FDA Approves Xolair® (omalizumab) for Subcutaneous Use for People with Chronic Idiopathic Urticaria (CIU), a Form of Chronic Hives
March 21st, 2014
On March 21, 2014, the FDA approved Xolair for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives for people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy.
1 Asthma and Allergy Foundation of America (AAFA) website. “Chronic Urticaria (Hives).” http://www.aafa.org/display.cfm?id=9&sub=23&cont=328. Accessed March 11, 2014.
2 American Academy of Allergy Asthma & Immunology (AAAAI) website. “Skin Allergy Overview.” http://www.aaaai.org/conditions-and-treatments/allergies/skin-allergy.aspx. Accessed March 11, 2014.
3 Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy 2011; 66: 317–330.
4 Census Bureau Projects U.S. Population of 317.3 Million on New Year's Day. United States Census Bureau. December 30, 2013. http://www.census.gov/newsroom/releases/archives/population/cb13-tps112.html. Accessed March 11, 2014.
5 Xolair® Full Prescribing Information. Genentech. March 21, 2014.
6 S. Saini. Chronic urticaria: Clinical manifestations, diagnosis, pathogenesis, and natural history. http://www.uptodate.com/contents/chronic-urticaria-clinical-manifestations-diagnosis-pathogenesis-and-natural-history. Accessed March 11, 2014.
Important Safety Information
The most important information patients should know about XOLAIR is that a severe allergic reaction called anaphylaxis can happen when a patient receives 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. Patients must go to the nearest emergency room right away if they 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
The patient’s healthcare provider will monitor the patient closely for symptoms of an allergic reaction while they are receiving XOLAIR and for a period of time after the patient’s injection. The patient’s healthcare provider should talk to the patient about getting medical treatment if they have symptoms of an allergic reaction after leaving the healthcare provider’s office or treatment center.
Patients must not receive XOLAIR if they are allergic to omalizumab or any of the ingredients in XOLAIR.
Before receiving XOLAIR, patients must tell their healthcare provider about all of their medical conditions, including if they:
- have any other allergies (such as food allergy or seasonal allergies)
- 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 a patient’s unborn baby
- are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive XOLAIR
Patients must tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.
- XOLAIR should be given by a healthcare provider, in a healthcare setting
- XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks
- In asthma patients, a blood test for a substance called IgE must be performed prior to starting XOLAIR to determine the appropriate dose and dosing frequency
- In patients with chronic hives, a blood test is not necessary to determine the dose or dosing frequency
- Patients must not decrease or stop taking any of their other asthma or hive medicine unless their healthcare providers tell them to
- Patients may not see improvement in their symptoms right away after XOLAIR treatment
Possible side effects of XOLAIR
XOLAIR may cause serious side effects, including:
- See,“What is the most important information I should know about XOLAIR” in the XOLAIR Medication Guide at http://www.xolair.com regarding the risk of anaphylaxis
- 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 who take XOLAIR get these symptoms 1 to 5 days after receiving a XOLAIR injection. If a patient has any of these symptoms, they must tell their healthcare provider
- Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. The patient’s healthcare provider can test the patient’s stool to check if they 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 this is caused by XOLAIR
The most common side effects of XOLAIR:
- In adults and children 12 years of age and older with asthma: pain especially in the arms and legs, dizziness, feeling tired, skin rash, bone fractures, and pain or discomfort of the ears
- In children 6 to less than 12 years of age with asthma: common cold symptoms, headache, fever, sore throat, pain or discomfort of your ear, abdominal pain, nausea, vomiting and nose bleeds
- In people with chronic idiopathic urticaria: nausea, headaches, swelling of the inside of the nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection
These are not all the possible side effects of XOLAIR. Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.Report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at 888-669-6682.
“Chronic idiopathic urticaria can be difficult to manage because its causes are unknown, and other approved medicines aren’t effective enough for many patients. We are pleased to have Xolair as a new option for people with this serious skin condition.”