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.

ITOVEBI (NDA-219249)

(INAVOLISIB)

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

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04/15/2026 (SUPPL-4)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.6 Renal Impairment

Additions and/or revisions underlined:

Reduce the dosage in patients with moderate (eGFR 30 to less than 60 mL/min) and severe (eGFR less than 30 mL/min) renal impairment [see Dosage and Administration (2.5)]. No dosage modification is recommended in patients with mild renal impairment (eGFR 60 to less than 90 mL/min).

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

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

How should I store ITOVEBI?

Store ITOVEBI at room temperature between 68°F to 77°F (20°C to 25°C).
Store ITOVEBI in the original container and keep the bottle tightly closed to protect from moisture.

Keep ITOVEBI and all medicines out of the reach of children.

09/25/2025 (SUPPL-2)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hyperglycemia

Additions and/or revisions underlined:

Severe or fatal hyperglycemia, including ketoacidosis, can occur in patients treated with ITOVEBI. Ketoacidosis with a fatal outcome has occurred in the postmarketing setting.

…

6 Adverse Reactions

6.2 Postmarketing Experience

Newly added subsection:The following adverse reactions have been identified during post-approval use of ITOVEBI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Metabolism and Nutrition Disorders: Ketoacidosis

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Advise patients that ITOVEBI may cause severe or fatal hyperglycemia, including ketoacidosis, and that monitoring fasting glucose levels before and periodically during therapy is needed. Advise patients to contact their healthcare provider immediately for signs and symptoms of hyperglycemia (e.g., excessive thirst, urinating more often, blurred vision, confusion, difficulty breathing, or increased appetite with weight loss) [see Warnings and Precautions (5.1)].

…

PATIENT INFORMATION

Additions and/or revisions underlined:

…

What are the possible side effects of ITOVEBI?

ITOVEBI may cause serious side effects, including:

High blood sugar levels (hyperglycemia). High blood sugar is common with ITOVEBI, and may be severe or fatal. Untreated severe hyperglycemia can lead to a condition called diabetic ketoacidosis that can happen in people treated with ITOVEBI. Diabetic ketoacidosis is a serious condition that requires treatment in a hospital and that can lead to death. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with ITOVEBI. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your
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