Drug Safety-related Labeling Changes (SrLC)

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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.

LIVTENCITY (NDA-215596)

(MARIBAVIR)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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11/21/2025 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions

Additions and/or revisions underlined:

The concomitant use of LIVTENCITY and certain drugs may result in potentially significant drug interactions, some of which may lead to reduced therapeutic effect of LIVTENCITY or adverse reactions of concomitant drugs [see Drug Interactions (7)].

See Table 4 for steps to prevent or manage these possible or known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during LIVTENCITY therapy; review concomitant medications during LIVTENCITY therapy and monitor for adverse reactions.

Maribavir is primarily metabolized by CYP3A4. Drugs that are strong inducers of CYP3A4 are expected to decrease maribavir plasma concentrations and may result in reduced virologic response. Thus, coadministration of LIVTENCITY with these drugs is not recommended, except with a dose adjustment when coadministered with selected anticonvulsants (carbamazepine and phenytoin). With moderate CYP3A4 inducers rifabutin (antimycobacterial) and phenobarbital (anticonvulsant), a dose adjustment is recommended [see Dosage and Administration (2.2, 2.3) and Drug Interactions (7.3)]. For other moderate CYP3A4 inducers, the appropriate maribavir dose adjustment has not been determined.

Use with Immunosuppressant Drugs

LIVTENCITY has the potential to increase the drug concentrations of certain immunosuppressant drugs where minimal concentration changes may lead to serious adverse events (including tacrolimus, cyclosporine, sirolimus and everolimus). Frequently monitor immunosuppressant drug levels throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY and adjust the immunosuppressant dose, as needed [see Drug Interactions (7.3) and Clinical Pharmacology (12.3)].

7 Drug Interactions

7.2 Potential for Other Drugs to Affect LIVTENCITY

Additions and/or revisions underlined:

Maribavir is a substrate of CYP3A4. Coadministration of LIVTENCITY with strong inducers of CYP3A4 is not recommended, except with a dose adjustment when coadministered with selected anticonvulsants (carbamazepine and phenytoin). With the moderate CYP3A4 inducers, rifabutin (antimycobacterial) and phenobarbital (anticonvulsant), a dose adjustment is recommended [see Dosage and Administration (2.2, 2.3) and Drug Interactions (7.3)]. For other moderate CYP3A4 inducers, the appropriate maribavir dose adjustment has not been determined.

7.3 Potential for LIVTENCITY to Affect Other Drugs

Additions and/or revisions underlined:

Maribavir is an inhibitor of P-gp and breast cancer resistance protein (BCRP). Coadministration of LIVTENCITY with drugs that are substrates of P-gp and/or BCRP where minimal concentration changes may lead to serious adverse events may result in a clinically relevant increase in plasma concentrations of these substrates (see Table 4). Table 4 provides a list of established or potentially clinically significant drug interactions, based on either clinical drug interaction studies or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or decrease in efficacy [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

Table 4: Established and Other Potentially Significant Drug Interactionsa

Addition of “A dose adjustment of LIVTENCITY to 800 mg twice daily is recommended when coadministered with rifabutin.” to the Clinical Comments section of table. Additions and/or revisions underlined; please refer to label for complete information.

09/08/2022 (SUPPL-3)

Approved Drug Label (PDF)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Information

Additions and revisions underlined:

How should I take LIVTENCITY?

Take LIVTENCITY exactly as your healthcare provider tells you to take it.
Take LIVTENCITY 2 times a day.
Take LIVTENCITY with or without food.
Swallow LIVTENCITY tablets whole.
If you are not able to swallow tablets whole, you can break apart (disperse) the tablets in drinking water or crush the tablets and mix with drinking water and take by mouth. See the “Instructions for Use” for detailed instructions on how to prepare and give a dose of LIVTENCITY tablets by dispersing or crushing tablets and taking by mouth.
If you have a Nasogastric (NG) or Orogastric (OG) Tube (French size 10 or larger), you can disperse the tablets and take through a NG or OG tube. See the “Instructions for Use” for detailed instructions on how to prepare and give a dose of LIVTENCITY tablets through a NG or OG Tube.