Below are the general guidelines for dosing Xolair (omalizumab). Note that these dosages may be adjusted on a case-by-case basis for individual patients. Always follow your prescribing physician’s instructions for taking Xolair.
The following information comes from DailyMed, an FDA label information provider.
What if I miss a dose of Xolair?
According to Cleveland Clinic, if you miss a dose of Xolair, contact your physician or pharmacist for further instructions.
What if I overdose on Xolair?
The maximum tolerated dose of XOLAIR has not been determined. Single intravenous doses of up to 4,000 mg have been administered to patients without evidence of dose limiting toxicities. The highest cumulative dose administered to patients was 44,000 mg over a 20-week period, which was not associated with toxicities.
Dosage and Administration
2.1 Dosage for Asthma
Administer XOLAIR 75 mg to 375 mg by subcutaneous injection every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL) measured before the start of treatment, and by body weight (kg).
Adjust doses for significant changes in body weight during treatment (see TABLES 1 and 2).
Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during XOLAIR treatment cannot be used as a guide for dose determination.
- Interruptions lasting less than one year: Dose based on serum IgE levels obtained at the initial dose determination.
- Interruptions lasting one year or more: Re-test total serum IgE levels for dose determination using TABLE 1 or 2, based on the patient’s age.
Periodically reassess the need for continued therapy based upon the patient’s disease severity and level of asthma control.
Adult and adolescent patients 12 years of age and older: Initiate dosing according to TABLE 1.
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Pediatric patients 6 to <12 years of age: Initiate dosing according to TABLE 2.
Table 2. Subcutaneous XOLAIR Doses Every 2 or 4 Weeks* for Pediatric Patients with Asthma Who Begin XOLAIR Between the Ages of 6 to <12 Years
2.2 Dosage for Chronic Idiopathic Urticaria
Administer XOLAIR 150 mg or 300 mg by subcutaneous injection every 4 weeks.
Dosing of XOLAIR in CIU patients is not dependent on serum IgE (free or total) level or body weight.
The appropriate duration of therapy for CIU has not been evaluated. Periodically reassess the need for continued therapy.
2.3 Administration
XOLAIR is available as a prefilled syringe and as a lyophilized powder in vial for reconstitution. Both XOLAIR prefilled syringe and lyophilized powder should be administered by a healthcare professional. Administer XOLAIR by subcutaneous injection. The injection may take 5-10 seconds to administer. Do not administer more than one injection per site. (TABLE 3, TABLE 4).
| XOLAIR Dose* | 75 mg Syringes | 150 mg Syringes | Total Volume Injected |
|---|---|---|---|
| 75 mg | 1 | 0 | 0.5 mL |
| 150 mg | 0 | 1 | 1 mL |
| 225 mg | 1 | 1 | 1.5 mL |
| 300 mg | 0 | 2 | 2 mL |
| 375 mg | 1 | 2 | 2.5 mL |
| *All doses in the table are approved for use in asthma patients. The 150 mg and 300 mg XOLAIR doses are also approved for use in CIU patients. |
| XOLAIR Dose* | Number of Vials | Number of Injections | Total Volume Injected |
|---|---|---|---|
| 75 mg | 1 | 1 | 0.6 mL |
| 150 mg | 1 | 1 | 1.2 mL |
| 225 mg | 2 | 2 | 1.8 mL |
| 300 mg | 2 | 2 | 2.4 mL |
| 375 mg | 3 | 3 | 3.0 mL |
| *All doses in the table are approved for use in asthma patients. The 150 mg and 300 mg XOLAIR doses are also approved for use in CIU patients. |
2.4 Preparation for Use and Injection of XOLAIR Prefilled Syringe
To prepare XOLAIR prefilled syringes for subcutaneous administration, please carefully read and adhere to these instructions for use.
XOLAIR prefilled syringes are available in 2 dose strengths. These instructions are to be used for both dose strengths. You should check the label on the carton that comes with the XOLAIR prefilled syringe to make sure that the dose is correct.
- XOLAIR 75 mg prefilled syringe with a blue needle shield
- XOLAIR 150 mg prefilled syringe with a purple needle shield
Storage Instructions
- Keep the unused syringe in the original carton and store the carton in a refrigerator at 36ËF to 46ËF (2ËC to 8ËC). Do not remove the syringe from its original carton during storage.
- Keep the XOLAIR syringe out of direct sunlight.
- Do not freeze.
- Do not use if the syringe has been frozen.
- Always keep the syringe dry.
Important Information about the Prefilled Syringe
- The removable needle cap of XOLAIR solution for injection in prefilled syringe contains a derivative of natural rubber latex [see DESCRIPTION (11)].
- Do not open the sealed outer carton until you are ready to inject XOLAIR.
- Do not take the needle cap off until you are ready to inject XOLAIR.
- Do not try to take the syringe apart at any time.
- Do not reuse the same syringe.
- Do not use if the syringe has been dropped or damaged.
- Do not use if the packaging is damaged or appears to be tampered with.
- Do not leave the syringe unattended.
- Keep the syringe out of the reach of children.
Preparing for the Injection
| 1Find a clean, flat, working surface.Each XOLAIR carton contains 1 syringe.Take the carton containing the syringe out of the refrigerator. | |
| 2Check the expiration date on the XOLAIR carton.Do not use it if the expiration date has passed because it may not be safe to use. If the expiration date has passed, safely dispose of the syringe in a sharps container (see STEP 14 at the end of these instructions for use). |  |
| 3Place the carton on a clean flat, surface.Set aside the carton for at least 15-30 minutes so the syringe can warm up on its own to room temperature (leave the syringe in the carton to protect it from light).If the syringe does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to push the plunger.Do not allow the syringe to become hot.Do not speed up the warming process in any way, and do not put the syringe in a microwave or in warm water. | |
| 4Open the carton.Wash your hands with soap and water.Take the blister pack out of the carton.Check the expiration date on blister pack.Do not use it if the expiration date has passed because it may not be safe to use. If the expiration date has passed, safely dispose of the syringe in a sharps container (see STEP 14 at the end of these instructions for use).Be careful when taking out the syringe. Do not flip the blister pack upside down to take out the syringe, and do not touch the back of the syringe. This may damage the syringe.Peel off the blister pack cover. Take the syringe out of the blister pack by holding the middle part of the syringe. When holding the syringe, make sure you always hold the syringe as shown.Do not handle the syringe by holding the plunger or needle cap. |   |
| 5Inspect the syringe closely.Check the syringe. The liquid in the syringe should be clear to slightly opalescent and colorless to pale brownish-yellow. Do not use the syringe if the liquid is cloudy, discolored, or contains foreign particles.Check the expiration date on the syringe. Do not use the syringe if the expiration date has passed because it may not be safe to use.If the medicine does not look as described or if the expiration date has passed, safely dispose of the syringe in a sharps container (see STEP 14 at the end of these instructions for use). |  |
| 6Choose an injection site.The recommended injection sites are the upper arm and the front and middle of the thighs.Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin.Choose a different injection site for each new injection at least 1 inch from the area used for the last injection. |  |
| 7Wipe the injection site with an alcohol pad in a circular motion and let it air dry for 10 seconds.Do not touch the injection site again before giving the injection.Do not fan or blow on the cleaned area. |  |
| Administering the Injection | |
| 8Hold the syringe firmly with 1 hand and pull the needle cap straight off with your other hand.Do not hold the plunger while you remove the needle cap.Do not touch the needle after removing the needle cap.Throw away the needle cap in a sharps container right away.There may be a small air bubble in the syringe. This is normal and you should not try to remove the air bubble.You may also see a drop of liquid at the end of the needle. This is also normal and will not affect the dose. |  |
| 9Use your other hand and gently pinch the area of skin that was cleaned. Hold the pinched skin tight.Pinching the skin is important to make sure that you inject under the skin (into the fatty area) but not any deeper (into muscle). | |
| 10Continue holding the syringe by the center and use a quick, dart-like motion to insert the needle all the way into the pinched skin at an angle between 45° to 90°. It is important to use the correct angle to make sure the medicine is delivered under the skin (into the fatty area), or the injection could be uncomfortable and the medicine may not work.Do not touch the plunger while inserting the needle into the skin.Do not insert the needle through clothing. Once the needle is inserted, hold the syringe tightly in place and do not change the angle of injection or insert the needle again. The patient should not move and should avoid sudden movements throughout the injection. |  |
| 11Slowly inject all of the medicine by gently pushing the plunger all the way down.You must press the plunger all the way down to make sure that the full dose of medicine gets injected. If the plunger is not fully pressed, the needle shield will not extend to cover the needle when it is removed. |  |
| 12Gently release the plunger and allow the needle to be covered by the needle-shield.If the needle is not covered, proceed carefully to dispose of the syringe (see STEP 14 at the end of these instructions for use). |  |
| After the Injection13There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site.Do not rub the injection site.If needed, you may cover the injection site with a small bandage.In case of skin contact with medicine, wash the area that touched the medicine with water. | |
| 14The XOLAIR prefilled syringe is a single-dose syringe and should not be used again.Put the used XOLAIR prefilled syringe in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the prefilled syringe in the trash.Do not put the needle cap back on the needle. |  |
2.5 Preparation for Use and Injection of XOLAIR Lyophilized Powder
The supplied XOLAIR lyophilized powder must be reconstituted with Sterile Water for Injection (SWFI) USP, using the following instructions:1)Before reconstitution, determine the number of vials that will need to be reconstituted (each vial delivers 150 mg of XOLAIR in 1.2 mL) (see TABLE 4).2)Draw 1.4 mL of SWFI, USP, into a 3 mL syringe equipped with a 1-inch, 18-gauge needle.3)Place the vial upright on a flat surface and using standard aseptic technique, insert the needle and inject the SWFI, USP, directly onto the product.4)Keeping the vial upright, gently swirl the upright vial for approximately 1 minute to evenly wet the powder. Do not shake.5)Gently swirl the vial for 5 to 10 seconds approximately every 5 minutes in order to dissolve any remaining solids. The lyophilized product takes 15 to 20 minutes to dissolve. If it takes longer than 20 minutes to dissolve completely, gently swirl the vial for 5 to 10 seconds approximately every 5 minutes until there are no visible gel-like particles in the solution. Do not use if the contents of the vial do not dissolve completely by 40 minutes.6)After reconstitution, XOLAIR solution is somewhat viscous and will appear clear or slightly opalescent. It is acceptable if there are a few small bubbles or foam around the edge of the vial; there should be no visible gel-like particles in the reconstituted solution. Do not use if foreign particles are present.7)Invert the vial for 15 seconds in order to allow the solution to drain toward the stopper.8)Use the XOLAIR solution within 8 hours following reconstitution when stored in the vial at 2ºC to 8ºC (36ºF to 46ºF), or within 4 hours of reconstitution when stored at room temperature. Reconstituted XOLAIR vials should be protected from sunlight.9)Using a new 3 mL syringe equipped with a 1-inch, 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. The reconstituted product is somewhat viscous. Withdraw all of the product from the vial before expelling any air or excess solution from 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.10)Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.11)Expel air, large bubbles, and any excess solution in order to obtain a volume of 1.2 mL corresponding to a dose of 150 mg of XOLAIR. To obtain a volume of 0.6 mL corresponding to a dose of 75 mg of XOLAIR, expel air, large bubbles and discard 0.6 mL from the syringe. A thin layer of small bubbles may remain at the top of the solution in the syringe12)Administer XOLAIR by subcutaneous injection. The injection may take 5-10 seconds to administer because the solution is slightly viscous. Do not administer more than 150 mg (contents of one vial) per injection site. Divide doses of more than 150 mg among two or more injection sites.
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