PROMACTA is a once-daily tablet that may help raise platelet counts in patients with chronic immune thrombocytopenia (cITP) when other treatments have not worked well enough. In clinical studies, PROMACTA increased and maintained platelet counts within the target range for most patients. It is important for patients taking PROMACTA to be monitored by their doctor and to report any side effects like liver problems, high platelet counts, eye problems or blood clots right away. Financial assistance and support programs are available for patients prescribed PROMACTA.
Jeremy Casson - An Architectural and Historical Journey Around Europe
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Promacta Once-Daily Tablet May Raise Platelet Levels in Patients with cITP
1. WITH MY
ONCE-DAILY TABLET
FOR THE
COUNT
INDICATIONS
PROMACTAÂŽ
is a prescription medicine used to treat
adults and children 1 year and older with low blood
platelet counts due to chronic immune (idiopathic)
thrombocytopenia (ITP), when other medicines to treat
your ITP or surgery to remove the spleen have not
worked well enough. PROMACTA is used to try to raise
platelet counts in order to lower your risk for bleeding.
IMPORTANT SAFETY INFORMATION
FOR PROMACTAÂŽ
(ELTROMBOPAG)
What is the most important information I should know
about PROMACTA?
PROMACTA can cause serious side effects, including:
Liver problems. If you have chronic HCV, and take
PROMACTA with interferon and ribavirin treatment,
PROMACTA may increase your risk of liver problems.
Tell your health care provider right away if you have any
of these signs and symptoms of liver problems:
⢠yellowing of the skin or the whites of the eyes (jaundice)
⢠unusual darkening of the urine
⢠unusual tiredness
⢠right upper stomach area (abdomen) pain
⢠confusion
⢠swelling of the stomach area (abdomen)
Please see Important Safety Information for
PROMACTA on pages 14-17.
Please see full Prescribing Information for
PROMACTA, including Boxed WARNING a
nd Medication Guide, in pocket.
IâM UP
2. PROMACTA is a once-daily drug that helps you with your chronic ITP
(cITP). Your doctor may consider PROMACTA if other treatments such as
corticosteroids havenât worked well enough for you. One tablet a day can
help raise platelet counts and keep them at safe and stable levels.*
What is PROMACTA
Side effects
Taking PROMACTA
Questions for your doctor
Financial Assistance
Tracking your progress
*The results seen with PROMACTA were similar among patients who were either
⢠Taking other medications to treat their cITP in addition to PROMACTA
⢠Had their spleen removed
⢠Had various levels of platelet counts when they started PROMACTA1-2
3
5
7
11
12
18
2Please see Important Safety Information for PROMACTA on pages 14-17.
UP next:
my Promacta journal
3. PROMACTA is a once-daily tablet that may raise platelet
levels in patients with cITP.*
In clinical studies of adults with cITP, PROMACTA increased
and maintained platelet counts within the target range*
defined by each study. Platelet counts increased as early as
1 to 2 weeks after starting treatment and decreased within
1 to 2 weeks after stopping treatment.1
MAY 8
My doctor explained to me how it worksâŚ
PROMACTA may increase platelet counts.
Platelets are produced in your bone marrow,
and they help your body stop bleeding when
you get a bruise or a cut. cITP is a condition
lasting six months or longer in which your body
does not have enough blood cell fragments,
called platelets, in the blood. PROMACTA may
increase platelet production in your body.1,3-5
And itâs all in a once-daily tablet.
She said with my platelets still low after my first
course of treatment, a different medicine could help.
Fingers crossed!
My doctor told me that clinical studies showed
PROMACTA working for a majority of patients.
4
Please see Important Safety Information for
PROMACTA on pages 14-17.
*Target range defined as platelet counts of 50-400 billion per liter
(50-400 X 109/L) during the 6-month period that patients received
PROMACTA or placebo.1
4. JUNE 8
I had some stomach pain and a mild fever, but I told my doctor
right away, and the side effects were manageable.
In clinical trials, the most common side effects of PROMACTA for adult
cITP were1
:
⢠Nausea
⢠Diarrhea
⢠Upper respiratory tract infection.
Symptoms may include runny
nose, stuffy nose, and sneezing
⢠Vomiting
⢠Muscle aches
⢠Urinary tract infection. Symptoms
may include frequent or urgent
need to urinate, low fever in some
people, pain or burning with
urination.
⢠Pain or swelling (inflammation)
in your throat or mouth
(oropharyngeal pain and pharyngitis)
⢠Abnormal liver function tests
⢠Back pain
⢠âFluâ-like symptoms (influenza)
including fever, headache,
tiredness, cough, sore throat,
and body aches
⢠Skin tingling, itching, or burning
⢠Rash
Always keep an eye on how your body
reacts to new medication. Contact your
doctor if your cITP symptoms donât
seem to be improving and tell your
doctor about any bruising or bleeding
that happens while you take, and after
you stop taking, PROMACTA.
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.
6
Please see Important Safety Information
for PROMACTA on pages 14-17.
5. Nutrition Facts
Serv. Size 4 cookies (32g)
Servings per Container 9
Calories 150
Calories from fat 60
Amount/Serving
Total Fat 7g
Sat. Fat 4.5g
Trans Fat 0g
Cholest. 0mg
Sodium 115mg
%DV*
11%
23%
0%
5%
Amount/Serving
Total Carb 20g
Dietary Fiber 1g
Sugars 10g
Protein 2mg
%DV*
7%
4%
VitaminA 5% â˘Vitamin C 3% ⢠Calcium 1% ⢠Iron 4%
INGREDIENTS: Enriched Flour (Wheat Flour,
Niacin, Reduced Iron, Vitamin B1, Vitamin B2,
Folic Acid), Sugar, Vegetable Oil, Whey, Dextrin,
Corn Syrup, Cornstarch, Salt, Baking Soda,
Molasses, Natural and Artificial Flavors, Eggs.
Your doctor will prescribe
the right dose for you.
When you take PROMACTA, thereâs a âbefore-or-afterâ
rule you should always keep in mind. See this guideline:
I take PROMACTA at least 1 hour
When I have more than 50mg of
Here are some examples of foods that have more
than 50 mg of calcium:
⢠Dairy products (yogurt, cheese, milk, ice cream)
⢠Calcium-fortified foods (orange juice, dry cereal, bread)
⢠Leafy green vegetables (collard greens, spinach)
Check the labels of any food or supplement to be sure.
JULY 12
Pay attention to
the serving size.
If you eat more,
youâre also
getting more
calcium.
Eating enough
of these vitamins
may reduce the
risk of some
diseases and
conditions, and
can improve
your overall
health.
To be considered
low-calcuim, a food
should contain
5% or less of the
recommended
daily value, or
apporximately 50
mg. If you eat more
tha one low-calcium
food, make sure you
pay attention to the
combined total.
Besides milk, cream, butter and
cheese, calcium can also be
found in casein whey, and lactose.
8
Please see Important Safety Information for
PROMACTA on pages 14-17.
PROMACTA tablets
are taken once-daily
and are available in
4 strengths.
12.5 mg
25 mg
50 mg
75 mg
Iâm making PROMACTA part of my daily routine.
The meal time considerations are important
so that PROMACTA can work wellâŚ
before or 2 hours after a meal.
2 hours before or 4 hours after.
calcium: I take PROMACTA at least
Tablets not actual size.
6. AUGUST 2
Talk to your doctor about what may work best for you.
Hereâs one example for a 9 PM bedtime, but you can
work PROMACTA into your own daily meal routine.
I got the PROMACTA Meal Planner today
You can always download a copy from our
site at www.up-for-promacta.com.
Be sure to use the treatment journal in the
back of this brochure to help you and your
doctor monitor your treatment progress.
I donât eat any dairy-rich
I donât eat any food after 7:00 PM
I take PROMACTA at 9:00 PM
10
Please see Important Safety Information for PROMACTA on pages 14-17.
I can fit PROMACTA into my busy lifeâŚ
You must take your PROMACTA every day to
ensure that it works. Reach out to your doctor
with any questions about dose, side effects and
length of therapy.
products after 5:00 PM
from my doctor. It offers tips and examples
to help me manage my new routine!
7. You may have many questions about cITP and PROMACTA before or after you start treatment.
The more you know, the better prepared youâll be to get started.
Here are some questions you could ask your
doctor before treatment:
⢠How will cITP continue to affect my life?
⢠What are all my treatment options?
⢠Which treatment do you
recommend for me now? Why?
⢠What can I expect from treatment?
⢠Will I have to take more that one medication
to continue treating my condition?
Here are some questions about PROMACTA:
⢠How and when should I take PROMACTA?
⢠How long will I have to take PROMACTA?
⢠How will I know if my treatment is working?
⢠What drugs or supplements may affect PROMACTA?
⢠What are the possible side effects with PROMACTA?
⢠What special precautions should I follow?
⢠What should I do if I miss a dose?
⢠How often will I have blood tests?
⢠When should I contact you
immediately?
⢠What should I do in case of
emergency or overdose?
⢠How should I store PROMACTA tablets?
⢠What else do you think is important for me
to know about PROMACTA?
SEPTEMBER 15
You may be eligible for immediate co-pay savings on your next prescription:
⢠Pay no more than $25 per month out of pocket
⢠Easy sign-up, no additional fees
⢠Available to most patients with commercial insurance
⢠Covers up to $15,000 per calendar year
To find out if you are eligible to save on your next prescription,
call (877) 577-7756 or visit www.copay.novartisoncology.com
Limitations apply. See program terms and conditions.
Terms and Conditions
This offer is valid only for those with commercial insurance. Offer not valid
under Medicare, Medicaid, or any other federal or state program. Not valid
for cash-paying patients, where product is not covered by patientâs commercial
insurance, or where plan reimburses you for entire cost of your prescription
drug. Offer is not valid where prohibited by law. Valid only in the United
States and Puerto Rico. This program is not health insurance. Offer may not
be combined with any other rebate, coupon or offer. The card is property of
Novartis Pharmaceuticals Corporation and must be returned upon request.
Novartis reserves the right to rescind, revoke, or amend the program without
notice. Patient certifies responsibility for complying with applicable limitations,
if any, of any commercial insurance and reporting receipt of program rewards, if
necessary, to any commercial insurer. This offer expires on December 31, 2016.
Patient Instructions
Patients with commercial insurance will be responsible for up to $25 and the
program pays the remaining copay or coinsurance until you reach the yearly
maximum or $15,000.00. After the program maximum, you will be responsible
for the difference. Questions should be directed to: 877-577-7756. When you
use this offer you are certifying that you understand the program rules, regula-
tions, and terms and conditions and that you will disclose and report the use of
this offer as may be required by your insurer. You are not eligible if prescriptions
are paid by any federal or state program, or where prohibited by law; and you
will otherwise comply with the terms and conditions above.
12Please see Important Safety Information for PROMACTA on pages 14-17.
PROMACTA OFFERS FINANCIAL SUPPORT THROUGH THE UNIVERSAL
CO-PAY CARD AND PATIENT ASSISTANCE NOW ONCOLOGY
8. Novartis Oncology is committed to helping patients receive the medicines they need.
Patient Assistance Now Oncology (PANO) offers quick and easy access to information
about their wide range of resources.
Here are some of the ways they can help:
⢠Provide information about financial or co-pay
assistance that may be available through
independent charitable foundations
⢠Offer support with insurance verification to
help you understand your financial
responsibilities and where to get your drugs
⢠Assist with changes in your insurance plan
when your coverage changes
⢠Help find a pharmacy covered by your
plan and get medication based on your
plan guidelines
⢠Provide Medicare education
⢠Support for Novartis Oncology
medication
IMPORTANT SAFETY INFORMATION FOR PROMACTAÂŽ
(ELTROMBOPAG)
What is the most important information I should know
about PROMACTA?
PROMACTA can cause serious side effects, including:
Liver problems. If you have chronic HCV, and take PROMACTA
with interferon and ribavirin treatment, PROMACTA may increase
your risk of liver problems. Tell your health care provider right
away if you have any of these signs and symptoms of liver
problems:
⢠yellowing of the skin or the whites of the eyes (jaundice)
⢠unusual darkening of the urine
⢠unusual tiredness
⢠right upper stomach area (abdomen) pain
⢠confusion
⢠swelling of the stomach area (abdomen)
What are the possible side effects of PROMACTA?
PROMACTA may cause serious side effects, including:
⢠Abnormal liver function tests. Your health care provider will
order blood tests to check your liver before you start taking
PROMACTA, and during your treatment. In some cases,
treatment with PROMACTA may need to be stopped due to
changes in your liver function tests
⢠High platelet counts and higher risk for blood clots. Your risk of
getting a blood clot is increased if your platelet count is too high
during treatment with PROMACTA. Your risk of getting a blood
clot may also be increased during treatment with PROMACTA
if you have normal or low platelet counts. You may have severe
problems or die from some forms of blood clots, such as clots
that travel to the lungs or that cause heart attacks or strokes.
Your health care provider will check your blood platelet counts,
and change your dose or stop PROMACTA if your platelet
counts get too high. Tell your health care provider right away if
you have signs and symptoms of a blood clot in the leg such as
swelling, pain, or tenderness.People with chronic liver disease
may be at risk for a type of blood clot in the stomach area. Tell
your health care provider right away if you have stomach area
pain that may be a symptom of this type of blood clot
⢠New or worsened cataracts (a clouding of the lens in the eye).
New or worsened cataracts have happened in people taking
PROMACTA. Your health care provider will check your eyes
before and during your treatment with PROMACTA. Tell your
health care provider about any changes in your eyesight while
taking PROMACTA
What should I tell my health care provider before taking
PROMACTA?
Before you take PROMACTA, tell your health care provider if you:
⢠have liver or kidney problems
⢠have or had a blood clot
⢠have a history of cataracts
⢠have had surgery to remove your spleen (splenectomy)
⢠have bleeding problems
⢠are Asian and have Chinese, Japanese, Taiwanese, or Korean
ancestry. You may need a lower dose of PROMACTA
⢠have any other medical conditions
⢠are pregnant or plan to become pregnant. It is not known if
PROMACTA will harm an unborn baby
⢠are breastfeeding or plan to breastfeed. It is not known if
PROMACTA passes into your breast milk. You and your health
care provider should decide whether you will take PROMACTA
or breastfeed. You should not do both
You can get information about the PANO support programs in 2 ways:
Call 1-800-282-7630 to speak with a representative dedicated to making access to therapy
as simple and convenient as possible; or Visit www.OncologyAccessNow.com
14
9. IMPORTANT SAFETY INFORMATION FOR PROMACTAÂŽ
(ELTROMBOPAG)
Tell your health care provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements. PROMACTA may affect the way certain
medicines work. Certain other medicines may affect the way
PROMACTA works.
Especially tell your health care provider if you take:
⢠certain medicines used to treat high cholesterol, called âstatinsâ
⢠a blood thinner medicine
Certain medicines may keep PROMACTA from working correctly.
Take PROMACTA at least 2 hours before or 4 hours after taking
these products:
⢠antacids used to treat stomach ulcers or heartburn
⢠multivitamins or products that contain iron, calcium, aluminum,
magnesium, selenium, and zinc which may be found in mineral
supplements
Ask your health care provider if you are not sure if your medicine is
one that is listed above.
Know the medicines you take.
Keep a list of them, and show it to your health care provider and
pharmacist when you get a new medicine.
What should I avoid while taking PROMACTA?
Avoid situations and medicines that may increase your risk of
bleeding.
The most common side effects of PROMACTA in adults when
used to treat chronic ITP are:
⢠nausea
⢠diarrhea
⢠upper respiratory tract infection (symptoms may include runny
nose, stuffy nose, and sneezing)
⢠vomiting
⢠muscle aches
⢠urinary tract infection (symptoms may include frequent or urgent
need to urinate, low fever in some people, pain or burning with
urination)
⢠pain or swelling (inflammation) in your throat or mouth
(oropharyngeal pain and pharyngitis)
⢠abnormal liver function tests
⢠back pain
⢠flu-like symptoms including fever, headache, tiredness, cough,
sore throat, and body aches
⢠skin tingling, itching, or burning
⢠rash
The most common side effects of PROMACTA in children 1
year and older when used to treat chronic ITP are:
⢠upper respiratory tract infection (symptoms may include runny
nose, stuffy nose, and sneezing)
â˘pain or swelling (inflammation) in your nose or throat
(nasopharyngitis)
⢠cough
⢠diarrhea
⢠fever
⢠runny, stuffy nose (rhinitis)
⢠stomach (abdominal) pain
⢠pain or swelling (inflammation) in your throat or mouth
(oropharyngeal pain)
⢠toothache
⢠rash
⢠abnormal liver function tests
The most common side effects when PROMACTA is used in
combination with other medicines to treat chronic HCV are:
⢠low red blood cell count (anemia)
⢠fever
⢠tiredness
⢠headache
⢠nausea
⢠diarrhea
⢠decreased appetite
⢠flu-like symptoms including fever, headache, tiredness, cough,
sore throat, and body aches
⢠feeling weak
⢠trouble sleeping
⢠cough
⢠itching
⢠chills
⢠muscle aches
⢠hair loss
⢠swelling in your ankles, feet, and legs
The most common side effects when PROMACTA
is used to treat severe aplastic anemia are:
⢠nausea
⢠feeling tired
⢠cough
⢠diarrhea
⢠headache
⢠pain in arms, legs, hands, or feet
⢠shortness of breath
⢠fever
⢠dizziness
⢠pain in the nose or throat
⢠abdominal pain
⢠bruising
⢠muscle spasms
⢠abnormal liver function tests
⢠joint pain
⢠runny nose
16
10. Date of Doctorâs Visit:
Last Visit, we discussed:
What are your goals for your next visit?
Talk to your doctor
version of this broc
80,000
60,000
40,000
20,000
100,000
0
Date of visit
Treatment dose
Plateletcount
⢠100,000 â 450,000: A normal range for your platelet count
⢠Less than 50,000: ITP symptoms are rare. This is the goal platelet count of your cITP
⢠30,000 â 50,000: Excessive bleeding might occur, but usually only with trauma or su
⢠20,000 â 30,000a
: Therapeutic intervention usually initiatedb
a
In patients without symptoms, treatment is recommended for platelet counts 30,000 mm3
.
b
Primary treatment options for ITP usually include: corticosteroids, immunoglobin therapy, or splenectomy.
7/13 7/22 8/9
25 mg 25 mg 25 mg
Fill in the date of your visit and
your current treatment dose.
Plot your platelet
count after each
blood test
Logging your platelet count with each doctorâs visit
on the tracker in the back of this brochure can give
you valuable information about your treatment.
Itâs important to keep track of your treatment as it progresses. Make sure you
update your healthcare team at every visit. This will ensure youâre on the right
path with your PROMACTA treatment and help you and your team identify
where you may need more support.
IMPORTANT SAFETY INFORMATION FOR PROMACTAÂŽ
(ELTROMBOPAG)
Laboratory tests may show abnormal changes to the cells in
your bone marrow.
Tell your health care provider about any bruising or bleeding
that happens while you take, and after you stop taking, PROMACTA.
Tell your health care provider if you have any side effect that
bothers you or that does not go away.
If you take too much PROMACTA, you may have a higher risk of
serious side effects. Call your health care provider right away.
These are not all the possible side effects of PROMACTA. For
more information, ask your health care provider or pharmacist.
Call your doctor for medical advice about side effects. You may
report side effects to the FDA at 1-800-FDA-1088.
Keep PROMACTA and all medicines out of reach of children.
General information about the safe and effective use of
PROMACTA
Medicines are sometimes prescribed for purposes other than
those listed in a Medication Guide. Do not use PROMACTA
for a condition for which it was not prescribed. Do not give
PROMACTA to other people even if they have the same
symptoms that you have. It may harm them.
This is a summary of the most important information about
PROMACTA. If you would like more information, talk with your
health care provider. You can ask your health care provider or
pharmacist for information about PROMACTA that is written for
health professionals.
For more information about PROMACTA, go to
www.PROMACTA.com or call 1-844-PRO-MACT or
1-844-776-6228
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.
References: 1. PROMACTA [prescribing information]. East Hanover,
NJ: Novartis Pharmaceuticals Corp; 2015. 2. Cheng G, Saleh MN,
Marcher C, et al. Eltrombopag for management of chronic immune
thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study.
Lancet. 2011;377:393-402. 3. Mayo Clinic. Idiopathic thrombocytopenic
purpura (ITP): Diagnosis. http://www.mayoclinic.org/diseases-
conditions/idiopathic-thrombocytopenic-purpura/diagnosis-treatment/
diagnosis/dxc-20201266?p=1. Accessed May 31, 2016. 4. Mayo
Clinic. Idiopathic thrombocytopenic purpura (ITP): Symptoms and
causes. http://www.mayoclinic.org/diseases-conditions/idiopathic-
thrombocytopenic-purpura/symptoms-causes/dxc-20201224?p=1.
Accessed May 31, 2016. 5. ITP Foundation. What is ITP? http://www.
itpfoundation.org/itpdefined.htm#Forms%20of%20ITP. Accessed
May 31, 2016.
1818
YOUR TREATMENT JOURNAL
12. Talk to your doctor about any trends that you notice. A PDF
version of this brochure is available at www.up-for-promacta.com.
80,000
60,000
40,000
20,000
100,000
0
Date of visit
Treatment dose
Plateletcount
22
YOUR TREATMENT JOURNAL