Severe allergic reaction. When you receive Xolair, there’s a risk of a serious allergic reaction called anaphylaxis. This reaction can occur with the very first dose, or even after you’ve had many doses without issue. It might happen shortly after a Xolair injection or even days later. Anaphylaxis is life-threatening and requires immediate medical attention. If you experience any of the following symptoms of an allergic reaction, go to the emergency room right away:
- Wheezing, shortness of breath, coughing, chest tightness, or difficulty breathing
- Low blood pressure, dizziness, feeling faint, a rapid or weak heartbeat, anxiety, or a sense of “impending doom”
- Flushing, itching, hives, or feeling unusually warm
- Swelling of the throat or tongue, throat tightness, a hoarse voice, or trouble swallowing
Your healthcare provider will carefully monitor you for any signs of an allergic reaction during and after your Xolair treatment begins. It’s important to discuss with your provider what to do and how to seek medical help if you develop any of these allergic reaction symptoms.
Who should not receive Xolair?
Do not receive Xolair if you are allergic to omalizumab or any other component of the Xolair injection.
Important considerations before starting Xolair:
Before you start Xolair, it’s crucial to inform your healthcare provider about all your medical conditions, especially if you:
- Have a latex allergy or any other allergies, including seasonal allergies. The needle cap on Xolair prefilled syringes contains natural rubber latex.
- Experience sudden breathing problems (bronchospasm).
- Have a history of severe allergic reactions, known as anaphylaxis.
- Currently have or have ever had a parasitic infection.
- Have or have had cancer.
- Are pregnant or planning to become pregnant. It’s not yet known how Xolair might affect an unborn baby.
- Are breastfeeding or plan to breastfeed. It’s unknown if Xolair passes into breast milk. Discuss the best feeding options for your baby with your healthcare provider while you are using Xolair.
Medications and Xolair:
Tell your healthcare provider about all medications you are currently taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will you receive Xolair for food allergy?
- Initially, Xolair injections should always be administered by a healthcare professional in a medical setting.
- If your healthcare provider determines that you or a caregiver can administer Xolair prefilled syringe or autoinjector injections at home, you will receive thorough training on the correct preparation and injection techniques.
- Do not attempt to inject Xolair until you have been properly instructed by a healthcare provider. Always use Xolair exactly as prescribed by your healthcare provider.
- The Xolair autoinjector is approved for use in adults and adolescents 12 years and older. In children 12 years and older, Xolair prefilled syringe or autoinjector can be self-injected with adult supervision. For children aged 1 to 11 years, Xolair prefilled syringe injections must be given by a caregiver.
- Refer to the detailed Instructions for Use provided with Xolair for complete guidance on preparing and administering the injection.
- Xolair is administered as one or more subcutaneous injections (under the skin) every 2 or 4 weeks.
- For individuals with food allergies, a blood test to measure IgE levels is necessary before starting Xolair. This test helps determine the appropriate dose and frequency of Xolair.
- Continue to follow your prescribed food allergy management plan, including any medications or allergen immunotherapy, unless your healthcare provider instructs you otherwise.
- It may take time to see noticeable improvement in your food allergy symptoms with Xolair treatment. If your symptoms do not improve or worsen, contact your healthcare provider.
- In case of injecting more Xolair than prescribed, seek immediate medical advice from your healthcare provider.
What are the potential side effects of Xolair?
Serious side effects of Xolair may include:
- Cancer. Some individuals receiving Xolair have developed cancer in clinical studies.
- Fever, muscle aches, and rash. These symptoms have been reported in some patients 1 to 5 days after a Xolair injection. If you experience these, inform your healthcare provider.
- Parasitic infection. People at higher risk for parasite infections may develop one after starting Xolair. Your healthcare provider can perform stool tests to check for parasitic infections if needed.
- Heart and circulation problems. In some patients receiving Xolair, heart-related issues such as chest pain, heart attack, blood clots in the lungs or legs, and temporary stroke-like symptoms (weakness on one side, slurred speech, vision changes) have been reported. It is not yet established if Xolair is the direct cause of these problems.
Common side effects of Xolair in people with food allergy include: injection site reactions and fever.
This is not a complete list of all possible side effects. For medical advice about side effects, consult your doctor.
You can report side effects to the FDA at (800) FDA-1088 or online at www.fda.gov/medwatch. You can also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.
For comprehensive information, please refer to the full Prescribing Information, including the Medication Guide, for further Important Safety Information and the Instructions for Use.
