Prescription Drug Information: Tafinlar (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

50 mg capsules: Dark red capsule imprinted with ‘GS TEW’ and ‘50 mg’ available in bottles of 120 (NDC 0173-0846-08). Each bottle contains a silica gel desiccant.

75 mg capsules: Dark pink capsule imprinted with ‘GS LHF’ and ‘75 mg’ available in bottles of 120 (NDC 0173-0847-08). Each bottle contains a silica gel desiccant.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Inform patients of the following:

Confirmation of BRAF V600E or V600K mutation

TAFINLAR as a single agent: Evidence of BRAF V600E mutation in the tumor specimen using an FDA-approved test is necessary to identify patients for whom treatment is indicated [see Dosage and Administration (2.1)].
TAFINLAR with trametinib: Evidence of BRAF V600 mutation in tumor specimens using an FDA-approved test is necessary to identify patients for whom treatment is indicated [see Dosage and Administration (2.1)].

New cutaneous and non-cutaneous malignancies

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

TAFINLAR when 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

TAFINLAR can cause cardiomyopathy. Advise patients to immediately report any signs or symptoms of heart failure to their healthcare provider [see Warnings and Precautions (5.4)].

Uveitis

TAFINLAR can cause uveitis, including iritis and iridocyclitis. Advise patients to contact their healthcare provider if they experience any changes in their vision [see Warnings and Precautions (5.5)].

Serious febrile reactions

TAFINLAR can cause pyrexia including serious febrile reactions. Inform patients that the incidence and severity of pyrexia are increased when TAFINLAR is given in combination with trametinib. Instruct patients to contact their healthcare provider if they develop fever while taking TAFINLAR [see Warnings and Precautions (5.6)].

Serious skin toxicities

TAFINLAR can cause serious skin toxicities. Advise patients to contact their healthcare provider for progressive or intolerable rash [see Warnings and Precautions (5.7)].

Hyperglycemia

TAFINLAR can impair glucose control in diabetic patients resulting in the need for more intensive hypoglycemic treatment. Advise patients to contact their healthcare provider to report symptoms of severe hyperglycemia [see Warnings and Precautions (5.8)].

Glucose-6-phosphate dehydrogenase (G6PD) deficiency

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

TAFINLAR can cause fetal harm if taken during pregnancy. Advise a pregnant woman of the potential risk to a fetus [see Warnings and Precautions (5.10), Use in Specific Populations (8.1, 8.3)].

Females and males of reproductive potential

Instruct females of reproductive potential to use non-hormonal, effective non-hormonal contraception during treatment and for 2 weeks after discontinuation of treatment with TAFINLAR. Advise patients to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, while taking TAFINLAR [see Warnings and Precautions (5.10), Use in Specific Populations (8.1, 8.3)].

Infertility

Advise males and females of reproductive potential of the potential risk for impaired fertility with TAFINLAR [see Use in Specific Populations (8.3)].

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)].

Instructions for taking Tafinlar

Instruct patients to take TAFINLAR at least 1 hour before or at least 2 hours after a meal [see Dosage and Administration (2.2)].

TAFINLAR is a registered trademark of the GSK group of companies.

THxID™ is a trademark of bioMérieux.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2015, GSK group of companies. All rights reserved.

TFR:4PI

MEDICATION GUIDE

TAFINLAR® (TAFF-in-lar)

(dabrafenib)

capsules

If your healthcare provider prescribes TAFINLAR for you to be taken 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 the risk of new cancers:

TAFINLAR, when used alone or with trametinib, may cause a type of skin cancer, called cutaneous squamous cell carcinoma (cuSCC). New melanoma lesions may happen in people who take TAFINLAR alone or with trametinib.

TAFINLAR with trametinib, may cause new cancers including basal cell carcinoma.

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 two 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 with a medicine called trametinib, to treat people with 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.

Your healthcare provider will perform a test to make sure that TAFINLAR is right for you.

TAFINLAR alone or with trametinib is not used to treat people with a type of skin cancer called wild-type BRAF melanoma.

It is not known if TAFINLAR alone or TAFINLAR with trametinib is safe and effective in children.

What should I tell my healthcare provider before taking TAFINLAR?

Before you take TAFINLAR, tell your healthcare provider 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
have any other medical conditions are pregnant or plan to become pregnant. TAFINLAR can harm your unborn baby.
Females who are able to become pregnant should use birth control (contraception) during treatment with TAFINLAR, and for 2 weeks after the last dose of TAFINLAR alone, or for 4 months after the last dose when taking TAFINLAR with trametinib.
Birth control methods that contain hormones (such as birth control pills, injections, or patches) may not work as well during treatment with TAFINLAR alone or TAFINLAR and trametinib. You should use another effective method of birth control during treatment with TAFINLAR alone or TAFINLAR and trametinib.
Talk to your healthcare provider about birth control methods that may be right for you during this time.
Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with TAFINLAR alone or TAFINLAR and trametinib.
are breastfeeding or plan to breastfeed. It is not known if TAFINLAR passes into your breast milk.
Do not breastfeed during treatment and for 2 weeks after your last dose of TAFINLAR alone, or for 4 months after your last dose of TAFINLAR with trametinib. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. TAFINLAR and certain other medicines can affect each other, causing side effects. TAFINLAR may affect the way other medicines work, and other medicines may affect how TAFINLAR works. You can ask your pharmacist for a list of medicines that may interact with TAFINLAR.

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 TAFINLAR?

Take TAFINLAR exactly as your healthcare provider tells you. Do not change your dose or stop TAFINLAR unless your healthcare provider tells you.
Take TAFINLAR 2 times a day, about 12 hours apart.
Take TAFINLAR at least 1 hour before or 2 hours after a meal.
Do not open, crush, or break TAFINLAR capsules.
If you miss a dose of TAFINLAR, take it as soon as you remember. But, if it is within 6 hours of your next scheduled dose, just take your next dose at your regular time. Do not make up for the missed dose.

What are the possible side effects of TAFINLAR?

TAFINLAR may cause serious side effects, including:

See “What is the most important information I should know about TAFINLAR?”
TAFINLAR, when taken with trametinib, can cause serious bleeding problems, especially in your brain or stomach, and can lead to death. Call your healthcare provider and get medical help right away if you have any signs of bleeding, including:
headaches, dizziness, or feeling weak
cough up blood or blood clots
vomit blood or your vomit looks like “coffee grounds”
red or black stool that looks like tar
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 or racing
shortness of breath
swelling of your ankles or feet
feeling lightheaded
eye problems. TAFINLAR, when taken alone or with trametinib, can cause severe eye problems that can lead to blindness. Call your healthcare provider right away if you get these symptoms of eye problems:
blurred vision, loss of vision, or other vision changes
see color dots
halo (see blurred outline around objects)
eye pain, swelling, or redness
fever. Fever is common during treatment with TAFINLAR alone or with trametinib, but may also be serious. When taking TAFINLAR with trametinib, fever may happen more often or may be more severe. In some cases, chills or shaking chills, too much fluid loss (dehydration), low blood pressure, dizziness, or kidney problems may happen with the fever. Call your healthcare provider right away if you get a fever during treatment with TAFINLAR.
skin reactions. Rash is a common side effect of TAFINLAR when taken alone, or with trametinib. TAFINLAR, when taken alone or with trametinib, can also cause other skin reactions. In some cases these rashes and other skin reactions can be severe, and may need to be treated in a hospital. Call your healthcare provider if you get any of the following symptoms:
skin rash that bothers your or does not go away
acne
redness, swelling, peeling, or tenderness of hands or feet
skin redness
increased blood sugar (hyperglycemia). Some people may develop high blood sugar or worsening diabetes during treatment with TAFINLAR, alone or with trametinib. If you are diabetic, your healthcare provider should check your blood sugar levels closely during treatment with TAFINLAR alone or with trametinib. 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
TAFINLAR may cause healthy red blood cells to break down too early in people with G6PD deficiency. This may lead to a type of anemia called hemolytic anemia where the body does not have enough healthy red blood cells. Tell your healthcare provider if you have any of the following signs or symptoms:
yellow skin (jaundice)
weakness or dizziness
shortness of breath

The most common side effects of TAFINLAR alone or with trametinib include:

thickening of the outer layers of the skin
headache
joint aches
warts
hair loss
redness, swelling, peeling, or tenderness of hands or feet
cough

TAFINLAR may cause fertility problems in females. This could affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.

TAFINLAR may cause lower sperm counts in males. This could affect the ability to father a child. Talk to your healthcare provider if this is a concern for you.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of TAFINLAR. For more information about side effects, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store TAFINLAR?

Store TAFINLAR at room temperature, between 68°F to 77°F (20°C to 25°C).
Keep TAFINLAR and all medicine out of the reach of children.

General information about the safe and effective use of TAFINLAR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TAFINLAR for a condition for which it was not prescribed. Do not give TAFINLAR to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about TAFINLAR that is written for health professionals.

What are the ingredients in TAFINLAR?

Active ingredient: dabrafenib

Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose

Capsule shells: hypromellose, red iron oxide (E172), titanium dioxide (E171).

GlaxoSmithKline

Research Triangle Park, NC 27709

Revised: November 2015

TAFINLAR is a registered trademark of the GSK group of companies.

©2015, GSK group of companies. All rights reserved.

TFR:4MG

PRINCIPAL DISPLAY PANEL

NDC 0173-0846-08

Tafinlar®

(Dabrafenib) Capsules

50 mg

Rx only

120 Capsules

Federal Law requires dispensing of TAFINLAR® with the Medication Guide provided with this bottle.

Each capsule contains 59.25 mg dabrafenib mesylate equivalent to 50 mg dabrafenib.

Dosage: See accompanying prescribing information.

Store at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Do not use if printed safety seal under cap is broken or missing.

GlaxoSmithKline

RTP, NC 27709

10000000124205 Rev. 3/14
Tafinlar 50mg 120 count label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0173-0847-08

Tafinlar®

(Dabrafenib) Capsules

75 mg

Rx only

120 Capsules

Federal Law requires dispensing of TAFINLAR® with the Medication Guide provided with this bottle.

Each capsule contains 88.88 mg dabrafenib mesylate equivalent to 75 mg dabrafenib.

Dosage: See accompanying prescribing information.

Store at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Do not use if printed safety seal under cap is broken or missing.

GlaxoSmithKline

RTP, NC 27709

10000000124207 Rev. 3/14
Tafinlar 75mg 120 count label
(click image for full-size original)
TAFINLAR
dabrafenib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0846
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DABRAFENIB MESYLATE (DABRAFENIB) DABRAFENIB 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
FERRIC OXIDE RED
TITANIUM DIOXIDE
Product Characteristics
Color RED Score no score
Shape OVAL Size 18mm
Flavor Imprint Code GSTEW;50mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0173-0846-08 120 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202806 06/10/2013 08/31/2018
TAFINLAR
dabrafenib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0847
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DABRAFENIB MESYLATE (DABRAFENIB) DABRAFENIB 75 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
FERRIC OXIDE RED
TITANIUM DIOXIDE
Product Characteristics
Color RED Score no score
Shape OVAL Size 20mm
Flavor Imprint Code GSLHF;75mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0173-0847-08 120 CAPSULE in 1 BOTTLE None
2 NDC:0173-0847-65 56 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202806 06/10/2013 05/31/2018
Labeler — GlaxoSmithKline LLC (167380711)

Revised: 11/2015 GlaxoSmithKline LLC

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