OMALIZUMAB (Systemic)?
Some commonly used brand names are:
In the U.S.?
? Not commercially available in Canada.
Category
- Antiasthmatic
- Monoclonal antibody
Description
Omalizumab ((oh-mah-lye-ZOO-mab)) is used to treat moderate to severe persistentallergic 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 asthmasymptoms even though they are taking inhaled steroids, omalizumab helps toreduce the number of asthma attacks.
Omalizumab is a medicine called an IgE blocker. IgE is short for immunoglobulinE. IgE is a substance that occurs naturally in the body in small amounts. This substance plays an important role in allergic asthma. When people withallergic 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 bodythat can lead to asthma attacks and symptoms. Omalizumab works by helpingto block IgE.
This medicine is available only with your doctor's prescription, in thefollowing dosage forms:
Parenteral- Injection (U.S.)
Before Using This Medicine
In deciding to use a medicine,the risks of taking using the medicine must be weighed against the good itwill do. This is a decision you and your doctor will make. For omalizumab,the following should be considered:
Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to omalizumab. Also tell your doctor and pharmacist ifyou are allergic to any other substances, such as foods, preservatives, ordyes.
Pregnancy?Omalizumab has not been studied in pregnant women.However, omalizumab has not been shown to cause birth defects or other problemsin animal studies.
Breast-feeding?It is not known whether omalizumab passes intobreast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast feeding. Mothers who are usingthis medicine and wish to breast feed should discuss this with their doctor.
Children?Although there is no specific information comparingthe use of omalizumab in children with other age groups, this medicine isnot expected to cause different side effects or problems in children thanit does in older adults. This medicine can be used in children 12 years ofage and older.
Older adults?Many medicines have not been specifically studiedin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing theuse of omalizumab in the elderly with use in other age groups.
Other medicines?Omalizumab is approved for use in patients who are alreadytaking inhaled steroids. As with all medicines, be sure to tell your doctorabout any medicines you are taking for your asthma or any other condition.This includes prescription and nonprescription medicines, vitamins, and herbalsupplements.
Proper Use of This Medicine
Dosing?The dose of omalizumab will be different for different patients. The following information includes only the average doses of omalizumab.
You will receive omalizumab once every 2 or 4 weeks. Your dose will bedetermined by your IgE level, which your doctor will measure with a simpleblood 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 perdose. If you need more than 1 injection, each will be given in a differentplace on your body.
Omalizumab is not a rescue medication and should not be used to treat suddenasthma 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 orany other asthma medicine you are taking unless your doctor tells you to doso.
- For parenteral dosage form (injection):
- For allergic asthma:
- Adults?150 to 375 milligrams (mg) is administered by a shot(injection) under the skin every 2 or 4 weeks
- Children?Use and dose for children under 12 years of age mustbe determined by your doctor.
Precautions While Using This Medicine
If youstop receiving omalizumab injections, your symptoms can be expected to return.
You may not see immediate improvement in your asthma after omalizumab treatmentbegins. It takes time for the medicine to work. So if you don't feel a differenceright away, it doesn't mean omalizumab is not working. It is important tocontinue your omalizumab injections until your doctor tells you otherwise.
It is important to know the signs of an allergic reaction to this medicineand to know what to do. Get medical help immediately if you have any symptomssuch as rash, itching, and swelling of the tongue and throat.
Your doctor will ask you to remain at the healthcare facility or clinicfor a period of time after each injection to watch for immediate side effectsthat can be serious.
Side Effects of This Medicine
Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.
Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome.
More Common
Bleeding; blistering; body aches or pain; burning; chills; cold or flu-like symptoms; coldness; congestion; discolorationof 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 ortenderness 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 skim; body produces substancethat can bind to drug making it less effective or cause side effects; cracked, dry, scaly skin; earache; itching skin
Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.
Developed: 04/07/2004
