Brovana

January 31st, 2011 by Helen Scholz

What is the most important information I should know about BROVANA?
BROVANA is a medicine called a long-acting beta2-agonist or LABA. BROVANA is
used to treat chronic obstructive pulmonary disease (COPD).

âEUR¢ In patients with asthma, LABA medicines such as BROVANA may increase the
chance of asthma-related death from asthma problems.
âEUR¢ It is not known if LABA medicines, such as BROVANA, increase the chance of
death in patients with chronic obstructive pulmonary disease (COPD).
âEUR¢ BROVANA does not relieve sudden symptoms of COPD. Always have a short-
acting beta2-agonist medicine with you to treat sudden symptoms. If you do not have
an inhaled short-acting bronchodilator, call your healthcare provider to have one
prescribed for you.
âEUR¢ Get emergency medical care if:
âEUR¢ breathing problems worsen quickly
âEUR¢ you use your short-acting beta2-agonist medicine, but it does not relieve your
breathing problems
âEUR¢ Do not stop using BROVANA unless told to do so by your healthcare provider
because your symptoms might get worse.
âEUR¢ BROVANA should not be used in children. BROVANA has not been studied in
children.
What is BROVANA?
BROVANA is used long term, twice a day (morning and evening), in controlling
symptoms of chronic obstructive pulmonary disease (COPD) in adults with COPD.

LABA medicines such as BROVANA help the muscles around the airways in your lungs
stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and
shortness of breath.

What should I tell my healthcare provider before using BROVANA?
Tell your healthcare provider about all of your health conditions, including if you:
âEUR¢ have heart problems
âEUR¢ have high blood pressure
âEUR¢ have seizures
âEUR¢ have thyroid problems
âEUR¢ have diabetes
âEUR¢ have liver problems
âEUR¢ are pregnant or planning to become pregnant. It is not known if BROVANA
can harm your unborn baby.
âEUR¢ are breastfeeding. It is not known if BROVANA passes into your milk and if it
can harm your baby.
Tell your healthcare provider about all the medicines you take including
prescription and non-prescription medicines, vitamins and herbal supplements.
BROVANA and certain other medicines may interact with each other. This may cause
serious side effects.
Know the medicines you take. Keep a list of them to show your healthcare provider and
pharmacist each time you get a new medicine.
How should I use BROVANA?
Read the step-by-step instructions for using BROVANA at the end of this
Medication Guide.
âEUR¢ Use BROVANA exactly as prescribed. One ready-to-use vial of BROVANA is one
dose. The usual dose of BROVANA is 1 ready-to-use vial, twice a day (morning and
evening) breathed in through your nebulizer machine. The 2 doses should be about
12 hours apart. Do not use more than 2 vials of BROVANA a day.
âEUR¢ Do not mix other medicines with BROVANA in your nebulizer machine.
âEUR¢ If you miss a dose of BROVANA. Just skip that dose. Take your next dose at your
usual time. Do not take 2 doses at one time.
âEUR¢ While you are using BROVANA twice a day:
âEUR¢ do not use other medicines that contain a long-acting beta2-agonist (LABA) for
any reason
âEUR¢ do not use your short-acting beta2-agonist medicine on a regular basis (four times
a day).
âEUR¢ Make sure you always have a short-acting beta2-agonist medicine with you. Use your
short-acting beta2-agonist medicine if you have breathing problems between doses of
BROVANA.
âEUR¢ Do not change or stop any of your medicines to control or treat your COPD breathing
problems. Your healthcare provider will adjust your medicines as needed.
Call your healthcare provider or get emergency medical care right away if:
âEUR¢ your breathing problems worsen with BROVANA
âEUR¢ you need to use your short-acting beta2-agonist medicine more often than usual
âEUR¢ your short-acting beta2-agonist medicine does not work as well for you at relieving
symptoms
What are the possible side effects with BROVANA?
âEUR¢ In patients with asthma, LABA medicines such as BROVANA may increase the
chance of asthma-related death from asthma problems.
âEUR¢ serious allergic reactions including rash, hives, swelling of the face, mouth, and
tongue, and breathing problems. Call your healthcare provider or get emergency
medical care if you get any symptoms of a serious allergic reaction.
âEUR¢ chest pain
âEUR¢ increased or decreased blood pressure
âEUR¢ a fast and irregular heartbeat
âEUR¢ headache
âEUR¢ tremor
âEUR¢ nervousness
âEUR¢ dry mouth
âEUR¢ muscle cramps
âEUR¢ nausea, vomiting
âEUR¢ dizziness
âEUR¢ tiredness
âEUR¢ low or high blood potassium
âEUR¢ high blood sugar
âEUR¢ high blood acid
âEUR¢ trouble sleeping.

Tell your healthcare provider if you get any side effect that bothers you or that does not go away.
These are not all the side effects with BROVANA. Ask your healthcare provider or
pharmacist for more information.
How should I store BROVANA?
âEUR¢ Store BROVANA in a refrigerator between 36° to 46°F (2° to 8°C) in the protective
foil pouch. Protect from light and excessive heat. Do not open a sealed pouch until
you are ready to use a dose of BROVANA. Once a sealed pouch is opened,
BROVANA must be used right away. BROVANA may be used directly from the
refrigerator.
âEUR¢ BROVANA may also be stored at room temperature between 68oF to 77oF (20oC to
25oC) for up to 6 weeks (42 days). If stored at room temperature, discard
BROVANA if it is not used after 6 weeks or if past the expiration date, whichever is
sooner. Space is provided on the packaging to record room temperature storage
times.
âEUR¢ Do not use BROVANA after the expiration date provided on the foil pouch and vial.
âEUR¢ BROVANA should be colorless. Discard BROVANA if it is not colorless.
âEUR¢ Keep BROVANA and all medicines out of the reach of children.