Who is XOLAIR for?
XOLAIR® (omalizumab) for subcutaneous use is an
injectable prescription medicine for patients 12 years of age and
older. It is for patients with moderate to severe persistent allergic
asthma caused by year-round allergens in the air.
A skin or blood test
is done to see if you have allergic asthma. XOLAIR is for patients who
are not controlled by asthma medicines called inhaled steroids.
XOLAIR helps reduce the number of asthma attacks in people with
allergic asthma who still have asthma symptoms even though they are
taking inhaled steroids.
Important Limitations of Use
- XOLAIR has not been proven to work in other allergic
- XOLAIR is not a rescue medicine and should not be used to
treat sudden asthma attacks
- XOLAIR should not be used in children under 12 years of age
Important Safety Information
XOLAIR should always be injected in a doctor’s office.
You should read the Medication Guide
before starting XOLAIR treatment and before each and every treatment.
A severe allergic reaction called anaphylaxis
has happened in some patients after they received XOLAIR.
Anaphylaxis is a life-threatening condition and can lead to death,
so get emergency medical treatment right away if signs or symptoms
of anaphylaxis occur after receiving XOLAIR.
Signs and symptoms of anaphylaxis include:
- wheezing, shortness of breath, cough, chest tightness, or
- low blood pressure, dizziness, fainting, rapid or weak
heartbeat, anxiety, or feeling of “impending doom”
- flushing, itching, hives, or feeling warm
- swelling of the throat or tongue, throat tightness, hoarse
voice, or trouble swallowing
Anaphylaxis from XOLAIR can happen:
- right after receiving a XOLAIR injection or hours later
- after any XOLAIR injection. Anaphylaxis has occurred after the
first XOLAIR injection or after many XOLAIR injections
Your healthcare provider should watch you for some time in the
office for signs or symptoms of anaphylaxis after injecting XOLAIR.
If you have signs or symptoms of anaphylaxis, tell your healthcare
provider right away.
You should not receive XOLAIR if you have ever had an allergic
reaction to a XOLAIR injection. Do not use XOLAIR if you are allergic
to any of its ingredients.
In clinical studies, a variety of cancer types, including breast,
skin, prostate, and parotid (a type of salivary gland), were reported
in more patients who received XOLAIR than in patients who did not
XOLAIR is not a rescue medicine and should not be used to treat
sudden asthma attacks.
XOLAIR is not a substitute for the medicines you are already
taking. Do not change or stop taking any of your other asthma medicines
unless your doctor tells you to do so.
Some patients on XOLAIR may have an abnormal increase in
eosinophils (a type of white blood cell) in the blood or tissues,
sometimes causing an inflammation of blood vessels, which can lead to
rash, worsening of respiratory symptoms, heart trouble, and/or nerve
pain and weakness.
Joint inflammation or pain, rash, fever, and swollen lymph nodes
have been seen in some patients taking XOLAIR after the first or
subsequent injections. Talk to your doctor if you’ve experienced any of
these signs and symptoms.
The most commonly seen side effects occurring more frequently in
patients receiving XOLAIR than in patients who received placebo (an
injection with no active medicine) were joint pain, pain (general), leg
pain, tiredness (fatigue), dizziness, fracture, arm pain, itching,
inflammation of the skin, and earache.
In asthma studies, the most common side effects in patients, who
either needed to stop XOLAIR or needed medical attention, were
injection site reaction, viral infections, upper respiratory tract
infection, sinusitis, headache, and sore throat. These side effects
were seen at similar rates in XOLAIR-treated patients as in patients
that did not receive XOLAIR.
There are other possible side effects with XOLAIR. Talk to your
doctor for more information and if you have any questions about your
XOLAIR has not been studied in pregnant women. Pregnant women
exposed to XOLAIR are encouraged to enroll in the XOLAIR Pregnancy
Exposure Registry. You can get more information by calling
1-866-4XOLAIR (1-866-496-5247) or by speaking with your doctor.
You may report side effects to the FDA at 1-800-FDA-1088 or
You may also report side effects to Genentech at 1-888-835-2555.
Please see full Prescribing
Information, including Medication
Guide, for additional important safety information.