1.1 Asthma

XOLAIR is indicated for patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

XOLAIR has been shown to decrease the incidence of asthma exacerbations in these patients.

1.2 Chronic Idiopathic Urticaria (CIU)

XOLAIR is indicated for the treatment of adults and adolescents 12 years of age and older with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment.

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.

Table 1. Subcutaneous XOLAIR Doses Every 2 or 4 Weeks* for Patients 12 Years of Age and Older with Asthma

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).

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
  

Preparing for the Injection

1 Find a clean, flat, working surface. Each XOLAIR carton contains 1 syringe. Take the carton containing the syringe out of the refrigerator.
2 Check 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).
3 Place 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.
4 Open 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.
5 Inspect 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).
6 Choose 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.
7 Wipe 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
8 Hold 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.
9 Use 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).
10 Continue 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.
11 Slowly 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.
12 Gently 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 Injection 13 There 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.
14 The 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 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 among two or more injection sites.

5.1 Anaphylaxis

Anaphylaxis has been reported to occur after administration of XOLAIR in premarketing clinical trials and in postmarketing spontaneous reports [see Boxed Warning and Adverse Reactions (6.3)]. Signs and symptoms in these reported cases have included bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue. Some of these events have been life-threatening. In premarketing clinical trials in patients with asthma, anaphylaxis was reported in 3 of 3507 (0.1%) patients. Anaphylaxis occurred with the first dose of XOLAIR in two patients and with the fourth dose in one patient. The time to onset of anaphylaxis was 90 minutes after administration in two patients and 2 hours after administration in one patient.

A case-control study showed that, among XOLAIR users, patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis associated with XOLAIR, compared to those with no prior history of anaphylaxis [see Adverse Reactions (6.1)].

In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to XOLAIR use was estimated to be at least 0.2% of patients based on an estimated exposure of about 57,300 patients from June 2003 through December 2006. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond one year after beginning regularly scheduled treatment.

Administer XOLAIR only in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening. Observe patients closely for an appropriate period of time after administration of XOLAIR, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports [see Adverse Reactions (6)]. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs or symptoms occur.

Discontinue XOLAIR in patients who experience a severe hypersensitivity reaction [see Contraindications (4)].

5.2 Malignancy

Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR-treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of adults and adolescents ≥12 years of age with asthma and other allergic disorders. The observed malignancies in XOLAIR-treated patients were a variety of types, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and five other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to XOLAIR or use in patients at higher risk for malignancy (e.g., elderly, current smokers) is not known.

In a subsequent observational study of 5007 XOLAIR-treated and 2829 non-XOLAIR-treated adolescent and adult patients with moderate to severe persistent asthma and a positive skin test reaction or in vitro reactivity to a perennial aeroallergen, patients were followed for up to 5 years. In this study, the incidence rates of primary malignancies (per 1000 patient years) were similar among XOLAIR-treated (12.3) and non-XOLAIR-treated patients (13.0) [see Adverse Reactions (6)]. However, study limitations preclude definitively ruling out a malignancy risk with XOLAIR. Study limitations include: the observational study design, the bias introduced by allowing enrollment of patients previously exposed to XOLAIR (88%), enrollment of patients (56%) while a history of cancer or a premalignant condition were study exclusion criteria, and the high study discontinuation rate (44%).

5.3 Acute Asthma Symptoms

XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus.

5.4 Corticosteroid Reduction

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of XOLAIR therapy for asthma. Decrease corticosteroids gradually under the direct supervision of a physician. In CIU patients, the use of XOLAIR in combination with corticosteroids has not been evaluated.

5.5 Eosinophilic Conditions

In rare cases, patients with asthma on therapy with XOLAIR may present with serious systemic eosinophilia sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between XOLAIR and these underlying conditions has not been established.

5.6 Fever, Arthralgia, and Rash

In post-approval use, some patients have experienced a constellation of signs and symptoms including arthritis/arthralgia, rash, fever and lymphadenopathy with an onset 1 to 5 days after the first or subsequent injections of XOLAIR. These signs and symptoms have recurred after additional doses in some patients. Although circulating immune complexes or a skin biopsy consistent with a Type III reaction were not seen with these cases, these signs and symptoms are similar to those seen in patients with serum sickness. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms [see Adverse Reactions (6.3)].

5.7 Parasitic (Helminth) Infection

Monitor patients at high risk of geohelminth infection while on XOLAIR therapy. Insufficient data are available to determine the length of monitoring required for geohelminth infections after stopping XOLAIR treatment.

In a one-year clinical trial conducted in Brazil in adult and adolescent patients at high risk for geohelminthic infections (roundworm, hookworm, whipworm, threadworm), 53% (36/68) of XOLAIR-treated patients experienced an infection, as diagnosed by standard stool examination, compared to 42% (29/69) of placebo controls. The point estimate of the odds ratio for infection was 1.96, with a 95% confidence interval (0.88, 4.36) indicating that in this study a patient who had an infection was anywhere from 0.88 to 4.36 times as likely to have received XOLAIR than a patient who did not have an infection. Response to appropriate anti-geohelminth treatment of infection as measured by stool egg counts was not different between treatment groups.

5.8 Laboratory Tests

Serum total IgE levels increase following administration of XOLAIR due to formation of XOLAIR:IgE complexes [see Clinical Pharmacology (12.2)]. Elevated serum total IgE levels may persist for up to 1 year following discontinuation of XOLAIR. Do not use serum total IgE levels obtained less than 1 year following discontinuation to reassess the dosing regimen for asthma patients, because these levels may not reflect steady state free IgE levels [see Dosage and Administration (2.1)].

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

6.2 Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to omalizumab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading

Antibodies to XOLAIR were detected in approximately 1/1723 (<0.1%) of patients treated with XOLAIR in the clinical studies evaluated for approval of asthma in patients 12 years of age and older. In three pediatric studies, antibodies to XOLAIR were detected in one patient out of 581 patients 6 to <12 years of age treated with XOLAIR and evaluated for antibodies. There were no detectable antibodies in the patients treated in the phase 3 CIU clinical trials, but due to levels of XOLAIR at the time of anti-therapeutic antibody sampling and missing samples for some patients, antibodies to XOLAIR could only have been determined in 88% of the 733 patients treated in these clinical studies. The data reflect the percentage of patients whose test results were considered positive for antibodies to XOLAIR in ELISA assays and are highly dependent on the sensitivity and specificity of the assays.

6.3 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of XOLAIR in adult and adolescent patients 12 years of age and older. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Anaphylaxis: Based on spontaneous reports and an estimated exposure of about 57,300 patients from June 2003 through December 2006, the frequency of anaphylaxis attributed to XOLAIR use was estimated to be at least 0.2% of patients. Diagnostic criteria of anaphylaxis were skin or mucosal tissue involvement, and, either airway compromise, and/or reduced blood pressure with or without associated symptoms, and a temporal relationship to XOLAIR administration with no other identifiable cause. Signs and symptoms in these reported cases included bronchospasm, hypotension, syncope, urticaria, angioedema of the throat or tongue, dyspnea, cough, chest tightness, and/or cutaneous angioedema. Pulmonary involvement was reported in 89% of the cases. Hypotension or syncope was reported in 14% of cases. Fifteen percent of the reported cases resulted in hospitalization. A previous history of anaphylaxis unrelated to XOLAIR was reported in 24% of the cases.

Of the reported cases of anaphylaxis attributed to XOLAIR, 39% occurred with the first dose, 19% occurred with the second dose, 10% occurred with the third dose, and the rest after subsequent doses. One case occurred after 39 doses (after 19 months of continuous therapy, anaphylaxis occurred when treatment was restarted following a 3-month gap). The time to onset of anaphylaxis in these cases was up to 30 minutes in 35%, greater than 30 and up to 60 minutes in 16%, greater than 60 and up to 90 minutes in 2%, greater than 90 and up to 120 minutes in 6%, greater than 2 hours and up to 6 hours in 5%, greater than 6 hours and up to 12 hours in 14%, greater than 12 hours and up to 24 hours in 8%, and greater than 24 hours and up to 4 days in 5%. In 9% of cases the times to onset were unknown.

Twenty-three patients who experienced anaphylaxis were rechallenged with XOLAIR and 18 patients had a recurrence of similar symptoms of anaphylaxis. In addition, anaphylaxis occurred upon rechallenge with XOLAIR in 4 patients who previously experienced urticaria only.

Eosinophilic Conditions: Eosinophilic conditions have been reported [see Warnings and Precautions (5.5)].

Fever, Arthralgia, and Rash: A constellation of signs and symptoms including arthritis/arthralgia, rash (urticaria or other forms), fever and lymphadenopathy similar to serum sickness have been reported in post-approval use of XOLAIR [see Warnings and Precautions (5.6)].

Hematologic: Severe thrombocytopenia has been reported.

Skin: Hair loss has been reported.

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

In clinical studies 134 asthma patients and 37 CIU phase 3 study patients 65 years of age or older were treated with XOLAIR. Although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.

Prefilled Syringe

XOLAIR (omalizumab) injection is supplied as a sterile, preservative-free, clear to slightly opalescent and colorless to pale brownish-yellow solution for subcutaneous injection. XOLAIR (omalizumab) injection is available as a single-dose prefilled syringe.

Each 75 mg prefilled syringe delivers 75 mg omalizumab in 0.5 mL and contains L-arginine hydrochloride (21.05 mg), L-histidine (0.68 mg), L-histidine hydrochloride monohydrate (1.17 mg), and polysorbate 20 (0.2 mg) in Sterile Water for Injection (SWFI), USP.

Each 150 mg prefilled syringe delivers 150 mg omalizumab in 1 mL and contains L-arginine hydrochloride (42.1 mg), L-histidine (1.37 mg), L-histidine hydrochloride monohydrate (2.34 mg), and polysorbate 20 (0.4 mg) in SWFI, USP.

The needle cap contains a derivative of natural rubber latex which may cause allergic reactions in latex sensitive individuals.

Vial

XOLAIR (omalizumab) for injection is a sterile, white, preservative free, lyophilized powder in a single-dose vial. After reconstitution with 1.4 mL of Sterile Water for Injection, USP, the vial contains 150 mg of omalizumab per 1.2 mL of reconstituted solution for subcutaneous injection. Each 1.2 mL of reconstituted solution also contains L-histidine (1.3 mg), L-histidine hydrochloride monohydrate (2.1 mg), polysorbate 20 (0.4 mg) and sucrose (108 mg).

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

After SC administration, omalizumab was absorbed with an average absolute bioavailability of 62%. Following a single SC dose in adult and adolescent patients with asthma, omalizumab was absorbed slowly, reaching peak serum concentrations after an average of 7–8 days. In patients with CIU, the peak serum concentration was reached at a similar time after a single SC dose. The pharmacokinetics of omalizumab was linear at doses greater than 0.5 mg/kg. In patients with asthma, following multiple doses of XOLAIR, areas under the serum concentration-time curve from Day 0 to Day 14 at steady state were up to 6-fold of those after the first dose. In patients with CIU, omalizumab exhibited linear pharmacokinetics across the dose range of 75 mg to 600 mg given as single subcutaneous dose. Following repeat dosing from 75 to 300 mg every 4 weeks, trough serum concentrations of omalizumab increased proportionally with the dose levels.

In vitro, omalizumab formed complexes of limited size with IgE. Precipitating complexes and complexes larger than 1 million daltons in molecular weight were not observed in vitro or in vivo. Tissue distribution studies in Cynomolgus monkeys showed no specific uptake of 125I-omalizumab by any organ or tissue. The apparent volume of distribution of omalizumab in patients with asthma following SC administration was 78 ± 32 mL/kg. In patients with CIU, based on population pharmacokinetics, distribution of omalizumab was similar to that in patients with asthma.

Clearance of omalizumab involved IgG clearance processes as well as clearance via specific binding and complex formation with its target ligand, IgE. Liver elimination of IgG included degradation in the liver reticuloendothelial system (RES) and endothelial cells. Intact IgG was also excreted in bile. In studies with mice and monkeys, omalizumab:IgE complexes were eliminated by interactions with Fcγ receptors within the RES at rates that were generally faster than IgG clearance. In asthma patients omalizumab serum elimination half-life averaged 26 days, with apparent clearance averaging 2.4 ± 1.1 mL/kg/day. Doubling body weight approximately doubled apparent clearance. In CIU patients, at steady state, based on population pharmacokinetics, omalizumab serum elimination half-life averaged 24 days and apparent clearance averaged 240 mL/day (corresponding to 3.0 mL/kg/day for an 80 kg patient).

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies have been performed in animals to evaluate the carcinogenic potential of XOLAIR.

There were no effects on fertility and reproductive performance in male and female Cynomolgus monkeys that received XOLAIR at subcutaneous doses up to 75 mg/kg/week (approximately 10 times the maximum recommended human dose on a mg/kg basis).

14.1 Asthma

14.2 Chronic Idiopathic Urticaria

Prefilled Syringe

XOLAIR (omalizumab) injection is a clear to slightly opalescent and colorless to pale brownish-yellow solution in a single-dose prefilled glass syringe with a 26 gauge staked needle, rigid needle cap, and needle shield. Each carton contains one prefilled syringe.

Each XOLAIR 75 mg carton contains one single-dose 75 mg prefilled syringe with a blue needle shield (NDC 50242-214-01).

Each XOLAIR 150 mg carton contains one single-dose 150 mg prefilled syringe with a purple needle shield (NDC 50242-215-01).

Vial

XOLAIR is supplied as a lyophilized, white, sterile powder in a single-dose vial without preservatives. Each carton contains one 150 mg single-dose vial of XOLAIR® (omalizumab) for injection NDC 50242-040-62.

Information for Patients

Provide and instruct patients to read the accompanying Medication Guide before starting treatment and before each subsequent treatment. The complete text of the Medication Guide is reprinted at the end of this document.

Inform patients of the risk of life-threatening anaphylaxis with XOLAIR including the following points [see Boxed Warning and Warnings and Precautions (5.1)]:

• There have been reports of anaphylaxis occurring up to 4 days after administration of XOLAIR
• XOLAIR should only be administered in a healthcare setting by healthcare providers
• Patients should be closely observed following administration
• Patients should be informed of the signs and symptoms of anaphylaxis
• Patients should be instructed to seek immediate medical care should such signs or symptoms occur

Instruct patients receiving XOLAIR not to decrease the dose of, or stop taking any other asthma or CIU medications unless otherwise instructed by their physician. Inform patients that they may not see immediate improvement in their asthma or CIU symptoms after beginning XOLAIR therapy.

Inform patients the needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex