Ilana, a board-certified emergency medicine physician, lived with chronic hives for almost as long as she can remember. “I’ve had them since I was at least 8 years old,” she says. “It’s something that was a regular part of my high school and college life. I was just always a person who was itchy, and I didn’t know why. I had accepted it as a normal part of my life.”
Even as she grew older, she never considered being treated for chronic hives. She was often the student in class who was distracted and itching during exams, but dismissed the hives as something brought on by stress as a medical student or her allergies.
It’s estimated that about 1 in 5 people experience hives, or itchy, red or skin-colored welts, at some point in their lives. They’re often caused by an allergic reaction, but not always. If the hives come back over and over again for more than six weeks, and don’t have a known cause, it’s called chronic spontaneous urticaria, or CSU. It’s also commonly referred to as chronic idiopathic urticaria (CIU).
Finally, after many years of searching for answers as well as trying antihistamines, Ilana shared her symptoms with a medical school classmate and friend, Dr. Ari Zelig, who suggested that she come in for an appointment with him. Dr. Zelig is an allergist, which means he specializes in treating allergies and immune system diseases that can affect different parts of the body. He diagnosed her with CIU and recommended considering treatment. She finally felt relief. “It was nice to have a name for what I was experiencing,” she says. “It made it ‘real.’ It’s an actual condition that can be treated.”
Dr. Zelig says the severity and number of CSU outbreaks vary from person to person. “A common misconception is that chronic hives are caused by undiagnosed food allergies or an allergy to topical products, but that’s not the case with CSU. CSU is a condition where chronic hives occur without a known cause. While many patients think this is an external skin issue, chronic hives stem from within,” he says.
There are four common signs and symptoms that are indicative of CSU. These include:
- Red or skin-colored welts, or “wheals,” appearing anywhere on the body and varying in size, change shape and appear and fade repeatedly
- Itching that is intense
- Hives that turn white, or “blanch,” when they are pressed in the center
- Signs and symptoms persisting for more than six weeks and recurring frequently and unpredictably
Ilana was prescribed Xolair® (omalizumab), which is 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 treatment with antihistamines. Ilana and Dr. Zelig discussed the side effects, including the risk for a severe life-threatening allergic reaction, called anaphylaxis.
While experiences may vary, Ilana has noticed she experiences less hives and itching. “I’ve learned that chronic hives don’t have to be accepted as a ‘normal’ part of my life anymore,” she says. “I wish that I had known about the condition and potential treatment options earlier. It doesn’t have to be like that.”
Dr. Zelig encourages others who may be experiencing the symptoms of CSU to talk to an allergist about treatment options.
“It’s important to talk to an allergist about ways to control chronic hive outbreaks,” says Dr. Zelig. “CSU can be truly debilitating. No one should have to suffer in silence with CSU.”
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.