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.

JAYPIRCA (NDA-216059)

(PIRTOBRUTINIB)

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

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10/02/2026 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Infections

Additions and/or revisions underlined:

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients treated with JAYPIRCA. Across all clinical trials, Grade 3 or higher infections occurred in 23% of 1153 patients, most commonly pneumonia (13%), with fatal infections occurring in 4.3% of patients. Sepsis occurred in 4.8% of patients and febrile neutropenia in 3.3%. In patients with CLL/SLL, Grade 3 or higher infections occurred in 24% of patients, with fatal infections occurring in 5%. Opportunistic infections after treatment with JAYPIRCA have included, but are not limited to, Pneumocystis jirovecii pneumonia and fungal infection [see Adverse Reactions (6.1)].

…

5.2 Hemorrhage

Additions and/or revisions underlined:

Fatal and serious hemorrhage has occurred with JAYPIRCA. Major hemorrhage (defined as Grade 3 or higher bleeding or any central nervous system bleeding) occurred in 3.1% of 1153 patients treated with JAYPIRCA across all clinical trials, including gastrointestinal hemorrhage; fatal hemorrhage occurred in 0.3% of patients. Bleeding of any grade, excluding bruising and petechiae, occurred in 18% of patients [see Adverse Reactions (6.1)].

Major hemorrhage occurred in 1.8% of patients taking JAYPIRCA without antithrombotic agents and 1.3% of patients taking JAYPIRCA with antithrombotic agents.

…

5.3 Cytopenias

Additions and/or revisions underlined:

JAYPIRCA can cause cytopenias, including neutropenia, thrombocytopenia, and anemia.

Across all clinical trials, Grade 3 or 4 cytopenias, including decreased neutrophils (26%), decreased platelets (9%), and decreased hemoglobin (9%) developed in patients treated with JAYPIRCA. Grade 4 decreased neutrophils developed in 14% of patients and Grade 4 decreased platelets developed in 4.3% of patients [see Adverse Reactions (6.1)].

…

5.4 Second Primary Malignancies

Additions and/or revisions underlined:

Second primary malignancies, including non-skin carcinomas, developed in 10% of 1153 patients treated with JAYPIRCA monotherapy across all clinical trials. The most frequent malignancy was non-melanoma skin cancer, reported in 4.9% of 1153 patients. Other second primary malignancies included solid tumors (including genitourinary and breast cancers) and melanoma. Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

8 Use in Specific Populations

8.5 Geriatric Use

Additions and/or revisions underlined:

Of the patients with MCL who received the 200 mg dose of JAYPIRCA in BRUIN, 93 (78%) were 65 years of age and older and 39 (33%) were 75 years and older [see Clinical Studies (14.1)]. Clinical studies of JAYPIRCA did not include sufficient numbers of patients with MCL who were less than 65 years of age to determine whether older patients respond differently from younger adult patients. Of the patients with CLL/SLL who received the 200 mg once daily dose of JAYPIRCA in four clinical studies, 480 (61%) were 65 years of age and older and 165 (21%) were 75 years and older [see Clinical Studies (14.2)]. No overall differences in effectiveness were observed between younger and older patients.

In the pooled safety population in patients with hematologic malignancies, 720 (62%) were 65 years of age and older, while 266 (23%) were 75 years of age and older. Patients aged 65 years and older experienced higher rates of Grade 3 and higher adverse reactions and serious adverse reactions compared to patients who were less than 65 years of age.

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

PATIENT INFORMATION

Additions and/or revisions underlined:

What is JAYPIRCA?

JAYPIRCA is a prescription medicine used to treat adults with:

mantle cell lymphoma (MCL) that has come back (relapsed) or did not respond to previous treatment (refractory) and who have already received at least 2 treatments for their cancer, including a Bruton tyrosine kinase (BTK) inhibitor medicine.
relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated for their cancer with a covalent BTK inhibitor medicine.

CLL or SLL who have not previously been treated for their cancer and who have no known 17p deletion.

…

What are the possible side effects of JAYPIRCA? JAYPIRCA can cause serious side effects, including:

Infections can happen during treatment with JAYPIRCA. These infections can be serious and may lead to death. Your healthcare provider may prescribe vaccines and certain medicines if you have an increased risk of getting infections. Tell your healthcare provider right away if you develop any signs or symptoms of infection, including:

Fever
flu-like symptoms
chills
any other signs of infection
weakness

…

Liver Problems that may be severe, life-threatening, or lead to death. Your healthcare provider will do blood tests to check your liver before and during treatment with JAYPIRCA. Tell your healthcare provider or get medical help right away if you develop any signs of liver problems, including:

stomach pain or discomfort
yellow skin and eyes
dark-colored urine

…

12/02/2025 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Infections

Additions and/or revisions underlined:

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients treated with JAYPIRCA. Across clinical trials, Grade 3 or higher infections occurred in 25% of 704 patients, most commonly pneumonia (20%), with fatal infections occurring in 5% of patients. Sepsis occurred in 6% of patients and febrile neutropenia in 3.8%. In patients with CLL/SLL, Grade 3 or higher infections occurred in 32% of patients, with fatal infections occurring in 8%. Opportunistic infections after treatment with JAYPIRCA have included, but are not limited to, Pneumocystis jirovecii pneumonia and fungal infection [see Adverse Reactions (6.1)].

…

5.2 Hemorrhage

Additions and/or revision underlined:

Fatal and serious hemorrhage has occurred with JAYPIRCA. Major hemorrhage (defined as Grade 3 or higher bleeding or any central nervous system bleeding) occurred in 2.6% of 704 patients treated with JAYPIRCA, including gastrointestinal hemorrhage; fatal hemorrhage occurred in 0.3% of patients. Bleeding of any grade, excluding bruising and petechiae, occurred in 16% of patients [see Adverse Reactions (6.1)].

Major hemorrhage occurred in 0.6% of patients taking JAYPIRCA without antithrombotic agents and 2.0% of patients taking JAYPIRCA with antithrombotic agents. Consider the risks and benefits of antithrombotic agents when co-administered with JAYPIRCA. Monitor patients for signs of bleeding. Based on severity of bleeding, reduce dose, temporarily withhold, or permanently discontinue JAYPIRCA [see Dosage and Administration (2.2)].

…

5.3 Cytopenias

Additions and/or revisions underlined:

…

Across clinical trials, Grade 3 or 4 cytopenias, including decreased neutrophils (27%), decreased platelets (13%), and decreased hemoglobin (11%) developed in patients treated with JAYPIRCA. Grade 4 decreased neutrophils developed in 15% of patients and Grade 4 decreased platelets developed in 6% of patients [see Adverse Reactions (6.1)].

…

5.4 Cardiac Arrhythmias

Additions and/or revisions underlined:

Cardiac arrhythmias, including atrial fibrillation and atrial flutter, were reported in recipients of JAYPIRCA. Atrial fibrillation or flutter were reported in 3.4% of patients, with Grade 3 or 4 atrial fibrillation or flutter reported in 1.6% of 704 patients across clinical trials [see Adverse Reactions (6.1)]. Other serious cardiac arrhythmias such as supraventricular tachycardia and cardiac arrest occurred in 0.4% of patients. Patients with cardiac risk factors, such as hypertension, or previous arrhythmias may be at increased risk.

…

5.5 Second Primary Malignancies

Additions and/or revisions underlined:

Second primary malignancies, including non-skin carcinomas, developed in 9% of 704 patients treated with JAYPIRCA monotherapy across clinical trials. The most frequent malignancy was non-melanoma skin cancer, reported in 4.4% of 704 patients. Other second primary malignancies included solid tumors (including genitourinary and breast cancers) and melanoma. Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive additions and/or revisions, please refer to label for complete information.

8 Use in Specific Populations

8.5 Geriatric Use

Additions and/or revisions underlined:

Of the patients with MCL who received the 200 mg dose of JAYPIRCA in BRUIN, 93 (78%) were 65 years of age and older and 39 (33%) were 75 years and older [see Clinical Studies (14.1)]. Clinical studies of JAYPIRCA did not include sufficient numbers of patients with MCL who were less than 65 years of age to determine whether older patients respond differently from younger adult patients. Of the patients with CLL/SLL who received the 200 mg once daily dose of JAYPIRCA in BRUIN and BRUIN-321, 220 (65%) were 65 years of age and older and 78 (33%) were 75 years and older [see Clinical Studies (14.2)]. No overall differences in effectiveness were observed between younger and older patients.

In the pooled safety population in patients with hematologic malignancies in BRUIN and BRUIN CLL-321, 467 (66%) were 65 years of age and older, while 181 (26%) were 75 years of age and older. Patients aged 65 years and older experienced higher rates of Grade 3 and higher adverse reactions and serious adverse reactions compared to patients who were less than 65 years of age.

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

PATIENT INFORMATION

Additions and/or revisions underlined:

What is JAYPIRCA?

JAYPIRCA is a prescription medicine used to treat adults with:

mantle cell lymphoma (MCL) that has come back or did not respond to previous treatment and who have already received at least 2 treatments for their cancer, including a Bruton tyrosine kinase (BTK) inhibitor medicine.
chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or did not respond to previous treatment and who have already been treated with a BTK inhibitor for their cancer.
…
What are the possible side effects of JAYPIRCA?
JAYPIRCA can cause serious side effects, including:
…
The most common side effects of JAYPIRCA include:

decreased white blood cell
decreased platelet count count
decreased calcium
decreased red blood cell count
tiredness
…

06/04/2024 (SUPPL-2)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Hepatotoxicity, Including Drug-Induced Liver Injury

Newly added subsection:

Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including JAYPIRCA.

Evaluate bilirubin and transaminases at baseline and throughout treatment with JAYPIRCA. For patients who develop abnormal liver tests after JAYPIRCA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold JAYPIRCA. Upon confirmation of DILI, discontinue JAYPIRCA.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Hepatotoxicity, including DILI [see Warnings and Precautions (5.6)]

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

PATIENT COUNSELING INFORMATION

Newly added information:

Hepatotoxicity, Including Drug-Induced Liver Injury

Inform patients that liver problems, including severe, life-threatening, or fatal hepatitis, drug-induced liver injury and abnormalities in liver tests, may develop during JAYPIRCA treatment. Advise patients to contact their healthcare provider immediately if they experience abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.6)].

PATIENT INFORMATION

Additions and/or revisions underlined:

JAYPIRCA can cause serious side effects, including:

…

Liver Problems. Liver problems, which may be severe or life-threatening, or lead to death, can happen in people treated with JAYPIRCA. Your healthcare provider will do blood tests to check your liver before and during treatment with JAYPIRCA. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.