In a release issued earlier today by GoodRx, Inc. (Nasdaq: GDRX),
please note the announcement has been revised to include
information about Synjardy®, Synjardy XR® and Stiolto Respimat®.
Complete corrected text follows:
GoodRx, Inc. (Nasdaq: GDRX), America’s leading resource for
healthcare savings, and Boehringer Ingelheim, a privately-owned,
leading global biopharmaceutical company, today announced a new
joint effort to increase access to patient savings programs on the
GoodRx platform. Patients with type 2 diabetes or chronic
obstructive pulmonary disease (COPD) can now easily enroll in
manufacturer-sponsored copay programs for Boehringer Ingelheim’s
leading portfolio of medications to help reduce their out-of-pocket
costs, with additional medications that may be added to the
integration in the future. This integration and proposed
integrations have the potential to deliver approximately $15
million in available savings a year for those that need
life-enhancing medications, based on internal estimates.
Diabetes affects 1 in 10 Americans (more than 10% of the U.S.
population), with 1.5 million people newly diagnosed each year,
according to the CDC. Access to diabetes medications is a critical
and often life-threatening part of ongoing treatment, and cost is a
pressing barrier for many people with diabetes, with medical
expenditures approximately 2.3 times higher than they would be for
people without diabetes. The CDC also estimates COPD affects more
than 16 million people and is the third leading cause of death by
disease in the U.S. The combined economic burden of both these
conditions is estimated to be more than $286 billion ($237 billion
for diabetes and $49 billion for COPD) in direct medical costs each
year.
“As insurance deductibles increase, fewer medications are
covered by insurance, and more restrictions are placed on the
medications that are covered, patients are left carrying more of
the economic burden,” said Bansi Nagji, President of Healthcare at
GoodRx. “The integration of Boehringer Ingelheim’s savings programs
will help lower the affordability barrier for patients so they can
better access the medications they need.”
Consumers looking for manufacturer savings programs for diabetes
or COPD can go directly to the GoodRx website to find options
available from Boehringer Ingelheim. Those who qualify with
commercial insurance can find savings programs for their
prescription of Jardiance® (empagliflozin)*, Synjardy®
(empagliflozin/metformin HCI)*, Synjardy XR®
(empagliflozin/metformin HCI extended-release)*, Spiriva Respimat®
(tiotropium bromide), Stiolto Respimat® (tiotropium bromide and
olodaterol) and Combivent Respimat® (ipratropium bromide and
albuterol). *products in the Boehringer Ingelheim and Eli Lilly and
Company alliance portfolio
“The combination of Boehringer Ingelheim’s commitment to the
patients we serve and innovative approach to bringing
transformative therapies to market, and GoodRx’s trusted brand and
reach, means that we will be able to provide more patients with
seamless access to our support and savings programs,” said Chris
Marsh, Senior Vice President, Market Access, Boehringer Ingelheim
Pharmaceuticals, Inc. “We look forward to expanding our
collaborative partnership with GoodRx so we can help more people
living with chronic conditions find the appropriate savings program
and lower their out-of-pocket costs.”
About GoodRxGoodRx helps Americans get the
healthcare they need at a price they can afford. As America’s
leading resource for healthcare savings, GoodRx connects consumers
with affordable and convenient prescriptions and medical care,
including telehealth, mail order prescriptions, doctor visits, and
lab tests. We have helped Americans save over $30 billion since
2011 and are one of the most downloaded medical apps over the past
decade.
About Boehringer IngelheimBoehringer Ingelheim
is working on breakthrough therapies that improve the lives of
humans and animals. As a leading research-driven biopharmaceutical
company, the company creates value through innovation in areas of
high unmet medical need. Founded in 1885 and family-owned ever
since, Boehringer Ingelheim takes a long-term perspective. Around
52,000 employees serve more than 130 markets in the three business
areas, Human Pharma, Animal Health, and Biopharmaceutical Contract
Manufacturing.
Learn more at www.boehringer-ingelheim.us
Forward-Looking StatementsThis press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements contained
in this press release that do not relate to matters of historical
fact should be considered forward-looking statements, including
without limitation statements regarding consumer savings. These
statements are neither promises nor guarantees, but involve known
and unknown risks, uncertainties and other important factors that
may cause our actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, the important factors
discussed under the caption “Risk Factors” in GoodRx’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2020, and
our other filings with the SEC. These factors could cause actual
results to differ materially from those indicated by the
forward-looking statements made in this press release. Any such
forward-looking statements represent management’s estimates as of
the date of this press release. While we may elect to update such
forward-looking statements at some point in the future, we disclaim
any obligation to do so, even if subsequent events cause our views
to change.
ContactGoodRxLauren
Casparispress@goodrx.com
What
is
JARDIANCE?
(www.jardiance.com)JARDIANCE is a prescription medicine used along
with diet and exercise to lower blood sugar in adults with type 2
diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular
death in adults with type 2 diabetes who have known cardiovascular
disease.
JARDIANCE is not for people with type 1 diabetes. It may
increase their risk of diabetic ketoacidosis (increased ketones in
the blood or urine).
JARDIANCE is not for use to lower blood sugar in adults with
type 2 diabetes who have severe kidney problems, because it may not
work.IMPORTANT
SAFETY
INFORMATIONDo
not take JARDIANCE if you are allergic to empagliflozin or
any of the ingredients in JARDIANCE.
Do not take JARDIANCE if you are on
dialysis.
JARDIANCE
can
cause
serious
side
effects,
including:
- Ketoacidosis (increased ketones in your blood or
urine). Ketoacidosis is a serious condition which needs to
be treated in the hospital. Ketoacidosis may lead to death.
Ketoacidosis occurs in people with type 1 diabetes and can also
occur in people with type 2 diabetes taking JARDIANCE, even
if blood sugar is less than 250 mg/dL. Ketoacidosis has
also happened in people with diabetes who were sick or who had
surgery during treatment with JARDIANCE. Stop taking
JARDIANCE and call your doctor right away or go to the nearest
hospital emergency room if you get any of the following
symptoms, and if possible, check for ketones in your
urine:
-
nausea
- vomiting
- stomach-area (abdominal) pain
- tiredness
- trouble breathing
-
Dehydration.
JARDIANCE
can cause some people to become dehydrated (the loss of body water
and salt). Dehydration may cause you to feel dizzy, faint,
light-headed, or weak, especially when you stand up. Sudden
worsening of kidney function has happened in people who are taking
JARDIANCE.You may be at a higher risk of dehydration if you:
- take medicines to lower your blood pressure, including water
pills (diuretics)
- are on a low salt diet
- have kidney problems
- are 65 years of age or older
Talk to your doctor about what you can do to prevent
dehydration, including how much fluid you should drink on a daily
basis, and if you reduce the amount of food or liquid you drink, if
you are sick or cannot eat or start to lose liquids from your body
from vomiting, diarrhea, or being in the sun too long.
- Serious urinary tract infections. Serious
urinary tract infections can occur in people taking JARDIANCE and
may lead to hospitalization. Tell your doctor if you have symptoms
of a urinary tract infection, such as a burning feeling when
passing urine, a need to urinate often or right away, pain in the
lower part of your stomach or pelvis, or blood in the urine.
Sometimes people also may have a fever, back pain, nausea or
vomiting.
- Low blood sugar (hypoglycemia): If you take
JARDIANCE with another medicine that can cause low blood sugar,
such as sulfonylurea or insulin, your risk of low blood sugar is
higher. The dose of your sulfonylurea or insulin may need to be
lowered. Symptoms of low blood sugar may include:
- headache
- drowsiness
- weakness
- dizziness
- confusion
- irritability
- hunger
- fast heartbeat
- sweating
- shaking or feeling jittery
- Necrotizing fasciitis. A rare but serious bacterial
infection that causes damage to the tissue under the skin in the
area between and around your anus and genitals (perineum).
This bacterial infection has happened in women and men who take
JARDIANCE, and may lead to hospitalization, multiple surgeries, and
death. Seek medical attention immediately if you have fever
or are feeling very weak, tired or uncomfortable (malaise), and you
develop any of the following symptoms in the area between and
around your anus and genitals: pain or tenderness, swelling, and
redness of skin (erythema).
-
Vaginal
yeast
infection.
Talk to your doctor if you have vaginal odor, white or yellowish
vaginal discharge (discharge may be lumpy or look like cottage
cheese), and/or vaginal itching.
-
Yeast
infection
of
the
penis.
Swelling of an uncircumcised penis may develop that makes it
difficult to pull back the skin around the tip of the penis. Talk
to your doctor if you have redness, itching or swelling of the
penis, rash of the penis, foul smelling discharge from the penis,
and/or pain in the skin around penis.
- Allergic (hypersensitivity) reactions.
Symptoms of serious allergic reactions to JARDIANCE may include:
- swelling of your face, lips, throat and other areas of your
skin
- difficulty with swallowing or breathing
- raised, red areas on your skin (hives)
If you have any of these symptoms, stop taking JARDIANCE and
contact your doctor or go to the nearest emergency room right
away.
The
most
common
side
effects
of
JARDIANCE
include urinary tract infections and yeast infections in
females.These are not all the possible side effects of JARDIANCE.
For more information, ask your doctor or pharmacist.
Before taking JARDIANCE, tell your doctor about all of
your medical conditions, including if you:
- have kidney problems
- have liver problems
- have a history of infection of the vagina or penis
- have a history of urinary tract infections or problems with
urination
- are going to have surgery. Your doctor may stop your JARDIANCE
before you have surgery. Talk to your doctor if you are having
surgery about when to stop taking JARDIANCE and when to start it
again
- are eating less or there is a change in your diet
- have or have had problems with your pancreas, including
pancreatitis or surgery on your pancreas
- drink alcohol very often, or drink a lot of alcohol in the
short term (“binge” drinking)
- have type 1 diabetes. JARDIANCE should not be used to treat
people with type 1 diabetes.
- are pregnant or plan to become pregnant. JARDIANCE may harm
your unborn baby. Tell your doctor right away if you become
pregnant during treatment with JARDIANCE
- are breastfeeding or are planning to breastfeed. JARDIANCE may
pass into your breast milk and may harm your baby. Do not
breastfeed while taking
JARDIANCETell
your
doctor
about
all
the
medicines
you
take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements.
Especially
tell
your
doctor
if
you
take
water pills (diuretics) or medicines that can lower your blood
sugar, such as insulin.
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.
For more information, please see Prescribing Information and
Medication Guide.
CL-JAR-100080 06.15.2021
What are SYNJARDY and SYNJARDY XR?
SYNJARDY and SYNJARDY XR are prescription medicines that contain
2 diabetes medicines, empagliflozin (JARDIANCE) and metformin
hydrochloride. SYNJARDY and SYNJARDY XR can be used along with diet
and exercise to improve blood sugar in adults with type 2 diabetes,
and can be used in adults with type 2 diabetes who have known
cardiovascular (CV) disease when empagliflozin (JARDIANCE), one of
the medicines in SYNJARDY and SYNJARDY XR, is needed to reduce the
risk of CV death.
SYNJARDY and SYNJARDY XR are not for people with type 1
diabetes. It may increase their risk of diabetic ketoacidosis
(increased ketones in the blood or urine).
IMPORTANT SAFETY INFORMATION
SYNJARDY and SYNJARDY XR can cause serious side effects,
including:
Lactic acidosis (a build-up of lactic acid in the
blood). Metformin hydrochloride, one of the medicines in SYNJARDY
and SYNJARDY XR, can cause lactic acidosis, a rare but serious
condition that can cause death. Lactic acidosis is a medical
emergency and must be treated in a hospital.
Stop taking SYNJARDY and SYNJARDY XR and call your
doctor right away or go to the nearest hospital emergency room if
you get any of the following symptoms of lactic
acidosis: feel very weak and tired; have unusual (not
normal) muscle pain; have trouble breathing; have unexplained
stomach or intestinal problems with nausea and vomiting, or
diarrhea; have unusual sleepiness or sleep longer than usual; feel
cold, especially in your arms and legs; feel dizzy or lightheaded;
have a slow or irregular heartbeat.
You have a higher chance of getting lactic acidosis with
SYNJARDY or SYNJARDY XR if you: have moderate to
severe kidney problems ; have liver problems; drink a lot of
alcohol (very often or short term “binge” drinking); get dehydrated
(lose a large amount of body fluids); have
certain x-ray tests with injectable dyes or contrast
agents; have surgery or other procedure for which you need to
restrict the amount of food and liquid you eat and drink; have
congestive heart failure; have a heart attack, severe infection, or
stroke, or are 65 years of age or older.
Do not take SYNJARDY or SYNJARDY XR if
you:
- have severe
kidney problems, end stage renal disease, or are on dialysis
- have a condition
called metabolic acidosis or diabetic ketoacidosis (increased
ketones in the blood or urine)
- are allergic to
empagliflozin (JARDIANCE), metformin, or any of the ingredients in
SYNJARDY or SYNJARDY XR
SYNJARDY or SYNJARDY XR may cause serious side
effects, including:
Ketoacidosis (increased ketones in your blood or
urine). Ketoacidosis is a serious condition, which
needs to be treated in the hospital. Ketoacidosis may lead to
death. Ketoacidosis occurs in people with type 1 diabetes and in
people with type 2 diabetes taking SYNJARDY or SYNJARDY
XR, even if blood sugar is less than 250
mg/dL. Ketoacidosis has also happened in people with
diabetes who were sick or who had surgery during treatment with
SYNJARDY or SYNJARDY XR. Stop taking SYNJARDY or
SYNJARDY XR and call your doctor right away or go to the nearest
hospital emergency room if you get any of the following
symptoms, and, if possible, check for ketones in your
urine:
- nausea
- vomiting
- stomach-area
(abdominal) pain
- tiredness
- trouble
breathing
Dehydration. SYNJARDY or SYNJARDY XR can
cause some people to become dehydrated (the loss of body water and
salt). Dehydration may cause you to feel dizzy, faint,
light‐headed, or weak, especially when you stand up. Sudden
worsening of kidney function has happened in people who are taking
SYNJARDY or SYNJARDY XR.You may be at higher risk of dehydration if
you have kidney problems, are 65 years of age or older, are on a
low salt diet, or take medicines to lower your blood pressure,
including water pills (diuretics).
Talk to your doctor about what you can do to prevent
dehydration, including how much fluid you should drink on a daily
basis, and if you reduce the amount of food or liquid you drink, if
you are sick or cannot eat, or start to lose liquids from your body
from vomiting, diarrhea or being in the sun too long.
Serious urinary tract infections. Serious
urinary tract infections can occur in people taking SYNJARDY or
SYNJARDY XR, and may lead to hospitalization. Tell your doctor
if you have symptoms of a urinary tract infection, such as a
burning feeling when passing urine, a need to urinate often or
right away, pain in the lower part of your stomach or pelvis, or
blood in the urine. Sometimes people also may have a fever, back
pain, nausea, or vomiting.
Low blood sugar (hypoglycemia). If you
take SYNJARDY or SYNJARDY XR with another medicine that can
cause low blood sugar, such as a sulfonylurea or insulin, your risk
of getting low blood sugar is higher. The dose of your sulfonylurea
medicine or insulin may need to be lowered. Symptoms of low blood
sugar may include headache, drowsiness, weakness, irritability,
hunger, fast heartbeat, confusion, shaking or feeling jittery,
dizziness, or sweating.
Necrotizing fasciitis. A rare but
serious bacterial infection that causes damage to the tissue under
the skin in the area between and around your anus and genitals
(perineum). This bacterial infection has happened in
women and men who take SYNJARDY or SYNJARDY XR, and may lead
to hospitalization, multiple surgeries, and
death. Seek medical attention immediately if you have
fever or are feeling very weak, tired, or uncomfortable (malaise),
and you develop any of the following symptoms in the area between
and around your anus and genitals: pain or tenderness, swelling,
and redness of skin (erythema).
Vaginal yeast infection. Talk to your
doctor if you have vaginal odor, white or yellowish vaginal
discharge (discharge may be lumpy or look like cottage cheese),
and/or vaginal itching.
Yeast infection of the penis. Swelling of
an uncircumcised penis may develop that makes it difficult to pull
back the skin around the tip of the penis. Talk to your doctor if
you have redness, itching or swelling of the penis, rash of the
penis, foul smelling discharge from the penis, and/or pain in the
skin around penis.
Allergic (hypersensitivity)
reactions: Symptoms of serious allergic reactions to
SYNJARDY or SYNJARDY XR may include swelling of your face,
lips, throat, and other areas of your skin, difficulty with
swallowing or breathing, and raised, red areas on your skin
(hives). If you have any of these symptoms, stop taking SYNJARDY or
SYNJARDY XR and contact your doctor or go to the nearest
emergency room right away.
Low vitamin B12 (vitamin B12
deficiency). Using metformin for long periods of time
may cause a decrease in the amount of vitamin B12 in your blood,
especially if you have had low vitamin B12 blood levels before.
Your doctor may do blood tests to check your vitamin B12
levels.
The most common side effects of SYNJARDY or
SYNJARDY XR include urinary tract infections,
female genital infections, diarrhea, nausea, vomiting, gas, stomach
pain, indigestion, weakness, headache, and stuffy or runny nose and
sore throat.
These are not all the possible side effects of SYNJARDY or
SYNJARDY XR. For more information, ask your doctor or
pharmacist.
Before taking SYNJARDY or SYNJARDY XR, tell your
doctor about all of your medical conditions, including if
you:
- have kidney problems
- have liver problems
- have heart problems, including
congestive heart failure
- are 65 years of age or older
- have a history of infection of the
vagina or penis
- have a history of urinary tract
infection or problems with urination
- are going to have surgery. Your
doctor may stop your SYNJARDY or SYNJARDY XR before you have
surgery. Talk to your doctor if you are having surgery about when
to stop taking SYNJARDY or SYNJARDY XR and when to start it
again
- are eating less or there is a change
in your diet
- have or have had problems with your
pancreas, including pancreatitis or surgery on your pancreas
- drink alcohol very often, or drink a
lot of alcohol in the short term (“binge” drinking)
- are going to get an injection of dye
or contrast agents for an x-ray procedure. SYNJARDY or
SYNJARDY XR may need to be stopped for a short time. Talk to
your doctor about when you should stop SYNJARDY or SYNJARDY XR
and when you should start SYNJARDY or SYNJARDY XR again
- have type 1 diabetes. SYNJARDY or
SYNJARDY XR should not be used in people with type 1
diabetes
- have low levels of vitamin B12 in
your blood
- are pregnant or plan to become
pregnant. SYNJARDY or SYNJARDY XR may harm your unborn baby.
Tell your doctor right away if you become pregnant while taking
SYNJARDY or SYNJARDY XR
- are breastfeeding or plan to
breastfeed. SYNJARDY or SYNJARDY XR may pass into your breast milk
and may harm your baby. Talk with your doctor about the best way to
feed your baby if you are taking SYNJARDY or SYNJARDY XR. Do not
breastfeed while taking SYNJARDY
- are a person who has not gone
through menopause (premenopausal), who does not have periods
regularly or at all. SYNJARDY or SYNJARDY XR can cause the release
of an egg from an ovary in a person (ovulation). This can increase
your chance of getting pregnant
Tell your doctor about all the medicines you
take, including prescription or over‐the‐counter
medicines, vitamins, or herbal supplements. Especially
tell your doctor if you take: insulin or other
medicines that can lower your blood sugar or diuretics (water
pills).
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
Please see Prescribing Information and Medication
Guide for SYNJARDY.Please see Prescribing
Information and Medication Guide for
SYNJARDY XR.
CL-SY-100045 6.15.2021
IMPORTANT SAFETY INFORMATION
Do not use SPIRIVA RESPIMAT or SPIRIVA HANDIHALER if you are
allergic to tiotropium, ipratropium, atropine or similar drugs, or
any ingredient in these medicines.
SPIRIVA RESPIMAT or SPIRIVA HANDIHALER are not rescue medicines
and should not be used for treating sudden breathing problems. Your
doctor may give you other medicine to use for sudden breathing
problems.
SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause allergic
reactions. Symptoms can include raised red patches on your skin
(hives), itching, rash and/or swelling of the lips, tongue, or
throat that may cause difficulty in breathing or swallowing. If you
have any of these symptoms, stop taking the medicine and seek
emergency medical care.
Before using SPIRIVA HANDIHALER, tell your doctor if you have a
severe allergy to milk proteins.
SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause your breathing
to suddenly get worse (bronchospasm). If this happens, use your
rescue inhaler, stop taking SPIRIVA, and call your doctor right
away or seek emergency medical care.
SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can increase the pressure
in your eyes (acute narrow-angle glaucoma) which can cause the
following symptoms: eye pain, blurred vision, seeing halos or
colored images along with red eyes. If you have any of these
symptoms, stop taking your medicine and call your doctor right
away.
Dizziness and blurred vision may occur with SPIRIVA RESPIMAT or
SPIRIVA HANDIHALER. If you experience these symptoms, use caution
when engaging in activities such as driving a car, or operating
appliances or other machines.
SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause new or worsened
urinary retention. Symptoms of blockage in your bladder and/or
enlarged prostate may include difficulty passing urine and/or
painful urination. If you have any of these symptoms, stop taking
your medicine and call your doctor right away.
The most common side effects reported with SPIRIVA RESPIMAT in
patients with COPD include sore throat, cough, dry mouth, and sinus
infection.
The most common side effects reported with SPIRIVA HANDIHALER in
patients with COPD include upper respiratory tract infection, dry
mouth, sinus infection, sore throat, non-specific chest pain,
urinary tract infection, indigestion, runny nose, constipation,
increased heart rate, and blurred vision.
Do not swallow SPIRIVA capsules. The contents of the capsule
should only be inhaled through your mouth using the HANDIHALER
device.
Do not spray SPIRIVA RESPIMAT into your eyes, as this may cause
blurring of vision and pupil dilation.
Tell your doctor about all your medical conditions including
kidney problems, glaucoma, enlarged prostate, problems passing
urine, or blockage in your bladder.
Tell your doctor all the medicines you take, including eye
drops. Ask your doctor if you are taking any anticholinergic
medicines because taking them together with SPIRIVA can increase
side effects. Do not use SPIRIVA RESPIMAT and SPIRIVA HANDIHALER
together.
INDICATIONS
SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HANDIHALER are long-term,
once-daily, prescription maintenance medicines used to control
symptoms of chronic obstructive pulmonary disease (COPD) by
relaxing your airways and keeping them open. COPD includes chronic
bronchitis and emphysema. SPIRIVA RESPIMAT and SPIRIVA HANDIHALER
also reduce the likelihood of flare-ups (COPD exacerbations).
SPIRIVA is not a treatment for sudden symptoms of COPD.
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.
CL-SVR-0040 2.8.2016
APPROVED USE FOR STIOLTO RESPIMAT
STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol)
Inhalation Spray is a prescription medicine used long term, 2 puffs
1 time each day, in controlling symptoms in adults with chronic
obstructive pulmonary disease (COPD). COPD is a chronic lung
disease that includes chronic bronchitis, emphysema, or both.
STIOLTO is not for treating sudden symptoms of COPD. Always have
a rescue medicine with you to treat sudden symptoms.
STIOLTO is not for asthma.
IMPORTANT SAFETY INFORMATION FOR STIOLTO
RESPIMAT
Do not use STIOLTO if you have
asthma. People with asthma who take long-acting
beta2-agonist (LABA) medicines, such as olodaterol, (one of the
medicines in STIOLTO), without also using a medicine called an
inhaled corticosteroid, have an increased risk of serious problems
from asthma, including being hospitalized, needing a tube
placed in their airway to help them breathe, or death.
Do not use STIOLTO if you are allergic
to tiotropium, ipratropium, atropine or similar
drugs, olodaterol, or any ingredient in STIOLTO.
Call your healthcare provider or get emergency medical
care if you experience symptoms of a serious allergic
reaction including: rash, hives, itching, swelling of the face,
lips, tongue, throat, and difficulties in breathing or
swallowing.
Get emergency medical care if your
breathing problems worsen quickly or if you use your rescue inhaler
but it does not relieve your breathing problems. Call your
healthcare provider if breathing problems worsen over time while
using STIOLTO.
Do not use STIOLTO more often than prescribed by your
doctor. Do not use STIOLTO with other LABAs or
anticholinergics.
Do not use STIOLTO for treating sudden breathing
problems. Always have a rescue inhaler with you to
treat sudden symptoms.
Tell your doctor about all your medical
conditions including heart problems, high blood
pressure, seizures, thyroid problems, diabetes, kidney problems,
glaucoma, enlarged prostate, and problems passing urine.
STIOLTO can cause serious side
effects, including sudden shortness of breath that
may be life threatening, fast or irregular heartbeat, increased
blood pressure, chest pain, tremor, headache, nervousness, high
blood sugar, or low blood potassium that may cause muscle weakness
or abnormal heart rhythm. If any of these happens, stop taking
STIOLTO and seek immediate medical help.
STIOLTO can cause new or worsening eye
problems including narrow-angle glaucoma, and can
increase the pressure in your eyes, which can cause the following
symptoms: eye pain, blurred vision, seeing halos or colored images
along with red eyes. If you have any of these symptoms, stop taking
STIOLTO and call your doctor right away.
STIOLTO can cause new or worsened urinary
retention. Symptoms of urinary retention may include
difficulty passing urine, painful urination, urinating frequently,
or urinating in a weak stream or drips. If you have any of these
symptoms, stop taking STIOLTO and call your doctor right away.
The most common side effects of STIOLTO
are runny nose, cough, and back pain.
Tell your doctor about all the medicines you
take, including prescription and over-the-counter
medicines, eye drops, vitamins, and herbal supplements. STIOLTO and
certain other medicines may affect each other.
STIOLTO is for oral inhalation only.
The STIOLTO cartridge is only intended for use with the STIOLTO
RESPIMAT inhaler.
Do not spray STIOLTO into your eyes. Your
vision may become blurred and your pupils may become larger
(dilated).
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.
Read the step-by-step patient Instructions for Use for STIOLTO
RESPIMAT before you use your inhaler.
Please see accompanying full Prescribing
Information, Patient Information, and Instructions for
Use for STIOLTO RESPIMAT.
CL-STO-100022 6.5.2019
INDICATION FOR USE AND IMPORTANT SAFETY
INFORMATION
COMBIVENT RESPIMAT (ipratropium bromide and albuterol) is
indicated for use in patients with chronic obstructive pulmonary
disease (COPD) on a regular aerosol bronchodilator who continue to
have evidence of bronchospasm (airway narrowing) and who require a
second bronchodilator.
IMPORTANT SAFETY INFORMATION
Do not use COMBIVENT RESPIMAT if you are allergic to any of the
ingredients in COMBIVENT RESPIMAT or to atropine or other similar
drugs.
COMBIVENT RESPIMAT can cause the narrowing of the airways to get
worse (paradoxical bronchospasm) which may be life threatening. If
this happens, stop taking COMBIVENT RESPIMAT at once and call your
doctor or get emergency help.
COMBIVENT RESPIMAT can cause serious heart-related side effects,
such as palpitations, chest pain, rapid heart rate, high blood
pressure, tremor, or nervousness. Call your doctor if you
experience any of these symptoms.
Avoid spraying COMBIVENT RESPIMAT into your eyes. COMBIVENT
RESPIMAT may increase eye pressure which may cause or worsen some
types of glaucoma. If you have sudden vision changes, eye pain or
visual halos, stop taking COMBIVENT RESPIMAT and call your doctor
right away.
COMBIVENT RESPIMAT may cause difficulty with urination.
Dizziness and blurred vision may occur with COMBIVENT RESPIMAT.
Should you experience these symptoms, use caution when engaging in
activities such as driving a car or operating appliances or other
machines.
Do not use COMBIVENT RESPIMAT more often than your doctor has
directed. Deaths have been reported with similar inhaled medicines
in asthma patients who use the medicine too much. Seek medical
attention if your treatment with COMBIVENT RESPIMAT becomes less
effective for symptomatic relief, your symptoms become worse,
and/or you need to use the product more frequently than usual.
Allergic reactions may occur, including itching, swelling of the
face, lips, tongue, or throat (involving difficulty in breathing or
swallowing), rash, hives, bronchospasm (airway narrowing), or
anaphylaxis. Some of these may be serious. If you experience any of
these symptoms, stop taking COMBIVENT RESPIMAT at once and call
your doctor or get emergency help.
Tell your doctor about all your medical conditions, especially
if you have narrow-angle glaucoma, prostate or urinary problems, a
history of heart conditions (such as irregular heartbeat, high
blood pressure), thyroid disorder, or diabetes. Also tell your
doctor if you are pregnant or nursing.
Tell your doctor about all medicines you are taking, especially
heart medications or drugs to treat depression.
The most common side effects reported with use of COMBIVENT
RESPIMAT include infection of the ears, nose, and throat, runny
nose, cough, bronchitis, headache, and shortness of breath.
Click here for full Prescribing Information and Patient
Instructions for Use.
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.
CL-CBR-100003 10.30.2018
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