Tafinlar dabrafenib 10 mg Tablet, For Suspension, 210-count — NDC 0078-1154-21 (Billing 00078-1154-21)

1 INDICATIONS AND USAGE TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1 , 2.1 ) TAFINLAR is indicated, in combination with trametinib , for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.2 , 2.1 ) the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.

( 1.3 , 2.1 ) the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. ( 1.4 , 2.1 ) the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options. ( 1.5 , 2.1 ) the treatment of adult and 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.

This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.6 , 2.1 ) the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

( 1.7 , 2.1 ) Limitations of Use : TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. ( 1.8 , 12.1 ) TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors. ( 5.2 )

1.1BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma TAFINLAR ® is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

1.2BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)] .

1.3Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection [see Dosage and Administration (2.1)] .

1.4BRAF V600E Mutation-Positive Metastatic NSCLC TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test [see Dosage and Administration (2.1)] .

1.5BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options [see Dosage and Administration (2.1)] .

1.6BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors TAFINLAR is indicated, in combination with trametinib, for the treatment of adult and 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 [see Dosage and Administration (2.1)] . This indication… [Excerpted — this section continues on DailyMed.]

2 DOSAGE AND ADMINISTRATION The recommended dosage of TAFINLAR in adult patients is 150 mg (two 75 mg capsules) orally twice daily. The recommended dosage for TAFINLAR in pediatric patients is based on body weight. Take TAFINLAR at least 1 hour before or 2 hours after a meal. ( 2 )

2.1Patient Selection Melanoma Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR as a single agent [see Warnings and Precautions (5.2), Clinical Studies (14.1)] . Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Warnings and Precautions (5.2), Clinical Studies (14.2, 14.3)] . Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics .

NSCLC Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Clinical Studies (14.4)] . Information on FDA-approved tests for the detection of BRAF V600E mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics . ATC Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Clinical Studies (14.5)] .

Information on FDA-approved tests for the detection of BRAF V600E mutations in ATC is available at: http://www.fda.gov/CompanionDiagnostics . Solid Tumors Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Clinical Studies (14.6)] . An FDA-approved test for the detection of BRAF V600E mutation in solid tumors other than melanoma and NSCLC is not currently available.

Low-Grade Glioma Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Clinical Studies (14.7)] . An FDA-approved test for the detection of BRAF V600E mutation in LGG is not currently available.

2.2Recommended Dosage TAFINLAR Capsules Adult Patients The recommended dosage for TAFINLAR capsules in adult patients is 150 mg taken orally twice daily [see Dosage and Administration (2.3)] . Pediatric Patients The recommended dosage for TAFINLAR capsules in pediatric patients who weigh at least 26 kg is based on body weight (Table 1) [see Dosage and Administration (2.3)] . A recommended dosage of TAFINLAR capsules has not been established in patients who weigh less than 26 kg.

Table 1. Recommended Dosage for TAFINLAR Capsules in Pediatric Patients (Weight-based) Body Weight Recommended Dosage 26 to 37 kg 75 mg orally twice daily 38 to 50 kg 100 mg orally twice daily 51 kg or greater 150 mg orally twice daily TAFINLAR Tablets for Oral Suspension Adult and Pediatric Patients The recommended dosage for TAFINLAR tablets for oral suspension for adult and pediatric patients is based on body weight (Table 2) [see Dosage and Administration (2.3)] . Table 2.

Recommended Dosage for TAFINLAR Tablets for Oral Suspension in Adult and Pediatric Patients (Weight-based) Body Weight Recommended Dosage 8 to 9 kg 20 mg twice daily 10 to 13 kg 30 mg twice daily 14 to 17 kg 40 mg twice daily 18 to 21 kg 50 mg twice daily 22 to 25 kg 60 mg twice daily 26 to 29 kg 70 mg twice daily 30 to 33 kg 80 mg twice daily 34 to 37 kg 90 mg twice daily 38 to 41 kg 100 mg twice daily 42 to 45 kg 110 mg twice daily 46 to 50 kg 130 mg twice daily ≥ 51 kg 150 mg twice daily Duration of Treatment The recommended duration of treatment for patients with unresectable or metastatic melanoma or solid tumors, metastatic NSCLC, or locally advanced or metastatic anaplastic thyroid cancer is until disease progression or unacceptable toxicity.

The recommended duration of treatment in the adjuvant melanoma setting is until disease recurrence or unacceptable toxicity for up to 1 year. The recommended duration of treatment for pediatric patients with LGG is until disease p… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS TAFINLAR Capsules: 50 mg: Dark red capsule imprinted with ‘GS TEW’ and ‘50 mg’. 75 mg: Dark pink capsule imprinted with ‘GS LHF’ and ‘75 mg’. TAFINLAR Tablets for Oral Suspension: 10 mg: White to slightly yellow, round, biconvex 6 mm tablet debossed with “D” on one side and “NVR” on the other, contains berry flavor. TAFINLAR Capsules: 50 mg, 75 mg ( 3 ) TAFINLAR Tablets for Oral Suspension: 10 mg ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). New Primary Cutaneous and Non-Cutaneous Malignancies Advise patients that TAFINLAR increases the risk of developing new primary cutaneous and non-cutaneous malignancies. Advise patients to contact their healthcare provider immediately for any new lesions, changes to existing lesions on their skin, or signs and symptoms of other malignancies [see Warnings and Precautions (5.1)] .

Hemorrhage Advise patients that TAFINLAR administered with trametinib increases the risk of intracranial and gastrointestinal hemorrhage. Advise patients to contact their healthcare provider to seek immediate medical attention for signs or symptoms of unusual bleeding or hemorrhage [see Warnings and Precautions (5.3)] . Cardiomyopathy Advise patients that TAFINLAR can cause cardiomyopathy and to immediately report any signs or symptoms of heart failure to their healthcare provider [see Warnings and Precautions (5.4)] .

Uveitis Advise patients that TAFINLAR can cause uveitis, including iritis and iridocyclitis and to contact their healthcare provider if they experience any changes in their vision [see Warnings and Precautions (5.5)] . Serious Febrile Reactions Advise patients that TAFINLAR can cause pyrexia, including serious febrile reactions. Inform patients that the incidence and severity of pyrexia are increased when TAFINLAR is administered with trametinib.

Instruct patients to contact their healthcare provider if they develop a fever while taking TAFINLAR [see Warnings and Precautions (5.6)] . Serious Skin Toxicities Advise patients that TAFINLAR can cause serious skin toxicities and to contact their healthcare provider for progressive or intolerable rash. Advise patients to contact their healthcare provider immediately if they develop signs and symptoms of a severe skin reaction [see Warnings and Precautions (5.7)] .

Hyperglycemia Advise patients that TAFINLAR can impair glucose control in diabetic patients resulting in the need for more intensive hypoglycemic treatment and to contact their healthcare provider to report symptoms of severe hyperglycemia [see Warnings and Precautions (5.8)] . Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency Advise patients that TAFINLAR may cause hemolytic anemia in patients with G6PD deficiency. Advise patients with known G6PD deficiency to contact their healthcare provider to report signs or symptoms of anemia or hemolysis [see Warnings and Precautions (5.9)] .

Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus [see Warnings and Precautions (5.12), Use in Specific Populations (8.1, 8.3)] . Advise females to contact their healthcare provider of a known or suspected pregnancy. Advise females of reproductive potential to use effective non-hormonal contraception during treatment and for 2 weeks after discontinuation of treatment with TAFINLAR.

Advise male patients with female partners of reproductive potential to use condoms during treatment with TAFINLAR and for 2 weeks after the last dose. Lactation Advise women not to breastfeed during treatment with TAFINLAR and for 2 weeks after the last dose of TAFINLAR [see Use in Specific Populations (8.2)] . Infertility Advise males and females of reproductive potential of the potential risk for impaired fertility with TAFINLAR [see Use in Specific Populations (8.3)].

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)] . tHxID ™ is a trademark of bioMérieux.

Oncomine ™ Dx Target Test… [Excerpted — this section continues on DailyMed.]

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: March 2025 MEDICATION GUIDE TAFINLAR ® (TAFF-in-lar) (dabrafenib) capsules TAFINLAR ® (TAFF-in-lar) (dabrafenib) tablets for oral suspension Important information: If your healthcare provider prescribes TAFINLAR for you to be taken or given with trametinib, also read the Patient Information leaflet that comes with trametinib.

What is the most important information I should know about TAFINLAR? TAFINLAR may cause serious side effects, including: Risk of new cancers. TAFINLAR, when used alone or with trametinib, may cause skin cancers, called cutaneous squamous cell carcinoma (cuSCC), keratoacanthoma, basal cell carcinoma, or melanoma.

Talk with your healthcare provider about your risk for these cancers. Check your skin and tell your healthcare provider right away about any skin changes, including a: new wart skin sore or reddish bump that bleeds or does not heal change in size or color of a mole Your healthcare provider should check your skin before treatment with TAFINLAR, every 2 months during treatment with TAFINLAR, and for up to 6 months after you stop taking TAFINLAR to look for any new skin cancers. Your healthcare provider should also check for cancers that may not occur on the skin.

Tell your healthcare provider about any new symptoms that develop during treatment with TAFINLAR. See "What are the possible side effects of TAFINLAR?" for more information about side effects. What is TAFINLAR?

TAFINLAR is a prescription medicine used: alone or in combination with a medicine called trametinib to treat a type of skin cancer called melanoma: ○ that has spread to other parts of the body or cannot be removed by surgery, and ○ that has a certain type of abnormal “BRAF” gene. in combination with trametinib, to help prevent melanoma that has a certain type of abnormal “BRAF” gene from coming back after the cancer has been removed by surgery. in combination with trametinib to treat a type of lung cancer called non-small cell lung cancer (NSCLC): ○ that has spread to other parts of the body, and ○ that has a certain type of abnormal “BRAF” gene. in combination with trametinib to treat a type of thyroid cancer called anaplastic thyroid cancer (ATC): ○ that has spread to other parts of the body and you have no satisfactory treatment options , and ○ that has a certain type of abnormal “BRAF” gene. in combination with trametinib to treat solid tumors in adults and children 1 year and older: ○ that cannot be removed with surgery or have spread to other parts of the body, and that have gotten worse (progressed), and you have no satisfactory treatment options, and ○ that have a certain type of abnormal “BRAF” gene. in combination with trametinib to treat a type of brain tumor called glioma in children 1 year and older: ○ that is low-grade glioma (LGG), and ○ that have a certain type of abnormal “BRAF” gene, and ○ who require a medicine by mouth or injection (systemic therapy).

TAFINLAR is not for use in treating people with colorectal cancer or wild-type BRAF solid tumors. Your healthcare provider will perform a test to make sure that TAFINLAR is right for you. It is not known if TAFINLAR used in combination with trametinib is safe and effective in children less than 1 year of age.

It is not known if TAFINLAR used alone is safe and effective in children. Before you take or give TAFINLAR, tell your healthcare provider about all of your medical conditions, including if you: have had bleeding problems have heart problems have eye problems have liver or kidney problems have diabetes plan to have surgery, dental, or other medical procedures have a deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme are pregnant or plan to become pregnant. TAFINLAR can harm your unborn baby.

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 ef… [Excerpted — this section continues on DailyMed.]

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: March 2024 INSTRUCTIONS FOR USE TAFINLAR ® (TAFF-in-lar) (dabrafenib) tablets for oral suspension This “Instructions for Use” contains information on how to prepare and take or give TAFINLAR tablets for oral suspension.

Important information you need to know before taking or giving TAFINLAR tablets for oral suspension Read this “Instructions for Use” carefully before you prepare and take or give TAFINLAR oral suspension for the first time and each time you get a refill. There may be new information. This “Instructions for Use” does not take the place of talking with your healthcare provider about your or your child’s medical condition and treatment.

Your healthcare provider or pharmacist should show you how to prepare and take or give a dose of TAFINLAR oral suspension correctly. Always take or give TAFINLAR exactly as your healthcare provider tells you to. If you have any questions about how to prepare and take or give a dose of TAFINLAR oral suspension, talk to your healthcare provider or pharmacist.

Always use the dosing cup that comes with your TAFINLAR pack. If your pack does not contain a dosing cup, contact your healthcare provider or pharmacist. Use only clean water to rinse.

Do not use soap or dishwashing liquid to clean the dosing cup. If at any time TAFINLAR oral suspension gets on your or your child’s skin, wash the area well with soap and water. If at any time TAFINLAR oral suspension gets in your or your child’s eyes, rinse the eyes well with cool water.

If you spill any TAFINLAR oral suspension, follow the instructions at the end of this “Instructions for Use” in Section E. “How to clean up any spilled TAFINLAR oral suspension”. You will receive the TAFINLAR tablets in a sealed bottle. The TAFINLAR tablets must be mixed in water before taking or giving a dose of TAFINLAR oral suspension.

The tablets break apart (disperse) in the water and may not fully dissolve. Follow the instructions below to mix the tablets in water. The TAFINLAR pack should contain: You will also need drinking water.

For taking or giving a dose of the TAFINLAR oral suspension by swallowing, go to Section A. For taking or giving a dose of the TAFINLAR oral suspension through a feeding tube or using an oral syringe, go to Section B. Section A.

Preparing and taking or giving a dose of the TAFINLAR oral suspension by swallowing directly from the dosing cup If any of the TAFINLAR oral suspension comes into contact with your skin or eyes when you are following the steps below, follow instructions in the section “Important information you need to know before taking or giving TAFINLAR tablets for oral suspension”. To prepare and take or give a dose of TAFINLAR oral suspension, you will need: the prescribed number of tablets 1 dosing cup 1 teaspoon drinking water To take or give a dose of TAFINLAR oral suspension by mouth (swallowing the TAFINLAR oral suspension), you or your child can drink it directly from the dosing cup.

Step 1. Wash and dry your hands before preparing TAFINLAR tablets as an oral suspension. Add cool drinking water up to the markings on the dosing cup, as follows: Note: The amount of water does not need to be exact.

If the prescribed dose is 1 to 4 tablets, you will need about 5 mL of water. If the prescribed dose is 5 to 15 tablets, you will need about 10 mL of water. Step 2.

Remove the bottle cap by pushing down and turning counter-clockwise in the direction of the arrow, as shown. Do not throw away (dispose of) the cap. If you are opening the bottle for the first time, remove the seal from the bottle.

Step 3. Count out the prescribed number of tablets into your hand. Add the prescribed number of tablets into the water in your dosing cup.

The bottle contains 2 plastic canisters to keep the tablets dry. If either canister falls out when you are taking out the tablets, re-insert it back into the bottle. Step 4.

Place the cap back onto th… [Excerpted — this section continues on DailyMed.]