Drug Detail:Xolair (Omalizumab [ oh-ma-liz-oo-mab ])
Generic Name: OMALIZUMAB 202.5mg in 1.4mL
Dosage Form: injection, solution
Drug Class: Selective immunosuppressants
Overview of Dosage Determination
Asthma and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL) measured before the start of treatment, and by body weight (kg). For patients with both asthma and CRSwNP, dosing determination should be based on the primary diagnosis for which XOLAIR is being prescribed. Adjust doses for significant changes in body weight during treatment (see Tables 1 and 2 for treatment of asthma and Table 3 for treatment of CRSwNP).
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 (Table 1 or 2 for treatment of asthma, based on the patient's age, and Table 3 for treatment of CRSwNP).
Recommended Dosage for Asthma
The recommended dosage for treatment of asthma is XOLAIR 75 mg to 375 mg by subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL) measured before the start of treatment and by body weight (kg) [see Dosage and Administration (2.1)].
- Adult and adolescent patients 12 years of age and older: Initiate dosing according to Table 1.
- Pediatric patients 6 to <12 years of age: Initiate dosing according to Table 2.
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Recommended Dosage for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Administer XOLAIR 75 mg to 600 mg by subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL) measure before the start of treatment and by body weight (kg) [see Dosage and Administration (2.1)].
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Recommended Dosage for Chronic Spontaneous Urticaria (CSU)
Administer XOLAIR 150 mg or 300 mg by subcutaneous injection every 4 weeks. Dosing of XOLAIR in CSU patients is not dependent on serum IgE (free or total) level or body weight.
Administration Overview
Administer XOLAIR by subcutaneous injection. XOLAIR is intended for use under the guidance of a healthcare provider. Initiate therapy in a healthcare setting and once therapy has been safely established, the healthcare provider may determine whether self-administration of XOLAIR prefilled syringe by the patient or caregiver is appropriate, based on careful assessment of risk for anaphylaxis and mitigation strategies.
Selection of Patients for Self-Administration of XOLAIR Prefilled Syringe
Healthcare providers should consider known risk factors for anaphylaxis to XOLAIR [see Warnings and Precautions (5.1)] and mitigation strategies when selecting patients for self-administration. Patient-specific factors including the following criteria should be considered:
- 1)
- Patient should have no prior history of anaphylaxis, including to XOLAIR or other agents, such as foods, drugs, biologics, etc.
- 2)
- Patient should receive at least 3 doses of XOLAIR under the guidance of a healthcare provider with no hypersensitivity reactions
- 3)
- Patient or caregiver is able to recognize symptoms of anaphylaxis
- 4)
- Patient or caregiver is able to treat anaphylaxis appropriately
- 5)
- Patient or caregiver is able to perform subcutaneous injections with XOLAIR prefilled syringe with proper technique according to the prescribed dosing regimen and Instructions for Use
XOLAIR Prefilled Syringe
Instruct patients or caregivers to follow the directions provided in the "Instructions for Use" for preparation and administration of XOLAIR Prefilled Syringe [see Instructions for Use].
- Adolescents 12 years of age and older: XOLAIR prefilled syringe may be self-administered under adult supervision.
- Pediatric Patients 6 to 11 years of age: XOLAIR prefilled syringe should be administered by a caregiver.
Administration Instructions
- Visually inspect the contents of the prefilled syringe for particulate matter and discoloration prior to administration. XOLAIR prefilled syringe solution should be clear and colorless to pale brownish yellow. Do not use the prefilled syringe if the medicine is cloudy, discolored, or contains particles.
- Determine the number of Prefilled Syringes needed for patient's dosage (see Table 4).
- For patients requiring more than 1 injection to complete a full dose, administer each injection at least 1 inch apart from other injection sites.
- Administer subcutaneous injection into the thigh or abdomen, avoiding the 2-inch (5 cm) area directly around the navel. The outer area of the upper arms may be used only if the injection is being given by a caregiver or healthcare provider [see Instructions for Use]. The injection may take 5-10 seconds to administer.
| XOLAIR Dose* | 75 mg Syringes | 150 mg Syringes | Total Volume Injected |
|---|---|---|---|
|
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| 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 |
| 450 mg | 0 | 3 | 3 mL |
| 525 mg | 1 | 3 | 3.5 mL |
| 600 mg | 0 | 4 | 4 mL |
Preparation for Use and Injection of XOLAIR Lyophilized Powder
XOLAIR lyophilized powder should only be prepared and injected by a healthcare provider. 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 5).
| 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 |
| 450 mg | 3 | 3 | 3.6 mL |
| 525 mg | 4 | 4 | 4.2 mL |
| 600 mg | 4 | 4 | 4.8 mL |
- 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 syringe.
- 12)
- 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 between two or more injection sites. Choose a different injection site for each new injection at least 1 inch from the area used for other injections.
