Drug Safety-related Labeling Changes (SrLC)
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Guide
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.
TRUQAP (NDA-218197)
(CAPIVASERTIB)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
06/12/2026 (SUPPL-4)
5 Warnings and Precautions
5.1 Hyperglycemia
Additions and/or revisions underlined:
TRUQAP can cause
severe hyperglycemia, including diabetic ketoacidosis and
fatal outcomes. Withhold TRUQAP in clinical situations known to increase
the risk of severe hyperglycemia or ketoacidosis (e.g., suspected
serious infection or acute illness). Before initiating treatment
with TRUQAP, test fasting glucose levels (FPG or FBG), HbA1C levels, and
optimize fasting glucose.
After initiating treatment with TRUQAP, monitor or self-monitor fasting glucose levels on Day 3 or 4 of the dosing week during weeks 1, 2, 4, 6 and 8; then monthly while on treatment with TRUQAP; and as clinically indicated. Monitor HbA1C levels every 3 months during treatment with TRUQAP and as clinically indicated and manage changes as appropriate. Patients with a history of well-controlled Type 2 diabetes mellitus may require intensified anti-hyperglycemic treatment and require close monitoring of fasting glucose levels.
. . .
The safety of TRUQAP has not been established in patients with Type 1 diabetes or Type 2 diabetes that is uncontrolled or requiring insulin at baseline as these patients were excluded from clinical studies [see Clinical Studies (14.1,14.2)].
Based on the severity of the hyperglycemia, withhold, reduce dose, or permanently discontinue TRUQAP [see Dosage and Administration (2.5)].
CAPItello-291
Increased fasting glucose from baseline occurred in 37% of patients treated with TRUQAP, including 11% of patients with Grade 2 (FG greater than 160 to 250 mg/dL), 2% with Grade 3 (FG greater than 250 to 500 mg/dL), and 1.1% with Grade 4 (FG greater than 500 mg/dL) events.
The median time to first occurrence of hyperglycemia was 15 days (range: 1 to 367). Dose reduction for hyperglycemia was required in 0.6% of patients and permanent discontinuation was required in 0.6% of patients.
Diabetic metabolic decompensation occurred in 0.6% of patients, including diabetic ketoacidosis in 0.3%.
In CAPItello-291, 12% (43/355) of patients who received TRUQAP had an anti-hyperglycemic medication regimen either initiated or changed during the study, including treatment with insulin in 4.8% (17/355) of patients.
CAPItello-281
Increased fasting glucose from baseline occurred in 69% of patients treated with TRUQAP, including 25% of patients with Grade 2 (FG greater than 160 to 250 mg/dL), 12% with Grade 3 (FG greater than 250 to 500 mg/dL), and 1.2% of patients with Grade 4 (FG greater than 500 mg/dL) events.
The median time to first occurrence of hyperglycemia was 71 days (range: 1 to 1454). Dose reduction for hyperglycemia was required in 8.7% of patients and permanent discontinuation was required in 2.4% of patients.
Diabetic ketoacidosis occurred in 1.2% of patients.
In CAPItello-281, 41% (204/503) of patients who received TRUQAP had an anti-hyperglycemic medication regimen either initiated or changed during the study, including treatment with insulin in 16% (81/503) of patients.
5.2 Diarrhea
Additions and/or revisions underlined:
TRUQAP can cause severe diarrhea associated with dehydration.
Monitor patients for signs and symptoms of diarrhea. Advise patients to increase oral fluids and start antidiarrheal treatment at the first sign of diarrhea while taking TRUQAP. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity [see Dosage and Administration (2.5)].
CAPItello-291
Diarrhea occurred in 72% of patients. Grade 3 or 4 diarrhea occurred in 9% of patients. The median time to first occurrence was 8 days (range 1 to 519). In the 257 patients with diarrhea, 59% required anti-diarrheal medications to manage symptoms. Dose reductions were required in 8% of patients, and 2% of patients permanently discontinued TRUQAP due to diarrhea. In patients with Grade ? 2 diarrhea (n=93) with at least 1 grade improvement (n=89), median time to improvement from the first event was 4 days (range: 1 to 154).
CAPItello-281
In CAPItello-281, diarrhea of any grade occurred in 264 (52%) patients, Grade 3 occurred in 31 (6%) patients and
Grade 4 occurred in 1 (0.2%) patient. The median time to first occurrence was 12 days (range: 3 to 48). In the study, dose reductions were required in 26 (5%) patients and 6 (1.2%) patients discontinued TRUQAP due to diarrhea. In the
264 patients with diarrhea, anti-diarrheal medication was required in 64% (170/264) of patients to manage diarrhea symptoms.
5.3 Cutaneous Adverse Reactions
Additions and/or revisions underlined:
TRUQAP can cause cutaneous adverse reactions, which can be severe, including erythema multiforme (EM), palmar-plantar erythrodysesthesia, and drug reaction with eosinophilia and systemic symptoms (DRESS).
Monitor patients for signs and symptoms of cutaneous adverse reactions. Early consultation with a dermatologist is recommended. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity [see Dosage and Administration (2.5)].
CAPItello-291
Cutaneous adverse reactions occurred in 58% of patients. Grade 3 or 4 cutaneous adverse reactions occurred in 17% of patients receiving TRUQAP. EM occurred in 1.7% of patients, and DRESS occurred in 0.3% of patients. Dose reduction was required in 7% of patients and 7% of patients permanently discontinued TRUQAP due to cutaneous adverse reactions.
The median time to onset of cutaneous adverse reactions was 13 days (range 1 to 575 days). Among the 204 patients with cutaneous adverse reactions, 44% (90/204) required corticosteroid treatment. Of these, 37% (76/204) were treated with topical corticosteroids and 19% (39/204) with systemic corticosteroids. In patients with Grade ? 2 cutaneous adverse reaction (n=116) with at least 1 grade improvement (n=104), median time to improvement from the first event was 12 days (range 2 to 544).
CAPItello-281
Cutaneous adverse reactions occurred in 53% of patients. Grade 3 cutaneous adverse reactions occurred in 84 (17%) patients and Grade 4 occurred in 1 (0.2%) patient. In the study, dose reduction was required in 58 (12%) patients and 38 (8%) patients discontinued TRUQAP due to rash. The median time to onset of rash was 13 days (range: 11 to 63 days). Among the 265 patients with cutaneous adverse reactions, 80% (212/265) required treatment and 91% (242/265) recovered in the study. Of these, 54% (115/212) were treated with topical corticosteroids and 25% (54/212) with systemic corticosteroids.
5.4 Embryo-Fetal Toxicity
Additions and/or revisions underlined:
. . .
TRUQAP is used in combination with fulvestrant or abiraterone. Refer to the Full Prescribing Information of fulvestrant or abiraterone for pregnancy and contraception information6 Adverse Reactions
6.1 Clinical Trials Experience
Extensive changes; please refer to label for complete information8 Use in Specific Populations
8.3 Females and Males of Reproductive Potential
Additions and/or revisions underlined:
TRUQAP is used in combination with fulvestrant or abiraterone. Refer to the Full Prescribing Information of fulvestrant or abiraterone for contraception and infertility information.
. . .
8.5 Geriatric Use
Additions and/or revisions underlined:
. . .
Of the 503 patients who received TRUQAP in CAPItello-281, 331 (66%) patients were greater than or equal to 65 years of age and 85 (17%)
patients were greater than or equal to 75 years of age. No overall differences in the efficacy of TRUQAP were observed between patients
greater than or equal to 65 years of age and younger patients. Analysis of the safety of TRUQAP comparing patients greater than or equal to 65 years of age to younger patients suggest a higher incidence of Grade 3 to 5 adverse reactions (77% versus 60%), dosage reductions (36% versus 24%), dose interruptions (72% versus 53%), and permanent discontinuations (27% versus 7%), respectively. The differences in Grade 3 or 4 adverse reactions between patients greater than or equal to 65 years of age and younger patients was primarily driven by an increased incidence of hyperglycemia and hypokalemia.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or revisions underlined:
. . .
Advise patients that TRUQAP can cause hyperglycemia and that they will need to monitor their fasting blood glucose and HbA1C periodically during therapy. Advise patients to withhold TRUQAP in clinical situations known to increase the risk of severe hyperglycemia or ketoacidosis (e.g., suspected serious infection or acute illness). Advise patients to contact their healthcare provider immediately for signs and symptoms of hyperglycemia (e.g., excessive thirst, urinating more often, blurred vision, mental confusion, difficulty breathing, or increased appetite with weight loss) or ketoacidosis [see Warnings and Precautions (5.1)].
. . .
Refer to the Full Prescribing Information of fulvestrant or abiraterone for pregnancy and contraception information. Lactation
PATIENT INFORMATION
Additions and/or revisions underlined:
. . .
the medicines abiraterone and prednisone to treat adults who have PTEN-deficient prostate cancer that has spread to other parts of the body (metastatic). Your healthcare provider will test your prostate cancer to see if it has PTEN deficiency to make sure that TRUQAP is right for you.
. . .
For women who have not reached menopause or are just starting menopause, your healthcare provider will prescribe a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist to take with TRUQAP and fulvestrant. For men, your healthcare provider may prescribe a LHRH agonist to take with TRUQAP and fulvestrant.
For men who have not had surgery to remove both testicles (bilateral orchiectomy), your healthcare provider
will prescribe a gonadotropin-releasing hormone (GnRH) to take with TRUQAP along with abiraterone and prednisone.
. . .
High blood sugar levels (hyperglycemia). Hyperglycemia is common with TRUQAP and can be severe. Hyperglycemia has happened in people with and without a history of diabetes. Untreated severe hyperglycemia can lead to a condition called diabetic ketoacidosis that can happen in people treated with TRUQAP. 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 TRUQAP. It is not known if TRUQAP is safe in people with type 1 diabetes or people who use insulin to treat their diabetes. Your healthcare provider will monitor your blood sugar levels more often if you have a history of diabetes. If you have a fever, chills, infection, serious injury, or a new illness, tell your healthcare provider before taking your next dose. Tell your healthcare provider right away if you develop symptoms of hyperglycemia, including:
. . .