Omalizumab

Yes

Pregnancy: Data in pregnant women are insufficient to inform on drug associated risk; monoclonal antibodies, such as omalizumab, are transported across placenta in a linear fashion as pregnancy progresses; potential effects on fetus are likely to be greater during second and third trimesters of pregnancy; in women with poorly or moderately controlled asthma, evidence demonstrates that there is increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control

Lactation: Unknown if distributed into breast milk; use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Included as part of the PRECAUTIONS section.

Your pharmacist can provide more information about omalizumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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• Asthma Complexities
• Asthma Medications

Omalizumab is part of the drug class:

• OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if omalizumab is excreted in human breast milk or if it will harm your nursing baby.

Omalizumab comes as a solution to be injected just under the skin. It is usually given by injection once every 2 weeks, or once every 4 weeks, by a healthcare provider in a doctor's office or other medical setting. 

Your doctor will determine the omalizumab dose you require. The dose varies depending on your weight and your IgE level. IgE is a natural substance in your body that that is elevated in allergic asthma. A blood test is used to test your IgE level.

WARNING: Anaphylaxis

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, observe patients closely for an appropriate period of time after omalizumab administration. Health care providers administering omalizumab should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur.

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 in adults and children who are at least 6 years old. Omalizumab is used when asthma symptoms are not controlled by asthma inhaled steroid medicine. Omalizumab is not a rescue medicine for treating an asthma attack.

Omalizumab is also used to treat chronic hives (idiopathic urticaria) in adults and children who are at least 12 years old, after antihistamines have been tried without success.

Omalizumab may also be used for purposes not listed in this medication guide.

Before you start treatment with omalizumab, your doctor may perform an allergy skin test or blood test to make sure this medicine is right for you.

Omalizumab is injected under the skin. A healthcare provider will give you this injection. Omalizumab is usually given every 2 or 4 weeks.

You will be watched closely for a short time after receiving omalizumab, to make sure you do not have an allergic reaction to the medication.

Your condition may be treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

If you also use a steroid medicine, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks.

While using omalizumab, you may need frequent medical tests, such as allergy tests and lung function tests. Your stools may also need to be checked for parasites, especially if you travel.

Your condition may not improve right away. 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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Antiasthmatic and antiallergic agent; a chimeric human-murine (humanized) IgG1κ anti-IgE monoclonal antibody.1 2 3 4

Absorption

Bioavailability

Absorbed slowly; peak serum concentrations attained after an average of 7–8 days.1 Absolute bioavailability averages 62%.1

Onset

Serum free IgE concentrations reduced ≤1 hour following administration in patients with asthma.1

Maximum suppression of serum free IgE concentrations observed 3 days after first dose in patients with chronic idiopathic urticaria.1

Duration

Total IgE does not return to pretreatment concentrations for ≤1 year after drug discontinuance in patients with asthma.1

Free and total IgE concentrations returned toward pretreatment values (i.e., free IgE concentrations increased, total IgE concentrations decreased) over 16-week follow-up period following discontinuance of omalizumab in patients with chronic idiopathic urticaria.1

Distribution

Extent

In animals, no specific uptake of radiolabeled drug by any organ or tissue.1

Elimination

Metabolism

Degradation of omalizumab (IgG1κ monoclonal antibody) by the reticuloendothelial system and endothelial cells in the liver, and clearance of omalizumab-IgE complexes by the reticuloendothelial system.1

Elimination Route

Eliminated in part into the bile as unchanged drug.1

Half-life

26 days in asthmatic patients.1

24 days in patients with chronic idiopathic urticaria.1

Storage

Parenteral

Ship at ≤30°C.1 Store at 2–8°C.1 10 When reconstituted with sterile water for injection, solutions prepared in single-use vials are stable for ≤8 hours at 2–8°C or ≤4 hours at room temperature.1 Protect reconstituted vials from sunlight.1

• Importance of providing a copy of the manufacturer’s medication guide for omalizumab to the patient each time the drug is dispensed.1 8 9

• Risk of potentially life-threatening anaphylaxis after any dose of omalizumab.1 8 9 Importance of informing patients of signs and symptoms of anaphylaxis.8 9 (See Sensitivity Reactions under Cautions.)

• Importance of receiving omalizumab in a health-care setting (e.g., clinician’s office) where monitoring for possible anaphylaxis can be performed.1 8 9 10 (See Medical Personnel and Facilities under Cautions.)

• Importance of informing patients of potential for delayed anaphylaxis (e.g., up to 4 days after administration).1 8

• Importance of seeking emergency medical attention if signs or symptoms of anaphylaxis occur after leaving the clinician’s office.1 8 9

• Importance of patient understanding how to obtain emergency medical treatment and further medical care for anaphylaxis.8

• Importance of adherence to dosing schedules of concomitant therapy for asthma or chronic idiopathic urticaria, including not altering the dose or frequency of such drugs unless otherwise instructed by a clinician.1 8 9

• Importance of informing patients of possible delay in the effectiveness of omalizumab upon treatment initiation.1 8

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

Use omalizumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• rhuMAb-E25

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Subcutaneous [preservative free]:

Xolair: 150 mg (1 ea)

• Monoclonal Antibody, Anti-Asthmatic

Refer to adult dosing.

For SubQ injection only; doses >150 mg should be divided over more than one injection site (eg, 225 mg or 300 mg administered as two injections, 375 mg administered as three injections). Injections may take 5 to 10 seconds to administer (solution is slightly viscous). Administer only under direct medical supervision and observe patient for a minimum of 2 hours following administration of any dose given.

Anaphylactic/hypersensitivity reactions, baseline serum total IgE; FEV1, peak flow, and/or other pulmonary function tests; monitor for signs of infection

Substance Name

Omalizumab

CAS Registry Number

242138-07-4

Drug Class

Anti-Allergic Agents

Anti-Asthmatic Agents

Antibodies, Monoclonal

Antibodies, Anti-Idiotypic