US Healthcare Professionals

For adults 18 years of age and older with chronic rhinosinusitis with nasal polyps (CRSwNP) who are not adequately controlled on nasal corticosteroids.

CLINICAL TRIAL RESULTS

XOLAIR helps make nasal polyps a smaller part of your life

Shrink the polyps

Smaller polyps

Relieve the congestion

Less congestion

Smaller polyps

In clinical studies,* XOLAIR was proven to reduce the size of stubborn nasal polyps and help free up clogged nasal passages in as little as 4 weeks.
 

Proven results at 24 weeks
In one study, XOLAIR reduced polyps size by 18% compared to a 2% reduction with steroid nasal spray alone. In a second study, XOLAIR reduced polyp size by 14% compared to 5% reduction with steroid nasal spray alone

Nasal polyp scores were measured using endoscopy and scored according to size and extent of reach into the nasal cavity (on scale of 0 to 4 per nostril) for a total nasal polyp score (0/best to 8/worst).

Less congestion

In clinical studies,* XOLAIR rapidly cleared away congestion to provide noticeable relief in as little as 4 weeks.
 

Proven results at 24 weeks
In one study, XOLAIR reduced congestion by 38% as compared to a 16% reduction with steroid nasal spray alone. In a second study, XOLAIR reduced congestion by 30% compared to 9% reduction with steroid nasal spray alone. An image of a woman walking outside.

Nasal congestion was measured by a daily assessment on a severity scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe) by those participating in the clinical trials.

 

Shrink the polyps

Smaller polyps

Smaller polyps

In clinical studies,* XOLAIR was proven to reduce the size of stubborn nasal polyps and help free up clogged nasal passages in as little as 4 weeks.
 

Proven results at 24 weeks
In one study, XOLAIR reduced polyps size by 18% compared to a 2% reduction with steroid nasal spray alone. In a second study, XOLAIR reduced polyp size by 14% compared to 5% reduction with steroid nasal spray alone

Nasal polyp scores were measured using endoscopy and scored according to size and extent of reach into the nasal cavity (on scale of 0 to 4 per nostril) for a total nasal polyp score (0/best to 8/worst).
 

Relieve the congestion

Less congestion

Less congestion

In clinical studies,* XOLAIR rapidly cleared away congestion to provide noticeable relief in as little as 4 weeks.
 

Proven results at 24 weeks
In one study, XOLAIR reduced congestion by 38% as compared to a 16% reduction with steroid nasal spray alone. In a second study, XOLAIR reduced congestion by 30% compared to 9% reduction with steroid nasal spray alone. An image of a woman walking outside.

Nasal congestion was measured by a daily assessment on a severity scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe) by those participating in the clinical trials.

 

*XOLAIR was studied in 2 clinical trials with 265 adults with uncontrolled nasal polyps. Each study lasted 24 weeks. Patients were not required to be taking oral steroids or have surgery before starting XOLAIR.

"I can smell fresh air again."

2x icon

 

Help improve your sense of smell...

In clinical trials lasting 24 weeks, XOLAIR improved sense of smell 2x more than steroid nasal spray alone.†

There was up to a 22% improvement with XOLAIR compared with 8% for steroid nasal spray alone.
 

2x icon

Help improve your sense of smell...

In clinical trials lasting 24 weeks, XOLAIR improved sense of smell 2x more than steroid nasal spray alone.†

There was up to a 22% improvement with XOLAIR compared with 8% for steroid nasal spray alone.
 

Measurable relief of
nuisance nasal symptoms

XOLAIR improved both runny nose and postnasal drip at week 24.

Relieve your runny nose. Up to a 41% reduction compared to 16% for corticosteroids alone. Decrease your post-nasal drip. Up to a 42% reduction compared to 8% for nasal steroids alone.

†The average Sense of Smell Score was better for people taking XOLAIR and steroid nasal spray compared to those taking steroid nasal spray alone. Sense of smell was recorded by patients each day over 24 weeks on a severity scale of 0 to 3 points (0=none, 1=mild, 2=moderate, 3=severe). At the end of the survey, the daily scores were averaged and compared to the scores at the beginning to measure improvement.

‡Symptom severity was recorded by patients over 24 weeks on a scale of 0 to 3 points (0=none, 1=mild, 2=moderate, 3=severe). At the end of the survey, the daily scores were averaged and compared to the scores at the beginning to measure improvement.

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IMPORTANT SAFETY INFORMATION & INDICATION

What is XOLAIR?

XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in people 18 years of age and older when medicines to treat CRSwNP called nasal corticosteroids have not worked well enough. It is not known if XOLAIR is safe and effective in people with CRSwNP under 18 years of age.

What is the most important information I should know about XOLAIR?

Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction: a

  • 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

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.

Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.

Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:

  • have a latex allergy or any other allergies (such as seasonal allergies). The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex.
  • have sudden breathing problems (bronchospasm)
  • have ever had a severe allergic reaction called anaphylaxis
  • have or have had a parasitic infection
  • have or have had cancer
  • are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I receive and use XOLAIR?

  • When starting treatment, XOLAIR should be given by your healthcare provider in a healthcare setting.
  • Do not try to inject XOLAIR until you have been shown the right way to give XOLAIR prefilled syringe or autoinjector injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider.
  • The XOLAIR autoinjector (all doses) is intended for use only in adults and adolescents aged 12 years and older. For children 12 years of age and older, XOLAIR prefilled syringe or autoinjector may be self-injected under adult supervision. 
  • See the detailed Instructions for Use that comes with XOLAIR for information on the right way to prepare and inject XOLAIR.
  • XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.
  • In people with CRSwNP, a blood test for a substance called IgE must be performed before starting XOLAIR to determine the appropriate dose and dosing frequency.
  • Do not decrease or stop taking any of your other asthma or CRSwNP medicine unless your healthcare providers tell you to.
  • You may not see improvement in your symptoms right away after XOLAIR treatment. If your symptoms do not improve or get worse, call your healthcare provider.
  • If you inject more XOLAIR than prescribed, call your healthcare provider right away.

What are the possible side effects of XOLAIR?

XOLAIR may cause serious side effects, including:

  • Cancer. Cases of cancer were observed in some people who received XOLAIR.
  • Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs.
  • Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider.
  • Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection.
  • Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether these are caused by XOLAIR.

The most common side effects of XOLAIR in adults with chronic rhinosinusitis with nasal polyps: headache, injection site reactions, joint pain, upper abdominal pain, and dizziness.

These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Medication Guide, for additional Important Safety Information and Instructions for Use.