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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.
PHYRAGO (NDA-216099)
(DASATINIB)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
08/01/2025 (SUPPL-5)
5 Warnings and Precautions
5.1 Myelosuppression
Additions and/or revisions underlined:
. . .
In pediatric patients with Ph+ ALL treated with PHYRAGO in combination with chemotherapy, perform CBCs prior to the start of each block of chemotherapy and as clinically indicated.
During the consolidation blocks of chemotherapy, perform CBCs every 2 days until recovery.
. . .
5.3 Fluid Retention
Additions and/or revisions underlined:
. . .
In pediatric patients with chronic phase CML, cases of Grade 1 or 2 fluid retention were reported in 10.3% of patients.
. . .
6 Adverse Reactions
6.1 Clinical Trials Experience
Extensive changes; please refer to label for complete information
8 Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
Ph+ CML in Chronic Phase
The safety and effectiveness of dasatinib monotherapy have been demonstrated in pediatric patients with newly diagnosed chronic phase CML [see Clinical Studies (14.3)]. There are no data in children under 1 year of age. Adverse reactions associated with bone growth and development were reported in 5 (5.2%) of patients [see Warnings and Precautions (5.10)].
Ph+ ALL
The safety and effectiveness of dasatinib in combination with chemotherapy have been demonstrated in pediatric patients one year and over with newly diagnosed Ph+ ALL. Use of dasatinib in pediatric patients is supported by evidence from one pediatric study. There are no data in children under 1 year of age. One case of grade 1 osteopenia was reported.
The safety profile of dasatinib in pediatric subjects was comparable to that reported in studies in adult subjects [see Adverse Reactions (6.1) and Clinical Studies (14.3, 14.4)].
Monitor bone growth and development in pediatric patients [see Warnings and Precautions (5.10)].
Pediatric Patients with Difficulty Swallowing Tablets
Five patients with Ph+ ALL 2 to 10 years of age received at least one dose of dasatinib tablet dispersed in juice on Study CA180372. The exposure for dispersed tablets was 36% lower as compared to intact tablets in pediatric patients. Due to unavailable clinical data, it is unclear whether dispersing PHYRAGO tablets significantly alters the safety and/or efficacy of PHYRAGO.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Additions and/or revisions underlined:
. . .
What is PHYRAGO?
. . .
children 1 year of age and older with Ph+ CML in chronic phase.
children 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.
It is not known if PHYRAGO is safe and effective in children under 1 year of age.
. . .
How should I take PHYRAGO?
. . .
Swallow PHYRAGO whole. Do not crush, cut or chew the tablets.
If your child cannot swallow tablets whole, talk with your healthcare provider.
. . .
Low blood cell counts. Low blood cell counts are common with dasatinib and can be severe, including low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Your healthcare provider will do blood tests to check your blood cell counts regularly during your treatment with PHYRAGO. Call your healthcare provider right away if you have a fever or any signs of an infection during treatment with PHYRAGO.
. . .
The most common side effects of dasatinib in children receiving dasatinib with chemotherapy include:
swelling, pain and redness of the lining of your mouth, tiredness throat, stomach and bowel (mucositis)
constipation
low white blood cell counts with fever
abnormal heart rate
fever
high blood pressure (hypertension)
diarrhea
swelling
nausea
infections
vomiting
low blood pressure
muscle pain
decreased appetite
stomach-area (abdominal) pain
allergic reactions
cough
shortness of breath
headache
nose bleed
rash
numbness or tingling of your hands and feet
feeling confused or disoriented
. . .
12/03/2024 (SUPPL-3)
7 Drug Interactions
7.1 Effect of Other Drugs on DasatinibAdditions and/or revisions underlined:
…
Antacids
Avoid concomitant use of PHYRAGO with antacids. If concomitant use of an antacid cannot be avoided, administer the antacid at least 2 hours prior to or 2 hours after the dose of PHYRAGO [see Dosage and Administration (2.2)].
Concomitant use with antacids decreases dasatinib plasma concentrations [see Clinical Pharmacology (12.3)], which may reduce PHYRAGO efficacy.
07/31/2024 (SUPPL-4)
6 Adverse Reactions
6.2 Postmarketing ExperienceAdditions and/or revisions underlined:
…
Respiratory, thoracic, and mediastinal disorders: interstitial lung disease, chylothorax
…