What is omalizumab?
Omalizumab is an antibody that helps decrease allergic responses in the body.
Omalizumab is used to treat moderate to severe asthma that is caused by allergies.
Omalizumab is usually given after other asthma medications have been tried without successful
treatment of symptoms.
Omalizumab may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking omalizumab?
Do not use this medication if you are allergic to omalizumab.
Before using omalizumab, tell your doctor if you have any other medical conditions or if you
take other medicines.
Using this medication may increase your risk of certain types of cancers of the breast, skin,
prostate, or salivary gland. Talk to your doctor about your individual risk.
FDA pregnancy category B. This medication is not expected to be harmful to an unborn
baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Your name may need to be listed on a pregnancy registry if you become pregnant while you are
using this medication or within 8 weeks after receiving at least one dose of omalizumab. The purpose of
this registry is to track the outcome of the pregnancy and delivery to evaluate whether omalizumab had
any effect on the baby.
Omalizumab may pass into breast milk and could harm a nursing baby. Do not use this
medication without telling your doctor if you are breast-feeding a baby.
How should I take omalizumab?
Use this medication exactly as it was prescribed for you. Do not use the medication in larger
amounts, or use it for longer than recommended by your doctor.
Omalizumab is given as an injection under the skin. Your doctor, nurse, or other healthcare
provider will give you this injection. Omalizumab is usually given every 2 or 4 weeks.
You may be shown how to inject your medicine at home. Do not self-inject this medicine if you
do not fully understand how to give the injection and properly dispose of used needles and syringes.
Use each disposable needle only one time. Throw away used needles in a puncture-proof
container (ask your pharmacist where you can get one and how to dispose of it). Keep this container
out of the reach of children and pets.
Omalizumab will not treat an asthma attack that has already begun. It does not work fast
enough to reverse the symptoms of an attack of asthma or bronchospasm. Use only a fast-acting
inhalation medication to treat an asthma attack.
Asthma is often treated with a combination of different drugs. To best treat your condition, use
all of your medications as directed by your doctor. Be sure to read the medication guide or patient
instructions provided with each of your medications. Do not change your doses or medication schedule
without advice from your doctor.
If you also use a steroid medication, do not stop using the steroid suddenly. Talk with your
doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma
attacks.
Your symptoms may not improve right away once you start receiving omalizumab. For best
results, keep receiving the medication as directed. Talk with your doctor if your symptoms do not
improve after a few weeks of treatment.
It is important to use omalizumab regularly to get the most benefit. Get your prescription refilled
before you run out of medicine completely.
To be sure this medication is helping your condition, your doctor may want you to have allergy
tests and lung function tests on a regular basis. Do not miss any scheduled visits to your doctor.
Store omalizumab in the refrigerator but do not allow it to freeze.
What happens if I miss a dose of omalizumab?
Contact your doctor if you miss a dose of omalizumab.
Where can I get more information about omalizumab?
Your pharmacist has information about omalizumab written for health professionals that you may read.
What are the possible side effects of omalizumab?
Some people using omalizumab have had a severe, life-threatening allergic reaction to this
medication, either right after the injection or hours later. Allergic reaction may occur even after using
the medication regularly for a year or longer.
Get emergency medical help if you have any of these
signs of an allergic reaction:
-
wheezing, tightness in your chest, trouble breathing;
-
hives or skin rash;
-
feeling anxious or light-headed, fainting;
-
warmth or tingling under your skin; or
-
swelling of your face, lips, tongue, or throat.
Other serious side effects include easy bruising or bleeding, or unusual
weakness.
Less serious side effects may be more likely to occur, such as:
-
pain;
-
tired feeling;
-
joint or muscle pain;
-
dizziness;
-
ear pain;
-
hair loss;
-
mild itching or skin rash;
-
sore throat or cold symptoms; or
-
redness, bruising, warmth, burning, stinging, itching, pain,
or swelling of your skin where the injection was given.
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. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about omalizumab?
Some people using omalizumab have had a severe, life-threatening allergic reaction to this
medication, either right after the injection or hours later. Allergic reaction may occur even after using
the medication regularly for a year or longer.
Get emergency medical help if you have any of these
signs of an allergic reaction:
wheezing, tightness in your chest, trouble breathing; hives or skin rash; feeling anxious or
light-headed, fainting; warmth or tingling under your skin; or swelling of your face, lips, tongue, or
throat.
Asthma is often treated with a combination of different drugs. To best treat your condition, use
all of your medications as directed by your doctor. Be sure to read the medication guide or patient
instructions provided with each of your medications. Do not change your doses or medication schedule
without advice from your doctor.
If you also use a steroid medication, do not stop using the steroid suddenly. Talk with your
doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma
attacks.
Your symptoms may not improve right away once you start receiving omalizumab. For
best results, keep receiving the medication as directed. Talk with your doctor if your symptoms do not
improve after a few weeks of treatment.
It is important to use omalizumab regularly to get the most benefit. Get your prescription refilled
before you run out of medicine completely.
Using this medication may increase your risk of certain types of cancers of the breast, skin,
prostate, or salivary gland. Talk to your doctor about your individual risk.
What should I avoid while taking omalizumab?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while
you are using omalizumab.
What other drugs will affect omalizumab?
There may be other drugs that can affect omalizumab. Tell your doctor about all the
prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal
products, and drugs prescribed by other doctors. Do not start using a new medication without telling
your doctor.
What happens if I have an overdose of omalizumab?