Omalizumab

Omalizumab (Omalizumab) is a medicine used to treat certain allergic diseases such as allergic asthma and allergic rhinitis (seasonal or year-round). It is a monoclonal antibody that blocks the action of immunoglobulin E (IgE), an important mediator of allergic reactions.

The action of omalizumab is that it binds to IgE in blood and inhaled allergens, preventing their interaction with mastocytes and basophils, which play a key role in the development of allergic reactions. This helps reduce symptoms of allergic asthma and rhinitis such as itching, mucous membrane swelling, coughing and breathing difficulties.

Omalizumab is usually used in patients in whom allergies cause severe symptoms and satisfactory control of symptoms cannot be achieved with other medications. The dosage and regimen of omalizumab is determined by a physician and may vary depending on the patient's specific situation.

Indications Omalizumab

Omalizumab (Omalizumab) is used to treat the following conditions:

1. AllergicAsthma: Omalizumab is used to manage symptoms of allergic asthma in patients who have:

   • Asthma is seasonal or persistent.
   • Asthma symptoms are not controlled by standard medications, including inhaled glucocorticosteroids.
   • There is a positive allergy test for certain allergens.
   • IgE (immunoglobulin E) levels in the blood meet the recommended values for prescribing the medicine.

2. Chronic idiopathic urticaria: Omalizumab may be used to treat chronic idiopathic urticaria (urticaria of unknown origin) in patients whose symptoms cannot be controlled with standard antihistamines.

When considering treatment with omalizumab, it is always advisable to consult with an allergist or pulmonologist who will evaluate the indications and decide if this medication is appropriate for the individual patient. Omalizumab is usually only prescribed if standard medications are not effective and if there are appropriate allergic and immunologic indications.

Release form

Omalizumab (Omalizumab) is available as a solution for injection. This solution is for intravenous (IV) injection and is available in special syringes or ampoules.

The dosage and dosage form of omalizumab may vary by country and manufacturer. Patients usually receive omalizumab injections from a doctor or medical staff, as they must be administered intravenously and under medical supervision.

It is important to follow your doctor's recommendations regarding the dosage and frequency of omalizumab administration, as these may vary depending on the specific indications and needs of the patient. Treatment with omalizumab is usually administered under strict medical supervision to maximize safety and efficacy.

Pharmacodynamics

The pharmacodynamics of omalizumab include the following highlights:

1. Inhibition of immunoglobulin E (IgE) binding: Omalizumab binds to IgE molecules, which play an important role in allergic reactions. It prevents IgE from binding to their receptors on the surface of mastocytes and basophils.
2. Reducing the release of inflammatory mediators: By binding IgE and inhibiting mastocytes and basophils, omalizumab reduces the release of inflammatory mediators such as histamine, leukotrienes, and prostaglandin.
3. Reduction of inflammatory responses: Reducing the release of inflammatory mediators leads to a reduction in the symptoms of allergic asthma and chronic urticaria. Omalizumab helps control allergic reactions and reduces the frequency and severity of exacerbations.

The pharmacodynamics of omalizumab can reduce the body's sensitivity to allergens and improve the quality of life of patients with allergic diseases. Treatment with omalizumab is usually prescribed by a physician and monitored throughout the course of treatment for optimal results.

Pharmacokinetics

The pharmacokinetics of omalizumab (Omalizumab) are generally characterized as follows:

1. Intravenous administration: Omalizumab is given intravenously, which is usually given by a doctor or medical staff.
2. Metabolism and excretion: The drug is normally metabolized in the body and excreted through the kidneys. Omalizumab is slowly metabolized, which contributes to its prolonged action.
3. Duration of action: The effect of a single injection of omalizumab may last for several weeks. Therefore, treatment is usually given at intervals to be adjusted by the doctor.
4. Blood levels: Blood levels of omalizumab are usually monitored by a physician to ensure that therapeutic concentrations of the drug are effectively maintained.
5. Individual Differences: The pharmacokinetics of omalizumab may vary from patient to patient and may be affected by factors such as patient weight, IgE levels, and other factors.
6. Regularity of administration: It is important to take omalizumab regularly as prescribed by your doctor to maximize the effectiveness of treatment.

Treatment with omalizumab is usually carried out under strict medical supervision, and patients should follow all of their doctor's recommendations regarding dosage and intervals between injections. This helps to maximize the benefits of treatment and minimize the risks of possible side effects.

Dosing and administration

The dosage and route of administration of omalizumab (Omalizumab) may vary depending on the individual patient and the nature of the disease for which the drug is prescribed. Omalizumab is usually administered by your doctor as a subcutaneous (under the skin) injection. Here are general recommendations for dosage and route of administration:

1. Asthma:

   • For adults and adolescents over 12 years of age with severe allergic asthma, the dosage is usually 150-375 mg (depending on weight and IgE levels) subcutaneously once every 2-4 weeks.
   • For children 6 to 12 years of age with severe allergic asthma, the dosage depends on weight and IgE levels and is usually 75 to 150 mg subcutaneously once every 2 to 4 weeks.

2. Allergic rhinitis and urticaria:

   • For adults and adolescents over 12 years of age with allergic rhinitis or urticaria, the dosage is usually 150-375 mg (depending on weight and IgE levels) subcutaneously once every 2-4 weeks.
   • For children 6 to 12 years of age with allergic rhinitis, the dosage depends on weight and IgE levels and is usually 75 to 150 mg subcutaneously once every 2 to 4 weeks.

Always follow your doctor's recommendations for the exact dosage and schedule of omalizumab, as they can be individualized to your specific situation and needs. Omalizumab injections are usually administered by medical staff in a clinic or hospital, but in some cases your doctor may be able to train you to administer the drug subcutaneously yourself if the necessary equipment and skills are available.

Use Omalizumab during pregnancy

The use of omalizumab (Omalizumab) during pregnancy should be considered with caution and the decision to prescribe this drug should be made after careful discussion with your doctor. The use of omalizumab in pregnant women may arise if the benefits of treatment outweigh the potential risks to the mother and fetus.

It is important to consider the following points:

1. Indications: Omalizumab is usually prescribed when allergic asthma or chronic idiopathic urticaria cannot be controlled with standard medications. The physician should assess how severe and uncontrollable the symptoms are in a pregnant woman and, based on this assessment, decide whether omalizumab is appropriate.
2. Potential risks: There is limited information on the safety of omalizumab for the fetus, animal studies have shown no teratogenic effects, but data on its effects in pregnant women are insufficient. Therefore, the potential risks to the fetus and pregnant woman should be carefully evaluated by a physician.
3. Monitoring: If omalizumab has been prescribed during pregnancy, the woman should receive medical monitoring and supervision by a doctor throughout the pregnancy.
4. Risk of anaphylaxis: There is a risk of anaphylactic reactions to omalizumab and pregnant women should be alert to this. If any symptoms of an allergic reaction occur, including rash, swelling, difficulty breathing, or redness of the skin, medical attention should be sought immediately.

The decision to use omalizumab during pregnancy should be individualized and based on a careful assessment of benefits and risks in each case. Pregnant women and their physicians should make informed treatment decisions together.

Contraindications

Contraindications to the use of omalizumab (Omalizumab) may include the following conditions or situations:

1. Individual intolerance: If a patient has a known individual intolerance to omalizumab or any of its components, the drug is contraindicated.
2. Serious allergic reactions: If the patient has a history of serious allergic reactions to omalizumab or similar biologics, the use of omalizumab may be contraindicated.
3. Adolescents under 12 years of age: In some countries, omalizumab is not recommended for children under 12 years of age or its safety and efficacy in this age group have not been established. However, in some cases, a doctor may decide to prescribe omalizumab to younger children if it is considered necessary and safe to do so.
4. Pregnancy and breastfeeding: The use of omalizumab in pregnant women or during breastfeeding may require special attention and consideration of benefits and risks under medical supervision. The drug should be administered only when the benefit to the mother outweighs the potential risks to the fetus or child during breastfeeding.
5. Serious infections: Omalizumab may worsen the control of some infections, so its use may be contraindicated in the presence of serious infections. The doctor should assess the patient's condition and decide whether treatment with omalizumab is appropriate in this case.

Patients should always discuss their medical status and medical history with their doctor to ensure that omalizumab is safe and appropriate for their particular situation. The decision to initiate or discontinue omalizumab treatment should be made by a physician based on individual clinical circumstances.

Side effects Omalizumab

Omalizumab (Omalizumab) may cause various side effects, although they may not occur in all patients. Side effects may include:

1. Injection site reactions: These may include pain, redness, itching, swelling or hypersensitivity at the injection site. These symptoms are usually mild and temporary.
2. Anapylaxis: Very rarely, omalizumab may cause anaphylactic reactions, which are severe allergic reactions. Symptoms of anaphylaxis include difficulty breathing, swelling, skin rashes, dizziness, and decreased blood pressure. These reactions require immediate medical attention and possibly discontinuation of omalizumab.
3. Upper respiratory tract infections: Some patients receiving omalizumab may experience more frequent upper respiratory tract infections such as runny nose, cough, and sore throat.
4. Abdominalpain: Abdominal pain, nausea, vomiting, and diarrhea may occur in some patients receiving omalizumab.
5. Skin reactions: Rash, itching, or skin rashes may occur.
6. Headache: Some patients may experience headaches.
7. Reduced platelet count: In rare cases, omalizumab may cause a decrease in the number of platelets in the blood (thrombocytopenia).
8. Other rare side effects: These may include changes in liver function, asthenic syndrome (weakness and fatigue), back pain, etc.

It is important to note that not all patients receiving omalizumab will have side effects, and most side effects are usually easily manageable and temporary. It is always important to discuss any unusual symptoms or reactions with the doctor who prescribed omalizumab treatment and follow their recommendations for monitoring and managing side effects.

Overdose

An overdose of omalizumab (Omalizumab) is extremely rare, as doses are usually calculated individually for each patient and prescribed by a medical specialist. However, if too high a dose of omalizumab is accidentally administered, side effects similar to those that may occur with standard doses of the drug may occur.

If you suspect an overdose of omalizumab or if serious adverse reactions occur after its administration, it is important to seek medical attention immediately. Treatment of the overdose will focus on relieving symptoms and keeping the patient stable. This may include symptomatic treatment of allergic reactions or other unwanted effects.

It is important to always follow your doctor's recommendations on the dosage and route of administration of omalizumab and not to administer large amounts of the drug without his or her approval. If you have any questions or concerns about omalizumab treatment, discuss them with your doctor.

Interactions with other drugs

Omalizumab (Omalizumab) is a monoclonal antibody for the treatment of allergic asthma and allergic rhinitis. It has no known serious interactions with other medicines. However, as with any medication, it is important to discuss all medications you are taking with your doctor to make sure they are safe and compatible with omalizumab.

Some patients receiving omalizumab may reduce the use of other medicines, such as glucocorticosteroid inhalers and bronchodilators, because omalizumab may improve control of asthma symptoms. It is important to discuss any changes in treatment with your doctor and not to change the dosage of other medicines without his or her permission.

You should also tell your doctor about any other medications, vitamins, supplements, or herbal remedies you are taking so that he or she can evaluate possible interactions and take the necessary precautions.

Storage conditions

It is important to store omalizumab according to the manufacturer's recommendations, usually between 2°C and 8°C (36°F to 46°F), and to avoid freezing the drug.

Shelf life

The expiration date of omalizumab (Omalizumab) may vary depending on the manufacturer and the form of the drug (e.g. Ampoules, vials). Usually, the expiration date is indicated on the drug package or label.

The expiration date should be strictly observed, as the efficacy and safety of the drug may decrease after its expiry. If the expiration date of omalizumab has expired, you should contact your healthcare provider or pharmacy to obtain a new package with an up-to-date expiration date.