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Overview

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This medicine contains an important and useful components, as it consists of
Bismuth Subcitrate Potassium, Tetracycline Hydrochloride, Metronidazoleis available in the market in concentration

Name

Trastuzumab

Precaution

Before initiating **Trastuzumab**, it is important for patients to consult their healthcare provider, particularly if they have any of the following conditions: - **Cardiovascular Disease**: **Trastuzumab** can cause heart problems, including **congestive heart failure** (CHF), **decreased left ventricular ejection fraction (LVEF)**, and **cardiomyopathy**. Patients with existing heart conditions or a history of heart failure should be closely monitored during treatment. Pre-treatment cardiac assessment and regular follow-up monitoring are essential. - **Pregnancy and Lactation**: **Trastuzumab** is classified as **Pregnancy Category D** (risk to the fetus), meaning it should only be used during pregnancy if absolutely necessary. It is excreted in breast milk, so it is advised that breastfeeding should be avoided during treatment and for at least **6 months** after discontinuation. - **Liver Dysfunction**: Patients with **liver disease** or **liver dysfunction** should use **Trastuzumab** with caution, as it may increase the risk of liver toxicity. - **Allergic Reactions**: Severe allergic reactions, such as **hypersensitivity**, may occur. Patients with known hypersensitivity to **Trastuzumab** or any of its components should avoid using the drug. - **Pulmonary Toxicity**: **Trastuzumab** can rarely cause **pulmonary toxicity**. It is crucial to monitor patients for respiratory symptoms such as **cough** or **shortness of breath**.

Indication

**Trastuzumab** is a monoclonal antibody that is primarily used in the treatment of certain types of cancer, specifically those that overexpress the **HER2 (human epidermal growth factor receptor 2)** protein: - **Breast Cancer**: It is indicated for the treatment of **HER2-positive breast cancer**. This includes: - **Early-stage HER2-positive breast cancer** (after surgery) as part of adjuvant therapy. - **Metastatic HER2-positive breast cancer**, either alone or in combination with chemotherapy agents like **paclitaxel** or **docetaxel**. - **Recurrent HER2-positive breast cancer** that has spread to other areas of the body. - **Gastric Cancer**: **Trastuzumab** is also used in combination with chemotherapy to treat **HER2-positive gastric (stomach) cancer**, particularly in patients with **advanced or metastatic gastric cancer**.

Contra indication

**Trastuzumab** should not be used in the following situations: - **Known Hypersensitivity**: Patients who are allergic to **Trastuzumab** or any of its components should not receive the medication. - **Severe Cardiac Dysfunction**: **Trastuzumab** is contraindicated in patients with **severe heart failure** or **left ventricular dysfunction** due to the risk of exacerbating **cardiomyopathy** or causing **heart failure**. - **Pregnancy**: As **Trastuzumab** can cause harm to the fetus, it is contraindicated in pregnancy unless the benefits outweigh the risks. If pregnancy occurs during treatment, the drug should be discontinued immediately.

Side Effect

Common and severe side effects of **Trastuzumab** include: - **Common Side Effects**: - **Fatigue**: Many patients experience **fatigue** during treatment with **Trastuzumab**. - **Nausea and Vomiting**: These are frequent side effects, especially when used in combination with chemotherapy. - **Fever and Chills**: Infusion reactions can result in fever, chills, or rigors, particularly during the initial infusion. - **Diarrhea**: Diarrhea can occur in some patients, often with chemotherapy regimens. - **Serious Side Effects**: - **Cardiac Toxicity**: **Trastuzumab** can cause heart problems, including **congestive heart failure**, **left ventricular dysfunction**, and **arrhythmias**. Regular cardiac monitoring is required. - **Pulmonary Issues**: Rare but severe **pulmonary toxicity** can occur, presenting as cough, dyspnea, or respiratory distress. - **Severe Infusion Reactions**: Some patients may experience **severe infusion-related reactions**, which can include difficulty breathing, low blood pressure, or anaphylactic reactions. - **Hematologic Issues**: **Anemia**, **leukopenia**, or **neutropenia** may occur, especially when used with chemotherapy agents.

Pregnancy Category ID

4

Mode of Action

**Trastuzumab** is a **monoclonal antibody** that specifically targets the **HER2** receptor, a protein overexpressed on the surface of some cancer cells, particularly in **HER2-positive breast cancer** and **gastric cancer**: - **HER2 Receptor Inhibition**: **Trastuzumab** binds to the extracellular portion of the **HER2 receptor** and blocks its activation. By doing so, it inhibits the signaling pathways that promote cancer cell growth and survival. - **Antibody-Dependent Cellular Cytotoxicity (ADCC)**: **Trastuzumab** also stimulates the immune system, leading to **antibody-dependent cellular cytotoxicity (ADCC)**. This process enhances the immune system’s ability to recognize and destroy HER2-positive cancer cells. - **Inhibition of Tumor Growth**: Through blocking HER2 signaling and stimulating immune responses, **Trastuzumab** impedes tumor cell proliferation and can help shrink tumors.

Interaction

**Trastuzumab** may interact with other medications, affecting either its effectiveness or causing potential side effects: - **Chemotherapy**: When used with chemotherapy agents like **taxanes** (e.g., **paclitaxel**) or **anthracyclines** (e.g., **doxorubicin**), there may be an increased risk of **cardiovascular toxicity**, especially heart-related issues. Cardiac monitoring is essential. - **Cardiotoxic Drugs**: Combining **Trastuzumab** with other drugs that cause heart damage, such as **doxorubicin**, **cyclophosphamide**, or other **anthracyclines**, can increase the risk of **heart failure**. Close monitoring of cardiac function is required. - **Vaccines**: Immunosuppressive effects from **Trastuzumab** could reduce the effectiveness of **live vaccines**. Patients should avoid receiving live vaccines during treatment. - **Other HER2-targeting Drugs**: Concomitant use with other **HER2-targeted therapies** (e.g., **lapatinib**, **pertuzumab**) may have an additive effect on the risk of **cardiovascular issues** or other side effects, so careful evaluation is needed before co-administration.

Pregnancy Category Note

Information not available

Adult Dose

The typical dosing for **Trastuzumab** varies based on the treatment regimen and the type of cancer: - **Initial Dose**: The **initial dose** of **Trastuzumab** is typically **8 mg/kg** of body weight, administered intravenously. - **Subsequent Doses**: Following the initial dose, the maintenance dose is usually **6 mg/kg** every **3 weeks** via intravenous infusion. For patients on **weekly therapy**, the dose is typically reduced to **2 mg/kg** once a week. - **Gastric Cancer**: The dosing for **gastric cancer** is similar, with an initial dose of **8 mg/kg**, followed by **6 mg/kg** every 3 weeks.

Child Dose

**Trastuzumab** is not commonly prescribed for pediatric patients, and its use in children has not been extensively studied. However, in cases where **HER2-positive cancers** are diagnosed in children, dosing is often based on body weight and follows similar guidelines as for adults. Pediatric use should be considered only under the care of a specialist with experience in **pediatric oncology**. **Consultation with a healthcare provider** is essential before starting **Trastuzumab** therapy, as the medication requires careful monitoring for **cardiovascular side effects**, **infusion reactions**, and other complications, depending on the specific cancer being treated.

Renal Dose

There is no specific dose adjustment required for **Trastuzumab** in patients with renal impairment, as the drug is not primarily excreted through the kidneys. However, patients with severe **renal dysfunction** should be monitored closely for side effects, and dose adjustments should be considered if other concurrent treatments are affecting renal function.

Administration

Information not available