Introduction

Tazumab IV Infusion 440 mg/20 ml is a monoclonal antibody used in the treatment of HER2-positive breast cancer and other HER2-overexpressing cancers. It specifically targets the HER2 receptor, a protein found in high quantities on some cancer cells, which promotes their growth. Tazumab IV Infusion 440 mg/20 ml is used either alone or in combination with other chemotherapy drugs.

Uses

Tazumab IV Infusion 440 mg/20 ml is primarily used for:

  • Treatment of HER2-positive breast cancer
  • Treatment of HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma
  • Adjuvant therapy for early-stage HER2-positive breast cancer
  • Treatment of HER2-positive metastatic breast cancer

Brand Name Tazumab
Type IV Infusion
Weight 440 mg/20 ml
Generic Trastuzumab
Manufacturer Drug International Ltd.
Available in English বাংলা

Mechanism of Action

Tazumab IV Infusion 440 mg/20 ml binds to the extracellular domain of the HER2 receptor on cancer cells, inhibiting cell proliferation by preventing HER2 receptor signaling. It also mediates antibody-dependent cellular cytotoxicity (ADCC), wherein the immune system targets and destroys HER2-positive cancer cells. This dual action helps control the growth of tumors that overexpress the HER2 protein.

How Long Does It Take to Work?

The onset of action depends on the stage and type of cancer being treated. Some patients may notice effects within weeks, while others may require longer treatment periods before noticeable clinical responses are observed. Regular monitoring and imaging tests are used to assess efficacy.

Absorption

Tazumab IV Infusion 440 mg/20 ml is administered intravenously, so it is immediately available in the bloodstream. The absorption is bypassed as it is directly infused into the circulatory system.

Route of Elimination

Tazumab IV Infusion 440 mg/20 ml is cleared from the body primarily via the reticuloendothelial system. It undergoes proteolytic degradation into smaller peptides and amino acids, and renal excretion is not a major pathway for its elimination.

Dosage

The dosage of trastuzumab varies depending on the indication:

  • For HER2-positive breast cancer (adjuvant setting): Initial loading dose of 8 mg/kg IV, followed by 6 mg/kg IV every three weeks for a total of one year or until disease progression.
  • For HER2-positive metastatic breast cancer: Loading dose of 4 mg/kg IV, followed by 2 mg/kg IV weekly or 6 mg/kg IV every three weeks.
  • For HER2-positive gastric cancer: Initial dose of 8 mg/kg IV, followed by 6 mg/kg IV every three weeks.
Dosage should be adjusted based on tolerance and response to therapy.

Administration

Tazumab IV Infusion 440 mg/20 ml is administered via intravenous infusion. The initial dose is infused over 90 minutes, and if well tolerated, subsequent doses can be given over 30 minutes. Healthcare professionals should monitor the patient during and after the infusion for any adverse reactions.

Side Effects

Common side effects of trastuzumab include:

  • Fever
  • Nausea
  • Fatigue
  • Chills
  • Headache
  • Rash
  • Diarrhea
Serious side effects include:
  • Cardiotoxicity (heart failure)
  • Infusion reactions (fever, chills, breathing difficulties)
  • Pulmonary toxicity
  • Hypersensitivity reactions

Toxicity

Tazumab IV Infusion 440 mg/20 ml's primary toxicities include cardiotoxicity, which can result in decreased left ventricular ejection fraction and heart failure, particularly when used with anthracycline-based chemotherapy. Monitoring of cardiac function is essential during treatment.

Precautions

Precautions include:

  • Monitor cardiac function before and during therapy, especially in patients with pre-existing heart disease.
  • Careful monitoring for infusion reactions and pulmonary toxicity is required.
  • Discontinue trastuzumab if severe infusion reactions occur.

Interaction

Tazumab IV Infusion 440 mg/20 ml may interact with:

  • Anthracycline chemotherapy agents (increased risk of cardiotoxicity)
  • Other immunotherapy drugs
  • Radiation therapy (increased risk of lung injury)

Disease Interaction

Tazumab IV Infusion 440 mg/20 ml should be used cautiously in patients with:

  • Pre-existing cardiac disease, especially heart failure
  • Pulmonary conditions, including interstitial lung disease

Drug Interaction

Concomitant use with other cardiotoxic drugs, such as anthracyclines (e.g., doxorubicin), can increase the risk of heart failure. Combining trastuzumab with chemotherapy may enhance its effectiveness but also increase the risk of adverse effects.

Food Interactions

No significant food interactions are reported with trastuzumab. However, patients should follow their healthcare provider’s dietary recommendations, especially regarding heart health and general well-being during cancer treatment.

Pregnancy Use

Tazumab IV Infusion 440 mg/20 ml is categorized as a Pregnancy Category D drug by the FDA. It can cause fetal harm, including oligohydramnios (reduced amniotic fluid), renal issues, and fetal death. It is contraindicated during pregnancy unless the potential benefit outweighs the risk. Effective contraception should be used during and for at least seven months after treatment.

Lactation Use

It is not known whether trastuzumab is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued during trastuzumab therapy and for at least seven months after the last dose.

Acute Overdose

There is limited information regarding trastuzumab overdose. In case of overdose, patients should be closely monitored for signs of toxicity, particularly cardiotoxicity and infusion reactions, and symptomatic treatment should be provided.

Contraindication

Tazumab IV Infusion 440 mg/20 ml is contraindicated in patients with:

  • Known hypersensitivity to trastuzumab or any component of the formulation
  • Severe cardiac impairment (e.g., uncontrolled heart failure)

Use Direction

Tazumab IV Infusion 440 mg/20 ml is to be used under the supervision of a healthcare professional experienced in the administration of cancer therapies. Dosages and schedules should be followed as per the healthcare provider's instructions, with regular monitoring for side effects and treatment response.

Storage Conditions

Tazumab IV Infusion 440 mg/20 ml should be stored in a refrigerator at 2-8°C (36-46°F) and protected from light. It should not be frozen or shaken. After reconstitution, it can be stored for up to 24 hours at 2-8°C, but must be used within this time frame.

Volume of Distribution

The volume of distribution of trastuzumab is approximately 44 mL/kg, indicating it primarily remains within the vascular compartment and extracellular fluid spaces.

Half Life

The half-life of trastuzumab ranges from 5 to 12 days, depending on the dose and frequency of administration. In metastatic breast cancer, the half-life is generally longer, around 28.5 days, with continued use.

Clearance

Tazumab IV Infusion 440 mg/20 ml is cleared via the reticuloendothelial system. Its clearance decreases with increasing doses and is influenced by body weight and disease burden, as well as by factors such as pre-existing cardiac conditions.

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