Important Information about ADVAIR DISKUS
ADVAIR D
ISKUS
IOO/
50
. 250/50. 5 0 0 /
bo
(fluticasone propionate 100, 250, 000 meg and salm eterol SO meg inhalation pow der)
What is the m ost im portant inform ation I should know about ADVAIR DISKUS?
In patients with asthma, long-acting beta.-agonist medicines such as salmeterol (one ot the medications in ADVAIR )
may increase the chance of death from asthma problems. In a large asthma study, more patients who used
salmeterol died from asthma problems compared with patients who did not use salmeterol. So ADVAIR is not for
patients whose asthma is well controlled on another asthma controller medicine such as low- to medium-dose
inhaled corticosteroids or only need a fast-acting inhaler once in a while. Talk with your doctor about this risk and the
benefits of treating your asthma with ADVAIR.
ADVAIR should not be used to treat a severe attack of asthma or chronic obstructive pulmonary disease |COPD)
requ ring emergency medical treatment.
ADVAIR should not be used to relieve sudden symptoms or sudden breathing problems. Always have a fast-acting
inhaler with you to treat sudden breathing difficulty. If you do not have a fast-acting inhaler, contact your doctor to
have one prescribed for you.
What is ADVAIR DISKUS?
There are two medicines in ADVAIR: Fluticasone propionate, an inhaled anti-inflammatory belonging to a group of
medcines commonly referred to as corticosteroids: and salmeterol. a long-acting, irhaled bronchodilator belonging to
a greup of medicines commonly referred to as beta.-agonists. There are 3 strengths olADVAJR: 100/50.250/50.500/50.
For Asthma
•
ADVAIR is approved for the maintenance treatment of asthma in pat ents 4 years of age and older. ADVAIR should
only be used If your doctor decides that another asthma controller medicine alone does not control your asthma
or that you need 2 asthma controller medications.
•
The strength of ADVAIR approved for patients ages 4 to 11 years who experience symptoms on an inhaled
corticosteroid is ADVAIR DISKUS 100/50 All 3 strengths are approved for patients with asthma ages 12 years
and older.
For COPD associated with chronic bronchitis
ADVAJR 250/50 is the only approved dose for the maintenance treatment of airflow obstruction in patients with
COPD associated with chronic bronchitis. The benefit of using ADVAIR for longer than 6 months has not been
evaluated. The way anti-inflammatories work in the treatment of COPD is not well defined.
Who should not take ADVAIR DISKUS?
You should not start ADVAIR if your asthma is becoming significantly or rapidly worse, which can be life threatening.
Serious respiratory events, including death, have been reported in patients who started takng salmeterol in this
situation, although it is not possible to tell whether salmeterol contributed to these events. This may also occur in
patients with less severe asthma.
You shculd not take ADVAJR if you have had an allergic reacton to it or any of its components (salmeterol, fluticasone
propionate, or lactose). Tell your doctor if you are allergic to ADVAIR, any other medications, or food products If you
experience an allergic reaction after taking ADVAIR, stop using ADVAIR immediately and contact your doctor. Allergic
reactions are when ycu experience one or more of the following: choking; breathing problems; swelling of the face,
mouth and/or tongue, rash; hives; itching; or welts on the skin.
Tell your doctor about the following:
•
If you arc using your fast-acting inhaler more often or using more doses than you normally do (c.g.
. 4 or more
inhalations of your fast-acting inhaler for 2 or more days in a row or a whole canister of your fast-acting inhaler
in 8 weeks' time), it could be a sign that your asthma s getting worse. If this occurs, tell your doctor immediately.
•
If you have been using your fast-acting inhaler regularly (e g., four times a day). Your doctor may tell you to step
the regular use of these medications.
•
If your peak flow meter results decrease. Your doctor will tell you the numbers that are right for you.
•
If you have asthma and your symptoms do not improve after using ADVAJR regularly for 1 week.
•
If you have been on an oral steroid, like prednisone, and are now using ADVAIR. You should be very careful as ycu
may be less able to heal after surgery, infection, or serious injury. It takes a number of months for the body to
recover its ability to make its own steroid hormones after use of oral steroids Switching from an oral steroid may
also unmask a condition previously suppressed by the oral steroid such as allergies, conjunctivitis, eczema,
arthntis. ar.d eosincphilic conditions. Symptoms of an eo9nophilic condition can include rash, worsening breathing
problems, heart complications, and/or feeling of ‘pins and needles'' or numbness in the arms and legs Talk to your
doctor immediately if you experience any of these symptoms.
•
Sometimes patients experience unexpected bronchospasm right after taking ADVAIR. This condition can be life
threatening and if it occurs, you should immediately stop using ADVAIR and seek immediate medical attention.
•
if you have any type of heart disease such as coronary artery disease, irregular heart beat or high blood pressure.
ADVAIR should be used with caution. Be sure to talk with your doctor about your condition because salmeterol,
one of the components of ADVAIR. may affect the heart by increasing heart rate and blood pressure. It may cause
symptoms such as heart fluttering, chest pain, rapid heart rate, tremor, or nervousness.
•
If you have seizures, overactive thyroid gland, liver problems, or are sensitive to certain medications for breathing.
• If your breathing problems get worse over time or if your fast-acting inhaler does not work as well for you while
using ADVAIR. If yuur breathing problems worsen quickly, get emergency medical care.
•
if you nave been exposed to or currently nave cmckenpox or measles or n you nave an immune system prooiem.
Patients using medications that weaken the immune system are more likely to get infections than healthy
individuals. ADVAIR contains a corticosteroid (fluticasone propionate) which may weaken the immune system.
Infections like chickenpox and measles, for example, can be very senous or even fatal in susceptible patients using
corticosteroids.
How should I take ADVAIR DISKUS?
ADVAIR should be used 1 inhalation, twice a day (morning and evening). ADVAIR should never be taken more than
1 inhalation twice a day. The full benefit of taking ADVAIR may take l week or longer.
If you miss a dose of ADVAIR. just skip that dose. Take your next dose at your usual time. Do not take two doses at
one time.
Do not stop using ADVAIR unless told to do so by your doctor because your symptoms might get worse.
Do not change or stop any of your medicines used to control or treat your breath ng problems. Your doctor will adjust
your medicines as needed.
When using ADVAIR, remember:
•
Never breathe into or take the DISKUS apart.
•
Always use the DISKUS in a level position.
•
After each inhalation, rinse your mouth v/ith water without swallowing.
•
Never wash any part of the DISKUS. Always keep it in a dry place.
•
Never take an extra dose, even if you feel you did not receive a dose.
•
Discard 1 month after removal from the foil pouch.
•
Do not use ADVAIR with a spacer device
Children should use ADVAIR with an adult's help as instructed by the child's doctor.
Can I take ADVAIR DISKUS with other medications?
Tell your doctor about all the medications you take, including prescription and nonprescription medications vitamins,
and herbal supplements.
If you are taking ADVAIR DISKUS, do not use other long-acting beta-agonist—
containing medications, such as
SEREVENT DISKUS or Foradih Aerolizer, for any reason.
If you take ritonavir (an HIV medication), tell your doctor. Ritonavir may interact with ADVAIR and could cause serious
side effects. The anti-HIV medicines Norvir* Soft Gelatin Capsules, Norvir Oral Solution, and Kaletra contain ritonavir.
No formal drug interaction studies have been performed with ADVAIR.
In clinical studies, there were rx> differences in effects on the heart when ADVAIR was taken with varying ameunts of
albuterol. The effect of using ADVAIR in patients with asthma while taking more than 9 puffs a day of albuterol has
not been studied.
ADVAIR should be used with extreme caution during and up to 2 weeks after treatment with monoamine oxidase
(MAO) inhibitors or tricydc antidepressants since these medications can cause ADVAIR to have an even greater effect
on the circulatory system.
ADVAJR should be used with caution in people who are taking ketoconazole (an antifungus medication) or other drugs
broken down by the body in a similar way. These mediations can cause ADVAIR to have greater steroid side effects.
Generally, people with asthma should not take beta-blockers because they counteract the effects of beta.-agomsts
and may also cause severe bronchospasm. However, in some cases, for instance, following a heart attack, selective
beta-blockers may still be used if there is no acceptable alternative.
The ECG changes and'or low blood potassium that may occur with some diuretics may be made worse by ADVAIR.
especially at higher-than-recommended doses. Caution should be used when these drugs are used together.
In clinical studies, there was no difference in side effects when ADVAIR was taken with methylxanthines (e.g.,
theophylline) or with FLONASE (fluticasone propionate).
What are other im portant safety considerations w ith ADVAIR DISKUS?
Pneumonia: Lower respiratory tract infections, including pneumonia, have been reported with the use of inhaled
corticosteroids, including ADVAIR. There was a higher incidence of pneumonia reported In patients with COPD
taking ADVAIR DISKUS in clinical studies.
Osteoporosis: Long-term use of inhaled corticosteroids may result In bone loss (osteoporosis). Patients who are at risk
tor increased bone loss (tobacco use. advanced age, inactive lifestyle, poor nutrition, family history of
osteoporosis, or tong-term use of drugs such as corticosteroids) may have a greater risk with ADVAJR. If you have risk
factors for bene loss, you should talk to your doctor about ways to reduce your risk and whether you should have
your bone density evaluated.
Glaucoma and cataracts: Glaucoma, increased pressure in the eyes, and cataracts have been reported with
the use of inhaled steroids, including fluticasone propionate, a medicine contained in ADVAIR. Regular eye
examinations should be considered if you are taking ADVAIR.
Blood sugar: Salmeterol may affect blood sugar and/or cause low blood potassium in some patients, which could
lead to a side effect like an irregular heart rate. Significant changes in blood sugar and blood potassium were seen
infrequently in clinical studies v/ith ADVAJR.
Growth: Inhaled steroids may cause a reduction in growth velocity in children and adolescents.
Steroids: Taking steroids can affect your body's ability to make its own steroid hormones, which arc needed during
infections and times of severe stress to your body, such as an operation. These effects can sometimes be seen with
inhaled steroids (but it is more common v/ith oral steroids), especially when taken at higher-than-recommended
doses over a long period of time. In some cases, these effects may be severe. Inhaled steroids often help control
symptoms with less side effects than oral steroids.
Yeast infections: Patients taking ADVAIR may develop yeast infections of the mouth and/or throat (“thrush”) that
should be treated by their doctor.
Tuberculosis or other untreated infections: ADVAIR should be used with caution if at all, in patients with
tuberculosis, herpes infections of the eye, cr other untreated infections.
What are the other possible side effects o f ADVAIR DISKUS?
ADVAIR may produce side effects in some patients. In clinical studies, the most common side effects with ADVAIR
included:
•
Respiratory infections
•
Bronchitis
•
Musculoskeletal pain
•
Throat irritation
•
Cough
•
Dizziness
•
Hoarseness
•
Headaches
•
Fever
•
Sinus infection
•
Nausea and vomiting
•
Ear, nose, and throat infections
• Yeast infection of the mouth
• Diarrhea
• Nosebleed
Tell your doctor about any side effect that bothers you or that does not go away. These are not all the side effects
with ADVAIR Ask your doctor or pharmacist for more information.
What if I am pregnant, planning to become pregnant, or nursing?
Talk to your doctor about the benefits and risks of using ADVAIR during pregnancy, labor, or if you are nursing. There
have been no studies of ADVAIR used during pregnancy, labor, or in nursing women. Salmeterol is known to interfere
with labor contractions. It is not known whether ADVAIR is excreted in breast milk, but ether corticosteroids have been
detected in human breast milk. Fluticasone propionate, like other corticosteroids, has been associated with birth
defects in animals le g.
. cleft palate and fetal death) Salmeterol showed no effect on fertility in rats at 180 times the
maximum recommended daily dose.
What other im portant tests were conducted w ith ADVAIR?
There is no evidence of enhanced toxicity with ADVAIR compared with the components administered separately. In
animal studies with doses much higher than those used in humans, salmeterol was associated with uterine tumors.
Your healthcare professional can tell you more about how drugs are tested on animals and what the results cf these
tests may mean to your safety.
For more inform ation on ADVAIR DISKUS
This page is only a bnef summary of important information about ADVAIR DISKUS. For more information, talk to your
doctor. You can also visit www.ADVAfi.com or call 1 -888-825-5249. Patients recer/mg ADVAIR DISKUS should read
the medication guide pro/ided by the pharmacist v/ith the prescription.
ADVAJR. ADVAIR DISKUS. FLONASE. SEREVENT. and DISKUS are registered trademarks of GlaxoSmthKlme. The
following are registered trademarks of their respective manufacturers: ForadiVAstellas Pharma Inc.: Aerolizer/Novartis
AG: Norvir and Kaletra/Abbott Laboratories.
GlaxoSmithKline
GlaxoSmithKline
Research Triangle Park, NC 27709
ADD: 2PI
October 2007
©2007 The GlaxoSmithKline Group of Companies All rights reserved. Printed m
USA. AD4156R0 December 2007
