 6 kilograms (kg) who:
- have received an allogeneic hematopoietic stem cell (bone marrow) transplant, and
- have a high risk for getting CMV infection and disease.
- CMV disease in adults and children 12 years of age and older weighing at least 88.2 lbs (40 kg) who:
- have received a kidney transplant, and
- have a high risk for getting CMV disease.
It is not known if PREVYMIS is safe and effective in:
- children under 6 months of age or weighing less than 13.2 lbs (6 kg) who received a hematopoietic stem cell transplant, or
- children under 12 years of age or weighing less than 88.2 lbs (40 kg) who received a kidney transplant.
Important Safety Information
Do not take PREVYMIS if you take pimozide or ergot alkaloids.
If you are taking PREVYMIS with cyclosporine, do not take pitavastatin or simvastatin.
Before taking PREVYMIS, tell your healthcare provider about all your medical conditions, including if you have kidney or liver problems; are pregnant or plan to become pregnant, since it is not known if PREVYMIS will harm your unborn baby; and if you are breastfeeding or plan to breastfeed, since it is not known if PREVYMIS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking PREVYMIS.
Tell your healthcare provider 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 can cause serious side effects.
Know the medicines you take. Keep a list of medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider 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 healthcare provider first.
The most common side effects of PREVYMIS in adults who have received a hematopoietic stem cell transplant include: nausea, diarrhea, vomiting, swelling in your arms and legs, cough, headache, tiredness, and stomach (abdominal) pain.
The most common side effect of PREVYMIS in adults who have received a kidney transplant is diarrhea.
The side effects of PREVYMIS in children are similar to the side effects in adults.
These are not all the possible side effects of PREVYMIS.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please read the accompanying Patient Information and Instructions for Use for PREVYMIS, and discuss them with your doctor.
The Physician Prescribing Information also is available.