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.

TALZENNA (NDA-211651)

(TALAZOPARIB TOSYLATE)

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

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06/12/2025 (SUPPL-13)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Myelosuppression

Additions and/or revisions underlined:

. . .

In TALAPRO-2, Grade ?3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 48%, 19%, and 9% of patients receiving TALZENNA and enzalutamide. Forty-two percent of patients (216/511) required a red blood cell transfusion, including 25% (127/511) who required more than one transfusion.

Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 8%, 3%, and 0.4%

of patients.

. . .

7 Drug Interactions

Additions and/or revisions underlined:

. . .

HRR Gene-mutated mCRPC

The effect of coadministration of P-gp inhibitors on talazoparib exposure when TALZENNA is taken with enzalutamide has not been studied. Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a P-gp inhibitor [see Dosage and Administration (2.5)].

. . .

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

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TALZENNA if you get certain side effects.

. . .

TALZENNA is a prescription medicine used:

alone to treat adults with human epidermal growth factor receptor 2 (HER2)-negative breast cancer:

who have a certain type of an abnormal inherited BRCA gene, and
whose cancer has spread to other parts of the body (locally advanced or metastatic). Your healthcare provider will perform a test to make sure that TALZENNA is right for you.

. . .

Before taking TALZENNA, tell your healthcare provider about all of your medical conditions, including if you:

have kidney problems.

are pregnant or plan to become pregnant. TALZENNA can harm your unborn baby and may cause loss of pregnancy (miscarriage). You should not become pregnant during treatment with TALZENNA.

Females who are able to become pregnant:

Your healthcare provider may do a pregnancy test before you start treatment with TALZENNA.
You should use effective birth control (contraception) during treatment with TALZENNA and for 7 months after the last dose of TALZENNA. Talk to your healthcare provider about forms of birth control that may be right for you.
Tell your healthcare provider right away if you are pregnant or think you are pregnant during treatment with TALZENNA.

. . .

06/20/2023 (SUPPL-10)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Myelodysplastic Syndrome/Acute Myeloid Leukemia

Additions and revisions underlined:

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, has been reported in patients who received TALZENNA.

Overall, MDS/AML has been reported in 0.4% (3 out of 788) of solid tumor patients treated with TALZENNA as a single agent in clinical studies. In TALAPRO-2, MDS/AML occurred in 2 out of 511 (0.4%) patients treated with TALZENNA and enzalutamide and in 0 out of 517 (0%) patients treated with placebo and enzalutamide [see Adverse Reactions (6.1)]. The durations of TALZENNA treatment in these five patients prior to developing MDS/AML were 0.3, 1, 2, 3, and 5 years, respectively. Most of these patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy.

Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous chemotherapy. Monitor blood counts monthly during treatment with TALZENNA. For prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If counts do not recover within 4 weeks, refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue TALZENNA.

5.2 Myelosuppression

Additions and revisions underlined:

Myelosuppression consisting of anemia, neutropenia, and/or thrombocytopenia, have been reported in patients treated with TALZENNA [see Adverse Reactions (6.1)].

Grade > or = 3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 39%, 21%, and 15% of patients receiving TALZENNA as a single agent. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 0.7%, 0.3%, and 0.3% of patients.

In TALAPRO-2, Grade ?3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 45%, 18%, and 8% of patients receiving TALZENNA and enzalutamide. Overall, 39% of patients (199/511) required a red blood cell transfusion, including 22% (111/511) who required multiple transfusions. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 7%, 3%, and 0.4% of patients.

Withhold TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. Monitor blood counts monthly during treatment with TALZENNA. If hematological toxicities do not resolve within 28 days, discontinue TALZENNA and refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics [see Dosage and Administration (2.5)].

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label

7 Drug Interactions

7.1 Effect of Other Drugs on TALZENNA

Additions and revisions underlined:

Effect of P-gp Inhibitors

Breast Cancer

Avoid coadministration of TALZENNA with the following P-gp inhibitors: itraconazole, amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil. If coadministration of TALZENNA with these P-gp inhibitors cannot be avoided, reduce the dose of TALZENNA [see Dosage and Administration (2.7)]. When the P-gp inhibitor is discontinued, increase the dose of TALZENNA [see Dosage and Administration (2.7)].

Coadministration of TALZENNA with these P-gp inhibitors increased talazoparib concentrations [see Clinical Pharmacology (12.3)], which may increase the risk of adverse reactions.

Monitor for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with other P-gp inhibitors [see Dosage and Administration (2.5)].

HRR Gene-mutated mCRPC

The effect of coadministration of P-gp inhibitors on talazoparib exposure when TALZENNA is taken in combination with enzalutamide has not been studied. Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a P-gp inhibitor [see Dosage and Administration (2.5)].

Effect of BCRP Inhibitors

Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a BCRP inhibitor [see Dosage and Administration (2.5)].

Coadministration of TALZENNA with BCRP inhibitors may increase talazoparib exposure [see Clinical Pharmacology (12.3)], which may increase the risk of adverse reactions.

8 Use in Specific Populations

8.1 Pregnancy

Additions and revisions underlined:

Talazoparib caused embryo-fetal death at doses > or = 0.015 mg/kg/day (approximately 0.24 times the AUC in patients at the recommended dose of 1 mg daily).

8.3 Females and Males of Reproductive Potential

Additions and revisions underlined:

TALZENNA can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1)].

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating TALZENNA treatment.

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of TALZENNA.

8.5 Geriatric Use

Additions and revisions underlined:

In clinical trials of TALZENNA enrolling 494 patients with advanced solid tumors who received TALZENNA 1 mg daily as a single agent, 85 (17%) patients were > or = 65 years of age, and this included 19 (4%) patients who were > or =75 years old. There were 5 patients > or = 85 years old. In the TALAPRO-2 trial, of 197 patients who received TALZENNA, 77% were > or = 65 years of age, while 30% were > or = 75 years of age. No overall differences in safety or effectiveness of TALZENNA were observed between these patients and younger patients.

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

Patient Information

Extensive changes; please refer to label

09/20/2021 (SUPPL-8)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Myelodysplastic Syndrome/Acute Myeloid Leukemia

(Additions and/or revisions underlined)

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) have been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in <1% (3 out of 787, 0.4%) of solid tumor patients treated with TALZENNA in clinical studies. The duration of TALZENNA treatment in these three patients prior to developing MDS/AML was 4 months, 24 months, and 60 months respectively. These patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy.

Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous chemotherapy. Monitor complete blood counts for cytopenia at baseline and monthly thereafter. For prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If the levels have not recovered after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue TALZENNA.

09/09/2021 (SUPPL-7)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.7 Hepatic Impairment

(Additions and/or revisions are underlined)

No dose modification is recommended for patients with mild, moderate, or severe hepatic impairment (based on NCI criteria) [see Clinical Pharmacology (12.3)].

03/09/2020 (SUPPL-5)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.6 Renal Impairment

Additions and/or revisions underlined:

Patients with moderate or severe renal impairment have a higher exposure to TALZENNA than patients with normal renal function. Reduce the recommended dose of TALZENNA in patients with moderate (CLcr 30 – 59 mL/min) and severe (CLcr 15 – 29 mL/min) renal impairment. Monitor patients with severe renal impairment for potential increased adverse reactions and adjust dosing accordingly [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)]. No dose adjustment is required for patients with mild renal impairment (CLcr 60 – 89 mL/min). TALZENNA has not been studied in patients requiring hemodialysis [see Clinical Pharmacology (12.3)].

09/24/2019 (SUPPL-2)

Approved Drug Label (PDF)

7 Drug Interactions

7.1 Effect of Other Drugs on TALZENNA

(additions and/or revisions are underlined)

Effect of P-gp Inhibitors

Coadministration with P-gp inhibitors may increase talazoparib exposure.

In patients with advanced solid tumors, coadministration of a P-gp inhibitor (itraconazole) increased talazoparib plasma exposure by 56%. In the clinical studies, coadministration with P-gp inhibitors including amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil resulted in an approximate 45% increase in talazoparib exposure and an increase in the rate of TALZENNA dose reduction. If coadministration of TALZENNA with these P-gp inhibitors cannot be avoided, reduce the TALZENNA dose. When the P-gp inhibitor is discontinued, increase the TALZENNA dose (after 3–5 half-lives of the inhibitor) to the dose used prior to the initiation of the P-gp inhibitor.

When coadministering TALZENNA with P-gp inhibitors not listed above, monitor patients for potential increased adverse reactions.

Effect of BCRP inhibitors

Coadministration with BCRP inhibitors may increase talazoparib exposure. If coadministration cannot be avoided, monitor patients for potential increased adverse reactions when coadministering.