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Treatment guide for patients and caregivers
FOR PATIENTS WITH A CERTAIN TYPE OF BRAF+ ADVANCED MELANOMA
TAFINLAR + MEKINIST
A treatment option specifically
made for your type of melanoma
for more moments
INDICATION
TAFINLAR® (dabrafenib) and MEKINIST® (trametinib) are prescription medicines that can be used in combination to treat people with a
type of skin cancer called melanoma:
• That has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable), and
• That has a certain type of abnormal “BRAF” (V600E or V600K mutation-positive) gene.
TAFINLAR, in combination with MEKINIST, is not used to treat people with a type of skin cancer called wild-type BRAF melanoma.
MEKINIST should not be used to treat people who already have received a BRAF inhibitor for treatment of their melanoma.
Your health care provider will perform a test to make sure that TAFINLAR and MEKINIST, in combination, are right for you.
It is not known if TAFINLAR and MEKINIST, in combination, are safe and effective in children.
Please see Important Safety Information throughout this brochure, and the Summary of Important Information on pages 10-13.
Table of Contents
Y
ou are probably experiencing many emotions as you process all
the information provided by your doctor. The good news is that
you have a treatment option that’s made for your type of cancer, plus
the support of your family, friends, and health care team. This guide is
meant to help you and those close to you understand your treatment with
TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) combination therapy.
Please see Important Safety Information throughout this brochure, and the Summary of Important Information on pages 10-13.
Understanding your type of
advanced melanoma
4
What is a BRAF mutation?
5
A treatment option that’s made for your
type of cancer
6
Potential benefits of TAFINLAR + MEKINIST
therapy
8
Summary of Important Information
10
Getting started on TAFINLAR + MEKINIST
14
Storing TAFINLAR and MEKINIST
15
Getting the most out of your treatment
16
Questions to ask your doctor
16
Tips your doctor may suggest for coping
with fever
18
Tips your doctor may suggest for managing
other common side effects
19
Frequently asked questions
20
How can I learn more about melanoma?
21
Resources and support
22
4
5
Understanding your type of advanced melanoma
What is a BRAF mutation?
Understanding your type of advanced melanoma (unresectable or metastatic) is the first part of your treatment journey.
It will help you to understand why your doctor has prescribed TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) for you,
and will help you in conversations with your health care team.
Sometimes changes occur within the DNA of your cells. The type of advanced melanoma you have can be based on the
presence or absence of genetic changes within the melanoma cells. These genetic changes are referred to as “mutations.”
Two common types of mutations found in advanced melanoma are
Melanoma is a type of skin cancer
that begins in the cells which give
skin its color (melanocytes).
BRAF V600E and V600K.
It means that the BRAF gene within the cell is damaged, and sends
the wrong signals, causing cells to grow and spread out of control.
“Metastatic” means that your
cancer (in this case, melanoma)
has spread to other parts of
your body—either through
your bloodstream or your
lymph nodes.
An “inoperable” tumor is
sometimes referred to as
“unresectable.” Both terms
mean that the tumor or tumors
can’t be completely removed
by surgery, either because they
have spread to too many places
or their location makes the
surgery very challenging.
Doctors will determine the stage
of your melanoma, according
to the extent of cancer in
your body, by using physical
examinations and specific
imaging tests. With advanced
melanoma, a biopsy (or tissue
sample) of the cells will be
tested to see if it contains a
BRAF mutation, other gene
mutation, or no known mutation.
As many as 50% of patients with advanced melanoma
have one of these gene mutations.
When doctors know for sure that the advanced melanoma has a damaged BRAF gene, they call it “BRAF-positive”
advanced melanoma. You may see this written as “BRAF+” advanced melanoma.
BRAF
Knowing your BRAF mutation status can be crucial when choosing an
appropriate treatment.
IMPORTANT SAFETY INFORMATION
TAFINLAR and MEKINIST may cause serious side effects, including the risk of new cancers: TAFINLAR, when used
in combination with MEKINIST, may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). New
melanoma lesions have also occurred. TAFINLAR and MEKINIST in combination may cause new cancers, including basal
cell carcinoma. Talk with your health care provider about your risk for these cancers.
Check your skin and tell your health care provider right away about any skin changes, including a new wart, skin sore, or
reddish bump that bleeds or does not heal, or a change in size or color of a mole.
Please see Important Safety Information throughout this brochure, and the Summary of Important Information on
pages 10-13.
IMPORTANT SAFETY INFORMATION (continued)
Your health care provider should check your skin before you start
treatment, and every 2 months while on treatment, to look for any
new skin cancers. Your health care provider should continue to check
your skin for 6 months after you stop taking TAFINLAR and MEKINIST.
Your health care provider should also check for cancers that may
not occur on the skin. Tell your health care provider about any new
symptoms that have developed while taking TAFINLAR and MEKINIST
in combination.
6
7
A treatment option that’s made for your type of cancer
Patients with BRAF mutations have the option of taking targeted therapies, such as BRAF and MEK inhibitors, which
are designed to target cells with the BRAF gene mutation and treat this form of advanced melanoma. These targeted
therapies are intended to work by blocking the action of certain proteins associated with the BRAF gene so that they
inhibit the faulty signals that can lead to the growing and spreading of cancer cells such as melanoma. Targeted therapy
can also affect healthy cells.
TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) combination therapy targets 2 different points in a pathway that sends
signals in cells. Although TAFINLAR + MEKINIST combination therapy has been studied in patients who have advanced
melanoma with a mutated BRAF gene, the way that TAFINLAR + MEKINIST combination therapy works has only been
shown in laboratory studies. Medical research has shown that TAFINLAR + MEKINIST combination therapy may slow the
growth of certain melanoma cancer cells that have an abnormal BRAF gene.
TAFINLAR + MEKINIST combination therapy
can be used to treat people with a type of
advanced melanoma:
that has spread to other parts of the body (for
example, the liver, lungs, and brain) or cannot
be removed by surgery, and
that has a certain type of abnormal BRAF (V600E
or V600K mutation–positive) gene as determined
by an FDA-approved test
IMPORTANT SAFETY INFORMATION (continued)
TAFINLAR and MEKINIST in combination may cause serious side effects, including:
Bleeding problems. TAFINLAR and MEKINIST in combination can cause serious bleeding problems, especially in your
brain or stomach, and can lead to death. Call your health care provider and get medical help right away if you have any
signs of bleeding, including:
• headaches, dizziness, or feeling weak
• coughing up blood or blood clots
• vomiting blood or your vomit looks like “coffee grounds”
• red or black stools that look like tar
Please see Important Safety Information throughout this brochure,
and the Summary of Important Information on pages 10-13.
7
8
9
Potential benefits of TAFINLAR + MEKINIST therapy
TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) may offer a chance to extend your life*
Patients taking TAFINLAR + MEKINIST
lived significantly longer than patients
taking TAFINLAR
Patients lived longer without their disease
worsening with TAFINLAR + MEKINIST
Half of patients taking each treatment were
alive after:
Half of patients taking each treatment were alive
without their disease worsening after:
TAFINLAR
TAFINLAR
+
+
MEKINIST
MEKINIST
TAFINLAR
TAFINLAR
25.1
25.1 18.7
18.7
VS
MONTHS
MONTHS
VS
MONTHS
MONTHS
TAFINLAR
TAFINLAR
+
+
MEKINIST
MEKINIST
More patients had their tumors shrink or disappear (known as the "overall response rate")
with TAFINLAR + MEKINIST
Overall
response rate
TAFINLAR + MEKINIST
66%
Overall
response rate
TAFINLAR
TAFINLAR
TAFINLAR
9.39.3 8.88.8
VS
51%
VS
MONTHS
MONTHS
MONTHS
MONTHS
*As demonstrated by a clinical trial that included 423 adult patients with BRAF V600E/K mutation–positive unresectable or metastatic melanoma that was
previously untreated. Patients were treated with a combination of TAFINLAR + MEKINIST or TAFINLAR alone.
IMPORTANT SAFETY INFORMATION (continued)
Tumors disappeared completely in 10% of patients taking TAFINLAR + MEKINIST and 8% of patients
taking TAFINLAR
Tumors shrank in 56% of patients taking TAFINLAR + MEKINIST and 42% of patients taking TAFINLAR
Tumors shrank or disappeared for an average of 9.2 months with TAFINLAR + MEKINIST and 10.2 months
with TAFINLAR
Inflammation of the colon and bleeding in the stomach or intestines. MEKINIST, alone or in combination with
TAFINLAR, can cause inflammation of the colon and bleeding in the stomach or intestines that can lead to death. Tell your
health care provider immediately if you have any of the following symptoms:
IMPORTANT SAFETY INFORMATION (continued)
• diarrhea
• stomach or abdominal pain
Eye problems. TAFINLAR and MEKINIST, in combination, can cause severe eye problems that can lead to blindness. Call
your health care provider right away if you get these symptoms of eye problems:
• fever
• nausea
Blood clots. TAFINLAR and MEKINIST in combination can cause blood clots in your arms or legs, which can travel to your
lungs and lead to death. Get medical help right away if you have the following symptoms:
• blurred vision, loss of vision, or other vision changes
• seeing color dots
• chest pain
• sudden shortness of breath or trouble breathing
• pain in your legs with or without swelling
Lung or breathing problems. TAFINLAR and MEKINIST, in combination, can cause lung or breathing problems. Tell your
health care provider if you have any new or worsening symptoms of lung or breathing problems, including:
• swelling in your arms or legs
• a cool pale arm or leg
Heart problems, including heart failure. Your health care provider should check your heart function before you start
taking TAFINLAR and MEKINIST in combination, and during treatment. Call your health care 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
• halo (seeing blurred outline around objects)
• eye pain, swelling, or redness
• shortness of breath
• cough
• swelling of your ankles and feet
• feeling lightheaded
Please see Important Safety Information throughout this brochure,
and the Summary of Important Information on pages 10-13.
10
11
Summary of IMPORTANT INFORMATION
What are TAFINLAR® (dabrafenib) and MEKINIST® (trametinib)?
TAFINLAR and MEKINIST are prescription medicines used in combination 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 health care provider will perform a test to make sure that TAFINLAR and MEKINIST are right for you. TAFINLAR and
MEKINIST are not used to treat people with a type of skin cancer called wild-type BRAF melanoma. MEKINIST should not
be used to treat people who already have received a BRAF inhibitor for treatment of their melanoma.
It is not known if TAFINLAR and MEKINIST are safe and effective in children.
What is the most important information I should know about TAFINLAR and MEKINIST?
TAFINLAR and MEKINIST may cause serious side effects, including the risk of new cancers such as a type of skin cancer
called cutaneous squamous cell carcinoma, basal cell carcinoma, or new melanoma lesions. Talk to your health care
provider about your risk for these cancers.
Check your skin and tell your health care provider right away about any skin changes including a new wart, skin sore, or
reddish bump that bleeds or does not heal, or a mole that changes size or color.
Your health care provider should check your skin before treatment with TAFINLAR and MEKINIST, every 2 months during
treatment and for up to 6 months after you stop taking TAFINLAR and MEKINIST to look for any new skin cancers. Your
health care provider should also check for cancers that may not occur on the skin. Tell your health care provider about any
new symptoms that develop during treatment with TAFINLAR and MEKINIST.
What warnings should I know about TAFINLAR and MEKINIST?
TAFINLAR and MEKINIST may cause serious side effects, including:
Blood clots. TAFINLAR and MEKINIST in combination can cause blood clots in your arms or legs, which can travel to your
lungs and lead to death. Get medical help right away if you have the following symptoms:
chest pain
swelling in your arms or legs
sudden shortness of breath or trouble breathing
a cool pale arm or leg
pain in your legs with or without swelling
Heart problems, including heart failure. Your health care provider should check your heart function before you start
taking TAFINLAR and MEKINIST in combination, and during treatment. Call your health care 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
swelling of your ankles and feet
shortness of breath
feeling lightheaded
Eye problems. TAFINLAR and MEKINIST, in combination, can cause severe eye problems that can lead to blindness. Call
your health care provider right away if you get these symptoms of eye problems:
blurred vision, loss of vision, or other vision changes
halo (seeing blurred outline around objects)
seeing color dots
eye pain, swelling, or redness
Lung or breathing problems. TAFINLAR and MEKINIST, in combination, can cause lung or breathing problems. Tell
your health care provider if you have any new or worsening symptoms of lung or breathing problems such as shortness of
breath or cough.
Fever. Fever is common during treatment with TAFINLAR and MEKINIST, but it may also be serious. When taking
TAFINLAR and MEKINIST, in combination, fever may happen often or may be 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 health care provider right away if you get a fever while taking TAFINLAR or MEKINIST.
Skin reactions. Rash is a common side effect of TAFINLAR and MEKINIST in combination. In some cases these rashes and
other skin reactions can be severe, and may need to be treated in a hospital. Call your health care provider if you get any
of the following symptoms:
Bleeding problems. TAFINLAR and MEKINIST in combination can cause serious bleeding problems, especially in your
brain or stomach, and can lead to death. Call your health care provider and get medical help right away if you have any
signs of bleeding, including:
skin rash that bothers you or does not go away
headaches, dizziness, or feeling weak
acne
coughing up blood or blood clots
vomiting blood or your vomit looks like
“coffee grounds”
redness, swelling, peeling, or tenderness of hands
or feet
skin redness
red or black stools that look like tar
Inflammation of the colon and bleeding in the stomach or intestines. MEKINIST, alone or in combination with
TAFINLAR, can cause inflammation of the colon and bleeding in the stomach or intestines that can lead to death. Tell your
health care provider immediately if you have any of the following symptoms:
diarrhea
fever
stomach or abdominal pain
nausea
Please see Important Safety Information throughout this brochure,
and the Summary of Important Information on pages 10-13.
12
13
Summary of IMPORTANT INFORMATION (continued)
Increased blood sugar (hyperglycemia). Some people may develop high blood sugar or worsening diabetes during
treatment with TAFINLAR® (dabrafenib) and MEKINIST® (trametinib) in combination. If you are diabetic, your health care
provider should check your blood sugar levels closely during treatment with TAFINLAR and MEKINIST. Your diabetes
medicine may need to be changed. Tell your health care provider if you have symptoms of severe high blood sugar such
as increased thirst, urinating more often than normal, or producing an increased amount of urine.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency. 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 health care provider if you have any of the following signs or symptoms:
yellow skin (jaundice), weakness or dizziness, or shortness of breath.
What should I tell my health care provider before taking TAFINLAR and MEKINIST?
Before you take TAFINLAR and MEKINIST, tell your health care provider if you:
Have had bleeding problems or blood clots
Have inflammation of the colon
Have heart problems
Have eye problems
Have lung or breathing problems
Have high blood pressure (hypertension)
Have liver or kidney problems
Have diabetes
Have a deficiency of the glucose-6-phosphate
dehydrogenase (G6PD) enzyme
Have any other medical conditions
Plan to have surgery, dental, or other medical
procedures
Are pregnant or plan to become pregnant
– TAFINLAR and MEKINIST, in combination, may harm
your unborn baby. Females who are able to become
pregnant should use birth control (contraception)
during treatment with TAFINLAR and MEKINIST,
in combination, and for 4 months after stopping
treatment with TAFINLAR and MEKINIST.
– Birth control using hormones (such as birth control
pills, injections, or patches) may not work as well
while you are taking TAFINLAR and MEKINIST in
combination. You should use another effective
method of birth control while taking TAFINLAR and
MEKINIST in combination. Talk to your health care
provider about birth control methods that may be
right for you during this time.
– TAFINLAR and MEKINIST in combination may cause
fertility problems in females. This could affect your
ability to become pregnant.
– TAFINLAR may cause lower sperm counts in males.
This could affect the ability to father a child. Talk to
your health care provider if this is a concern for you.
Are breastfeeding or planning to breastfeed
– It is not known if TAFINLAR or MEKINIST passes into
your breast milk. Do not breastfeed during treatment
and for 4 months after your last dose of TAFINLAR
and MEKINIST. Talk to your health care provider about
the best way to feed your baby during this time.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Taking TAFINLAR and MEKINIST with certain other medicines can affect each other,
causing side effects. TAFINLAR and MEKINIST may affect the way other medicines work, and other medicines can affect
how TAFINLAR and MEKINIST work. You can ask your pharmacist for a list of medicines that may interact with TAFINLAR
and MEKINIST. Know the medicines you take. Keep a list of them to show your health care provider and pharmacist when
you get a new medicine.
What are other side effects of TAFINLAR and MEKINIST in combination?
Other common side effects of TAFINLAR and MEKINIST in combination include:
Nausea
Swelling of the face, arms, or legs
Chills
Headache
Diarrhea
Joint aches
Vomiting
Cough
High blood pressure (hypertension)
– Your health care provider should check your blood
pressure during treatment. Call your health care
provider right away if you develop high blood
pressure, your blood pressure worsens, or you have a
severe headache, lightheadedness, or dizziness
General Information about the Safe and Effective Use of TAFINLAR and MEKINIST
Do not use TAFINLAR and MEKINIST for a condition for which it was not prescribed. Do not give TAFINLAR and MEKINIST
to other people, even if they have the same symptoms that you have. It may harm them. You can ask your health care
provider or pharmacist for information about TAFINLAR and MEKINIST that is written for health care professionals.
These are not all of the possible side effects of TAFINLAR and MEKINIST. For more information, talk with your health care
provider or pharmacist or call 1-888-669-6682. The FDA-approved product labeling or prescribing information can be found
at www.us.tafinlarmekinist.com.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
Please see Important Safety Information throughout this brochure,
and the Summary of Important Information on pages 10-13.
14
15
Getting started on TAFINLAR + MEKINIST
Storing TAFINLAR and MEKINIST
Recommended dose: TAFINLAR® (dabrafenib) 150 mg twice daily +
MEKINIST® (trametinib) 2 mg once daily by mouth
Storing TAFINLAR
Store TAFINLAR at room temperature, between 68°F and 77°F
Storing MEKINIST
1st Dose
Morning
TAFINLAR 150 mg
(2 x 75 mg)
12-HOUR
INTERVAL
BETWEEN
TAFINLAR
DOSES
Store MEKINIST in the refrigerator between 36°F and 46°F. Do not freeze
Once
Daily
2nd Dose
Evening
TAFINLAR 150 mg
(2 x 75 mg)
MEKINIST 2 mg
Take MEKINIST at the same time each
day with either the morning dose or
evening dose of TAFINLAR
Keep MEKINIST dry and away from moisture and light
The bottle of MEKINIST contains a packet that helps keep your medicine dry. Do not throw away this packet
Keep MEKINIST in its original bottle. Do not place tablets in a pill box
Safely throw away MEKINIST that is expired or no longer needed
Keep TAFINLAR, MEKINIST, and all medicines out of the reach of children.
Take your medication on an empty stomach at least 1 hour before or at least 2 hours after eating.
Important dosing information
Do not open, crush, or break TAFINLAR capsules
If you miss a dose of TAFINLAR or MEKINIST, take it as soon as you remember, unless:
– You’ve missed TAFINLAR and it is within 6 hours of your next scheduled dose, or
– You’ve missed MEKINIST and it is within 12 hours of your next scheduled dose
In either case, just take your next dose at the regular time. Do not make up for the missed dose.
It is important that you understand and follow your doctor’s directions for taking TAFINLAR + MEKINIST.
Do not change your dose, or stop TAFINLAR or MEKINIST, unless your doctor tells you to.
IMPORTANT SAFETY INFORMATION (continued)
Fever. Fever is common during treatment with TAFINLAR and MEKINIST, but it may also be serious. When taking
TAFINLAR and MEKINIST, in combination, fever may happen often or may be 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
health care provider right away if you get a fever while taking TAFINLAR or MEKINIST.
Skin reactions. Rash and other skin reactions are a common side effect of TAFINLAR and MEKINIST in combination. In
some cases these rashes and other skin reactions can be severe, and may need to be treated in a hospital. Call your health
care provider if you get any of the following symptoms:
• skin rash that bothers you or does not go away
• acne
Develop a routine for taking your medicine that fits your daily schedule
For example, you can take
TAFINLAR + MEKINIST in the morning
at 8 am, 1 hour before breakfast…
…and then you can take
TAFINLAR again in the evening at
8 pm, at least 2 hours after dinner
• 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 and MEKINIST in combination. If you are diabetic, your health care provider should check
your blood sugar levels closely during treatment with TAFINLAR and MEKINIST. Your diabetes medicine may need to be
changed. Tell your health care 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
Please see Important Safety Information throughout this brochure,
and the Summary of Important Information on pages 10-13.
16
17
Getting the most out of your treatment
It is important to keep an open dialogue with your doctor. This will help you have more productive conversations so that,
together, you can get the most out of your TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) combination therapy.
BEFORE STARTING TREATMENT
Tell your health care provider about all the medications you take, and if you:
Have had bleeding problems or blood clots
Have heart problems
Have eye problems
Have lung or breathing problems
Have high blood pressure (hypertension)
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 enzyme
Have any other medical conditions
Are pregnant or plan to become pregnant
Are breastfeeding or plan to breastfeed
Questions to ask your doctor
Talking openly with the doctor is important in making informed decisions about your treatment journey. These
suggested questions are a starting point to help you learn more about your cancer care and treatment. You are also
encouraged to ask additional questions that are important to you.
How will we know if the treatment is working?
Do I need to change what I eat during treatment?
Is there anything I can do to help manage
side effects?
Are there any limits on what I can do?
What symptoms or side effects should I tell you
about right away?
Will I need special tests such as imaging scans
and blood tests, and how often?
What kind of exercise should I do, and how often?
IMPORTANT SAFETY INFORMATION (continued)
TAFINLAR may cause healthy red blood cells to break down too early in people with glucose-6-phosphate
dehydrogenase (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 health care provider if you have any of the following signs or symptoms:
• yellow skin (jaundice)
• weakness or dizziness
• shortness of breath
TAFINLAR and MEKINIST, in combination, can harm your unborn baby. Females who are able to become pregnant
should use birth control (contraception) during treatment with TAFINLAR and MEKINIST in combination, and for 4 months
after stopping treatment with TAFINLAR and MEKINIST.
Please see Important Safety Information throughout this brochure,
and the Summary of Important Information on pages 10-13.
18
19
Tips your doctor may suggest for coping with fever
Fever is a common side effect of TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) combination therapy. When taking
TAFINLAR + MEKINIST, fever may occur frequently or may be severe. In some cases, chills or shaking chills, too much fluid
loss (called “dehydration”), low blood pressure, dizziness, or kidney problems can occur with the fever.
What to do if you think you may have a fever
As soon as you start feeling unusually warm or cold, check your temperature. Call your health care provider right away
if you get a fever while taking TAFINLAR + MEKINIST. Your health care provider may recommend that you:
Drink liquids (for example,
water, soups, ice pops).
Place a cold cloth on your
forehead if you feel hot.
Get plenty of rest.
Use over-the-counter antifever
medicines such as acetaminophen
or ibuprofen.
Tips your doctor may suggest for managing other
common side effects
As with many medications, you may experience some side effects while taking TAFINLAR + MEKINIST. Below are some
common side effects of TAFINLAR + MEKINIST treatment and tips your doctor may suggest to help you manage them.
Talk to your health care provider right away if you experience any side effects. Your doctor may choose to modify,
interrupt, or discontinue your dosage.
IMPORTANT SAFETY INFORMATION (continued)
Birth control using hormones (such as birth control pills, injections, or patches) may not work as well while you are taking
TAFINLAR and MEKINIST in combination. You should use another effective method of birth control while taking TAFINLAR
and MEKINIST in combination.
Talk to your health care provider about birth control methods that may be right for you during this time.
Tell your health care provider right away if you become pregnant, or think you might be pregnant, during treatment with
TAFINLAR and MEKINIST in combination.
RASH
JOINT ACHES
Your health care provider may give you a
range of recommendations, from limiting
exposure to the sun to using a gentle,
thick, alcohol-free emollient cream to
soothe affected areas. In some cases these
rashes and other skin reactions can be
severe, and may need to be treated in
a hospital.
Your health care provider may suggest
over-the-counter nonsteroidal
anti-inflammatory drugs to help
relieve pain and swelling, along with
icing and resting the affected area.
HEADACHE
DIARRHEA
Your health care provider may suggest
over-the-counter pain relievers such
as acetaminophen or ibuprofen, along
with lifestyle modifications including
dietary, sleep, and stress reduction.
Your health care provider may
recommend a specific diet plan
along with an increase in fluids and
a decrease in greasy foods, spicy
foods, or foods containing dairy.
Keep track of your side effects, and inform your doctor about
any side effect that bothers you or that does not go away.
Additional common side effects:
Other common side effects include cough, nausea, chills, vomiting, high blood pressure (hypertension), and swelling
of the face, arms, or legs
If you experience side effects, your doctor may decide to adjust your dose or stop TAFINLAR and/or MEKINIST.
Do not change your dose or stop TAFINLAR or MEKINIST unless your doctor tells you to.
IMPORTANT SAFETY INFORMATION (continued)
Common side effects of TAFINLAR and MEKINIST when used in combination include:
• nausea
• chills
• diarrhea
• vomiting
• high blood pressure (hypertension)
Please see Important Safety Information throughout this brochure, and the Summary of Important Information on
pages 10-13.
• s welling of the face,
arms, or legs
• headache
• joint aches
• cough
20
21
Frequently asked questions
Q
Q
Q
Q
HOW LONG DO I TAKE TAFINLAR® (dabrafenib) + MEKINIST® (trametinib)?
A
Keep taking TAFINLAR + MEKINIST for as long as your doctor tells you.
WHAT IF I MISS A DOSE?
A
If you miss a dose of TAFINLAR or MEKINIST, take it as soon as you remember.
But if you miss TAFINLAR, and it is within 6 hours of your next scheduled dose, or
if you miss MEKINIST, and it is within 12 hours of your next scheduled dose, just
take your next dose at the regular time. Do not make up for the missed dose.
WHAT CAN I DO ABOUT SIDE EFFECTS?
A
Your doctor may change, temporarily interrupt, or stop your dose of TAFINLAR
and/or MEKINIST during your treatment to help manage side effects. If you have
any questions about your treatment, talk to your doctor.
How can I learn more about melanoma?
Many organizations offer support and information for people with cancer. Some of the websites listed here provide
information about health insurance issues, treatment options, and support programs available for people with
advanced melanoma. Several of the websites offer forums where you can connect with other patients and caregivers.
National Cancer Institute
http://www.cancer.gov/cancertopics/types/skin
Melanoma International Foundation
http://melanomainternational.org
Melanoma Research Foundation (MRF)
https://www.melanoma.org
American Academy of Dermatology
https://www.aad.org/public/diseases/skincancer/melanoma
AIM at Melanoma
https://www.aimatmelanoma.org/
National Comprehensive Cancer Network
(NCCN) Guidelines for Patients with Melanoma
http://www.nccn.org/patients/guidelines/
melanoma/index.html
Skin Cancer Foundation
http://www.skincancer.org
The organizations and websites listed above are external to Novartis. Novartis does not have control over the
information provided on these websites and, therefore, cannot guarantee their accuracy and completeness. Any
information you receive from these sites should not replace the medical advice from your health care provider.
DO I NEED TO TAKE EVERY DOSE?
A
It is important to take TAFINLAR + MEKINIST exactly as your doctor tells you.
Do not change your dose or stop taking TAFINLAR or MEKINIST unless your
doctor tells you.
IMPORTANT SAFETY INFORMATION (continued)
New or worsening high blood pressure (hypertension). Your health care provider should check your blood
pressure during treatment with MEKINIST. Call your health care provider right away if you develop high blood
pressure, your blood pressure worsens or you have severe headache, lightheadedness, or dizziness.
IMPORTANT SAFETY INFORMATION (continued)
Fertility problems. TAFINLAR and MEKINIST, in combination, may cause fertility problems in females. This could
affect your ability to become pregnant. Talk to your health care provider if this is a concern for you.
Low sperm counts. TAFINLAR may cause lower sperm counts in males. This could affect the ability to father a child.
Talk to your health care provider if this is a concern for you.
Please see Important Safety Information throughout this brochure,
and the Summary of Important Information on pages 10-13.
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23
Resources and support
At Novartis Pharmaceuticals Corporation, we are committed to supporting you with your treatment with
TAFINLAR® (dabrafenib) and MEKINIST® (trametinib). That is why we developed several assistance programs—
to help you access the medicine you need.
Co-pay Assistance Program
ELIGIBLE PATIENTS PAY A $10 CO-PAY FOR THEIR
TAFINLAR AND MEKINIST PRESCRIPTIONS*
ay a $10 co-pay for a 30-day supply of TAFINLAR or MEKINIST
P
– Minimum 14-day supply
– Maximum 90-day supply
ave up to the maximum of $15,000 per calendar year on
S
each product
Save an unlimited number of times through December 31, 2017
*Limitations apply. This offer is not valid under Medicare, Medicaid, or any other federal or state program, or for cash-paying patients. Novartis reserves
the right to rescind, revoke, or amend this program without notice. For full Terms and Conditions, go to www.copay.novartisoncology.com.
Patient Assistance Now Oncology
Novartis Oncology is committed to helping patients who are living
with cancer receive the medicines they need. Patient Assistance Now
Oncology (PANO) offers quick and easy access to information about
our wide range of resources.
You can get information about our PANO support programs in 2 ways:
Call 1-800-282-7630 to speak with a member of our knowledgeable staff dedicated to making
access to therapy as simple and convenient as possible; or
Visit our website at: www.OncologyAccessNow.com/patient
Free 30-day trial
Eligible patients can receive a one-time, per-dose, free 30-day supply of TAFINLAR and MEKINIST for a US Food and
Drug Administration–approved indication. Your supply will be shipped directly to you so you can get started with
treatment immediately.
Ask your doctor or nurse about the TAFINLAR and MEKINIST 30-day free-trial program.
Please see Important Safety Information throughout this brochure,
and the Summary of Important Information on pages 10-13.
FOR PATIENTS WITH A CERTAIN TYPE OF BRAF+ ADVANCED MELANOMA
BRAF
Because you are BRAF+, there is a treatment option made specifically for your type of cancer.
IMPORTANT SAFETY INFORMATION (continued)
Nursing mothers. It is not known if TAFINLAR® (dabrafenib) and/or MEKINIST® (trametinib) pass into your breast milk. Do not
breastfeed during treatment, and for 4 months after your last dose of TAFINLAR and MEKINIST. Talk to your health care provider
about the best way to feed your baby during this time.
These are not all of the possible side effects of TAFINLAR and MEKINIST. For more information about side effects, ask your
health care provider or pharmacist.
Before you take TAFINLAR and MEKINIST in combination, tell your health care provider if you:
• have had bleeding problems or blood clots
• have diabetes
• have inflammation of the colon
• plan to have surgery, dental, or other medical procedures
• have heart problems
• have a deficiency of the G6PD enzyme
• have eye problems
• have any other medical conditions
• have lung or breathing problems
• are pregnant or plan to become pregnant
• have high blood pressure (hypertension)
• are breastfeeding or plan to breastfeed
• have liver or kidney problems
Please see Important Safety Information throughout this brochure, and the Summary of Important Information on
pages 10-13.
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936-1080 © 2017 Novartis 3/17 MAF-1159137