Pronunciation:

oh-mah-LYE-zoo-mab

Brand Names:

• Xolair

Dosage Forms:

• Powder for Solution

Warnings:

Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab. Anaphylaxis has occurred as early as after the first dose of omalizumab, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, patients should be closely observed for an appropriate period of time after omalizumab administration, and health care providers administering omalizumab should be prepared to manage anaphylaxis that can be life-threatening. Patients should also be informed of the signs and symptoms of anaphylaxis and instructed to seek immediate medical care should symptoms occur .

Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab. Monitor patients closely after omalizumab administration and be prepared to manage life-threatening anaphylactic reactions .

Classifications:

Therapeutic—

Antiasthma

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Omalizumab is used to treat moderate to severe persistent allergic asthma. Omalizumab is a shot (injection) given under the skin (subcutaneous). The shot is given every 2 or 4 weeks. For many patients who still have asthma symptoms even though they are taking inhaled steroids, omalizumab helps to reduce the number of asthma attacks.

Omalizumab is a medicine called an IgE blocker. IgE is short for immunoglobulin E. IgE is a substance that occurs naturally in the body in small amounts. This substance plays an important role in allergic asthma. When people with allergic asthma breathe in a year-round allergen, such as cat or dog dander, their bodies make more IgE. This may cause a series of reactions in your body that can lead to asthma attacks and symptoms. Omalizumab works by helping to block IgE.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of omalizumab in children below 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of omalizumab in the elderly.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. Omalizumab is given as a shot under your skin .

You will receive omalizumab once every 2 or 4 weeks. Your dose will be determined by your IgE level, which your doctor will measure with a simple blood test before treatment begins, and your body weight. Based on your dose, your doctor will also tell you if you will need 1, 2, or 3 injections per dose. If you need more than 1 injection, each will be given in a different place on your body.

Omalizumab is not a rescue medication and should not be used to treat sudden asthma attacks. It is not a substitute for the medicines you are already taking. Never suddenly stop taking, or change the dose of your inhaled steroids or any other asthma medicine you are taking unless your doctor tells you to do so.

Precautions While Using This Medicine:

If you stop receiving omalizumab injections, your symptoms can be expected to return.

You may not see immediate improvement in your asthma after omalizumab treatment begins. It takes time for the medicine to work. It is important to continue your omalizumab injections until your doctor tells you otherwise.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have any symptoms such as wheezing, shortness of breath, cough, chest tightness, trouble breathing, dizziness, fainting, rapid or weak heartbeat, anxiety, flushing, itching, hives, feeling warm, swelling of the throat or tongue, throat tightness, hoarseness, or trouble swallowing .

Your doctor will ask you to remain at the healthcare facility or clinic for at least two hours after each injection to watch for immediate side effects that can be serious .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Cough

difficulty swallowing

dizziness

fast heartbeat

hives

itching

malignant tumor

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

shortness of breath

skin rash

tightness in chest

unusual tiredness or weakness

wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Bleeding

blistering

body aches or pain

burning

chills

cold or flu-like symptoms

coldness

congestion

discoloration of skin

dryness or soreness of throat

feeling of pressure

fever

headache

hoarseness

infection

inflammation

itching

leg pain

lumps

muscle or joint pain

numbness

pain

pain or tenderness around eyes and cheekbones

redness

runny nose

scarring

shortness of breath or troubled breathing

sore throat

soreness

stinging

stuffy or runny nose

swelling

tender, swollen glands in neck

tenderness

tingling

trouble in swallowing

ulceration

voice changes

warmth

Less common or uncommon

Arm pain

blistering, crusting, irritation, itching, or reddening of skin

body produces substance that can bind to drug making it less effective or cause side effects

cracked, dry, scaly skin

earache

itching skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.