Description
Omalizumab injection is used to treat moderate to severe persistent allergic asthma. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines. This medicine will not relieve an asthma attack that has already started. Your doctor will perform a skin or blood test to check if you have allergies to year-round allergens.
Omalizumab injection is also used to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in patients who have tried other medicines (eg, nasal corticosteroids) but they did not work well enough.
Omalizumab injection is also used to treat food allergy. It is used to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic.
Omalizumab injection is also used to treat chronic idiopathic urticaria (CIU) in patients who continue to have hives that are not controlled by an antihistamine (allergy medicine).
Omalizumab is a medicine called an IgE blocker. IgE is short for immunoglobulin E, 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 to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Solution
- Powder for Solution
Before Using
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.
Pediatric
Appropriate studies on the relationship of age to the effects of omalizumab injection to treat asthma in children younger than 6 years of age, chronic rhinosinusitis with nasal polyps in children, chronic idiopathic urticaria in children younger than 12 years of age, and food allergy in children younger than 1 year of age have not been performed. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omalizumab injection in the elderly.
Breastfeeding
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.
Drug Interactions
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.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to latex or
- Asthma attack or
- Bronchospasm (breathing problem), acute or
- Other allergic conditions (besides asthma)—Should not be used in patients with these conditions.
- Cancer, or history of or
- Parasite infection, or history of—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given as a shot under your skin, usually in the upper arms, stomach, or thighs.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
If you are receiving this medicine for asthma or nasal polyps, 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 steroid medicine (inhaled or taken by mouth) unless your doctor tells you to do so.
If you are receiving this medicine for chronic idiopathic urticaria, you will receive this medicine every 4 weeks.
Omalizumab injection may also be given at home to patients who have received at least 3 doses of this medicine under the supervision of a doctor. If you are using this medicine at home, your doctor or nurse will teach you how to inject the medicine. Be sure that you understand exactly how to use this.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into scars, moles, or skin areas that are red, bruised, tender, hard, or not intact.
This medicine comes in 2 forms: an autoinjector and a prefilled syringe. Your doctor will tell you which dosage form you should use.
Check the liquid in the autoinjector or prefilled syringe. It should be clear and colorless to pale brownish yellow. Do not use this medicine if it is cloudy, discolored, or if you see particles in it. Do not use the autoinjector or prefilled syringe if it looks damaged or has been dropped.
To use the autoinjector:
- Wash your hands with soap and water before and after using this medicine.
- Allow the autoinjector to warm to room temperature for 30 to 45 minutes before using it. Do not warm using heat sources (including warm water, microwave).
- Do not hold the autoinjector by the cap. Hold the autoinjector by the middle. Do not remove the cap until you are ready to inject.
- Hold the autoinjector with one hand and pull the cap straight off with your other hand. Do not twist the cap. Do not put the cap back on.
- Hold the autoinjector at a 90 degree angle. Place the autoinjector flat against your skin, then firmly press down. You will hear a "click" sound. Your injection begins when the first click is heard. Do not move the autoinjector.
- Keep holding the autoinjector against your skin. The green indicator will move within the viewing window. You will hear a second click. The second click tells you that the injection is almost complete. You will see the green indicator stop moving and completely fill the viewing window. If the window has not turned green, this means you may not have received the full dose.
- Remove the autoinjector by pulling it straight up from the skin. The needle guard will automatically extend and lock over the needle.
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Allow the prefilled syringe to warm to room temperature for 15 to 30 minutes before using it. Do not warm using heat sources (including warm water, microwave).
- Peel off the blister pack cover. Do not flip the blister pack upside down to take out the prefilled syringe. Hold the middle part of the prefilled syringe when taking it out. Do not touch the needle-shield wings. Do not hold the plunger or needle cap.
- Hold the prefilled syringe firmly with one hand and pull the needle cap straight off with your other hand. Do not twist the needle cap. Do not hold, push, or pull the plunger while removing the needle cap. Do not touch the needle or let it touch any surfaces. Do not recap the needle.
- Pinch the skin. Insert the needle into your skin at about a 45 to 90 degree angle. Do not touch the plunger while inserting the needle into the skin. Do not insert the needle through clothing. Do not move and avoid sudden movements when giving the injection.
- Push the plunger head all the way down until all the medicine is injected. If the plunger is not fully pressed, the needle-shield will not extend to cover the needle when it is removed.
- Release the plunger and allow the needle to be covered by the needle-shield.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (autoinjector or prefilled syringe):
- For asthma:
- Adults and children 12 years of age and older—Dose is based on IgE level and body weight, and must be determined by your doctor. The dose is usually 150 to 375 milligrams (mg) injected under your skin every 2 or 4 weeks. Your doctor may adjust your dose as needed and tolerated.
- Children 6 to younger than 12 years of age—Dose is based on IgE level and body weight, and must be determined by your doctor. The dose is usually 75 to 375 mg injected under your skin every 2 or 4 weeks. Your doctor may adjust your dose as needed and tolerated.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For chronic rhinosinusitis with nasal polyps (CRSwNP):
- Adults—Dose is based on IgE level and body weight, and must be determined by your doctor. The dose is usually 75 to 600 milligrams (mg) injected under your skin every 2 or 4 weeks. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For chronic idiopathic urticaria:
- Adults and children 12 years of age and older—150 or 300 milligrams (mg) injected under your skin every 4 weeks. The 300 mg dose may be given as one shot or as two 150 mg. Your doctor may adjust your dose as needed and tolerated.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For food allergy:
- Adults and children 1 year of age and older—Dose is based on IgE level and body weight, and must be determined by your doctor. The dose is usually 75 to 600 milligrams (mg) injected under your skin every 2 or 4 weeks. Your doctor may adjust your dose as needed and tolerated.
- Children younger than 1 year of age—Use and dose must be determined by your doctor.
- For asthma:
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Protect the medicine from direct light. Keep the medicine in the original carton until you are ready to use it. Throw away any unused medicine after 4 hours of removing from the refrigerator. Do not use if the autoinjector or prefilled syringe has been frozen.
Before giving an injection, you can remove the carton and place it back in the refrigerator if needed. The total combined time out of the refrigerator should not be more than 2 days.
Throw away the used autoinjector or prefilled syringe in a sharps disposal container or in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests and other exams may be needed to check for unwanted effects.
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, which can be life-threatening and requires immediate medical attention. Anaphylaxis may occur right away or up to 4 days after receiving this medicine. Tell your doctor right away if you or your child have a rash, cough, chest tightness, trouble breathing, lightheadedness, dizziness, fainting, rapid or weak heartbeat, anxiety, flushing, itching, hives, feeling warm, swelling of the throat or tongue, throat tightness, hoarseness, or trouble swallowing after receiving this medicine.
A rare but serious condition called eosinophilia (increased white blood cells in the body) may occur while you are receiving this medicine. A condition called vasculitis (inflammation of the blood vessels) may also be present. Eosinophilia can be serious and requires immediate medical attention. Tell your doctor right away if you or your child have worsening lung symptoms, rash or bruising of the skin, fever, chest pain, or burning, tingling, or numbness in the hands and feet after receiving this medicine.
Your doctor will ask you or your child to remain at the healthcare facility or clinic for at least 2 hours after each injection to watch for immediate side effects that can be serious.
Some patients who are receiving this medicine may have fever, rash, or muscle or joint pain. Tell your doctor right away if you or your child have any of these symptoms.
Using this medicine may increase your risk of getting certain cancers or infections. Talk to your doctor if you or your child have concerns about this risk.
The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before receiving this medicine.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Side Effects
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 or nurse immediately if any of the following side effects occur:
Less common
- Blistering, crusting, irritation, itching, or reddening of the skin
- body produces substance that can bind to drug making it less effective or cause side effects
- difficulty in moving
- muscle pain or stiffness
- pain in the joints
- stomach pain
Rare
- Chest tightness
- cough
- difficulty with swallowing
- dizziness
- fast heartbeat
- hives, itching, or skin rash
- malignant tumor
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- unusual tiredness or weakness
Incidence not known
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- chest pain
- chills
- fever
- painful or difficult urination
- pinpoint red spots on the skin
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- unusual bleeding or bruising
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, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- body aches or pain
- cold or flu-like symptoms
- congestion
- dryness or soreness of the throat
- headache
- hoarseness
- leg pain
- lumps
- pain or tenderness around the eyes and cheekbones
- stuffy or runny nose
- voice changes
Less common
- Arm pain
- cracked, dry, or scaly skin
- earache
Incidence not known
- Hair loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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