Brovana

• Overview
• Consumer Information
• Professional Information

 

Brovana Side Effects Center

What Is Brovana?

Brovana (arformoterol tartrate) Inhalation Solution is a bronchodilator used to prevent bronchoconstriction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Brovana will not treat a bronchospasm attack that has already begun.

What Are Side Effects of Brovana?

Common side effects of Brovana include:

• shakiness (tremor),
• nausea,
• vomiting,
• diarrhea,
• headache,
• nervousness,
• weakness,
• dizziness,
• dry mouth,
• trouble sleeping (insomnia),
• leg cramps,
• fever,
• stuffy nose, or
• hoarseness or deepened voice.

Tell your doctor if you have serious side effects of Brovana including:

• fast/pounding/irregular heartbeat,
• muscle cramps, or
• increased thirst or urination.

Dosage for Brovana

The recommended dose of Brovana Inhalation Solution is one 15 mcg unit-dose vial administered twice daily (morning and evening) by nebulization.

What Drugs, Substances, or Supplements Interact with Brovana?

Brovana may interact with aminophylline, theophylline, antibiotics, antidepressants, beta-blockers, diuretics (water pills), heart rhythm medicines, MAO inhibitors, narcotics, or steroids.

Brovana During Pregnancy and Breastfeeding

Tell your doctor all medications you use. During pregnancy, Brovana should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Brovana (arformoterol tartrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Brovana Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have;

• tremors, nervousness, chest pain, fast or pounding heartbeats;
• wheezing, choking, or other breathing problems after using this medicine;
• worsening breathing problems;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• chest pain, trouble breathing;
• back pain;
• diarrhea;
• leg cramps;
• skin rash;
• swelling in your legs;
• stuffy nose; or
• flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Brovana (Arformoterol Tartrate Inhalation Solution)

 

Brovana Professional Information

SIDE EFFECTS

Long-acting beta₂-adrenergic agonists, such as BROVANA, as monotherapy (without inhaled corticosteroids) for asthma increase the risk of asthma-related events. BROVANA Inhalation Solution is not indicated for the treatment of asthma [see WARNINGS AND PRECAUTIONS].

Beta₂-Agonist Adverse Reaction Profile

Adverse reactions to BROVANA Inhalation Solution are expected to be similar in nature to other beta₂-adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adults With COPD In Short-Term Trials (12 weeks)

The safety data described below for adults ≥35 years of age are based on 2 clinical trials of 12 weeks. In the 2 trials of 12 weeks duration, 1456 patients (860 males and 596 females, ages 34 to 89 years old) with COPD were treated with BROVANA Inhalation Solution 15 mcg twice daily, 25 mcg twice daily, 50 mcg once daily, salmeterol 42 mcg twice daily, or placebo. The racial/ethnic distribution in these two trials included 1383 Caucasians, 49 Blacks, 10 Asians, and 10 Hispanics, and 4 patients classified as Other. Among the 1,456 COPD patients in two 12-week, placebo-controlled trials, 288 were treated with BROVANA Inhalation Solution 15 mcg twice daily and 293 were treated with placebo. Doses of 25 mcg twice daily and 50 mcg once daily were also evaluated.

Table 1 shows adverse reaction rates among patients from these two trials where the frequency was greater than or equal to 2% in the BROVANA Inhalation Solution 15 mcg twice daily group and where the rate in the BROVANA Inhalation Solution 15 mcg twice daily group exceeded the rate in the placebo group. The total number and percent of patients who reported adverse events were 202 (70%) in the 15 mcg twice daily and 219 (75%) in the placebo groups. Ten adverse events demonstrated a dose relationship: asthenia, fever, bronchitis, COPD, headache, vomiting, hyperkalemia, leukocytosis, nervousness, and tremor.

Table 1: Number of Patients Experiencing Adverse Events from Two 12-Week, Double-Blind, Placebo-Controlled Clinical Trials

Total Patients	BROVANA Inhalation Solution 15 mcg twice daily		Placebo
	n	(%)	n	(%)
	288	(100)	293	(100)
Pain	23	(8)	16	(5)
Chest Pain	19	(7)	19	(6)
Back Pain	16	(6)	6	(2)
Diarrhea	16	(6)	13	(4)
Sinusitis	13	(5)	11	(4)
Leg Cramps	12	(4)	6	(2)
Dyspnea	11	(4)	7	(2)
Rash	11	(4)	5	(2)
Flu Syndrome	10	(3)	4	(1)
Peripheral Edema	8	(3)	7	(2)
Lung Disorder*	7	(2)	2	(1)
* Reported terms coded to “Lung Disorder” were predominantly pulmonary or chest congestion.

Adverse events occurring in patients treated with BROVANA Inhalation Solution 15 mcg twice daily with a frequency of <2%, but greater than placebo, were as follows:

Body as a Whole: abscess, allergic reaction, digitalis intoxication, fever, hernia, injection site pain, neck rigidity, neoplasm, pelvic pain, retroperitoneal hemorrhage

Cardiovascular: arteriosclerosis, atrial flutter, AV block, congestive heart failure, heart block, myocardial infarct, QT interval prolonged, supraventricular tachycardia, inverted T-wave

Digestive: constipation, gastritis, melena, oral moniliasis, periodontal abscess, rectal hemorrhage

Metabolic and Nutritional Disorders: dehydration, edema, glucose tolerance decreased, gout, hyperglycemia, hyperlipemia, hypoglycemia, hypokalemia

Musculoskeletal: arthralgia, arthritis, bone disorder, rheumatoid arthritis, tendinous contracture

Nervous: agitation, cerebral infarct, circumoral paresthesia, hypokinesia, paralysis, somnolence, tremor

Respiratory: carcinoma of the lung, respiratory disorder, voice alteration

Skin and Appendages: dry skin, herpes simplex, herpes zoster, skin discoloration, skin hypertrophy

Special Senses: abnormal vision, glaucoma

Urogenital: breast neoplasm, calcium crystalluria, cystitis, glycosuria, hematuria, kidney calculus, nocturia, PSA increase, pyuria, urinary tract disorder, urine abnormality.

In these trials, the overall frequency of all cardiovascular adverse events was 6.9% in BROVANA Inhalation Solution 15 mcg twice daily and 13.3% in the placebo group. There were no frequently occurring specific cardiovascular adverse events for BROVANA Inhalation Solution (frequency ≥1% and greater than placebo). The rate of COPD exacerbations was also comparable between the BROVANA Inhalation Solution 15 mcg twice daily and placebo groups, 12.2% and 15.1%, respectively.

Adults With COPD In Long-Term (52-week) Safety Trial

BROVANA Inhalation Solution was evaluated in one 52 week double-blind, randomized, placebo-controlled, safety trial conducted in patients with moderate to severe COPD. The primary endpoint was time to either respiratory death or first COPD exacerbation-related hospitalization, whichever occurred first. The event had to be a death or hospitalization for which the patient's respiratory status was predominant and/or inciting contributor, as determined by the clinical investigator. The objective of the trial was to demonstrate that the risk of respiratory death or COPD exacerbation-related hospitalization for patients treated with BROVANA Inhalation Solution was not greater than 40% more than the risk for patient treated with placebo. A total of 841 patients (479 males and 361 females, ages 41 to 94 years old) with COPD were randomized: 420 to BROVANA Inhalation Solution 15 mcg twice daily and 421 to placebo. Of the randomized patients, 255 (61%) in the BROVANA Inhalation Solution group and 211 (50%) in the placebo group, completed one year of treatment. The trial objective was met demonstrating that COPD patients treated with BROVANA Inhalation Solution are not at an increased risk of respiratory death or COPD exacerbation-related hospitalizations compared to placebo.

Read the entire FDA prescribing information for Brovana (Arformoterol Tartrate Inhalation Solution)

&Copy; Brovana Patient Information is supplied by Cerner Multum, Inc. and Brovana Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.