tafinlar + mekinist - novartis · mekinist tafinlar mekinist tafinlar 25.1 vs 9.3 vs months 18.7...

Treatment guide for patients and caregivers

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.

TAFINLAR + MEKINIST

FOR PATIENTS WITH A CERTAIN TYPE OF BRAF+ ADVANCED MELANOMA

A treatment option specifically made for your type of melanoma

for more moments

Table of ContentsUnderstanding your type of advanced melanoma

What is a BRAF mutation?

A treatment option that’s made for your type of cancer

Potential benefits of TAFINLAR + MEKINIST therapy

Summary of Important Information

Getting started on TAFINLAR + MEKINIST

Storing TAFINLAR and MEKINIST

Getting the most out of your treatment

Questions to ask your doctor

Tips your doctor may suggest for coping with fever

Tips your doctor may suggest for managing other common side effects

Frequently asked questions

How can I learn more about melanoma?

Resources and support


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You 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.

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“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.

Melanoma is a type of skin cancer that begins in the cells which give skin its color (melanocytes).

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.

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.

What is a BRAF mutation?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.”

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 V600E and V600K.Two common types of mutations found in advanced melanoma are

Knowing your BRAF mutation status can be crucial when choosing an appropriate treatment.BRAF

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.

As many as 50% of patients with advanced melanoma have one of these gene mutations.

Understanding your type of advanced melanomaUnderstanding 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.


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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

A treatment option that’s made for your type of cancerPatients 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.

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


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Potential benefits of TAFINLAR + MEKINIST therapy

66%

51%

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Overall response rate

Overall response rate

More patients had their tumors shrink or disappear (known as the "overall response rate") with TAFINLAR + MEKINIST

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

Half of patients taking each treatment were alive after:

Half of patients taking each treatment were alive without their disease worsening after:

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

9.3VS VS25.1MONTHS

18.7MONTHS MONTHS

8.8MONTHS

TAFINLAR +MEKINIST TAFINLAR


9.3VS VS25.1MONTHS

18.7MONTHS MONTHS

8.8MONTHS



IMPORTANT SAFETY INFORMATION (continued)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• seeing color dots

• halo (seeing blurred outline around objects)• 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, including:

• shortness of breath• cough

TAFINLAR + MEKINIST

TAFINLAR

* 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)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• stomach or abdominal pain

• 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:

• chest pain• sudden shortness of breath or trouble breathing• pain in your legs with or without swelling

• 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

• swelling of your ankles and feet• feeling lightheaded


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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:

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

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

stomach or abdominal pain

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:

chest pain

sudden shortness of breath or trouble breathing

pain in your legs with or without swelling

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

swelling of your ankles and feet

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

seeing color dots

halo (seeing blurred outline around objects)

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:

skin rash that bothers you or does not go away

acne

redness, swelling, peeling, or tenderness of hands or feet

skin redness


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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.

Summary of IMPORTANT INFORMATION (continued)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

Chills

Diarrhea

Vomiting

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

Swelling of the face, arms, or legs

Headache

Joint aches

Cough

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.


http://www.fda.gov/medwatch

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Storing TAFINLAR and MEKINIST

Keep TAFINLAR, MEKINIST, and all medicines out of the reach of children.

Storing TAFINLAR

Store TAFINLAR at room temperature, between 68°F and 77°F

Storing MEKINIST

Store MEKINIST in the refrigerator between 36°F and 46°F. Do not freeze

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

Getting started on TAFINLAR + MEKINIST

Take your medication on an empty stomach at least 1 hour before or at least 2 hours after eating.

Recommended dose: TAFINLAR® (dabrafenib) 150 mg twice daily + MEKINIST® (trametinib) 2 mg once daily by mouth

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

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.

TAFINLAR 150 mg(2 x 75 mg)

1st DoseMorning

TAFINLAR 150 mg(2 x 75 mg)

2nd DoseEvening

12-HOUR INTERVAL BETWEEN TAFINLAR

DOSESMEKINIST 2 mg

Take MEKINIST at the same time each day with either the morning dose or

evening dose of TAFINLAR

OnceDaily

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

• 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


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Getting the most out of your treatmentIt 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 TREATMENTTell 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

How will we know if the treatment is working?

Is there anything I can do to help manage side effects?

What symptoms or side effects should I tell you about right away?

Do I need to change what I eat during treatment?

Are there any limits on what I can do?

What kind of exercise should I do, and how often?

Will I need special tests such as imaging scans and blood tests, and how often?

Questions to ask your doctorTalking 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.

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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.


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Tips your doctor may suggest for coping with feverFever 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.

RASH 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.

JOINT ACHES 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 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.

DIARRHEA 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.

Tips your doctor may suggest for managing other common side effectsAs 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.

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)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.

IMPORTANT SAFETY INFORMATION (continued)Common side effects of TAFINLAR and MEKINIST when used in combination include:

• nausea• chills• diarrhea• vomiting• high blood pressure (hypertension)

• swelling of the face, arms, or legs

• headache• joint aches• cough

Keep track of your side effects, and inform your doctor about any side effect that bothers you or that does not go away.


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Q AWHAT IF I MISS A DOSE?

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.

Frequently asked questions

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.

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.


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.

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.Q

Q

A

A

HOW LONG DO I TAKE TAFINLAR® (dabrafenib) + MEKINIST® (trametinib)?

WHAT CAN I DO ABOUT SIDE EFFECTS?

Keep taking TAFINLAR + MEKINIST for as long as your doctor tells you.

Q ADO I NEED TO TAKE EVERY DOSE?

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.

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.


National Cancer Institutehttp://www.cancer.gov/cancertopics/types/skin

Melanoma Research Foundation (MRF)https://www.melanoma.org

AIM at Melanomahttps://www.aimatmelanoma.org/

National Comprehensive Cancer Network (NCCN) Guidelines for Patients with Melanomahttp://www.nccn.org/patients/guidelines/melanoma/index.html

Melanoma International Foundationhttp://melanomainternational.org

American Academy of Dermatology https://www.aad.org/public/diseases/skin-cancer/melanoma

Skin Cancer Foundationhttp://www.skincancer.org

http://www.cancer.gov/cancertopics/types/skin

https://www.melanoma.org/

https://www.aimatmelanoma.org

https://www.nccn.org/patients/guidelines/melanoma/index.html

https://www.nccn.org/patients/guidelines/melanoma/index.html

http://melanomainternational.org

https://www.aad.org/public/diseases/skin-cancer/melanoma

https://www.aad.org/public/diseases/skin-cancer/melanoma

http://www.skincancer.org

22 23

Resources and supportAt 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*

* 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.

Pay a $10 co-pay for a 30-day supply of TAFINLAR or MEKINIST – Minimum 14-day supply – Maximum 90-day supply

Save up to the maximum of $15,000 per calendar year on each product

Save an unlimited number of times through December 31, 2017

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 trialEligible 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.

http://www.copay.novartisoncology.com

http://www.OncologyAccessNow.com/patient

FOR PATIENTS WITH A CERTAIN TYPE OF BRAF+ ADVANCED MELANOMA

Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080 © 2017 Novartis 3/17 MAF-1159137

Because you are BRAF+, there is a treatment option made specifically for your type of cancer.BRAF



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 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

• plan to have surgery, dental, or other medical procedures

• have a deficiency of the G6PD enzyme

• have any other medical conditions

• are pregnant or plan to become pregnant

• are breastfeeding or plan to breastfeed

tafinlar + mekinist - novartis · mekinist tafinlar mekinist tafinlar 25.1 vs 9.3 vs months 18.7...

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