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.

VIJOICE (NDA-215039)

(ALPELISIB)

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

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07/22/2025 (SUPPL-3)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Addition of the following to the bulleted line listing:

. . .

Other Clinical Trials Experience

The following additional adverse reactions and laboratory abnormality have been identified following administration of

VIJOICE: hypersensitivity, lipase increased, dermatitis, and abdominal pain.

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

MEDICATION GUIDE

Addition of the following to the bulleted line listing:

. . .

How should I take VIJOICE?

Read the detailed “Instructions for Use” that comes with VIJOICE for information about the right way to prepare and take or give a dose of VIJOICE tablets or oral granules.

. . .

VIJOICE tablets:

VIJOICE tablets can be swallowed whole, or prepared as a suspension to take or give by mouth or through a feeding tube.

If you are taking or giving VIJOICE tablets whole:
- Swallow VIJOICE tablets whole and take with food. Do not chew, divide, or crush the tablets.
- Do not take VIJOICE tablets that are broken, cracked, or that look damaged.
If you cannot swallow tablets whole or need to use a feeding tube, you will need to mix VIJOICE tablets with water before taking or giving the dose.

VIJOICE oral granules:

VIJOICE oral granules can be placed directly onto the tongue and swallowed with water,or mixed with a beverage or soft food to take or give by mouth, or mixed with water to give through a feeding tube.

. . .

11/17/2022 (SUPPL-1)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Severe Hypersensitivity

Additions and revisions underlined:

Severe hypersensitivity reactions, including anaphylaxis, anaphylactic shock, and angioedema, have occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE.

5.5 Diarrhea or Colitis

Additions and revisions underlined:

Severe diarrhea, resulting in dehydration and in some cases in acute kidney injury, as well as colitis, have occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE. VIJOICE is not approved for use in the oncology setting.

In the EPIK-P1 study, 16% of patients experienced Grade 1 diarrhea during treatment with VIJOICE [see Adverse Reactions (6.1)].

Monitor patients for diarrhea and additional symptoms of colitis, such as abdominal pain and mucus or blood in stool. Interrupt, reduce the dose or permanently discontinue VIJOICE based on the severity of diarrhea or colitis [see Dosage and Administration (2.3)].

6 Adverse Reactions

Additions and revisions underlined:

The following clinically significant adverse reactions are discussed elsewhere in the labeling:

Severe Hypersensitivity [see Warnings and Precautions (5.1)]
Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)]
Hyperglycemia [see Warnings and Precautions (5.3)]
Pneumonitis [see Warnings and Precautions (5.4)]
Diarrhea or Colitis [see Warnings and Precautions (5.5)]

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

PATIENT COUNSELING INFORMATION

Additions and revisions underlined:

Hyperglycemia

Advise patients and their caregivers that VIJOICE may cause hyperglycemia and requires monitoring of fasting glucose periodically during therapy. Advise patients and their caregivers of the signs and symptoms of hyperglycemia (e.g., excessive thirst, urinating more often than usual or higher amount of urine than usual, or increased appetite with weight loss) [see Warnings and Precautions (5.3)].

Pneumonitis

Inform patients and their caregivers that VIJOICE may cause pneumonitis and to immediately report new or worsening respiratory symptoms [see Warnings and Precautions (5.4)].

Diarrhea or Colitis

Advise patients and their caregivers that VIJOICE may cause diarrhea, which may be severe, and to start anti-diarrheal treatment, increase oral fluids, and notify their healthcare provider if diarrhea occurs while taking VIJOICE [see Warnings and Precautions (5.5)].

Advise patients and their caregivers that VIJOICE may cause colitis and to notify their healthcare provider immediately of any symptoms of colitis, such as abdominal pain and mucus or blood in stool, while taking VIJOICE [see Warnings and Precautions (5.5)].

Patient Information

Additions and revisions underlined:

VIJOICE may cause serious side effects, including:

- Severe allergic reactions. Tell your healthcare provider or get medical help right away if you have trouble breathing, swelling of the face or throat, flushing, rash, fever, or fast heart rate during treatment with VIJOICE.

. . .

- Diarrhea or colitis (inflammation of your intestines). Diarrhea is common with VIJOICE and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with VIJOICE. Your healthcare provider may tell you to drink more fluids or take medicines to treat diarrhea or colitis.