A ragweed pollen as a treatment for a ragweed allergy? It`s called

Transcription

A ragweed pollen as a
treatment for a ragweed allergy?
It’s called immunotherapy.
RAGWITEK is a prescription medicine used for sublingual (under the tongue) immunotherapy to treat ragweed pollen
allergies that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes. RAGWITEK may
be prescribed for persons 18 through 65 years of age who are allergic to ragweed pollen.
Not actual size
RAGWITEK is taken for about 12 weeks before the ragweed pollen season and throughout
ragweed pollen season.
RAGWITEK is NOT a medication that gives immediate relief for symptoms of ragweed allergy.
Important Safety Information about RAGWITEK
•
RAGWITEK can cause severe allergic reactions that may be life-threatening. Stop taking RAGWITEK and get
medical treatment right away if you have any of the following symptoms after taking RAGWITEK:
m Trouble breathing
m Throat tightness or swelling
m Trouble swallowing or speaking
m Dizziness or fainting
m Rapid or weak heartbeat
m Severe stomach cramps or pain, vomiting, or diarrhea
m Severe flushing or itching of the skin
•
Do not take RAGWITEK if you have severe, unstable or uncontrolled asthma; had a severe allergic reaction in the past
that included trouble breathing, dizziness or fainting, or rapid or weak heartbeat; had difficulty with breathing due to swelling
of the throat or upper airway after using any sublingual immunotherapy before; have ever been diagnosed with eosinophilic
esophagitis; or are allergic to any of the inactive ingredients contained in RAGWITEK.
•
For home administration of RAGWITEK, your doctor will prescribe auto-injectable epinephrine, a medicine you can
inject if you have a severe allergic reaction after taking RAGWITEK. Talk to your doctor or read the epinephrine
patient information if you have any questions about the use of auto-injectable epinephrine.
•
The first dose of RAGWITEK must be taken in the doctor’s office. After taking the first tablet, you will be watched
for at least 30 minutes for symptoms of a serious allergic reaction.
Please read the Medication Guide for RAGWITEK, including the information
about severe allergic reactions, and discuss it with the doctor. The physician
Prescribing Information also is available.
Understanding what causes your symptoms
is the first step to managing your allergies
In this brochure, you’ll learn about:
•
Why you react to an allergen
•
Your immune system and allergic reactions
•
Various treatment options, including immunotherapy
If you’re allergic to ragweed pollen, you may find yourself struggling with symptoms like stuffy nose, itchy eyes and sneezing.
These symptoms can make your life more difficult during allergy season, especially when you’re outdoors. What’s more, it can be
frustrating to suffer from the same symptoms each season.
1
What is an allergen?
An allergen is a substance in the environment that causes an allergic reaction in
some people. This brochure focuses on a specific allergen, ragweed pollen.
Your immune system and allergic reactions
When you suffer from ragweed allergies, the symptoms you experience are the
result of your body’s immune system reacting to ragweed allergens in the environment.
When you breathe in these allergens, your immune system forms antibodies
that trigger a chemical response causing symptoms like stuffy nose, runny nose,
sneezing, or itchy eyes. These familiar allergy symptoms are actually signs of your
immune system overreacting to the allergen.
Pinpointing your allergy sensitivity
People with allergies can be sensitive to many different allergens. Taking note of
when and where you experience allergy symptoms can help you and your doctor
figure out if you may be allergic to ragweed pollen.
Ask yourself:
• Are symptoms at their worst during ragweed pollen season (late summer
and fall)?
• Does avoiding outdoor activity during ragweed pollen season help
your symptoms?
• Do symptoms go away when it’s raining or when you go away on vacation?
2
Allergy testing
Your doctor may determine what is causing your allergic reaction by listening to your allergy experiences and performing skin
and/or blood tests. You may also be asked about how much your symptoms bother you and how well you can manage them.
Together, the test results and your allergy experiences may help your doctor identify the allergen that triggers your symptoms.
Treatment options
Just as different people react differently to different allergens, they react differently to treatment, too. Some people may use more than one treatment.
Once your doctor knows what allergens cause your symptoms, he or she will be able to help you plan the best approach for treating your
symptoms. Try to avoid the allergens that are giving you trouble. But because this isn’t always easy to do, you may consider treatment options.
Generally, these fall into two categories:
1. Symptom-relieving medication
During an allergic reaction, your immune system releases chemicals such as histamine that are responsible for the symptoms
you experience. Many medications delivered in the form of pills, eye drops and nasal sprays are designed to help
block those chemicals, helping to relieve your symptoms. These are available over the counter and by prescription.
2. Immunotherapy
Immunotherapy is typically given as “allergy shots” and is designed to treat the underlying cause of your
symptoms by giving you small amounts of the allergen over time. Immunotherapy may work with your
immune system to help change how your body reacts to allergens. It may help gradually build
tolerance to specific allergens.
3
RAGWITEK is ragweed allergy immunotherapy in a tablet
RAGWITEK is a different form of allergy
immunotherapy. Instead of a shot, it’s a once-a
day tablet that is made to dissolve quickly under
Not actual size
the tongue. Do not swallow for 1 minute after
taking RAGWITEK. Made from small amounts of natural short
ragweed pollen, RAGWITEK treats the ragweed allergies that
cause eye and nose symptoms. It’s the only oral immunotherapy
tablet that’s been approved by the FDA for adults 18 to 65
years of age.
•
RAGWITEK can cause severe allergic reactions that may be life-threatening.
Stop taking RAGWITEK and get medical treatment right away if you have
any of the following symptoms after taking RAGWITEK:
m Trouble breathing
•
Do not take RAGWITEK if you have severe, unstable or uncontrolled asthma; had
a severe allergic reaction in the past that included trouble breathing, dizziness or
fainting, or rapid or weak heartbeat; had difficulty with breathing due to swelling
of the throat or upper airway after using any sublingual immunotherapy before;
have ever been diagnosed with eosinophilic esophagitis; or are allergic to any
of the inactive ingredients contained in RAGWITEK.
RAGWITEK is a daily dose of immunotherapy
Taking a tablet of natural short ragweed
pollen daily may help you gradually build
tolerance, so you become less sensitive to
ragweed pollen.
The first
tablet of
RAGWI TEK
must be ta ken
in the doctor’s
office
The
ragweed pollen
in RAGWITEK
helps you become
less sensitive to
ragweed pollen
Taking the first tablet in your doctor’s office
The first dose of RAGWITEK must be taken in the
doctor’s office. After taking the first tablet, you will be
observed for at least 30 minutes by a healthcare
professional for symptoms of a serious allergic
reaction. If the first dose is well tolerated, later doses
will be taken at home.
•For home administration of RAGWITEK, your doctor will prescribe auto-injectable
epinephrine, a medicine you can inject if you have a severe allergic reaction
after taking RAGWITEK. Talk to your doctor or read the epinephrine patient
information if you have any questions about the use of auto-injectable
epinephrine.
•The first dose of RAGWITEK must be taken in the doctor’s office. After
taking the first tablet, you will be watched for at least 30 minutes for
symptoms of a serious allergic reaction.
4
Why your doctor will prescribe epinephrine
When you’re taking RAGWITEK, your doctor will also prescribe auto-injectable
epinephrine for you to use at home should you have a severe allergic reaction.
You should discuss the proper use of auto-injectable epinephrine with your doctor.
Possible side effects of RAGWITEK™ (Short Ragweed Pollen Allergen Extract)
The most commonly reported side effects were itching of the mouth, lips, or tongue,
swelling under the tongue, or throat irritation. These side effects, by themselves,
were not dangerous or life-threatening.
Stop taking RAGWITEK and get medical treatment right away if you have any
of the following symptoms after taking RAGWITEK:
• Trouble breathing
• Throat tightness or swelling
• Trouble swallowing or speaking
• Dizziness or fainting
• Rapid or weak heartbeat
• Severe stomach cramps or pain, vomiting, or diarrhea
• Severe flushing or itching of the skin
RAGWITEK™ (Short Ragweed Pollen Allergen Extract)
is clinically proven to help prevent ragweed allergy symptoms
RAGWITEK was tested in clinical studies of adults with a history of ragweed allergy
symptoms. In two clinical studies, RAGWITEK provided significant relief of ragweed
allergy symptoms (sneezing, runny or itchy nose, stuffy or congested nose, or itchy
and watery eyes) throughout a ragweed pollen season, including when ragweed
pollen counts were highest (sometimes known as the
“peak” of the season). RAGWITEK also
reduced the need for over-the-counter
and prescription allergy medications
throughout the same ragweed
pollen season, including
the peak of the seasona.
RAGWITEK
was proven
to provide significant
relief of eye and nose
symptoms throughout
the entire ragweed
pollen season
It is important that you talk to your doctor to make sure you understand what is a
severe allergic reaction to RAGWITEK.
•
You should tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription and herbal
supplements. Keep a list of them and show it to your doctor and pharmacist each
time you get a new supply of RAGWITEK. Ask your doctor or pharmacist for
advice before taking RAGWITEK.
•
Stop RAGWITEK and contact your doctor if you have any of the following
after taking RAGWITEK: Any type of a serious allergic reaction; throat tightness
that worsens or swelling of the tongue or throat that causes trouble speaking,
breathing or swallowing; asthma or any other breathing condition that gets worse
or heartburn, difficulty swallowing, pain with swallowing, or chest pain that does
not go away or worsens. Also stop taking RAGWITEK following mouth surgery
procedures (such as tooth removal) or if you develop any mouth infections, ulcers
or cuts in the mouth or throat.
a
Standard allergy medications. These generally included systemic and topical antihistamines, topical steroids, and oral corticosteroids.
•The most commonly reported side effects were itching of the mouth, lips, or
tongue, swelling under the tongue, or throat irritation. These side effects, by
themselves, were not dangerous or life-threatening.
•Your doctor may decide that RAGWITEK is not the best treatment for you if
you have asthma; plan to become pregnant or are breast-feeding; are unable
or unwilling to administer epinephrine; or are taking certain medicines,
including other allergen immunotherapy.
5
When to start RAGWITEK™ (Short Ragweed Pollen Allergen Extract)
Although you may not be experiencing symptoms, the best
time to start talking to your doctor about RAGWITEK is at least
a few months before ragweed allergy season starts. Starting
treatment early may give your body time to become less
sensitive in preparation for the ragweed pollen season.
Tips to
remember
your RAGWITEK
every day
It’s recommended that you start taking RAGWITEK at
least 12 weeks before the ragweed pollen season and
continue daily until the end of the ragweed pollen season.
The importance of taking RAGWITEK every day
Immunotherapy is designed to repeatedly expose your
body to small amounts of an allergen. That’s why it’s
important to take RAGWITEK every day, as your doctor
prescribes, even when you don’t have symptoms.
RAGWITEK dissolves under your tongue
RAGWITEK tablets dissolve quickly when
placed under the tongue. Do not swallow
for 1 minute after taking RAGWITEK. Do
not take with food or water.
Remember to take RAGWITEK™
(Short Ragweed Pollen Allergen Extract) daily
•
ake it a part of your daily routine
M
Take it at the same time every day
• Put it somewhere visible that you return
to every day
•
?
•
Is RAGWITEK right for me?
• When should I start taking RAGWITEK?
• How should I take RAGWITEK?
Ask
your doctor
these
questions
More questions? Write them here.
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
•
Stop taking RAGWITEK and get medical treatment right away if you
have any of the following symptoms after taking RAGWITEK:
m Trouble breathing
epinephrine.
•
•The first dose of RAGWITEK must be taken in the doctor’s office. After
taking the first tablet, you will be watched for at least 30 minutes for
symptoms of a serious allergic reaction.
•
supplements. Keep a list of them and show it to your doctor and pharmacist
each time you get a new supply of RAGWITEK. Ask your doctor or pharmacist
for advice before taking RAGWITEK.
6
How your immune system
causes allergy symptoms
•
breathing or swallowing; asthma or any other breathing condition that gets
worse or heartburn, difficulty swallowing, pain with swallowing, or chest pain
that does not go away or worsens. Also stop taking RAGWITEK following
mouth surgery procedures (such as tooth removal) or if you develop any mouth
infections, ulcers or cuts in the mouth or throat.
•
Stop taking RAGWITEK and get medical treatment right away if you have any
of the following symptoms after taking RAGWITEK:
m Trouble breathing
7
RAGWI TEK treats ragweed allergies
that cause symptoms
•
•
epinephrine.
•The first dose of RAGWITEK must be taken in the doctor’s office. After taking
the first tablet, you will be watched for at least 30 minutes for symptoms of
a serious allergic reaction.
•
breathing or swallowing; asthma or any other breathing condition that gets worse
or heartburn, difficulty swallowing, pain with swallowing, or chest pain that does
not go away or worsens. Also stop taking RAGWITEK following mouth surgery
procedures (such as tooth removal) or if you develop any mouth infections, ulcers
or cuts in the mouth or throat.
8
FAQs about RAGWITEK™ (Short Ragweed Pollen Allergen Extract)
What is RAGWITEK?
RAGWITEK is a prescription immunotherapy medicine used to treat ragweed pollen
allergies that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy
and watery eyes. It can be prescribed for people 18 through 65 years old who are
allergic to ragweed pollen.
RAGWITEK is taken for about 12 weeks before the ragweed pollen season and
throughout ragweed pollen season.
RAGWITEK does NOT provide immediate relief for ragweed allergy symptoms.
How can I find out if RAGWITEK is right for me?
Only a doctor can decide if RAGWITEK is right for you. Your doctor may do skin
and/or blood tests to help determine which allergen causes your symptoms. If the test
indicates that you are allergic to short ragweed pollen, your doctor will then decide if
RAGWITEK is an appropriate treatment for you. To find out more about RAGWITEK,
make an appointment with your allergy specialist.
Who should not take RAGWITEK?
You should not take RAGWITEK if:
• You have severe, unstable or uncontrolled asthma.
• You had a severe allergic reaction in the past that included any of these symptoms:
m Trouble breathing
• You have ever had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before.
• You have ever been diagnosed with eosinophilic esophagitis.
• You are allergic to any of the inactive ingredients contained in RAGWITEK.
The inactive ingredients contained in RAGWITEK are: gelatin, mannitol and sodium hydroxide.
What are the possible side effects of RAGWITEK?
The most commonly reported side effects were itching of the mouth, lips, or tongue,
swelling under the tongue, or throat irritation. These side effects, by themselves, were
not dangerous or life-threatening. RAGWITEK can cause severe allergic reactions
that may be life-threatening. Symptoms of allergic reactions to RAGWITEK include:
trouble breathing; throat tightness or swelling; trouble swallowing or speaking; dizziness
or fainting; rapid or weak heartbeat; severe stomach cramps or pain, vomiting, or
diarrhea; or severe flushing or itching of the skin. For additional information on the
possible side effects of RAGWITEK talk with your doctor or pharmacist. You may report
side effects to the U.S. Food and Drug Administration (FDA) at 1- 800-FDA-1088 or
www.fda.gov/medwatch.
When will RAGWITEK start to work?
It takes time for RAGWITEK to treat your allergies. In clinical studies, people who
started taking RAGWITEK at least 12 weeks before the start of the ragweed
allergy season:
• Had fewer eye and nose symptoms throughout the same season
• Used less symptom-relieving allergy medications throughout the same season
• Experienced relief when pollen levels were their highest
How long do I keep taking RAGWITEK?
RAGWITEK is taken once daily for about 12 weeks before ragweed pollen season
and throughout the ragweed pollen season. Talk to your doctor about how long
you should take RAGWITEK.
•
Stop taking RAGWITEK and get medical treatment right away if you have
m Trouble breathing
9
FAQs about RAGWITEK™ (Short Ragweed Pollen Allergen Extract)
How should I take RAGWITEK?
Take the tablet from the blister package after carefully removing the foil with dry
hands. Place the tablet under your tongue right away, where it will dissolve quickly.
Do not swallow for 1 minute. Do not take RAGWITEK with food or beverage.
Do not eat or drink for 5 minutes after taking the tablet. Wash hands after taking
the tablet.
Take the first tablet of RAGWITEK in your doctor’s office. After taking the first tablet,
you will be watched for at least 30 minutes for symptoms of a serious allergic
reaction. If you tolerate the first dose of RAGWITEK, you will continue RAGWITEK
therapy at home by taking 1 tablet every day.
What happens if I miss a dose?
If you forget to take RAGWITEK, do not take a double dose. Take the next dose at
your normal scheduled time the next day. Take RAGWITEK as prescribed by your
doctor until the end of the treatment course. If you miss more than one dose of
RAGWITEK, contact your doctor before restarting.
(continued)
Do I need to take RAGWITEK with water?
Do not use food or water to take the tablet. Do not drink or eat for 5 minutes
after taking the tablet.
Can I take other medications with RAGWITEK?
You should tell your doctor if you are taking or have recently taken any other medicines,
including non-prescription and herbal supplements. Keep a list of them and show it to
your doctor and pharmacist each time you get a new supply of RAGWITEK.
How do I store RAGWITEK?
Keep RAGWITEK out of the reach of children. RAGWITEK
should be stored at room temperature,15ºC to 30ºC
(59ºF to 86ºF). Store RAGWITEK in original package
and keep package and tablets dry.
Keep
tablets
dry
•
• You should tell your doctor if you are taking or have recently taken any other
epinephrine.
•The first dose of RAGWITEK must be taken in the doctor’s office. After taking
the first tablet, you will be watched for at least 30 minutes for symptoms of a
serious allergic reaction.
• Stop RAGWITEK and contact your doctor if you have any of the following after
taking RAGWITEK: Any type of a serious allergic reaction; throat tightness that
worsens or swelling of the tongue or throat that causes trouble speaking,
breathing or swallowing; asthma or any other breathing condition that gets
worse or heartburn, difficulty swallowing, pain with swallowing, or chest pain
that does not go away or worsens. Also stop taking RAGWITEK following
mouth surgery procedures (such as tooth removal) or if you develop any mouth
infections, ulcers or cuts in the mouth or throat.
10
Make an appointment and ask your specialist if RAGWITEK is right for you.
Visit ragwitek.com to learn more and sign up for helpful tools and resources.
RAGWITEK is a prescription medicine used for sublingual (under the tongue) immunotherapy to treat ragweed pollen allergies that can cause
sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes. RAGWITEK may be prescribed for persons 18 through 65 years of age
who are allergic to ragweed pollen.
RAGWITEK is taken for about 12 weeks before the ragweed pollen season and throughout ragweed pollen season.
RAGWITEK is NOT a medication that gives immediate relief for symptoms of ragweed allergy.
RAGWITEK can cause severe allergic reactions that may be life-threatening. Stop taking RAGWITEK and get medical treatment right away if you have
m Trouble breathing
Please read the Medication Guide for RAGWITEK, including the information about severe allergic reactions, and discuss it with the doctor.
The physician Prescribing Information also is available.
Learn more about RAGWITEK at ragwitek.com
Copyright © 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. Printed in USA. RESP-1098680-0000 07/14

A ragweed pollen as a treatment for a ragweed allergy? It`s called

Transcription

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