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IMPORTANT SAFETY INFORMATION
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Taking XOLAIR Step by Step

If you're 12 or older, adding XOLAIR to your current asthma treatments with inhaled steroids may reduce the number of attacks you have. Of course, it's normal to have concerns about starting a new treatment and what you can expect. Keep in mind that there are a lot of important factors to understand and consider when choosing a treatment. And every treatment has potential benefits and risks for you.

How XOLAIR is given

XOLAIR is given by subcutaneous injection (which means an injection just under the skin) every 2 or every 4 weeks. This is performed by a doctor or nurse in a doctor's office, clinic, hospital, or similar setting.

Xolair has not been proven to work in other allergic conditions. Xolair is not a rescue medication and should not be used to treat sudden asthma attacks.

Your healthcare provider should watch you for some time in the office for signs or symptoms of anaphylaxis after injecting XOLAIR. Anaphylaxis is a life-threatening condition and can lead to death. Seek emergency medical treatment right away. Signs and symptoms of anaphylaxis include wheezing, shortness of breath, cough, chest tightness, trouble breathing, low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom".

How your dosage is determined

Your doctor will decide how much and how often you should receive XOLAIR based on your weight and levels of immunoglobulin E (IgE).

You should read the Medication Guide before starting XOLAIR treatment and before each and every treatment. Please see below for additional important safety information.

You're ready for XOLAIR. Now what?

If you and your doctor think XOLAIR is the right treatment for you, here's what generally happens next:

  • Your doctor will submit a statement of medical necessity (SMN) to a Specialty Pharmacy for XOLAIR or XOLAIR Access Solutions. (A Specialty Pharmacy is a type of pharmacy that handles medicines like XOLAIR. XOLAIR Access Solutions provides coverage reimbursement support and patient assistance services.) Please be sure to sign all appropriate forms
  • The Specialty Pharmacy or XOLAIR Access Solutions will let you know if your insurance will cover XOLAIR—most insurance companies cover XOLAIR but you may need prior authorization based on your health history and specific insurance plan
  • The Specialty Pharmacy will contact you to verify your information—it's important to always return phone calls regarding XOLAIR treatment to make sure your insurance company and Specialty Pharmacy have all the information they need
  • If you need additional information about medical coverage for XOLAIR, please speak with your doctor
  • You must authorize your Specialty Pharmacy to ship XOLAIR to your doctor's office and pay any co-payment to the Specialty Pharmacy prior to delivery. If you have concerns about your copay, click here to learn about our co-pay program
  • Contact your doctor's office and they'll help you start your treatment with XOLAIR

Below is a list of Specialty Pharmacies that handle XOLAIR. They can help your doctor receive the proper supply of XOLAIR for you.

Genentech and Novartis do not endorse the use of any of the listed pharmacies in particular.

  • Accredo Nova Factor, Inc.
    Ph: (866) 839-2162, Fax: (866) 531-1025
  • ACRO
    Ph: (800) 906-7798, Fax: (877) 381-3806
  • Aetna
    Ph: (866) 782-2779, Fax: (866) 329-2779
  • CIGNA Tel-Drug
    Ph: (800) 351-3606, Fax: (800) 351-3616
  • CuraScript Pharmacy, Inc. (Precision Rx)
    Ph: (888) 281-5464, Fax: (866) 269-3113
  • CVS/Caremark Rx, Inc.
    Ph: (800) 237-2767, Fax: (800) 323-2445
  • Walgreen's Specialty Pharmacy (McKesson SP, Medmark, Option Care)
    Ph: (866) 823-2712, Fax: (877) 231-8302
  • Prescription Solutions
    Ph: (888) 293-9309, Fax: (800) 853-3844

For comprehensive information on our programs to help you pay for Xolair, visit Xolair Access Solutions.

As you're getting ready for treatment with XOLAIR, it's important to know that it can take some time for the insurance process to go through. So be patient.

Who is XOLAIR for?

XOLAIR® (omalizumab) for subcutaneous use is an injectable, prescription medicine for patients 12 years of age and older. It is for patients with moderate to severe persistent allergic asthma caused by year-round allergens in the air. A skin or blood test is done to see if you have allergic asthma. XOLAIR is for patients who are not controlled by asthma medicines called inhaled steroids.

XOLAIR helps reduce the number of asthma attacks in people with allergic asthma who still have asthma symptoms even though they are taking inhaled steroids.

Important Limitations of Use

  • XOLAIR has not been proven to work in other allergic conditions
  • XOLAIR is not a rescue medicine and should not be used to treat sudden asthma attacks
  • XOLAIR should not be used in children under 12 years of age

IMPORTANT SAFETY INFORMATION

XOLAIR should always be injected in a doctor's office. You should read the Medication Guide before starting XOLAIR treatment and before each and every treatment.

A severe allergic reaction called anaphylaxis has happened in some patients after they received XOLAIR. Anaphylaxis is a life-threatening condition and can lead to death, so get emergency medical treatment right away if signs or symptoms of anaphylaxis occur after receiving XOLAIR.

Signs and symptoms of anaphylaxis include:
  • wheezing, shortness of breath, cough, chest tightness, or trouble breathing
  • low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom"
  • flushing, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Anaphylaxis from XOLAIR can happen:

  • right after receiving a XOLAIR injection or hours later
  • after any XOLAIR injection. Anaphylaxis has occurred after the first XOLAIR injection or after many XOLAIR injections.

Your healthcare provider should watch you for some time in the office for signs or symptoms of anaphylaxis after injecting XOLAIR. If you have signs or symptoms of anaphylaxis, tell your healthcare provider right away.

You should not receive XOLAIR if you have ever had an allergic reaction to a XOLAIR injection. Do not use XOLAIR if you are allergic to any of its ingredients.

In clinical studies, a variety of cancer types, including breast, skin, prostate, and parotid (a type of salivary gland), were reported in more patients who received XOLAIR than in patients who did not receive XOLAIR.

XOLAIR is not a rescue medicine and should not be used to treat sudden asthma attacks.

XOLAIR is not a substitute for the medicines you are already taking. Do not change or stop taking any of your other asthma medicines unless your doctor tells you to do so.

Some patients on XOLAIR may have an abnormal increase in eosinophils (a type of white blood cell) in the blood or tissues, sometimes causing an inflammation of blood vessels, which can lead to rash, worsening of respiratory symptoms, heart trouble, and/or nerve pain and weakness.

Joint inflammation or pain, rash, fever, and swollen lymph nodes have been seen in some patients taking XOLAIR, after the first or subsequent injections. Talk to your doctor if you've experienced any of these signs and symptoms.

The most commonly seen side effects occurring more frequently in patients receiving XOLAIR than in patients who received placebo (an injection with no active medicine) were joint pain, pain (general), leg pain, tiredness (fatigue), dizziness, fracture, arm pain, itching, inflammation of the skin, and earache.

In asthma studies, the most common side effects in patients, who either needed to stop XOLAIR or needed medical attention, were injection site reaction, viral infections, upper respiratory tract infection, sinusitis, headache, and sore throat. These side effects were seen at similar rates in XOLAIR-treated patients as in patients that did not receive XOLAIR.

There are other possible side effects with XOLAIR. Talk to your doctor for more information and if you have any questions about your treatment.

XOLAIR has not been studied in pregnant women. Pregnant women exposed to XOLAIR are encouraged to enroll in the XOLAIR Pregnancy Exposure Registry. You can get more information by calling 1-866-4XOLAIR (1-866-496-5247) or by speaking with your doctor.

Please see full Prescribing Information, including Medication Guide for additional important safety information.