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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
PREVYMIS (NDA-209940)
(LETERMOVIR)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
08/30/2024 (SUPPL-12)
5 Warnings and Precautions
5.2 Risks Associated with Hydroxypropyl Betadex Excipient in Intravenous Formulation
Newly added subsection:
Intravenous formulation of PREVYMIS contains
the excipient hydroxypropyl betadex. PREVYMIS injection should be used only in patients
unable to take oral therapy and patients should be switched to oral PREVYMIS as soon as they are able to take oral medications. If possible, intravenous administration should
not exceed 4 weeks [see Dosage and
Administration (2.1)].
In patients with renal impairment, accumulation of hydroxypropyl betadex may occur. In adult patients with CLcr less than 50 mL/min and in pediatric patients with a similar degree of renal impairment (based on age- appropriate assessment of renal function) receiving PREVYMIS injection, closely monitor serum creatinine levels [see Dosage and Administration (2.7) and Use in Specific Populations (8.6)].
Animal studies have shown the potential for hydroxypropyl betadex to cause ototoxicity [see Nonclinical Toxicology (13.2)]. The active ingredient, letermovir, is not known to be associated with ototoxicity.
6 Adverse Reactions
6.1 Clinical Trials Experience
Additions and/or revisions underlined:
…
Pediatric Recipients of an Allogeneic HSCT
The safety of PREVYMIS was evaluated in 63 pediatric subjects aged 2 months to less than 18 years of age who received an allogeneic HSCT (P030). PREVYMIS was administered orally (tablet or pellet) or intravenously. The duration of PREVYMIS exposure ranged from 3 days to 102 days (median duration 84 days). The safety profile was consistent with the safety profile observed in clinical trials of PREVYMIS in adults [see Use in Specific Populations (8.4) and Clinical Studies (14.4)].
7 Drug Interactions
7.3 Established and Other Potentially Significant Drug Interactions
Changes to Table 11 to add dosage adjustment for pediatric patients 12 years of age and older when Prevymis is co-administered with cyclosporine.
Please refer to label to view Table 11.
8 Use in Specific Populations
8.4 Pediatric Use
Additions and/or
revisions underlined:
The safety and effectiveness of PREVYMIS have
been established for:
- Prophylaxis of CMV infection and disease in pediatric CMV-seropositive recipients of an allogeneic HSCT 6 months of age and older and weighing at least 6 kg, and
Prophylaxis of CMV disease in pediatric kidney transplant recipients 12 years of age and older and weighing at least 40 kg who are at high risk [D+/R-].
HSCT Recipients: The use of PREVYMIS for prophylaxis of CMV infection and disease in pediatric recipients of an allogeneic HSCT is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data from pediatric patients in TrialP030. The safety and pharmacokinetic results were similar to those in adults [see Warnings and Precautions (5.2), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical studies (14.2, 14.4)].
Kidney Transplant Recipients: The use of PREVYMIS for prophylaxis of CMV disease in high-risk [D+/R-] kidney transplant recipients 12 years of age and older and weighing at least 40 kg is supported by evidence from an adequate and well-controlled study in adults and safety data from pediatric HSCT recipients (Trial P030). Letermovir exposures are expected to be similar between adult and pediatric patients 12 years of age and older and weighing at least 40 kg [see Warnings and Precautions (5.2), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical studies (14.3, 14.4)].
The safety and effectiveness of PREVYMIS have not been established for:
HSCT recipients less than 6 months of age or weighing less than 6 kg, or
Kidney transplant recipients less than 12 years of age or weighing less than 40 kg.
8.6 Renal Impairment
Additions and/or
revisions underlined:
For
adult patients with CLcr greater than 10 mL/min (by Cockcroft-Gault equation), and pediatric patients
with a similar degree of renal impairment (based on age-appropriate assessment
of renal function), no dosage adjustment of PREVYMIS is required based on
renal impairment [see Clinical
Pharmacology (12.3)]. The safety
of PREVYMIS in adult patients
with end-stage renal disease (CLcr less than 10 mL/min) or in pediatric patients
with a similar degree of renal impairment (based on age-appropriate assessment of renal
function), including patients on dialysis, is unknown.
In adult patients with CLcr less than 50 mL/min and in pediatric patients with a similar degree of renal impairment (based on age-appropriate assessment of renal function) receiving PREVYMIS injection, accumulation of the intravenous vehicle, hydroxypropyl betadex, could occur. Closely monitor serum creatinine levels in these patients [see Dosage and Administration (2.7) and Warnings and Precautions (5.2)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONAdditions and/or
revisions underlined:
Advise the patient to read the FDA-approved patient
labeling (Patient Information and Instructions for Use).
…
Risks Associated with Hydroxypropyl Betadex Excipient in Intravenous Formulation
Inform patients that the intravenous formulation of PREVYMIS contains hydroxypropyl betadex which is eliminated through glomerular filtration and may accumulate in patients with renal impairment. In animals, hydroxypropyl betadex has been shown to cause ototoxicity [see Warnings and Precautions (5.2), Use in Specific Populations (8.6) and Nonclinical Toxicology (13.2)].
…
Advise patients that PREVYMIS injection should be used only in patients unable to take oral therapy and that patients should be switched to oral therapy as soon as they are able [see Dosage and Administration (2.1)].
For PREVYMIS
oral pellets, advise patients or caregivers to read and follow the Instructions
for Use for preparing and taking the correct dose [see Dosage and Administration (2.3, 2.4, 2.5, 2.6, 2.9)].
Storage
Advise patients to store PREVYMIS tablets and oral pellets in the original package until use [see How Supplied/Storage and Handling (16)].
Additions and/or revisions underlined:
…
PREVYMIS® (PREH-vih-miss) (letermovir) oral pellets
…
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:
o have received an allogeneic hematopoietic stem cell (bone marrow) transplant, and
o 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:
o have received a kidney transplant, and
o have a high risk for getting CMV disease.
It is not known if PREVMYIS 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.
…
· PREVYMIS comes as a tablet, oral pellets, or can be given by your healthcare provider through an IV line (intravenously).
· PREVYMIS given intravenously should be used only if you are unable to take PREVYMIS tablets or PREVYMIS oral pellets. You should switch to PREVYMIS tablets or PREVYMIS oral pellets as soon as you are able to.
Take PREVYMIS tablets or oral pellets exactly as your healthcare provider tells you to take it. Do not stop taking PREVYMIS without talking to your healthcare provider first.
Take PREVYMIS tablets or oral pellets 1 time a day.
It is important that you do not miss or skip doses of PREVYMIS.
If you miss a dose of PREVMYIS tablets or oral pellets, 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 or take more than your prescribed dose to make up for a missed dose.
If you take too much PREVYMIS tablets or oral pellets, call your healthcare provider right away.
If you take PREVYMIS tablets:
If you take PREVYMIS oral pellets:
Your healthcare provider will tell you the number of PREVYMIS oral pellet packets to take for your prescribed dose.
PREVMYIS oral pellets can be taken by mouth after mixing with soft food or given through a nasogastric tube (NG tube) or gastric tube (G tube).
See the Instructions for Use for the right way to prepare and take a dose of PREVYMIS oral pellets. Keep the Instructions for Use and follow it each time you prepare and take PREVYMIS oral pellets.
If you receive PREVYMIS through an IV line (intravenously):
You will receive PREVYMIS 1 time each day given over 1 hour.
If you miss or skip your dose of PREVYMIS, call your healthcare provider right away.
…
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.
How should I store PREVYMIS?
Store PREVYMIS tablets, PREVYMIS oral pellets, and PREVYMIS injection at room temperature between 68°F to 77°F (20°C to 25°C).
Store PREVYMIS tablets in the original package until you are ready to take it to protect from moisture.
Store PREVYMIS oral pellets in the original packet until you are ready to take them.
Store PREVYMIS injection in the original carton to protect from exposure to light.
What are the ingredients in PREVYMIS?
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, and triacetin. Carnauba wax is added as a polishing agent.
Oral Pellets: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone K-29/32.
Film coating: hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin.
Injection: hydroxypropyl betadex, sodium chloride, sodium hydroxide, and Water for Injection.
08/30/2024 (SUPPL-16)
5 Warnings and Precautions
5.2 Risks Associated with Hydroxypropyl Betadex Excipient in Intravenous Formulation
Newly added subsection:
Intravenous formulation of PREVYMIS contains
the excipient hydroxypropyl betadex. PREVYMIS injection should be used only in patients
unable to take oral therapy and patients should be switched to oral PREVYMIS as soon as they are able to take oral medications. If possible, intravenous administration should
not exceed 4 weeks [see Dosage and
Administration (2.1)].
In patients with renal impairment, accumulation of hydroxypropyl betadex may occur. In adult patients with CLcr less than 50 mL/min and in pediatric patients with a similar degree of renal impairment (based on age- appropriate assessment of renal function) receiving PREVYMIS injection, closely monitor serum creatinine levels [see Dosage and Administration (2.7) and Use in Specific Populations (8.6)].
Animal studies have shown the potential for hydroxypropyl betadex to cause ototoxicity [see Nonclinical Toxicology (13.2)]. The active ingredient, letermovir, is not known to be associated with ototoxicity.
6 Adverse Reactions
6.1 Clinical Trials Experience
Additions and/or revisions underlined:
…
Pediatric Recipients of an Allogeneic HSCT
The safety of PREVYMIS was evaluated in 63 pediatric subjects aged 2 months to less than 18 years of age who received an allogeneic HSCT (P030). PREVYMIS was administered orally (tablet or pellet) or intravenously. The duration of PREVYMIS exposure ranged from 3 days to 102 days (median duration 84 days). The safety profile was consistent with the safety profile observed in clinical trials of PREVYMIS in adults [see Use in Specific Populations (8.4) and Clinical Studies (14.4)].
7 Drug Interactions
7.3 Established and Other Potentially Significant Drug Interactions
Changes to Table 11 to add dosage adjustment for pediatric patients 12 years of age and older when Prevymis is co-administered with cyclosporine.
Please refer to label to view Table 11.
8 Use in Specific Populations
8.4 Pediatric Use
Additions and/or
revisions underlined:
The safety and effectiveness of PREVYMIS have
been established for:
- Prophylaxis of CMV infection and disease in pediatric CMV-seropositive recipients of an allogeneic HSCT 6 months of age and older and weighing at least 6 kg, and
Prophylaxis of CMV disease in pediatric kidney transplant recipients 12 years of age and older and weighing at least 40 kg who are at high risk [D+/R-].
HSCT Recipients: The use of PREVYMIS for prophylaxis of CMV infection and disease in pediatric recipients of an allogeneic HSCT is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data from pediatric patients in TrialP030. The safety and pharmacokinetic results were similar to those in adults [see Warnings and Precautions (5.2), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical studies (14.2, 14.4)].
Kidney Transplant Recipients: The use of PREVYMIS for prophylaxis of CMV disease in high-risk [D+/R-] kidney transplant recipients 12 years of age and older and weighing at least 40 kg is supported by evidence from an adequate and well-controlled study in adults and safety data from pediatric HSCT recipients (Trial P030). Letermovir exposures are expected to be similar between adult and pediatric patients 12 years of age and older and weighing at least 40 kg [see Warnings and Precautions (5.2), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical studies (14.3, 14.4)].
The safety and effectiveness of PREVYMIS have not been established for:
HSCT recipients less than 6 months of age or weighing less than 6 kg, or
Kidney transplant recipients less than 12 years of age or weighing less than 40 kg.
8.6 Renal Impairment
Additions and/or
revisions underlined:
For
adult patients with CLcr greater than 10 mL/min (by Cockcroft-Gault equation), and pediatric patients
with a similar degree of renal impairment (based on age-appropriate assessment
of renal function), no dosage adjustment of PREVYMIS is required based on
renal impairment [see Clinical
Pharmacology (12.3)]. The safety
of PREVYMIS in adult patients
with end-stage renal disease (CLcr less than 10 mL/min) or in pediatric patients
with a similar degree of renal impairment (based on age-appropriate assessment of renal
function), including patients on dialysis, is unknown.
In adult patients with CLcr less than 50 mL/min and in pediatric patients with a similar degree of renal impairment (based on age-appropriate assessment of renal function) receiving PREVYMIS injection, accumulation of the intravenous vehicle, hydroxypropyl betadex, could occur. Closely monitor serum creatinine levels in these patients [see Dosage and Administration (2.7) and Warnings and Precautions (5.2)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONAdditions and/or
revisions underlined:
Advise the patient to read the FDA-approved patient
labeling (Patient Information and Instructions for Use).
…
Risks Associated with Hydroxypropyl Betadex Excipient in Intravenous Formulation
Inform patients that the intravenous formulation of PREVYMIS contains hydroxypropyl betadex which is eliminated through glomerular filtration and may accumulate in patients with renal impairment. In animals, hydroxypropyl betadex has been shown to cause ototoxicity [see Warnings and Precautions (5.2), Use in Specific Populations (8.6) and Nonclinical Toxicology (13.2)].
…
Advise patients that PREVYMIS injection should be used only in patients unable to take oral therapy and that patients should be switched to oral therapy as soon as they are able [see Dosage and Administration (2.1)].
For PREVYMIS
oral pellets, advise patients or caregivers to read and follow the Instructions
for Use for preparing and taking the correct dose [see Dosage and Administration (2.3, 2.4, 2.5, 2.6, 2.9)].
Storage
Advise patients to store PREVYMIS tablets and oral pellets in the original package until use [see How Supplied/Storage and Handling (16)].
Additions and/or revisions underlined:
…
PREVYMIS® (PREH-vih-miss) (letermovir) oral pellets
…
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:
o have received an allogeneic hematopoietic stem cell (bone marrow) transplant, and
o 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:
o have received a kidney transplant, and
o have a high risk for getting CMV disease.
It is not known if PREVMYIS 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.
…
· PREVYMIS comes as a tablet, oral pellets, or can be given by your healthcare provider through an IV line (intravenously).
· PREVYMIS given intravenously should be used only if you are unable to take PREVYMIS tablets or PREVYMIS oral pellets. You should switch to PREVYMIS tablets or PREVYMIS oral pellets as soon as you are able to.
Take PREVYMIS tablets or oral pellets exactly as your healthcare provider tells you to take it. Do not stop taking PREVYMIS without talking to your healthcare provider first.
Take PREVYMIS tablets or oral pellets 1 time a day.
It is important that you do not miss or skip doses of PREVYMIS.
If you miss a dose of PREVMYIS tablets or oral pellets, 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 or take more than your prescribed dose to make up for a missed dose.
If you take too much PREVYMIS tablets or oral pellets, call your healthcare provider right away.
If you take PREVYMIS tablets:
If you take PREVYMIS oral pellets:
Your healthcare provider will tell you the number of PREVYMIS oral pellet packets to take for your prescribed dose.
PREVMYIS oral pellets can be taken by mouth after mixing with soft food or given through a nasogastric tube (NG tube) or gastric tube (G tube).
See the Instructions for Use for the right way to prepare and take a dose of PREVYMIS oral pellets. Keep the Instructions for Use and follow it each time you prepare and take PREVYMIS oral pellets.
If you receive PREVYMIS through an IV line (intravenously):
You will receive PREVYMIS 1 time each day given over 1 hour.
If you miss or skip your dose of PREVYMIS, call your healthcare provider right away.
…
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.
How should I store PREVYMIS?
Store PREVYMIS tablets, PREVYMIS oral pellets, and PREVYMIS injection at room temperature between 68°F to 77°F (20°C to 25°C).
Store PREVYMIS tablets in the original package until you are ready to take it to protect from moisture.
Store PREVYMIS oral pellets in the original packet until you are ready to take them.
Store PREVYMIS injection in the original carton to protect from exposure to light.
What are the ingredients in PREVYMIS?
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, and triacetin. Carnauba wax is added as a polishing agent.
Oral Pellets: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone K-29/32.
Film coating: hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin.
Injection: hydroxypropyl betadex, sodium chloride, sodium hydroxide, and Water for Injection.
08/02/2023 (SUPPL-10)
6 Adverse Reactions
6.1 Clinical Trials ExperienceAdditions and/or revisions underlined:
…
Adult CMV-seropositive Recipients [R+] of an Allogeneic HSCT
Prophylaxis Through Week 14 (~100 days) Post-HSCT
The safety of PREVYMIS was evaluated in a 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-HSCT. 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.
…
Prophylaxis From Week 14 (~100 days) Through Week 28 (~200 days) Post-HSCT
The safety of PREVYMIS was evaluated in a Phase 3 randomized, double-blind, placebo-controlled trial (P040) in which 218 subjects who completed PREVYMIS prophylaxis through ~100 days post-HSCT were randomized to treatment with PREVYMIS (N=144) or placebo (N=74) through Week 28 (~200 days) post- HSCT. Adverse events were those reported while subjects were on study drug or within two weeks of study drug completion/discontinuation.
The most commonly reported adverse events in P040 were similar to those reported in P001. Study drug was discontinued due to an adverse event in 5% of PREVYMIS subjects and 1% of placebo subjects. The cardiac adverse event rate was 4% in the PREVYMIS and placebo groups.
The rates of hematologic laboratory abnormalities were comparable in the PREVYMIS and placebo groups. Serum creatinine abnormalities > 1.5 mg/dL occurred in 15% of PREVYMIS and 8% of placebo subjects.
8 Use in Specific Populations
8.5 Geriatric UseAdditions and/or revisions underlined
Of the 373 subjects treated with PREVYMIS in Trial P001, 56 (15%) subjects were 65 years of age or older. Of 144 subjects treated with PREVYMIS in Trial P040, 32 (22%) subjects were 65 years of age or older. Of the 292 subjects treated with PREVYMIS in Trial P002, 48 (16%) subjects were 65 years of age or older. Safety and efficacy were similar across older and younger subjects in each trial. No dosage adjustment of PREVYMIS is required based on age [see Clinical Pharmacology (12.3)].
06/05/2023 (SUPPL-11)
6 Adverse Reactions
6.1 Clinical Trials Experience8 Use in Specific Populations
8.5 Geriatric UseAdditions and/or revisions underlined:
Of the 373 subjects treated with PREVYMIS in Trial P001, 56 (15%) subjects were 65 years of age or older. Of the 292 subjects treated with PREVYMIS in Trial P002, 48 (16%) subjects were 65 years of age or older. Safety and efficacy were similar across older and younger subjects in each trial. No dosage adjustment of PREVYMIS is required based on age [see Clinical Pharmacology (12.3)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATIONAdditions and/or
revisions underlined:
What is PREVYMIS?
PREVYMIS is a prescription medicine used to help prevent:
cytomegalovirus (CMV) infection and disease in adults who have received an allogeneic hematopoietic stem cell (bone marrow) transplant and who have a high risk for getting CMV infection and disease.
CMV disease in adults who have received a kidney transplant and who have a high risk for getting CMV disease.
…
Before taking PREVYMIS, tell your healthcare provider about all your medical conditions, including if you:
…
· If you take PREVYMIS tablets:
…
Take 1 PREVYMIS tablet 1 time a day.
…
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 or take more than your prescribed dose to make up for a missed dose.
…
What are the possible side effects of PREVYMIS?
The most common side effects of PREVYMIS in adults who have received a hematopoietic stem cell transplant include:
…
The most common side effect of PREVYMIS in adults who have received a kidney transplant is diarrhea.
…
03/23/2020 (SUPPL-6)
7 Drug Interactions
7.4 Drugs without Clinically Significant Interactions with PREVYMIS(addition underlined)
No clinically significant interactions were observed in clinical drug-drug interaction studies of letermovir and acyclovir, digoxin, mycophenolate mofetil, fluconazole, itraconazole, posaconazole, ethinyl estradiol, and levonorgestrel.
08/29/2019 (SUPPL-3)
7 Drug Interactions
7.1 Potential for Other Drugs to Affect PREVYMIS(additions/revisions are underlined)
Letermovir is a substrate of organic anion-transporting polypeptide 1B1/3 (OATP1B1/3) and P- glycoprotein (P-gp) transporters and UDP-glucuronosyltransferase 1A1/3 (UGT1A1/3) enzymes. Co- administration of PREVYMIS with drugs that are inhibitors of OATP1B1/3 transporters may result in increases in letermovir plasma concentrations (Table 3).
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.
(extensive changes to table; please refer to labeling)
03/05/2019 (SUPPL-1)
7 Drug Interactions
7.4 Drugs without Clinically Significant Interactions with PREVYMIS(addition underlined)
No clinically significant interactions were observed in clinical drug-drug interaction studies of letermovir and acyclovir, digoxin, mycophenolate mofetil, fluconazole, posaconazole, ethinyl estradiol, and levonorgestrel.