Omalizumab

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Generic Name of Omalizumab - Learn More

Omalizumab

Omalizumab Precaution - What You Need to Know

Before starting Omalizumab, it is essential for patients to consult their healthcare provider. Omalizumab is a monoclonal antibody used to treat asthma and chronic urticaria, and it carries certain precautions that should be carefully considered:

- Anaphylaxis: One of the major precautions is the potential risk of anaphylaxis (severe allergic reactions), which can occur after administration. The first injection should be administered in a healthcare setting with immediate access to emergency medical treatment.
- Infections: Omalizumab may increase the risk of certain infections, such as parasitic infections or respiratory infections. Patients should be monitored for any signs of infection, and any ongoing or recent infections should be discussed with a healthcare provider before starting the medication.
- Pregnancy and Breastfeeding: The safety of Omalizumab during pregnancy has not been established. It is important to consult a healthcare provider to evaluate the risks and benefits. Additionally, since Omalizumab may pass into breast milk, caution should be exercised when used by nursing mothers.
- Asthma Exacerbations: Omalizumab should not be used to treat acute asthma symptoms or status asthmaticus (a severe asthma attack). It is used for long-term control, so patients should continue to use their prescribed short-acting bronchodilators for acute symptoms.
- Cardiovascular Concerns: Patients with a history of cardiovascular conditions should discuss these with their healthcare provider, as some cardiovascular adverse events (such as hypertension or angina) have been reported in patients receiving Omalizumab.

Omalizumab Indication - Uses and Benefits

Omalizumab is primarily used for the treatment of moderate to severe asthma and chronic spontaneous urticaria (chronic hives). The following are the specific indications for its use:

- Asthma: Omalizumab is used as an add-on therapy for patients with moderate to severe persistent asthma that is inadequately controlled with inhaled corticosteroids. It is used in patients with allergic asthma, where the symptoms are triggered by allergens such as dust mites, mold, or pet dander. Omalizumab helps reduce the frequency and severity of asthma attacks and may reduce the need for oral steroids.
- Chronic Urticaria: For patients with chronic spontaneous urticaria (hives), Omalizumab is used when antihistamines and other treatments have failed. It helps reduce the frequency and severity of hives and associated symptoms, providing relief when other treatments do not work effectively.
- Allergic Rhinitis: Although not FDA-approved for all forms of allergic rhinitis, Omalizumab has shown efficacy in treating seasonal or perennial allergic rhinitis in some patients, particularly in those with a history of allergic asthma.

Omalizumab Contraindications - Important Warnings

Omalizumab should not be used in the following situations:

- Hypersensitivity to Omalizumab or Components: Any patient who has a known hypersensitivity (allergic reaction) to Omalizumab or any of its components (such as maltose) should avoid this medication.
- Acute Asthma: Omalizumab is not a rescue treatment and should not be used in patients with acute asthma attacks, status asthmaticus, or severe exacerbations of asthma. It is a preventive treatment.
- Pregnancy: Omalizumab is classified as a Category B drug (which means animal studies have not shown harm, but adequate human studies are lacking). However, it should be used during pregnancy only if clearly needed and after careful evaluation by a healthcare provider.
- Severe Anaphylaxis Risk: Individuals with a history of severe reactions to monoclonal antibodies or IgE-mediated reactions should not use Omalizumab.

Omalizumab Side Effects - What to Expect

Like all medications, Omalizumab can cause side effects. While most patients tolerate the drug well, potential side effects include:

- Common Side Effects:
- Injection site reactions (e.g., pain, swelling, or redness at the site of injection).
- Headache.
- Fatigue or tiredness.
- Upper respiratory infections (such as a runny nose or sore throat).

- Serious Side Effects:
- Anaphylaxis: A severe allergic reaction that can occur after administration of Omalizumab. Symptoms include difficulty breathing, swelling of the throat, rash, and dizziness. It requires immediate medical attention.
- Cardiovascular Events: Rare instances of angina or heart attack have been reported. Patients with a history of cardiovascular disease should be monitored closely.
- Thrombocytopenia (low platelet count): In some cases, Omalizumab has been linked to a decrease in platelets, increasing the risk of bleeding.
- Malignancy: Although not directly linked to cancer, there have been isolated reports of cancers (especially lymphomas) in patients receiving Omalizumab. Long-term monitoring is advised.
- Parasite Infections: The use of Omalizumab has been associated with an increased risk of parasitic infections, especially in patients with a history of parasitic conditions.

Omalizumab Pregnancy Category ID - Safety Information

2

Omalizumab Mode of Action - How It Works

Omalizumab is a monoclonal antibody that works by inhibiting IgE, the immunoglobulin E antibody that plays a central role in allergic reactions. Specifically, Omalizumab binds to free IgE in the bloodstream, preventing it from binding to mast cells and basophils. This action reduces the release of histamine and other inflammatory mediators from these cells, which are responsible for the symptoms of allergic reactions, including asthma and urticaria. By reducing IgE levels, Omalizumab decreases the overall allergic response and helps control inflammation and symptoms like wheezing, coughing, and hives.

Omalizumab Drug Interactions - What to Avoid

Omalizumab has a relatively low potential for interactions with other medications, but certain considerations are important:

- Other Medications for Asthma: Omalizumab is often used alongside inhaled corticosteroids, bronchodilators, or other asthma medications. However, there is a possibility of an additive effect with these medications, so regular monitoring is important to avoid excessive sedation or respiratory depression.
- Immunosuppressants: Omalizumab should be used with caution in patients on immunosuppressive drugs or undergoing biologic therapy for other conditions. The combination may increase the risk of infections, including opportunistic infections.
- Vaccines: It is recommended that patients on Omalizumab stay up to date with recommended vaccinations (such as the flu vaccine), but live vaccines should be avoided during treatment, as the immune response may be altered. Speak to a healthcare provider before receiving vaccines while on Omalizumab.

Omalizumab Adult Dose - Recommended Dosage

The typical dose of Omalizumab for adults with moderate to severe asthma is based on body weight and IgE levels. The dosing schedule generally follows:

- Initial Dosing: Omalizumab is usually administered every 2 to 4 weeks depending on the patient's body weight and serum IgE levels.
- Body weight (kg) and serum IgE levels (IU/mL) are taken into account to determine the specific dose.
- Starting dose typically ranges from 75 mg to 375 mg every 2 to 4 weeks.

For chronic spontaneous urticaria, the dosing schedule for adults may follow a similar regimen, starting at 150 mg every 4 weeks and adjusted as needed.

Omalizumab Child Dose - Dosage for Children

For children (aged 6 years and older) with moderate to severe asthma, the dosing of Omalizumab is similar to adults and is based on the child’s weight and IgE levels. The usual starting dose ranges from 75 mg to 375 mg every 2 to 4 weeks, depending on the individual characteristics.

Omalizumab can be used in children with allergic asthma, but it should only be initiated by an experienced healthcare provider, with careful monitoring throughout treatment.

Omalizumab Renal Dose - Dosage for Kidney Conditions

Currently, there are no significant renal dose adjustments for Omalizumab, as it is not primarily excreted by the kidneys. However, caution should be exercised in patients with severe renal impairment, and close monitoring of side effects is recommended.