Omalizumab injection (patient information)

IMPORTANT WARNING:
[UPDATE 07/02/2007] Genetech and FDA informed healthcare professionals and asthmatic patients that the prescribing information for omalizumab (Xolair) was revised to include a new BOXED WARNING, and updated WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections that address the risk of anaphylaxis (the onset of action can be delayed for 24 hours or more) when taking this medication. In addition, a new MEDICATION GUIDE was developed and will be provided to patients when a prescription for omalizumab is filled or refilled at the pharmacy. Due to the risk of anaphylaxis, omalizumab should only be administered to patients in a healthcare setting under direct medical supervision. Patients should be observed for an appropriate period of time following each omalizumab injection. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Xolair, http://www.fda.gov/cder/drug/InfoSheets/HCP/omalizumabHCP.htm, http://www.fda.gov/cder/foi/label/2007/103976s5102lbl.pdf and http://www.fda.gov/cder/foi/label/2007/103976s5102mg.pdf.

Why is this medication prescribed
Omalizumab injection is used to decrease the number of asthma attacks (wheezing, shortness of breath, and trouble breathing) in patients with allergic asthma whose symptoms are not controlled with inhaled steroids. Omalizumab is in a class of medications called monoclonal antibodies. It works by blocking the action of IgE cells (cells in the body that cause asthma symptoms) and stopping the release of substances in the body that cause an allergic response.

How should this medicine be used
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Omalizumab injection comes as a solution (liquid) to inject subcutaneously (under the skin). It is usually injected in a doctor's office once every 2 weeks or every 4 weeks.

Omalizumab may cause serious allergic reactions that are most likely to happen within 2 hours after you receive this medication, but may happen at any time during your treatment. You will have to stay at your doctor's office for at least 2 hours after you receive this medication.A doctor or nurse will watch you during this time to see if you are having a serious reaction to the medication. Tell your doctor or nurse right away if you experience any unusual symptoms, such as those listed in the SIDE EFFECTS section, after you receive omalizumab. Because an allergic reaction to omalizumab may happen after you leave your doctor's office, you may also be given another injectable medication for emergency use if you have certain side effects. Be sure that you know how to use this medication and to seek medical care immediately if these symptoms occur.

It may take some time before you feel the full benefit of omalizumab. Call your doctor if your asthma symptoms worsen. Talk to your doctor so that you know what to do if you have an asthma attack or breathing problems while receiving omalizumab. Do not decrease your dose or stop taking any other asthma medication that you may use to treat your condition, unless your doctor tells you to do so.

Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Before using omalizumab injection
 * tell your doctor and pharmacist if you are allergic to omalizumab, or any other medications.
 * tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking.
 * tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using omalizumab, call your doctor.
 * do not change the dose(s) of your other asthma medication(s) or stop taking them without talking to your doctor.

What special dietary instructions should I follow
Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose
If you miss an appointment to receive an injection of omalizumab you should call your health care doctor as soon as possible. The missed dose should be given as soon as it can be rescheduled.

Side effects
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Mild side effects
''Omalizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:''


 * pain, redness, swelling, warmth, burning, stinging, bruising, hardness (bump), or itching in the place omalizumab was injected
 * pain, especially in joints, arms, or legs
 * tiredness
 * ear pain

Severe side effects
''Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor or get medical care immediately:''


 * hives
 * rash
 * itching
 * difficulty breathing or swallowing
 * swelling of the face, throat, tongue, or lips
 * tightness in chest
 * flushing
 * dizziness
 * fainting
 * fast heartbeat
 * diarrhea
 * vomiting
 * stomach cramps

Omalizumab may increase the risk of developing cancer, including breast, skin, parotid (salivary gland, located near the mouth), and prostate cancer. Talk to your doctor about the risks of using this medication.

Omalizumab may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine
Your doctor will store this medication in his or her office.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking or have taken omalizumab.

Brand names

 * Xolair®