Xolair

Immunoglobulin E (IgE) Inhibitors
Immunotherapies for Reactive and Obstructive Airway Diseases

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Omalizumab is administered by subcutaneous injection only.

A health care professional should initiate omalizumab treatment in a health care setting that is equipped and prepared to identify and treat anaphylaxis until therapy has been safely established. Selection of patients for self-administration should be based on careful assessment of risk for anaphylaxis and mitigation strategies. The following patient specific criteria should be considered:[44070] [65315]
No prior history of anaphylaxis, including omalizumab or other agents, such as foods, drugs, biologics, etc.
Receipt of at least 3 doses of omalizumab under the supervision of a health care provider with no hypersensitivity reactions
Patient or caregiver is able to recognize symptoms of a severe hypersensitivity reaction (including anaphylaxis) and treat it appropriately
Patient or caregiver is able to perform subcutaneous injections with the omalizumab prefilled syringe with proper technique
Patients 12 years of age and older may self-administer under adult supervision
Observe the patient for an appropriate time after each injection (e.g., up to 120 minutes).
Instruct the patient to get immediate medical care if signs or symptoms of anaphylaxis or angioedema develop.[44070]
 
Prefilled Syringe Administration
Available for use in a prefilled syringe. Omalizumab prefilled syringes are available in 2 dose strengths:
Omalizumab 75 mg prefilled syringe comes with a blue needle shield.
Omalizumab 150 mg prefilled syringe with a purple needle shield.
The prefilled syringe solution should be clear and colorless to pale brownish yellow.
At least 15 to 30 minutes prior to injection, allow the carton containing the syringe to warm up to room temperature. Keep in the carton to protect it from light. Do not allow the syringe to become hot. Do not speed up the warming process by putting the syringe in the microwave or in warm water.
Do not open the sealed outer carton until ready to inject. Peel off the blister pack cover. Take the syringe out of the blister pack by holding the middle part of the syringe; do not handle by the needle cap or plunger. Do not take the syringe apart at any time.
Inspect the syringe closely. The liquid in the syringe should be clear to slightly opalescent and colorless to pale brownish-yellow. Do not use the syringe if the syringe is damaged or expired, or if the liquid is cloudy, discolored, or contains foreign particles.
Choose an injection site.
The recommended injection sites are the thigh or abdomen, avoiding the 2-inch area directly around the navel. The outer area of the upper arm may be used only if the injection is given by a caregiver or health care provider.
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.
Each subcutaneous injection should not exceed 150 mg per site; doses of more than 150 mg should be divided among 2 or more injection sites.
Wipe the injection site with an alcohol pad in a circular motion and let it air dry for 10 seconds.
Hold the syringe firmly with 1 hand and pull the needle cap straight off with your other hand. There may be a small air bubble in the syringe. This is normal; do 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.
Use your other hand and gently pinch the area of skin that was cleaned. Use a quick, dart-like motion to insert the needle all the way into the pinched skin at an angle between 45 degrees to 90 degrees. Do not insert the needle through clothing.
Once the needle is inserted, slowly inject all the medicine by gently pushing the plunger all the way down to ensure that the full dose gets injected. It may take 5 to 10 seconds to inject the dose, due to the somewhat viscous nature of the solution.
Gently release the plunger and allow the needle to be covered by the needle-shield.
Do not rub the injection site; may cover with a small bandage if needed.
Disposal: The prefilled syringe is a single-dose syringe and should not be used again. Dispose in an FDA-cleared sharps disposal container right away after use.[44070]
 
Reconstitution of Lyophilized powder vial
Determine the number of vials that will be needed for the patient's dose.
Reconstitute each 150-mg vial by injecting 1.4 mL of Sterile Water for Injection into the vial of omalizumab; reconstitution with 0.9% Sodium Chloride injection is NOT recommended due to noted incompatibility.[63020]
Keeping the vial upright, gently swirl for approximately 1 minute to evenly wet the powder. Do NOT shake.
Allow the vial to stand, and gently swirl the vial for 5 to 10 seconds approximately every 5 minutes to dissolve any remaining solids. Some vials may take longer than 20 minutes to dissolve completely. Do not use if the contents of the vial do not completely dissolve in 40 minutes.
The reconstituted solution should be clear or slightly opalescent and may have a few small bubbles or foam around the edge of the vial; there should be no visible gel-like or foreign particles in the solution.
The concentration of the reconstituted solution is 150 mg/1.2 mL (i.e., 125 mg/mL).
Storage: The reconstituted solution in the vial should be used within 8 hours of reconstitution when stored in the refrigerator (2 to 8 degrees C or 36 to 46 degrees F) or within 4 hours when stored at room temperature. Protect from direct sunlight.[44070]
 Preparing the dose from the vial
Invert the vial to allow the solution to drain toward the stopper. 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 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 the solution from the inverted vial.
Once the solution is in the syringe, replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
Expel air, large bubbles, and any excess solution in order to obtain a volume of 1.2 mL corresponding to 150 mg dose. To obtain a volume of 0.6 mL (a dose of 75 mg), 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.
 Subcutaneous Administration of reconstituted solution:
Choose and clean 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.
Each subcutaneous injection should not exceed 150 mg per site; doses of more than 150 mg should be divided among 2 or more injection sites.
Wipe the injection site with an alcohol pad in a circular motion and let it air dry for 10 seconds.
Inject subcutaneously. The subcutaneous injection may take 5 to 10 seconds to administer due to the viscous solution.
Dispose used needles and syringes in a FDA-cleared sharps disposal container right away after use.[44070]

bone fractures / Delayed / 2.0-2.0
new primary malignancy / Delayed / 0.5-0.5
angioedema / Rapid / 0.1-0.2
bronchospasm / Rapid / 0.1-0.2
serum sickness / Delayed / Incidence not known
serious hypersensitivity reactions or anaphylaxis / Rapid / Incidence not known
vasculitis / Delayed / Incidence not known
Churg-Strauss syndrome / Delayed / Incidence not known
pulmonary embolism / Delayed / Incidence not known
pulmonary hypertension / Delayed / Incidence not known
thromboembolism / Delayed / Incidence not known
stroke / Early / Incidence not known
thrombosis / Delayed / Incidence not known
myocardial infarction / Delayed / Incidence not known

dyspnea / Early / 0.1-0.2
antibody formation / Delayed / 0-0.1
cystitis / Delayed / 2.0
migraine / Early / 2.0
peripheral edema / Delayed / 2.0
erythema / Early / Incidence not known
lymphadenopathy / Delayed / Incidence not known
hypotension / Rapid / Incidence not known
thrombocytopenia / Delayed / Incidence not known
eosinophilia / Delayed / Incidence not known
angina / Early / Incidence not known

injection site reaction / Rapid / 0.6-45.0
infection / Delayed / 0.5-23.0
sinusitis / Delayed / 1.1-16.0
pharyngitis / Delayed / 6.6-11.0
arthralgia / Delayed / 2.9-8.0
dizziness / Early / 3.0-3.0
fatigue / Early / 3.0-3.0
abdominal pain / Early / 3.0-3.0
nausea / Early / 1.1-2.7
cough / Delayed / 1.1-2.2
pruritus / Rapid / 2.0-2.0
otalgia / Early / 2.0-2.0
syncope / Early / 0.1-0.2
fever / Early / 2.0
urticaria / Rapid / 2.0
alopecia / Delayed / 2.0
anxiety / Delayed / 2.0
headache / Early / 3.0
dental pain / Delayed / 2.0
epistaxis / Delayed / 3.0
myalgia / Early / 2.0
musculoskeletal pain / Early / 2.0
rash / Early / Incidence not known

Xolair, Xolair Prefilled

Rx

Monoclonal antibody directed against IgE given by subcutaneous injection
Used for moderate to severe allergic asthma in adult and pediatric patients 6 years and older, refractory chronic idiopathic urticaria in those 12 years and older, and for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults with an inadequate response to nasal corticosteroids, as add-on maintenance treatment
Anaphylactic reactions may develop after the first dose or during ongoing treatment; patients should receive doses in a health care setting and be observed after injections

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

75 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

150 mg or 300 mg subcutaneously every 4 weeks. Dosing is independent of serum IgE and body weight. Periodically reassess the need for continued treatment; optimal treatment duration has not been determined. In clinical trials, a larger proportion of patients treated with 300 mg every 4 weeks reported no itching or hives after 12 weeks of treatment compared to those treated with 150 mg every 4 weeks (36% vs. 15%).

150 mg or 300 mg subcutaneously every 4 weeks. Dosing is independent of serum IgE and body weight. Periodically reassess the need for continued treatment; optimal treatment duration has not been determined. In clinical trials, a larger proportion of patients treated with 300 mg every 4 weeks reported no itching or hives after 12 weeks of treatment compared to those treated with 150 mg every 4 weeks (36% vs. 15%).

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

75 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

600 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

600 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

225 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

600 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

600 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

A dosage cannot be recommended due to insufficient data in this weight group.

600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site.Adjust doses for significant changes in body weight.

600 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

A dosage cannot be recommended due to insufficient data in this weight group.

525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

600 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

A dosage cannot be recommended due to insufficient data in this weight group.

600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

A dosage cannot be recommended due to insufficient data in this weight group.

600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

A dosage cannot be recommended due to insufficient data in this weight group.

600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site.Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

A dosage cannot be recommended due to insufficient data in this weight group.

600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

A dosage cannot be recommended due to insufficient data in this weight group.

600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

A dosage cannot be recommended due to insufficient data in this weight group.

525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

A dosage cannot be recommended due to insufficient data in this weight group.

600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Cholera Vaccine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the live cholera vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to cholera bacteria after receiving the vaccine.
SARS-CoV-2 (COVID-19) vaccines: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine.

Xolair Subcutaneous Inj Pwd F/Sol: 202.5mg
Xolair Subcutaneous Inj: 0.5mL, 1mL, 75mg, 150mg

For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight, not to exceed 375 mg subcutaneously every 2 weeks.
For the treatment of chronic idiopathic urticaria: 300 mg subcutaneously every 4 weeks.
For the treatment of nasal polyps: Dose is determined by baseline serum IgE levels and body weight, not to exceed 600 mg subcutaneously every 2 weeks.

For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight, not to exceed 375 mg subcutaneously every 2 weeks.
For the treatment of chronic idiopathic urticaria: 300 mg subcutaneously every 4 weeks.
For the treatment of nasal polyps: Dose is determined by baseline serum IgE levels and body weight, not to exceed 600 mg subcutaneously every 2 weeks.

For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight, not to exceed 375 mg subcutaneously every 2 weeks.
For the treatment of chronic idiopathic urticaria: 300 mg subcutaneously every 4 weeks.
For the treatment of nasal polyps: Safety and efficacy have not been established.

12 years:
For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight, not to exceed 375 mg subcutaneously every 2 weeks.
For the treatment of chronic idiopathic urticaria: 300 mg subcutaneously every 4 weeks.
For the treatment of nasal polyps: Safety and efficacy have not been established.
 
6 to 11 years:
For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight.
6 to 11 years and more than 25 kg: Not to exceed 375 mg subcutaneously every 2 weeks.
6 to 11 years and 20 to 25 kg: Not to exceed 300 mg subcutaneously every 2 weeks.
For the treatment of chronic idiopathic urticaria or nasal polyps: Safety and efficacy have not been established.
 
1 to 5 years: Safety and efficacy have not been established for any indication.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Omalizumab binds to human IgE's high affinity Fc receptor (Fc epsilonRI), preventing the binding of IgE to a variety of cells associated with the allergic response and lowering free serum IgE concentrations. Avoiding the bridging between IgE and cells associated with allergic response prevents degranulation of such cells and, thereby, the release of inflammatory mediators. The early phase of allergic response is prevented as omalizumab prohibits IgE's binding to mast cells, preventing mast cell degranulation. The late phase of allergic response is prevented when the IgE-anti-IgE complex is unable to bind to (Fc epsilonRI) receptors on monocytes, eosinophils, dendritic cells, epithelial cells, and platelets, thus interfering with mediator/cytokine release. Omalizumab indirectly causes a notable down-regulation of (Fc epsilonRI) on basophils, and also prevents IgE from interacting with low affinity Fc receptors ((Fc epsilonRII)) on antigen-presenting cells. IgE-anti-IgE complexes are non-immunogenic with a half-life of about 40 days and persist in circulation for a prolonged time; these hexamers have unoccupied antigen binding sites and are able to remove from the circulation those allergens against which the patient's IgE is directed. Omalizumab has been found in clinical trials to reduce free serum IgE concentrations by more than 90%, considerably suppress eosinophils in induced sputum, and blunt both early and late phase allergic responses.

Omalizumab is administered by subcutaneous injection. Once omalizumab is in the serum, it forms complexes of limited size with IgE; there is no evidence of omalizumab distribution into any other tissues or organs. The apparent volume of distribution of omalizumab in patients with asthma following subcutaneous administration was 78 +/- 32 mL/kg; distribution of omalizumab was similar in patients with chronic idiopathic urticaria (CIU). 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 Fc-gamma receptors within the RES at rates that were generally faster than IgG clearance. In asthma patients, the omalizumab serum elimination half-life averaged 26 days, with apparent clearance averaging 2.4 +/- 1.1 mL/kg/day. Doubling body weight approximately doubled the apparent clearance in these patients. Studies suggested the pharmacokinetics of omalizumab in chronic rhinosinusitis with nasal polyps (CRSwNP) were consistent with that in asthma. In CSU 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 mL/kg/day for an 80 kg patient).
 
In patients with asthma, serum free IgE concentrations are reduced in a dose dependent manner within 1 hour of the first dose of omalizumab and are maintained between doses. The mean serum free IgE decrease is greater than 96% when using recommended dosages. Serum total IgE levels (i.e., bound and unbound) increase after the first dose due to the formation of omalizumab:IgE complexes, which have a slower elimination rate compared to free IgE. At 16 weeks after the first dose, average serum total IgE levels are 5-fold higher compared with pre-treatment when using standard assays. After discontinuation of omalizumab, the omalizumab-induced increase in total IgE and decrease in free IgE are reversible, with no observed rebound in IgE concentrations after drug washout. Total IgE concentrations do not appear to return to pre-treatment levels for up to 1 year after discontinuation of omalizumab.
 
In patients with CIU, omalizumab treatment led to a dose-dependent reduction of serum free IgE and an increase of serum total IgE levels, similar to the observations in asthma patients. Maximum suppression of free IgE was observed 3 days following the first subcutaneous dose. After repeat dosing once every 4 weeks, predose serum free IgE levels remained stable between 12 and 24 weeks of treatment. Total IgE levels in serum increased after the first dose due to the formation of omalizumab-IgE complexes which have a slower elimination rate compared with free IgE. After repeat dosing once every 4 weeks at 75 mg up to 300 mg, average predose serum total IgE levels at Week 12 were 2- to 3-fold higher compared with pre-treatment levels, and remained stable between 12 and 24 weeks of treatment. After discontinuation of omalizumab dosing, free IgE levels increased and total IgE levels decreased towards pre-treatment levels over a 16-week follow-up period.
 
In patients with CRSwNP, omalizumab treatment led to a reduction in serum free IgE and an increase in serum total IgE levels, similar to the observations in asthma patients. The mean total IgE concentrations at baseline were 168 IU/mL and 218 IU/mL in Nasal Polyp Trial 1 and 2, respectively. After repeated dosing every 2 or 4 weeks, with dosage and frequency according to Table 3, the mean predose free IgE concentrations at Week 16 were 10.0 IU/mL in Trial 1 and 11.7 IU/mL in Trial 2 and remained stable at 24 weeks of treatment. Total IgE levels in serum increased due to the formation of omalizumab-IgE complexes, which have a slower elimination rate compared with free IgE. After repeated dosing every 2 or 4 weeks, with dosage and frequency according to Table 3, mean and median predose serum total IgE levels at Week 16 were 3-to 4-fold higher compared with pre-treatment levels, and remained stable between 16 and 24 weeks of treatment.
 
Affected cytochrome P450 isoenzymes and drug transporters: None

After subcutaneous administration, omalizumab is absorbed slowly into the serum where it forms complexes with IgE. Maximum serum concentrations are achieved within 7 to 8 days. The average absolute bioavailability is 62%.

The data with omalizumab use during human pregnancy are insufficient to inform a drug-associated risk. There are no adequate and well-controlled studies in pregnant women and its ability to cause fetal harm or affect reproductive capacity is unknown. Monoclonal antibodies, such as omalizumab, are known to cross the placenta; therefore, omalizumab may be transmitted from the mother to the fetus. A registry study of omalizumab exposure in 250 pregnant women showed no increase in the rate of major birth defects or miscarriage. Although there was an increased rate of low birth weight among registry infants compared to infants in the other cohorts, women taking omalizumab during pregnancy had more severe asthma, which makes it difficult to determine if the low birth weight is due to the drug or disease severity. In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Thus, asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.

There are limited data regarding the use of omalizumab during breast-feeding. There is no information regarding the presence of omalizumab in human milk or the effects on milk production. A majority of the infants (80.9%, 186/230) in the pregnancy registry study of omalizumab were breastfed. Events categorized as "infections and infestations" were not significantly increased in infants exposed to omalizumab compared with infants who were not breastfed or infants who were breastfed without exposure to omalizumab. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.[44070]