Know the Risk for Asthma Patients
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- Information About the Risk
Due to an increased risk of asthma-related death, FDA has mandated that all long-acting beta2-adrenergic agonists (LABAs) and LABA-containing products, like SYMBICORT, carry a boxed warning. The boxed warning for SYMBICORT reads as follows:
WARNING: ASTHMA-RELATED DEATH
Long-acting beta2-adrenergic agonists (LABA), such as formoterol one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of the LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue SYMBICORT) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids [see Warnings and Precautions (5.1)].
See the full Prescribing Information for a more complete description of the risks associated with the use of SYMBICORT in the treatment of asthma.
- Key Data Regarding the Risk
FDA's decision to require a Risk Evaluation and Mitigation Strategy (REMS) and class-labeling changes to the drug labels for long-acting beta2-adreneric agonists (LABAs) is based on analyses from the Salmeterol Multi-center Asthma Research Trial (SMART), the Salmeterol Nationwide Surveillance study (SNS), and a meta-analysis conducted by FDA in 2008 and discussed at the joint Pulmonary Allergy Drugs, Drug Safety and Risk Management, and Pediatric Advisory Committees, held on December 10-11, 2008 (for complete safety reviews and background information discussed at this meeting, see the following link: December 10-11 2008 AC meeting).
SMART was a large, randomized, 28-week, placebo-controlled trial that evaluated patients 12 years of age and older receiving standard asthma therapy and the addition of either salmeterol or placebo. A total of 26,355 patients were evaluated in this study. Results showed that patients receiving salmeterol were at an increased risk for asthma-related death compared to patients receiving placebo (13/13,176 patients treated with salmeterol vs. 3/13,179 patients treated with placebo; RR 4.37, 95% CI 1.25, 15.34). Subgroup analyses were also performed and found that asthma-related death in Caucasians and African Americans occurred at a higher rate in patients using salmeterol compared to placebo. See Table 1 below for results from SMART.
Table 1. SMART Results
SMART Patients Asthma-Related Deaths in Salmeterol Group n (%*) Asthma-Related Deaths in Placebo Group n (%*) Relative Risk of Asthma-Related Death (95% Confidence Interval) Excess Deaths Expressed per 10,000 Patients† (95% Confidence Interval) All Patients§salmeterol: n = 13,176
placebo: n = 13,17913 (0.10%) 3 (0.02%) 4.37 (1.25, 15.34) 8 (3, 13) 
Caucasian Patientssalmeterol: n = 9,281
placebo: n = 9,3616 (0.07%) 1 (0.01%) 5.82 (0.70, 48.37) 6 (1, 10) African Americansalmeterol: n = 2,366
Patients
placebo: n = 2,3197 (0.31%) 1 (0.04%) 7.26 (0.89, 58.94) 27 (8, 46) 
* 28-week estimate, adjusted according to actual lengths of exposure to study treatment to account for early withdrawal of patients from the study.
† Estimate of the number of additional asthma-related deaths in patients treated with salmeterol in SMART, assuming 10,000 patients received salmeterol for a 28-week treatment period. Estimate calculated as the difference between the salmeterol and placebo groups in the rates of asthma-related death multiplied by 10,000.
§ The Total Population includes Caucasian, African American, Hispanic, Asian, and "Other" and "not reported". No asthma-related deaths occurred in the Hispanic (salmeterol n = 996, placebo n = 999), Asian (salmeterol n = 173, placebo n = 149), or "Other" (salmeterol n = 230, placebo n = 224) subpopulations. One asthma-related death occurred in the placebo group in the subpopulation whose ethnic origin was "not reported" (salmeterol n = 130, placebo n = 127).
The SNS was a 16-week, double-blind study that compared the addition of salmeterol or albuterol to standard asthma therapy in 25,180 asthma patients who were 12 years of age and older. In the study, there was an increase in the number of respiratory and asthma-related deaths in the salmeterol group (0.07% [12 out of 16,787 patients]) compared to the albuterol group (0.02% [2 out of 8,393 patients] relative risk of 3.0, p=0.105).
In preparation for the December 2008 Advisory Committee, FDA conducted a meta-analysis of 110 studies evaluating the use of LABAs in 60,954 patients with asthma. The meta-analysis used a composite endpoint to measure severe exacerbation of asthma symptoms (asthma-related death, intubation, and hospitalization). The results of the meta-analysis suggested an increased risk for severe exacerbation of asthma symptoms in patients using LABAs compared to those not using LABAs. The largest risk difference per 1000 treated patients was seen in children 4-11 years of age; see Table 2 below. The results of the meta-analysis were primarily driven by asthma-related hospitalizations. Other meta-analyses evaluating the safety of LABAs in the treatment of asthma have not shown a significant increase in the risk for severe asthma exacerbations.
Table 2. Meta-Analysis Results: Number of Patients Experiencing an Event¶
Patient Population LABA Patients Experiencing an Event Non-LABA Patients Experiencing an Event Risk Difference Estimate Per 1000 Treated Patients 95% Confidence Interval All Patients
n = 30,148
LABA patients
n = 30,806
non-LABA patients381 304 2.80 1.11-4.49 Patients ages
12 to 17 years
n = 3,103
LABA patients
n = 3,289
non-LABA patients48 30 5.57 0.21-10.92 Patients ages
4 to 11 years
n = 1,626
LABA patients
n = 1,789
non-LABA patients61 39 14.83 3.24-26.43 ¶ Event defined as the composite end point (asthma-related death, intubation, and hospitalization)
At this time, there are insufficient data to conclude whether using LABAs with an inhaled corticosteroid reduces or eliminates the risk of asthma-related death and hospitalizations. FDA is requiring the manufacturers of LABAs to conduct studies evaluating the safety of LABAs when used in conjunction with an inhaled corticosteroid.
Based on the available information, FDA concludes there is an increased risk for severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma. The Agency is requiring the implementation of a REMS and class-labeling changes to improve the safe use of these products.
See February 2010 LABA Drug Safety Communication for more information.
- New Prescribing Guidelines
Long-acting beta2-agonists (LABAs), a class of medications used for the treatment of asthma, now have new recommendations in their drug label intended to promote their safe use in the treatment of asthma.
In February 2010, the Agency announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma (see February 2010 LABA Drug Safety Communication).
In June 2010, the agency issued updated recommendations on the appropriate use of LABAs. See June 2010 LABA Drug Safety Communication for more information.
The new recommendations in the updated labels state:
- Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
- LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
- LABAs should only be used for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA.
- Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.
FDA has stated its belief that when LABAs are used according to the recommendations outlined above and in the approved drug labels, the benefits of LABAs in improving asthma symptoms outweigh their risks of increasing severe asthma exacerbations and deaths from asthma.
- Currently Available LABAs and Approved Uses
FDA Approved Long-Acting Beta Agonists
Brand Name# LABA Active Ingredient Corticosteroid Active Ingredient FDA-Approved Uses** SYMBICORT®
Inhalation AerosolFormoterol Budesonide Asthma, COPD 
Dulera® Inhalation
AerosolFormoterol Mometasone Asthma Serevent® Diskus® Salmeterol None Asthma, COPD,
exercise-induced bronchospasmForadil® Aerolizer® Formoterol None Asthma, COPD,
exercise-induced bronchospasmForadil® Certihaler®†† Formoterol None Asthma Advair Diskus® Salmeterol Fluticasone Asthma, COPD Advair® HFA Salmeterol Fluticasone Asthma Brovana® Arformoterol None COPD Perforomist® Formoterol None COPD 
# All trademarks are the property of their respective owners.
** Please see prescribing information for respective products for complete product information.
†† Not currently marketed in the US.
- Patient Counseling Information
Patient Counseling Information
See US Prescribing Information and Medication GuideAsthma-Related Death
See Medication Guide
Patients should be informed that formoterol fumarate dihydrate, one of the active ingredients in SYMBICORT, increases the risk of asthma-related death and may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. They should also be informed that data are not adequate to determine whether the concurrent use of inhaled corticosteroids, the other component of SYMBICORT, or other long-term asthma-control drugs mitigate this risk. See WARNINGS AND PRECAUTIONS Section 5.1 of the full Prescribing Information.Not for Acute Symptoms
SYMBICORT is not meant to relieve acute asthma symptoms or exacerbations of COPD and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist such as albuterol. (The physician should provide the patient with such medication and instruct the patient in how it should be used.)
Patients should be instructed to notify their physician immediately if they experience any of the following:
- Decreasing effectiveness of inhaled, short-acting beta2-agonists
- Need for more inhalations than usual of inhaled, short-acting beta2-agonists
- Significant decrease in lung function as outlined by the physician
Patients should not stop therapy with SYMBICORT without physician/provider guidance since symptoms may recur after discontinuation.
Do Not Use Additional Long-Acting Beta2-Agonists
When patients are prescribed SYMBICORT, other long-acting beta2-agonists should not be used. See WARNINGS AND PRECAUTIONS Section 5.3 of the full Prescribing Information.
Risks Associated With Corticosteroid Therapy
Local Effects: Patients should be advised that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with SYMBICORT, but at times therapy with SYMBICORT may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised. See WARNINGS AND PRECAUTIONS Section 5.4 of the full Prescribing Information.
Pneumonia: Patients with COPD have a higher risk of pneumonia and should be instructed to contact their healthcare provider if they develop symptoms of pneumonia. See WARNINGS AND PRECAUTIONS Section 5.5 of the full Prescribing Information.
Immunosuppression: Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. See WARNINGS AND PRECAUTIONS Section 5.6 of the full Prescribing Information.
Hypercorticism and Adrenal Suppression: Patients should be advised that SYMBICORT may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, patients should be instructed that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to SYMBICORT. See WARNINGS AND PRECAUTIONS Section 5.8 of the full Prescribing Information.
Reduction in Bone Mineral Density: Patients who are at an increased risk for decreased Bone Mineral Density (BMD) should be advised that the use of corticosteroids may pose an additional risk. See WARNINGS AND PRECAUTIONS Section 5.13 of the full Prescribing Information.
Reduced Growth Velocity: Patients should be informed that orally inhaled corticosteroids, a component of SYMBICORT, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route. See WARNINGS AND PRECAUTIONS Section 5.14 of the full Prescribing Information.
Ocular Effects: Long-term use of inhaled corticosteroids may increase the risk of some eye problems (cataracts or glaucoma); regular eye examinations should be considered. See WARNINGS AND PRECAUTIONS Section 5.15 of the full Prescribing Information.
Risks Associated With Beta-Agonist Therapy
Patients should be informed of adverse events associated with beta2-agonists, such as palpitations, chest pain, rapid heart rate, tremor or nervousness. See WARNINGS AND PRECAUTIONS Section 5.12 of the full Prescribing Information.
- Questions and Answers
Questions about LABA Safety and Risk Evaluation and Mitigation Strategy (REMS) for LABAs
Questions about SYMBICORT Inhalation Aerosol
Questions about LABA Safety and Risk Evaluation and Mitigation Strategy (REMS) for LABAs
Q1. Why is FDA requiring LABA manufacturers to have a risk management program for these medicines?
A. Despite the benefits of long-acting beta2-agonists (LABAs) in helping people with asthma and COPD breathe easier, FDA's analyses indicate there is an increase in the risk of severe exacerbation of asthma symptoms in some patients with asthma that use a LABA compared to patients with asthma that do not use a LABA. Because of this risk, FDA wants to make sure LABAs are used appropriately in patients with asthma. Even though LABAs are approved for use in asthma and COPD, FDA's new recommendations only apply to the use of LABAs in the treatment of asthma. In order to ensure the safe use of these medicines, FDA is requiring the manufacturers of LABAs to develop this risk management program for healthcare professionals and patients.
Q2. What is the goal of the new risk management program for LABAs?
A. The risk management program for LABAs requires the manufacturers to better inform healthcare professionals and patients about the risk of LABAs for patients with asthma and ways to decrease that risk while maintaining the benefits of the drug. Under the program, patients who have a prescription filled for a LABA will receive a revised Medication Guide that explains the risks and benefits of the medicine. In addition manufacturers of LABAs will update the prescribing information they provide to healthcare professionals to include the latest recommendations for safe use of these important medicines.
Q3. What are the key points people should know about the safe use of LABAs in patients with asthma?
A. The key points are:
- Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
- LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
- LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid.
- Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.
Q4. What are the names of LABA-containing medicines used to treat asthma?
A. Below are the names of the LABA-containing medicines approved by FDA to treat asthma:
Brand Name(s) Generic Name(s) Description SYMBICORT
Inhalation Aerosolformoterol and budesonideformoterol is a LABA and budesonide is a corticosteroid long-term asthma control medication
Dulera Inhalation
Aerosolformoterol and mometasone formoterol is a LABA and mometasone is a corticosteroid long-term asthma control medication Advair Diskus,
Advair HFAsalmeterol and fluticasone salmeterol is a LABA and fluticasone is a corticosteroid long-term asthma control medication Serevent Diskus salmeterol single ingredient LABA with no corticosteroid long-term asthma control medication Foradil Aerolizer formoterol single ingredient LABA with no corticosteroid long-term asthma control medication 
Q5. Why should LABAs only be used with a long-term asthma control medication, are they safer when used this way?
A. At this time, there is no conclusive evidence that the combination of a long-term asthma control medication with a LABA decreases or eliminates the risk of a LABA. More study and analysis is required in this area. FDA is requiring the manufacturers of LABAs to conduct studies evaluating the safety of LABAs when used with an inhaled corticosteroid to better understand this issue.
Because of the risks of LABAs, FDA recommends that a LABA should not be used for a patient whose asthma can be controlled with long-term asthma control medication, such as an inhaled corticosteroid. If a LABA needs to be added to that medicine, it should only be used until the patient's healthcare professional determines their asthma is under control, and then the LABA should be stopped if possible. This means it is always necessary for a patient to use a LABA in combination with a long-term asthma control medication.
Q6. What information did FDA review to help the Agency decide to require a risk management program?
A. FDA used a variety of studies and research in patients with asthma using a LABA. Two specific studies that provided valuable information were 1) the Salmeterol Multicenter Asthma Research Trial (SMART) and 2), the Salmeterol Nationwide Surveillance study (SNS). Salmeterol is the LABA in Serevent. Each of these studies showed a higher risk of death for patients with asthma that used a LABA (salmeterol) compared to patients with asthma that did not use a LABA. In addition, FDA used a research method called a meta-analysis to further understand the risks associated with the use of LABAs in patients with asthma. A meta-analysis uses data from multiple studies on a particular topic to enable scientists to combine information from those studies to make scientific conclusions or recommendations in that area. For more information on these specific studies, please see February 2010 LABA Drug Safety Communication for more information.
Q7. Why is the new risk management program designed for patients with asthma and not for patients with COPD, aren't LABAs used to treat both conditions?
A. LABAs are used to treat both asthma and COPD; however, the studies reviewed by FDA included patients using LABAs for the treatment of asthma. These studies indicated an increased risk of severe exacerbation of asthma symptoms leading to hospitalization and death in these patients. There is no evidence to conclude that people with COPD who use LABAs are at any greater risk compared to people with COPD who do not use LABAs. FDA does not recommend any change in the use of LABAs for COPD.
Questions about SYMBICORT Inhalation Aerosol
Q1. Why does SYMBICORT have a boxed warning?
A. Due to an increased risk of asthma-related death, FDA has mandated that all long-acting beta2- agonists (LABAs) and LABA-containing products, like SYMBICORT, carry a boxed warning. The boxed warning for SYMBICORT reads as follows:
WARNING: ASTHMA-RELATED DEATH
Long-acting beta2-adrenergic agonists (LABA), such as formoterol one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of the LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue SYMBICORT) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids [see Warnings and Precautions (5.1)].
See the full Prescribing Information for a more complete description of the risks associated with the use of SYMBICORT in the treatment of asthma.
Q2. What should I tell patients about the risk of asthma-related death?
A. Patients should be informed that formoterol fumarate dihydrate, one of the active ingredients in SYMBICORT, increases the risk of asthma-related death and may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. They should also be informed that data are not adequate to determine whether the concurrent use of inhaled corticosteroids, the other component of SYMBICORT, or other long-term asthma-control drugs mitigate this risk. See WARNINGS AND PRECAUTIONS Section 5.1 of the full Prescribing Information.
Q3. Can SYMBICORT be used for acute asthma symptoms?
A. No. SYMBICORT is not meant to relieve acute asthma symptoms or exacerbations of COPD and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist such as albuterol. (The physician should provide the patient with such medication and instruct the patient in how it should be used.)
Patients should be instructed to notify their physician immediately if they experience any of the following:
- Decreasing effectiveness of inhaled, short-acting beta2-agonists
- Need for more inhalations than usual of inhaled, short-acting beta2-agonists
- Significant decrease in lung function as outlined by the physician
Patients should not stop therapy with SYMBICORT without physician/provider guidance since symptoms may recur after discontinuation.
Q4. Can additional LABAs be used with SYMBICORT?
A. No. When patients are prescribed SYMBICORT, other long-acting beta2-agonists should not be used. See WARNINGS AND PRECAUTIONS Section 5.3 of the full Prescribing Information.
Q5. What are the risks of corticosteroid Therapy?
A. Local Effects: Patients should be advised that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with SYMBICORT, but at times therapy with SYMBICORT may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised. See WARNINGS AND PRECAUTIONS Section 5.4 of the full Prescribing Information.
Pneumonia: Patients with COPD have a higher risk of pneumonia and should be instructed to contact their healthcare provider if they develop symptoms of pneumonia. See WARNINGS AND PRECAUTIONS Section 5.5 of the full Prescribing Information.
Immunosuppression: Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. See WARNINGS AND PRECAUTIONS Section 5.6 of the full Prescribing Information.
Hypercorticism and Adrenal Suppression: Patients should be advised that SYMBICORT may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, patients should be instructed that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to SYMBICORT. See WARNINGS AND PRECAUTIONS Section 5.8 of the full Prescribing Information.
Reduction in Bone Mineral Density: Patients who are at an increased risk for decreased Bone Mineral Density (BMD) should be advised that the use of corticosteroids may pose an additional risk. See WARNINGS AND PRECAUTIONS Section 5.13 of the full Prescribing Information.
Reduced Growth Velocity: Patients should be informed that orally inhaled corticosteroids, a component of SYMBICORT, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route. See WARNINGS AND PRECAUTIONS Section 5.14 of the full Prescribing Information.
Ocular Effects: Long-term use of inhaled corticosteroids may increase the risk of some eye problems (cataracts or glaucoma); regular eye examinations should be considered. See WARNINGS AND PRECAUTIONS Section 5.15 of the full Prescribing Information.
Q6. What are the risks of beta-agonist Therapy?
A. Patients should be informed of adverse events associated with beta2-agonists, such as palpitations, chest pain, rapid heart rate, tremor or nervousness. See WARNINGS AND PRECAUTIONS Section 5.12 of the full Prescribing Information.
- Dear Health Care Professional Letter
- External Links to FDA Alert(s) for LABAs
For more information:
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm199565.htm
- Prescribing Information
- Medication Guide
, including Boxed WARNING, with Medication Guide.
This product information is intended for US health care professionals only.
