WARNING

Omalizumab is a medication used to treat moderate to severe persistent allergic asthma and chronic idiopathic urticaria (hives). Like any medication, it comes with potential risks and side effects. Here is a brief overview, but it’s important to note that individual responses can vary, and this information does not substitute professional medical advice:

• Allergic Reactions: Some people may experience allergic reactions to Omalizumab, including hives, rash, itching, swelling, severe dizziness, or difficulty breathing. Immediate medical attention is necessary if such reactions occur.
• Risk of Infections: Omalizumab may increase the risk of certain infections, such as upper respiratory tract infections and sinusitis. Patients should be monitored for signs of infection, and any new or worsening symptoms should be reported to a healthcare provider.
• Malignancies: There have been reports of an increased risk of malignancies (cancer) in patients treated with Omalizumab, but the causal relationship is not well-established. Patients should be monitored for the development of tumors.
• Eosinophilia: Eosinophilia (an increase in the number of eosinophils, a type of white blood cell) has been observed in some patients. Regular monitoring of blood counts may be necessary.
• Injection Site Reactions: Pain, redness, swelling, or bruising at the injection site may occur. Rotating injection sites and following proper injection techniques can help minimize these reactions.
• Cardiovascular and Cerebrovascular Events: Some studies suggest a potential association between Omalizumab and an increased risk of cardiovascular and cerebrovascular events, although more research is needed to establish a clear link.
• Respiratory System Effects: Patients with asthma should not abruptly stop inhaled or systemic corticosteroids upon starting Omalizumab, as this may result in exacerbation of asthma symptoms.

It’s crucial for individuals considering or using Omalizumab to discuss their medical history, including allergies and other medications, with their healthcare provider. Only a qualified healthcare professional can provide personalized advice based on an individual’s specific health status and needs.

Why is this medication prescribed?

Omalizumab is prescribed for the treatment of certain allergic conditions, particularly moderate to severe persistent allergic asthma and chronic idiopathic urticaria (CIU), also known as chronic spontaneous urticaria (CSU). It is a monoclonal antibody that works by reducing the body’s immune response to allergens. Omalizumab is prescribed for the treatment of certain allergic conditions, particularly:

• Allergic Asthma: Omalizumab is prescribed for individuals (both adults and children) with moderate to severe allergic asthma. It is typically used when other asthma medications, such as inhaled corticosteroids, are not effectively controlling symptoms.
• Chronic Idiopathic Urticaria (CIU): Omalizumab is indicated for the treatment of chronic idiopathic urticaria in patients who remain symptomatic despite antihistamine therapy. CIU is a condition characterized by the presence of hives (urticaria) for six weeks or longer without an identifiable cause.

How should this medicine be used?

The use of Omalizumab injection should be strictly based on the prescription and guidance provided by a healthcare professional. Here are general guidelines on how Omalizumab is commonly used:

• Administration: Omalizumab is usually administered as a subcutaneous injection (under the skin). Healthcare professionals, such as nurses or doctors, typically administer the injection. In some cases, patients may be trained to self-administer the injection at home under the guidance of a healthcare provider.
• Dosage and Frequency: The dosage of Omalizumab is determined by the prescribing healthcare professional based on factors such as the patient’s weight, severity of the condition, and response to treatment. The frequency of injections may vary, but it is commonly administered every two or four weeks.
• Injection Sites: The injection is typically given in the upper arm or thigh. The specific injection site may be guided by the healthcare provider, and patients should follow these instructions carefully.
• Compliance: It is crucial for patients to adhere to the prescribed dosing schedule. Missing doses may impact the effectiveness of the treatment.
• Monitoring: Patients receiving Omalizumab may be monitored regularly to assess the response to treatment and to identify any potential side effects. Regular check-ups with the healthcare provider are important to ensure that the medication is providing the desired therapeutic effect.
•  Patient Education: Patients should receive proper education on the correct technique for self-administration if applicable. It’s important for patients to understand the purpose of the medication, how it works, and potential side effects. Any concerns or questions should be discussed with the healthcare provider.
• Other Medications: Omalizumab is often used in conjunction with other asthma medications, and patients should continue to use their other prescribed medications unless otherwise directed by their healthcare provider.
• Allergic Reactions: Patients should be aware of the signs of allergic reactions and seek immediate medical attention if they experience symptoms such as difficulty breathing, swelling of the face or tongue, or severe itching.
• Important Note: The information provided here is a general guide, and specific instructions may vary based on individual patient characteristics and the healthcare provider’s recommendations. Patients should always follow the instructions provided by their healthcare provider and contact them with any questions or concerns regarding the use of Omalizumab.

It is crucial for individuals prescribed Omalizumab to have open communication with their healthcare provider, report any side effects promptly, and attend scheduled follow-up appointments for ongoing monitoring of their condition.

Other uses for this medicine

Omalizumab is primarily indicated for the treatment of allergic asthma and chronic idiopathic urticaria. However, it’s essential to note that the landscape of medical research and drug approvals can change. Always consult with a healthcare professional for the most up-to-date information.

What special precautions should I follow?

Patients using Omalizumab should be aware of certain precautions and considerations to ensure safe and effective use. Here are some special precautions:

• Hypersensitivity Reactions: Omalizumab itself can rarely cause hypersensitivity reactions. Patients should be monitored for signs of allergic reactions during and after administration. Seek immediate medical attention if symptoms such as difficulty breathing, swelling, or severe itching occur.
• Immunization: Patients should consult with their healthcare provider about vaccinations, as Omalizumab may affect the response to certain vaccines. Live vaccines should generally be avoided during Omalizumab treatment.
• Infections: Patients should inform their healthcare provider if they have any signs of infection. Omalizumab may be associated with an increased risk of certain infections, and caution should be exercised in individuals with pre-existing infections.
• Malignancy: Omalizumab’s long-term safety, especially regarding the risk of malignancies, is an area of ongoing research. Patients should discuss any history of cancer or concerns about malignancy risk with their healthcare provider.
• Pregnancy and Breastfeeding: The safety of Omalizumab during pregnancy and breastfeeding is not well established. It should be used during pregnancy only if clearly needed, and the potential benefits should outweigh potential risks.
• Liver Function: Omalizumab is metabolized in the liver, and caution should be exercised in individuals with impaired liver function. Regular monitoring of liver function may be recommended.
• Eosinophilic Conditions: Omalizumab has been associated with an increased risk of eosinophilia, a condition characterized by elevated levels of eosinophils (a type of white blood cell). Monitoring for eosinophilia may be necessary.
• Children and Adolescents: The safety and effectiveness of Omalizumab in children and adolescents for conditions other than allergic asthma have not been established.
• Renal Impairment: Omalizumab is not primarily cleared through the kidneys, so no dosage adjustment is generally required in individuals with renal impairment.

The information provided here is a general overview, and it’s essential to consult with a healthcare professional for personalized advice based on an individual’s specific health condition, medical history, and the most recent medical information available.

Always follow the instructions and recommendations provided by your healthcare provider for the safe and effective use of Omalizumab or any medication. If you have any concerns or experience unexpected side effects, contact your healthcare provider promptly.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with the use of Omalizumab. However, it’s essential to follow any dietary recommendations provided by your healthcare provider as part of your overall asthma or urticaria management plan.

What should I do if I forget a dose?

• If you miss a dose, contact your healthcare provider for guidance. It’s crucial to adhere to the prescribed dosing schedule for the optimal effectiveness of the medication.
• Do not double up on doses to make up for a missed one unless instructed to do so by your healthcare provider.

What side effects can this medication cause?

Omalizumab may cause side effects in some individuals. It’s important to note that not everyone will experience these side effects, and they can vary in severity. Common side effects are generally mild and may include:

• Hypersensitivity Reactions: Be aware of the signs of hypersensitivity reactions, including difficulty breathing, swelling, and severe itching. Seek immediate medical attention if these symptoms occur.
• Infections: Inform your healthcare provider of any signs of infection. Omalizumab may be associated with an increased risk of certain infections.
• Immunization: Discuss vaccinations with your healthcare provider, as Omalizumab may impact the response to certain vaccines. Live vaccines should generally be avoided.
• Malignancy: Discuss any history of cancer or concerns about malignancy risk with your healthcare provider.
• Pregnancy and Breastfeeding: Inform your healthcare provider if you are pregnant or planning to become pregnant. Use Omalizumab during pregnancy only if clearly needed, and breastfeeding should be discussed with your healthcare provider.
• Liver Function: If you have impaired liver function, exercise caution. Regular monitoring of liver function may be recommended.
• Eosinophilic Conditions: Be aware of the potential increased risk of eosinophilia. Regular monitoring may be necessary.
• Children and Adolescents: Understand that the safety and effectiveness of Omalizumab in children and adolescents for conditions other than allergic asthma have not been well established.

These side effects are often transient and may diminish with continued use. However, if any of these effects persist or worsen, it’s important to inform your healthcare provider.

Serious side effects are less common but may include:

• Chest Pain: Seek medical attention if you experience chest pain or discomfort.
• Irregular Heartbeat: Report any changes in your heartbeat to your healthcare provider.
• High Blood Pressure: In rare cases, levalbuterol can cause an increase in blood pressure.
• Allergic Reactions: Seek immediate medical attention if you experience symptoms of a serious allergic reaction, such as rash, itching, swelling, severe dizziness, or difficulty breathing.

It’s crucial to follow the prescribed dosage and instructions provided by your healthcare provider. If you are concerned about any side effects or have questions about the use of Xopenex HFA, consult with your healthcare professional. They can provide personalized guidance based on your medical history and individual health needs.

What should I know about storage and disposal of this medication?

Storage and Disposal of Omalizumab Injection:

• Storage:
  • Store Omalizumab as directed by your healthcare provider or pharmacist.
  • Generally, it may be stored in the refrigerator. Avoid freezing. Some formulations may be stored at room temperature for a short period; follow specific instructions provided with your medication.
• Handling: Handle Omalizumab with care, and ensure that it is not exposed to excessive heat, light, or vibration.
• Disposal: Dispose of used needles and syringes in a puncture-resistant container. Follow local regulations for the proper disposal of medical waste.

In case of emergency/overdose

• If you suspect an overdose or experience severe side effects, seek emergency medical attention immediately.
• Contact your local poison control center or emergency room for guidance.

What other information should I know?

• Follow-Up Appointments: Attend all scheduled follow-up appointments with your healthcare provider. Regular monitoring is essential to assess the response to treatment and manage any potential side effects.
• Inform Healthcare Providers: Inform all healthcare providers involved in your care (doctors, dentists, etc.) that you are receiving Omalizumab. This is important for coordinated care.
• Lab Tests: Your healthcare provider may order certain laboratory tests (e.g., blood tests) to monitor your response to Omalizumab and detect any potential side effects.
• Pregnancy and Breastfeeding: Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. The use of Omalizumab during pregnancy and breastfeeding should be discussed with your healthcare provider.
• Allergies: Inform your healthcare provider about any known allergies or adverse reactions to medications.
• Potential Drug Interactions: Inform your healthcare provider about all the medications, supplements, or herbal products you are taking. Some drugs may interact with Omalizumab.
• Response Time: It may take several weeks to months to experience the full benefits of Omalizumab. Continue to use it as directed by your healthcare provider, even if you do not immediately notice improvement in symptoms.
• Travel: If you plan to travel, discuss your medication schedule and any necessary accommodations with your healthcare provider. Carry a copy of your prescription and contact information for your healthcare provider.

Always consult with your healthcare provider or pharmacist for specific instructions related to the storage, disposal, and use of Omalizumab tailored to your individual circumstances.