Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | 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.

TAFINLAR (NDA-217514)

(DABRAFENIB MESYLATE)

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

Download Data

Expand all

03/26/2026 (SUPPL-11)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Table 14. Adverse Reactions (greater than or equal to 20%) in Adult Patients Treated with TAFINLAR Plus Trametinib in Study BRF117019

…

Clinically relevant adverse reactions for TAFINLAR in Study BRF117019 observed in less than 20% of patients who received TAFINLAR in combination with trametinib were: peripheral neuropathy (9%), decreased ejection fraction (8%), atrioventricular block (2.9%), uveitis (1.9%), hypersensitivity (1.9%), Guillain-Barré syndrome (< 1%), and sarcoidosis (< 1%).

…

04/07/2025 (SUPPL-9)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Uveitis

Additions and/or revisions underlined:

…

Cases of biocular panuveitis or biocular iridocyclitis have been reported in the post-marketing setting.

…

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Other clinically important adverse reactions for TAFINLAR across the COMBI-d and COMBI-v studies

(N = 559) observed in less than 10% of patients who received TAFINLAR administered with trametinib were:

…

Nervous System: Peripheral neuropathy, Guillain-Barré syndrome

…

Other clinically important adverse reactions for TAFINLAR in the COMBI-AD study observed in less than 20% of patients who received TAFINLAR administered with trametinib were: blurred vision (6%), decreased ejection fraction (5%), peripheral neuropathy (2.5%), rhabdomyolysis (< 1%), atrioventricular block (< 1%), Guillain-Barré syndrome (< 1%), and sarcoidosis (< 1%).

…

03/19/2025 (SUPPL-8)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors and LGG

The safety and effectiveness of TAFINLAR in combination with trametinib have been established in pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options; or with LGG with BRAF V600E mutation who require systemic therapy. Use of TAFINLAR in combination with trametinib for these indications is supported by evidence from studies X2101 and G2201 that enrolled 171 patients (1 to < 18 years of age) with BRAF V600 mutation-positive advanced solid tumors, of which 4 (2.3%) patients were 1 to < 2 years of age, 39 (23%) patients were 2 to < 6 years of age, 54 (32%) patients were 6 to < 12 years of age, and 74 (43%) patients were 12 to < 18 years of age [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14.6, 14.7)].

. . .

8.5 Geriatric Use

Additions and/or revisions underlined:

Of the 586 patients with various solid tumors who received single agent TAFINLAR, 22% were aged 65 years and older. Of the 187 patients with melanoma who received single-agent TAFINLAR in the BREAK-3 study, 21% were aged 65 years and older [see Clinical Studies (14.1)]. No overall differences in the effectiveness or safety of TAFINLAR were observed between geriatric patients as compared to younger adults in the BREAK-3 study.

. . .

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

MEDICATION GUIDE

Additions and/or revisions underlined:

. . .

Females who are able to become pregnant:

Your healthcare provider will do a test to see if you are pregnant before starting treatment with TAFINLAR.
You should use effective non-hormonal birth control (contraception) during treatment with TAFINLAR and for 2 weeks after your last dose of TAFINLAR.

. . .

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking TAFINLAR with certain other medicines may affect the way TAFINLAR and the other medicines work and may increase your risk of side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take or give TAFINLAR?

. . .

TAFINLAR capsules:

Take TAFINLAR 2 times a day, at the same time each day, about 12 hours apart.
Take TAFINLAR on an empty stomach (at least 1 hour before or 2 hours after a meal).
Take TAFINLAR capsules whole. Do not open, crush, or break TAFINLAR capsules.
If TAFINLAR capsules are prescribed for your child weighing at least 57 pounds (26 kg), your child’s healthcare provider will adjust their dose as your child grows.
Tell your healthcare provider if you or your child is not able to swallow TAFINLAR capsules whole.

TAFINLAR tablets for oral suspension:

If TAFINLAR tablets for oral suspension are prescribed for your child, your child’s healthcare provider will adjust their dose as your child grows.
TAFINLAR tablets for oral suspension are to be taken or given as a suspension only.
Do not swallow whole, chew or crush TAFINLAR tablets for oral suspension.
See the “Instructions for Use” that comes with the medicine for instructions on how to correctly prepare and take or give a dose of the TAFINLAR oral suspension.
After the TAFINLAR tablets for oral suspension are dispersed into an oral suspension, take or give the medicine right away from a dosing cup, oral syringe or feeding tube (10 French gauge or larger for 1 to 3 tablets, 12 French gauge or larger for 4 to 15 tablets).
Take or give TAFINLAR oral suspension 2 times a day, at the same time each day, about 12 hours apart.
Take or give each dose of TAFINLAR oral suspension on an empty stomach (at least 1 hour before or 2 hours after a meal). If necessary, breastfeeding or baby formula may be given on demand.
Throw away (dispose of) the prepared TAFINLAR oral suspension if it is not used within 30 minutes.

What are the possible side effects of TAFINLAR? TAFINLAR may cause serious side effects, including:

. . .

increased blood sugar (hyperglycemia). Some people may develop high blood sugar or worsening diabetes during treatment with TAFINLAR. If you are diabetic, your healthcare provider should check your blood sugar levels closely before and during treatment with TAFINLAR. Your diabetes medicine may need to be changed. Tell your healthcare provider if you have any of the following symptoms of severe high blood sugar:

increased thirst
urinating more often than normal, or urinating an increased amount of urine

. . .

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Administration

Instruct patients to take TAFINLAR capsules on an empty stomach (at least 1 hour before or 2 hours after a meal) [see Dosage and Administration (2.3)].
Instruct patients to take the oral suspension on an empty stomach (at least 1 hour before or 2 hours after a meal). Breastfeeding and/or baby formula may be given on demand if a pediatric patient is unable to tolerate the fasting conditions [see Dosage and Administration (2.3)].

03/07/2025 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Cardiomyopathy

Additions and/or revisions underline:

…

Assess LVEF by echocardiogram or multigated acquisition (MUGA) scan before initiation of TAFINLAR in combination with trametinib, one month after initiation, and then at 2- to 3-month intervals while on treatment. Withhold TAFINLAR for symptomatic cardiomyopathy or an absolute decrease in LVEF of greater than 20% from baseline that is below the institutional LLN. Resume TAFINLAR at the same dose level upon recovery of cardiac function to at least the institutional LLN for LVEF and absolute decrease to less than or equal to 10% compared to baseline [see Dosage and Administration (2.4)].

07/11/2024 (SUPPL-4)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Other clinically important adverse reactions for TAFINLAR in a pool of TAFINLAR monotherapy clinical studies observed in less than 10% of patients who received TAFINLAR were:

Gastrointestinal: Pancreatitis

Immune System: Hypersensitivity manifesting as bullous rash

Nervous System: Peripheral neuropathy

Renal and Urinary: Interstitial nephritis

Skin and Subcutaneous Tissue: Photosensitivity

…

Other clinically important adverse reactions for TAFINLAR across the COMBI-d and COMBI-v studies (N = 559) observed in less than 10% of patients who received TAFINLAR administered with trametinib were:

Cardiac: Atrioventricular block, bundle branch block Gastrointestinal: Colitis, gastrointestinal perforation, pancreatitis Immune System: Sarcoidosis

Nervous System: Peripheral neuropathy

Skin and Subcutaneous Tissue: Panniculitis, photosensitivity

…

Other clinically important adverse reactions for TAFINLAR in Study BRF113928 observed in less than 20% of patients who received TAFINLAR administered with trametinib were:

Cardiac: Atrioventricular block

Gastrointestinal: Pancreatitis

Nervous System: Peripheral neuropathy

Renal and Urinary: Tubulointerstitial nephritis

…

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

MEDICATION GUIDE

…

Tell your healthcare provider right away if you develop any new or worsening symptoms of a severe skin reaction, including:…

…

03/29/2024 (SUPPL-3)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Other clinically important adverse reactions for TAFINLAR across the COMBI-d and COMBI-v studies

(N = 559) observed in less than 10% of patients who received TAFINLAR administered with trametinib were:

Cardiac: Atrioventricular block, bundle branch block

Gastrointestinal: Colitis, gastrointestinal perforation, pancreatitis

Immune System: Sarcoidosis

Skin and Subcutaneous Tissue: Panniculitis, photosensitivity

…

Other clinically important adverse reactions for TAFINLAR in the COMBI-AD study observed in less than 20% of patients who received TAFINLAR administered with trametinib were: blurred vision (6%), decreased ejection fraction (5%), rhabdomyolysis (< 1%), atrioventricular block (< 1%), and sarcoidosis (< 1%).

…

Other clinically important adverse reactions for TAFINLAR in Study BRF113928 observed in less than 20% of patients who received TAFINLAR administered with trametinib were:

Cardiac: Atrioventricular block

…

Clinically relevant adverse reactions for TAFINLAR in Study BRF117019 observed in less than 20% of patients who received TAFINLAR in combination with trametinib were: decreased ejection fraction (8%), atrioventricular block (2.9%), uveitis (1.9%), and hypersensitivity (1.9%).

…

Clinically relevant adverse reactions for TAFINLAR in Study X2101 observed in less than 20% of patients (N=48) who received TAFINLAR in combination with trametinib were: atrioventricular block (2.1%).

…

6.2 Postmarketing Experience

Additions and/or revisions underlined:

Cardiac: Atrioventricular block complete

Immune System: Hemophagocytic lymphohistiocytosis (HLH) [see Warnings and Precautions (5.11)]

Skin and Subcutaneous Tissue: SCAR (including DRESS and SJS) [see Warnings and Precautions (5.7)]

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

MEDICATION GUIDE

Additions and/or revisions underlined:

What are the possible side effects of TAFINLAR?

TAFINLAR may cause serious side effects, including:

…

heart problems, including heart failure. Your healthcare provider should check your heart function before and during treatment with TAFINLAR. Call your healthcare provider right away if you have any of the following signs and symptoms of a heart problem:
- feeling like your heart is pounding, racing, or beating irregularly
- shortness of breath
- swelling of your ankles or feet
- feeling lightheaded
  …

02/27/2024 (SUPPL-2)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Other clinically important adverse reactions observed in less than 10% of patients (N = 586) treated with TAFINLAR were:

…

TAFINLAR as a Single Agent

…

Skin and Subcutaneous Tissue: Photosensitivity

TAFINLAR with Trametinib

…

Other clinically important adverse reactions for TAFINLAR across the COMBI-d and COMBI-v studies

(N = 559) observed in less than 10% of patients who received TAFINLAR administered with trametinib were:

…

Skin and Subcutaneous Tissue: Panniculitis, photosensitivity

…