(BPT) - Paid Story by Genentech and Novartis

For Robin, the itchiness started on her scalp and the back of her neck. Suspecting that she had hives, she saw a dermatologist, who prescribed a topical medication. Unfortunately, it didn't help Robin's symptoms and it would be two months before she had an accurate diagnosis.

'I'm the type of person who doesn't complain,' she says, 'so as bad as the hives were, I still pushed forward with my daily life.'

But the hives spread, so Robin continued her search for the right doctor, visiting both a rheumatologist and dermatologist. 'They gave me topical creams and steroids which helped initially, but the hives quickly came back,' she recalls. Finally, the dermatologist recommended she see an allergist.

That allergist, Dr. Ari Zelig diagnosed Robin with chronic spontaneous urticaria, or CSU - chronic hives with no known trigger. 'Hives are itchy welts that can be caused by an allergic reaction - but not always,' says Dr. Zelig. 'When there is no apparent cause and the hives come back repeatedly for more than six weeks, this is CSU.' Chronic hives can affect each person differently, but itchiness and skin discomfort are common symptoms for many living with the condition.

Dr. Zelig suggested Robin try Xolair^® (omalizumab), the first and only FDA-approved biologic treatment used to treat CSU in people 12 years of age and older who continue to have hives after receiving antihistamines. Robin and Dr. Zelig discussed its benefits and risks, including anaphylaxis, a severe life-threatening allergic reaction.

'Dr. Zelig said I was one of the worst cases of CSU that he had ever seen,' says Robin. 'But after several months, I started Xolair and my hives finally started to improve.'

For many patients with CSU, seeing a specialist like an allergist is one of the most important steps. CSU impacts approximately 1.6 million people in the U.S. and patients can have trouble finding the right doctor to diagnose it.

Sarah, another person living with CSU, developed hives across her arms, legs and stomach, and ultimately her whole body. 'I was in my allergist's office broken out in hives from head to toe, I was so ready to be rid of them, and she told me it was going to be okay.'

After trying antihistamines, her allergist recommended Xolair, which Sarah says helped clear up most of her hives.

Dr. Zelig points out that every patient's response to treatment is different. Sarah and her allergist discussed the side effects, including the risk for a severe life-threatening allergic reaction, called anaphylaxis. Therefore, once a CSU diagnosis is made, an allergist will work with patients to develop a plan and monitor response to treatment. Sarah says that her hives are far fewer and less frequent - and for her, that's a success.

'Some people will see their hives go away, possibly even completely,' says Dr. Zelig, 'while others will still have some hives sporadically. CSU symptoms, such as constant itchiness and hives can be debilitating, so reducing the number and severity of outbreaks is a win.'

Sam, a college student, also had a long path to the right doctor and treatment for his CSU. He first developed hives when he was home one summer and started feeling itchy after exercising. 'I looked down, and there were hundreds of hives all over my body,' he recalls. When the same thing happened the next day, he decided to see his family doctor.

The doctor thought it was allergies and prescribed antihistamines, which Sam says did not reduce his breakouts.

Ultimately, when Sam was back in college, he saw an allergist who quickly recognized his hives as CSU. 'She put me on Xolair and my hives began improving after several months,' says Sam.

'Because CSU has no known trigger, it can be harder to diagnose than other conditions,' says Dr. Zelig. 'But the welts and itchiness can cause extreme discomfort. If you think you might have CSU, speak with an allergist.'

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Xolair U.S. Indication

What is XOLAIR?

XOLAIR^® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if XOLAIR is safe and effective in people with CSU under 12 years of age.

XOLAIR is not used to treat other forms of hives.

IMPORTANT SAFETY INFORMATION

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:

• 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 food allergy or seasonal allergies). The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex
• 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.
• If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe injections, you should receive training on the right way to prepare and inject XOLAIR.
• Do not try to inject your XOLAIR prefilled syringe until you have been shown the right way to give XOLAIR injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider. For children 12 years of age and older, XOLAIR prefilled syringe 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 chronic hives, a blood test is not necessary to determine the dose or dosing frequency.
• Do not decrease or stop taking any of your other hive medicine unless your healthcare providers tell you to.
• You may not see improvement in your symptoms right away after XOLAIR treatment.
• 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.
• 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 people with chronic spontaneous urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.

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.

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