Xolair Caution For Usage

Incompatibilities: Powder and solvent for solution for injection: Xolair should not be mixed with any medication or diluents other than sterile water for injection.
Solution for injection in pre-filled syringe: This medicinal product must not be mixed with other medicinal products.
Instructions for Use and Handling: Xolair powder and solvent for solution for injection: The following information is intended for medical or healthcare professionals only.
Xolair 150 mg powder for solution for injection are supplied in a single-use vial and contain no antibacterial preservatives. Chemical and physical stability of the reconstituted product has been demonstrated for 8 hours at 2°C to 8°C and for 4 hours at 30°C. From a microbiological point of view, the product should be used immediately after reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should normally not be longer than 8 hours at 2°C to 8°C or 2 hours at 25°C.
The lyophilized product takes 15 to 20 minutes to dissolve, although in some cases it may take longer. The fully reconstituted product will appear clear to slightly opalescent, colorless to pale brownish-yellow and may have a few small bubbles or foam around the edge of the vial. Because the reconstituted product is somewhat viscous, care must be taken to WITHDRAW ALL OF THE PRODUCT from the vial before expelling any air or excess solution from the syringe in order to obtain the full 1.2 mL dose.
To prepare Xolair for subcutaneous administration, adhere to the following instructions: For Xolair 150 mg vials: 1. Draw 1.4 mL of water for injection from the ampoule into a syringe equipped with a large-bore 18-gauge needle.
2. With the vial placed upright on a flat surface, insert the needle and transfer the water for injections into the omalizumab vial using standard aseptic techniques, directing the water for injections directly onto the powder.
3. Keeping the vial in an upright position, vigorously swirl the upright vial (do not shake) for approximately 1 minute to evenly wet the powder.
4. To aid in dissolution after completing step 3, gently swirl the upright vial for 5 to 10 seconds approximately every 5 minutes in order to dissolve any remaining solids.
Note that in some cases it may take longer than 20 minutes for the powder to dissolve completely. If this is the case, repeat step 4 until there are no visible gel-like particles in the solution.
When the product is fully dissolved, there should be no visible gel-like particles in the solution. It is acceptable to have small bubbles or foam around the edge of the vial. The reconstituted product will appear clear or slightly opaque. Do not use if foreign particles are present.
5. Invert the vial for 15 seconds in order to allow the solution to drain towards the stopper. Using a new 3-cc syringe equipped with a large-bore, 18-gauge needle, insert the needle into the inverted vial. Position the needle tip at the very bottom of the solution in the vial stopper when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
6. Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
7. Expel air, large bubbles, and any excess solution in order to obtain the required 1.2 mL dose. A thin layer of small bubbles may remain at the top of the solution in the syringe. Because the solution is slightly viscous, the injection may take 5 to 10 seconds to administer. The vial delivers 1.2 mL (150 mg) of Xolair.
8. The injections are administered subcutaneously in the arm, thigh, or lower abdomen (but not the area of 5 centimeters around the navel). Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks. If the patient needs to give more than one injection for the full dose, choose a different injection site each time the patient injects.
Special precautions for disposal - Xolair powder and solvent for solution for injection: Any unused product or waste material should be disposed of in accordance with local requirements.
Instructions for Use and Handling: Xolair solution for injection in pre-filled syringe (pre-filled syringe with 26-gauge staked needle): Read all the way through these instructions before injecting. If the doctor decides that the patient or a caregiver may be able to give the injections of Xolair at home, the patient needs to be trained by the doctor, nurse or pharmacist before injecting themselves or others. Children (6 to less than 12 years of age) are not expected to inject Xolair themselves, however, if deemed appropriate by their doctor, a caregiver may give them their Xolair injection after proper training. The box contains Xolair pre-filled syringe(s) individually sealed in a plastic tray.
Xolair pre-filled syringe is available in 150 mg strength. The patient may receive this strength from the pharmacy.
Xolair 150 mg pre-filled syringe: After the medicine has been injected the syringe guard will be activated to cover the needle. This is intended to protect against accidental needle stick injuries.
Other items needed for injection: Alcohol swab, Cotton ball or gauze, Sharps disposal container.
Important safety information: Caution: Keep the syringe out of the sight and reach of children.
The needle cap of the syringe may contain dry rubber (latex), which should not be handled by anyone who is sensitive to this substance.
Do not open the sealed outer box until the medicine is ready to be used.
Do not use this medicine if either the seal on the outer box or the seal of the plastic tray is broken, as it may not be safe for you to use.
Do not use if the syringe has been dropped onto a hard surface or dropped after removing the needle cap.
Never leave the syringe where others might tamper with it.
Do not shake the syringe.
Be careful not to touch the syringe guard wings before use. If the wings are touched, the syringe guard may be activated too early.
Do not remove the needle cap until just before you give the injection.
The syringe cannot be re-used. Dispose of the used syringe immediately after use in a sharps container.
Storage of the Xolair pre-filled syringe: Store this medicine sealed in its outer box to protect it from light. Store in the refrigerator between 2°C and 8°C. DO NOT FREEZE.
Remember to take the syringe out of the refrigerator and allow it to reach room temperature (25°C) before preparing it for injection (about 30 minutes). Leave the syringe in the box to protect it from light. If necessary, the product may be returned to the refrigerator for later use. The total time that the syringe is kept at room temperature (25°C) before use must not exceed 48 hours.
Do not use the syringe after the expiry date which is stated on the outer box and syringe label. If it has expired, return the entire pack to the pharmacy.
The injection site: The injection site is the place on the body where the patient is going to use the syringe.
The recommended site is the front of the thighs. The patient may also use the lower abdomen, but not the area 5 centimeters around the navel (belly button).
If the patient needs to give more than one injection for the full dose, choose a different injection site each time the patient injects.
Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks.
If a caregiver is giving the injection, the outer upper arms may also be used.
Preparing the Xolair pre-filled syringe for use: Note: Depending on the dose prescribed by the doctor, the patient may need to prepare one or more pre-filled syringes, and inject the contents of them all. The following table gives examples of how many injections of each dose strength the patient needs for a given dose: See Table 13.

Click on icon to see table/diagram/image

1. Take the box containing the syringe out of the refrigerator and leave it unopened for about 30 minutes so that it reaches room temperature (leave the syringe in the box to protect it from light).
2. When the syringe is ready to be used, wash hands thoroughly with soap and water.
3. Clean the injection site with an alcohol swab.
4. Remove the plastic tray from the box and peel back the paper cover. Gripping the middle of the syringe guard, lift the syringe out of the tray.
5. Inspect the syringe. The liquid should be clear to slightly cloudy. Its color may vary from colorless to pale brownish-yellow. The patient may see an air bubble, which is normal. DO NOT USE if the syringe is broken or if the liquid looks distinctly cloudy or distinctly brown or contains particles. In all these cases, return the entire pack to the pharmacy.
6. Holding the syringe horizontally, look into the viewing window to check the expiry date printed on the label. Note: It is possible to rotate the inner part of the syringe assembly so that the label can be read in the viewing window. DO NOT USE if the product has expired. If expired, return the entire pack to the pharmacy.
How to use the Xolair pre-filled syringe: 1. Carefully remove the needle cap from the syringe. Discard the needle cap. The patient may see a drop of liquid at the end of the needle. This is normal.
2. Gently pinch the skin at the injection site and insert the needle. Push the needle all the way in to ensure that the medicine can be fully administered.
3. Hold the syringe. Slowly depress the plunger as far as it will go so that the plunger head is completely between the syringe guard wings.
4. Keep the plunger fully depressed while carefully lifting the needle straight out from the injection site.
5. Slowly release the plunger and allow the syringe guard to automatically cover the exposed needle.
There may be a small amount of blood at the injection site. Press the cotton ball or gauze over the injection site and hold it for 30 seconds. Do not rub the injection site. May cover the injection site with a small adhesive bandage, if needed.
Disposal instructions: Dispose of the used syringe immediately in a sharps container (closable, puncture resistant container). For the safety and health of the patient and others, needles and used syringes must never be re-used. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Do not throw away any medicines via wastewater or household waste. Ask a pharmacist how to throw away medicines that are no longer used. These measures will help protect the environment.
Special precautions for disposal - Xolair solution for injection in pre-filled syringe: Any unused product or waste material should be disposed of in accordance with local requirements.