Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Serious Asthma-Related Events – Hospitalizations, Intubations and Death
(Extensive changes; please refer to labeling)
6
Adverse Reactions
(Additions and/or revisions are underlined)
LABA use may result in the following:
Serious asthma-related events –
hospitalizations, intubations, death.
Cardiovascular and central nervous system
effects.
8
Use in Specific Populations
8.4 Geriatric Use
(Additions and/or
revisions are underlined)
Of the total number of asthma patients treated with SYMBICORT
twice daily in two 12-week studies and a 26-week postmarketing study,
791 were 65 years of age or older, of whom 141 were 75 years of age or older.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Advise the patient to read the FDA-approved patient labeling
(Patient Information and Instructions for Use).
Serious Asthma-Related Events: Inform patients
with asthma that LABA when used alone increases the risk of asthma-related
hospitalization or asthma-related death. Available data show that when
ICS and LABA are used together, such as with SYMBICORT, there is not a significant
increase in risk of these events.
Approved Drug Label (PDF)
5
Warnings and Precautions
Additions
and/or revisions underlined:
5.5
Pneumonia and Other Lower Respiratory Tract Infections
… In a 6-month lung function
study of 1704 patients with COPD, there was a higher incidence … Pneumonia did
not occur with greater incidence in the SYMBICORT 160/4.5 group (1.1 %)
compared with placebo (1.3%). In a 12-month lung function study of 1964
patients with COPD.
5.7
Transferring Patients From Systemic Corticosteroid Therapy
… During periods of stress, a severe
asthma attack or a severe COPD exacerbation, patients who have been
withdrawn from systemic corticosteroids should be instructed to resume oral
corticosteroids (in large doses) immediately and to contact their physicians
for further instruction. These patients should also be instructed to carry a
warning card indicating that they may need supplementary systemic
corticosteroids during periods of stress, a severe asthma attack, or a
severe COPD exacerbation … Lung function (mean forced expiratory volume
in 1 second [FEV1] or morning peak expiratory flow [PEF]), beta-agonist use,
and asthma or COPD symptoms should be carefully monitored during
withdrawal of oral corticosteroids.
5.8
Hypercorticism and Adrenal Suppression
Budesonide, a component of SYMBICORT,
will often help control asthma and COPD symptoms with less suppression
of HPA function …
5.13
Reduction in Bone Mineral Density
Effects of treatment with SYMBICORT
160/4.5, SYMBICORT 80/4.5, formoterol 4.5 mcg, or placebo on BMD was evaluated
in a subset of 326 patients (females and males 41 to 88 years of age) with COPD
in the 12-month lung function study. BMD evaluations …
5.15
Glaucoma and Cataracts
Effects of treatment with SYMBICORT
160/4.5, SYMBICORT 80/4.5, formoterol 4.5 mcg, or placebo on development of
cataracts or glaucoma were evaluated in a subset of 461 patients with COPD in
the 12-month lung function study. Ophthalmic examinations …
6
Adverse Reactions
6.2 Clinical Trials Experience in Chronic Obstructive Pulmonary Disease
Additions
and/or revisions underlined:
The safety data described below reflect
exposure to SYMBICORT 160/4.5 in 1783 patients. SYMBICORT 160/4.5 was studied
in two placebo-controlled lung function studies (6 and 12 months in duration),
and two active-controlled exacerbation studies (6 and 12 months in duration) in
patients with COPD.
The incidence of common adverse events …
There were no clinically important or
unexpected patterns of abnormalities observed for up to 1 year in chemistry, hematology,
ECG, ECG (Holter) monitoring, HPA-axis, bone mineral density and ophthalmology
assessments.
The safety findings from the two
double-blind, active-controlled exacerbations studies (6 and 12 months in
duration) in which 1012 adult COPD patients (616 males and 396 females) 40
years of age and older were treated with SYMBICORT 160/4.5, two inhalations
twice daily were consistent with the lung function studies.
8
Use in Specific Populations
8.5 Geriatric Use
Additions
and/or revisions underlined:
In the COPD studies of 6 to 12 months
duration, 810 patients treated with SYMBICORT 160/4.5, two
inhalations twice daily were 65 years old and above and of those, 177
patients were 75 years of age and older. No overall differences …
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Additions
and revisions underlined:
How should I use SYMBICORT?
What
are the possible side effects of SYMBICORT? SYMBICORT may cause serious side
effects
Fungal infection in your mouth or throat (thrush). Rinse your mouth
with water without swallowing after using SYMBICORT …
Increases
in blood sugar levels (hyperglycemia). The most common side effects of
SYMBICORT include:
Approved Drug Label (PDF)
5
Warnings and Precautions
5.4 Local Effects
(Additions and/or revisions are underlined)
Advise the patient to
rinse his/her mouth with water without swallowing following inhalation to help
reduce the risk of oropharyngeal candidiasis.
6
Adverse Reactions
6.1 Clinical Trials Experience in Asthma
(Additions and/or revisions are underlined)
Pediatric Patients 6 to Less than 12 Years of Age
The safety data for pediatric patients aged 6 to less
than 12 years is based on 1 trial of 12 weeks treatment duration. Patients (79
female and 105 male) receiving inhaled corticosteroid at trial entry were
randomized to SYMBICORT 80/4.5 (n=92) or budesonide pMDI 80 mcg (n=92), 2
inhalations twice daily. The overall safety profile of these patients was
similar to that observed in patients 12 years of age and older who received
SYMBICORT 80/4.5 twice daily in studies of similar design. Common adverse
reactions that occurred in patients treated with SYMBICORT 80/4.5 with a
frequency of greater than or equal to 3% and more frequently than patients
treated only with budesonide pMDI 80 mcg included upper respiratory tract
infection, pharyngitis, headache, and rhinitis.
8
Use in Specific Populations
8.1 Pregnancy
(Pregnancy and Lactation Labeling Rule (PLLR)
Conversion) (Extensive changes; please refer to label)
8.2 Lactation
(Pregnancy and Lactation Labeling Rule (PLLR)
Conversion; Additions and/or revisions
are underlined)
Risk Summary
There are no available data on the effects of
SYMBICORT, budesonide or formoterol fumarate on the breastfed
child or on milk production. Budesonide, like other inhaled
corticosteroids, is present in human milk.
There are no available data on the presence of formoterol fumarate in
human milk. Formoterol fumarate is present in rat milk [see Data]. The developmental and health benefits of breastfeeding
should be considered along with the mother’s clinical need for SYMBICORT and
any potential adverse effects on the breastfed infant from SYMBICORT or from
the underlying maternal condition.
Data
Human data with budesonide delivered via dry powder
inhaler indicates that the total daily oral dose of budesonide available in
breast milk to the infant is approximately 0.3% to 1% of the dose inhaled by
the mother…
In the fertility and reproduction study in rats, plasma
levels of formoterol were measured in pups on post natal day 15. It was
estimated that the maximum plasma concentration that the pups received from the
maternal animal, at the highest dose of 15 mg/kg, after nursing was 4.4% (0.24
nmol/L for a litter vs. 5.5 nmol/L for the mother).
8.4 Pediatric Use
(Additions and/or revisions are underlined)
The safety and effectiveness of SYMBICORT 80/4.5 in
asthma patients 6 to less than 12 years of age have been established in studies
of up to 12-week duration.
The safety and effectiveness of SYMBICORT in asthma
patients less than 6 years of age have not been established.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Advise the
patient to read the FDA-approved patient labeling (Medication Guide).
Instruct
patients to seek medical attention immediately if they experience any of the following:…
Local Effects: … Rinsing the
mouth with water without swallowing after inhalation is advised to
reduce the risk of thrush.
MEDICATION GUIDE
Additions and/or revisions are underlined)What is the most important information I should know about SYMBICORT? SYMBICORT can cause serious side effects, including:
People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as formoterol (one of the medicines in SYMBICORT) have an increased risk of death from asthma problems. It is not known whether budesonide, the other medicine in SYMBICORT, reduces the risk of death from asthma problems seen with formoterol. Call your healthcare provider if breathing problems worsen over time while using SYMBICORT. You may need different treatment. Get emergency medical care if:
breathing problems worsen quickly, and
you use your rescue inhaler medicine, but it does not relieve your breathing problems.
SYMBICORT should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma-control medicine, such as an inhaled corticosteroid.
When your asthma is well controlled, your healthcare provider may tell you to stop taking SYMBICORT. Your healthcare provider will decide if you can stop SYMBICORT without loss of asthma control. Your healthcare provider may prescribe a different long-term asthma-control medicine for you, such as an inhaled corticosteroid.
Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.
What is SYMBICORT?
SYMBICORT combines an inhaled corticosteroid medicine, budesonide and a LABA medicine, formoterol.
SYMBICORT is used for asthma and COPD as follows:
Asthma: SYMBICORT is used to control symptoms of asthma, and prevent symptoms such as wheezing in adults and children ages 6 and older.
SYMBICORT contains formoterol (the same medicine found in FORADIL AEROLIZER). LABA medicines such as formoterol increase the risk of death from asthma problems. SYMBICORT is not for adults and children with asthma who:
It is not known if SYMBICORT is safe and effective in children less than 6 years of age with asthma.
How do I use SYMBICORT?
While you are using SYMBICORT 2 times each day, do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicine are LABA medicines.
SYMBICORT does not relieve sudden symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
Call your healthcare provider or get medical care right away if:
you need to use your rescue inhaler medicine more often than usual
your rescue inhaler medicine does not work as well for you at relieving symptoms.
you need to use 4 or more inhalations of rescue inhaler medicine for 2 or more days in a row
you use one whole canister of your rescue inhaler medicine in 8 weeks’ time.
What are the possible side effects with of SYMBICORT?
SYMBICORT may cause serious side effects
Using too much of a LABA medicine may cause: …
Fungal infection in your mouth or throat (thrush). Rinse your mouth with water after using SYMBICORT to help reduce your chance of getting thrush.
Immune system effects and a higher chance for infections. Tell your healthcare provider about any signs of infection such as:
Fever
pain
body aches
chills
feeling tired
nausea
vomiting
Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicine.
Increased wheezing right after taking SYMBICORT. Always have a rescue inhaler with you to treat sudden wheezing.
Lower bone mineral density. This can happen in people who have a high chance for low bone mineral density (osteoporosis). Your healthcare provider should check you for this during treatment with SYMBICORT.
Swelling of your blood vessels. This can happen in people with asthma. Tell your healthcare provider right away if you have:
Decreases in blood potassium levels (hypokalemia).
Increases in blood sugar levels (hyperglycemia).
The most common side effects of SYMBICORT include:
Patients with asthma:
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