my treatment diary - novartis · (g6pd) enzyme have any other medical conditions plan to have...

Please see Important Safety Information throughout this brochure, and the Summary of Important Information on pages 4-9.

FOR PATIENTS WITH A CERTAIN TYPE OF BRAF+ ADVANCED MELANOMA

MyTreatment

DiaryINDICATION

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.

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IMPORTANT SAFETY INFORMATION

TAFINLAR® (dabrafenib) and MEKINIST® (trametinib) 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.

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.


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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:

Summary of IMPORTANT INFORMATION


6 7

feeling like your heart is pounding or racing shortness of breath swelling of your ankles and feet feeling lightheaded

Eye problems. TAFINLAR® (dabrafenib) and MEKINIST® (trametinib), 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

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 symptoms of severe high blood sugar such as increased thirst, urinating more often than normal, or urinating 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

Summary of IMPORTANT INFORMATION (continued)


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Are pregnant or plan to become pregnant – TAFINLAR® (dabrafenib) and MEKINIST® (trametinib), 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 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.

Summary of IMPORTANT INFORMATION (continued)


http://www.fda.gov/medwatch

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Table of Contents

Remember : Stay on top of your treatment. Keep track of all your upcoming appointments and important notes.

My current medications

My appointment calendar

Questions for my doctor or nurse

Tracking my side effects

Coping with cancer

My journal

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42

52

16

48

62

PHONE NUMBER

ADDRESS

ONCOLOGIST NAME

NURSE NAME

THIS DIARY BELONGS TO

PHONE NUMBER

PHONE NUMBER

PRIMARY CARE PROVIDER

EMERGENCY CONTACT NAME

PHONE NUMBER

SPECIALTY PHARMACY

PHONE NUMBER

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Know the medicines you take. It’s important for your doctor to be aware of what medicines you are taking. Use the following pages to write down the prescription drugs, nonprescription medicines, vitamins, and herbal supplements you take, and show a list to your health care provider and pharmacist when you get a new medicine.

My current medications

NOTESMEDICATION WHEN I TAKE ITFOR DOSE

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My current medications (continued)

NOTESMEDICATION WHEN I TAKE ITFOR DOSE

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THURSDAY FRIDAY SATURDAY NOTESSUNDAY MONDAY TUESDAY WEDNESDAY

MONTH

My appointment calendarThe following pages can be used to track upcoming doctor appointments, record notes about past visits, and set up reminders to refill prescriptions. Fill in the current month at the top of each page.

EXAMPLE

CALENDAR

“Attitude is a little thing that makes a big difference.“

—Winston Churchill

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THURSDAY FRIDAY SATURDAY


SUNDAY MONDAY TUESDAY WEDNESDAY

MONTH

NOTES

“Surround yourself with only people who are going to lift you higher.“

—Oprah Winfrey

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“Enjoy the little things, for one day you may look back and realize they were the big things.“

—Kurt Vonnegut




MONTH

NOTES

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“Spend each day with some laughter and some thought, to get your emotions going.“

—Jim Valvano




MONTH

NOTES

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“We must embrace pain and burn it as fuel for our journey.“

—Kenji Miyazawa




MONTH

NOTES

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“You never know how strong you are until being strong is the only choice you have.“

—Bob Marley




MONTH

NOTES

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MONTH

NOTES

“Toughness is in the soul and spirit, not in muscles.“

—Alex Karras

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MONTH

NOTES

“When you have exhausted all possibilities, remember this: you haven’t.“

—Thomas Edison

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MONTH

NOTES

“It’s hard to beat a person who never gives up.“

—Babe Ruth

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MONTH

NOTES

“A journey of a thousand miles begins with a single step.“

—Lao Tzu

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MONTH

NOTES

“Hope sees the invisible, feels the intangible, and achieves the impossible.“

—Helen Keller

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MONTH

NOTES

“Optimism is the foundation of courage.”

—Nicholas Murray Butler

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MONTH

NOTES

“It’s not the years in your life that count. It’s the life in your years.“

—Edward J. Stieglitz

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Questions for my doctor or nurseRecord any questions you might have for your health care team, as well as notes from your visit.

ABOUT

ANSWER

ASK DRDATE

ABOUT

ANSWER

ASK DRDATE

ABOUT

ANSWER

ASK DRDATE

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ABOUT

ANSWER

ASK DRDATE

ABOUT

ANSWER

ASK DRDATE

ABOUT

ANSWER

ASK DRDATE

Questions for my doctor or nurse (continued)Record any questions you might have for your health care team, as well as notes from your visit.

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ABOUT

ANSWER

ASK DRDATE

ABOUT

ANSWER

ASK DRDATE

ABOUT

ANSWER

ASK DRDATE

Questions for my doctor or nurse (continued)Record any questions you might have for your health care team, as well as notes from your visit.

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Tracking my side effectsRecord any side effects and the dates you experienced them.

SIDE EFFECT

DATE

MEDICATIONS TAKEN, IF ANY

■ MILD

■ MODERATE

■ SEVERE

■ MILD

■ MODERATE

■ SEVERE

SIDE EFFECT

DATE


■ MILD

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■ SEVERE

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SIDE EFFECT

DATE


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SIDE EFFECT

DATE


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SIDE EFFECT

DATE


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SIDE EFFECT

DATE


■ MILD

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■ SEVERE

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Tracking my side effects (continued)Record any side effects and the dates you experienced them.

SIDE EFFECT

DATE


■ MILD

■ MODERATE

■ SEVERE

■ MILD

■ MODERATE

■ SEVERE

SIDE EFFECT

DATE


■ MILD

■ MODERATE

■ SEVERE

■ MILD

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SIDE EFFECT

DATE


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■ SEVERE

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■ SEVERE

SIDE EFFECT

DATE


■ MILD

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■ SEVERE

■ MILD

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■ SEVERE

SIDE EFFECT

DATE


■ MILD

■ MODERATE

■ SEVERE

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SIDE EFFECT

DATE


■ MILD

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■ SEVERE

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■ SEVERE

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Being diagnosed with and living with melanoma can be difficult but, by making the right choices, you can take an active role in your treatment and live a healthier lifestyle. Here are some tips:

Ask for support from family, friends, and others. Reach out to loved ones who are willing to help out, listen, or just keep you company

Pay attention to your physical needs for rest, nutrition, and other self-care measures

Find ways to express your feelings such as talking, playing an instrument, painting, or writing

Give yourself solo time and space when you need it, and don’t feel bad about letting others know if you prefer to be alone

Walk or exercise. Be sure to talk with your cancer care team about your plans before starting a new exercise program or activity

Find out what helped other patients and families cope with cancer, and/or talk with other people diagnosed with the same type of cancer. Ask your health care team to recommend a support group, or look for one online

Talk with your doctor about other healthy lifestyle choices you can make

You may experience stress or other negative emotions throughout your treatment journey. Here are simple things you can do that may help:

Try a breathing technique, like the following one:

1. Lie down in a quiet room. Take a slow, deep breath2. As you breathe in, tense a muscle or group of muscles. For

example, clench your teeth or stiffen your arms or legs3. Keep your muscles tense for a second or two while holding your

breath. Then breathe out, release the tension, and let your body relax completely. Repeat the process with another muscle or muscle group

Meditate

Practice yoga

Try guided imagery, which uses words and sounds to help you imagine positive feelings or experiences, to focus and relax

“Once you choose hope, anything’s possible.”

—Christopher Reeve

Coping with cancer

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It is common for people with cancer to experience anxiety, especially when they have an upcoming scan. This is sometimes called “scanxiety,” and it can interfere with your everyday well-being.

Here are some tips for dealing with scanxiety:

Schedule tests early in the day, when possible, to reduce waiting time

Try the relaxation techniques mentioned on the previous page to help reduce negative thoughts

Distract yourself with music or a favorite book, or invite a loved one to accompany you to your appointment

Write down your thoughts in this diary. Express how this situation makes you feel and the emotions you are experiencing

Coping with cancer (continued)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® (dabrafenib) and MEKINIST® (trametinib) in combination.

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

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

IMPORTANT SAFETY INFORMATION (continued)


56 57

Heart problems, including heart failure. Your health care provider should check your heart function before you start taking TAFINLAR® (dabrafenib) and MEKINIST® (trametinib) 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



58 59

Eye problems. TAFINLAR® (dabrafenib) and MEKINIST® (trametinib), 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

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

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.

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.



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Tell your health care provider right away if you become pregnant, or think you might be pregnant, during treatment with TAFINLAR® (dabrafenib) and MEKINIST® (trametinib) in combination.

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

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.

Nursing mothers. It is not known if TAFINLAR and/or MEKINIST 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



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My journal

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My journal

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My journal

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My journal

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My journal

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Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TAFINLAR® (dabrafenib) and MEKINIST® (trametinib) 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.

Please read the Medication Guide for TAFINLAR and the Patient Information for MEKINIST, and discuss any questions you have with your health care provider.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Novartis at 1-888-669-6682.

my treatment diary - novartis · (g6pd) enzyme have any other medical conditions plan to have...

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