الأدوية والمكملات الغذائية

Proper Use

Drug information provided by: Merative, Micromedex®

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.

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.