Cabazitaxel Injection 60mg/1.5ml Technical Specification: 

Product Name:Cabazitaxel Injection 
Brand Name:Qtervaxia
Strength:60mg/1.5ml
Dosage Form:Liquid Injection
Packing:SINGLE USE VIAL
Route of Administration:For Intravenous Infusion only after Second Dilution
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Cabazitaxel injection is given together with a steroid medicine to treat men with metastatic (cancer that has already spread) castration-resistant prostate cancer (prostate cancer that cannot be treated by surgery or medicines that lower testosterone). Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of cancer cells.
Storage:Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Do not refrigerate.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Cabazitaxel Injection 60mg/1.5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cabazitaxel Injection 60mg/1.5ml
    Each vial OF 1.5ml of concentrate contains:
    Cabazitaxel…………………………60mg
    Excipients……………………………q.s.
  • Diluent for Cabazitaxel Injection
    Each vial contains:
    5.7ml of 13% (w/w) ethanol in water for Injection.

THERAPEUTIC INDICATION:

Cabazitaxel injection is given together with a steroid medicine to treat men with metastatic (cancer that has already spread) castration-resistant prostate cancer (prostate cancer that cannot be treated by surgery or medicines that lower testosterone). Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of cancer cells.

PACKING:

  • 60mg/1.5ml

DIRECTION OF USE:

For Intravenous Infusion only after Second Dilution

When diluted with the Diluent, the first diluted solution contains 10mg/vial of cabazitaxel.

Two-step dilution required: 

First Dilution: Add entire contents of the diluent (approximately 5.7 ml) to cabazitaxel to obtain a concentration of 10mg/ml.

Second Dilution: Withdraw the exact volume required from the 10mg/ml solution and dilute into 0.9% Sodium chloride or 5% dextrose solution to prepare the final infusion solution.

See package insert for full dilution information.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter. 

CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.

DO NOT USE PVC INFUSION CONTAINERS OR POLYURETHANE INFUSIONS SETS FOR PREPRATION AND ADMINISTRATION OF CABAZITAXEL SOLUTION.

For Intravenous Infusion only after Second Dilution

WARNING: Cytotoxic Agent – To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution. 

Cytotoxic Agent: Wear gloves at all times when handling containers. 

Keep out of reach of children

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Do not refrigerate.

Dosage: As directed by the Oncologist

Why Taj Pharmaceuticals?

Taj Pharma is your trusted source for Cabazitaxel Injection. Our unwavering commitment to pharmaceutical excellence, affordability, and patient well-being makes us the preferred choice for this critical medication. Choose Taj Pharma for your Cabazitaxel Injection needs and experience the following compelling reasons why we are your preferred partner in healthcare:

  • Pharmaceutical Excellence: Taj Pharma has a long-standing reputation for delivering pharmaceutical excellence. Our Cabazitaxel Injection undergoes rigorous quality control measures at every stage of production, ensuring it meets the highest industry standards. You can trust the purity, safety, and effectiveness of our medication.
  • Patient-Centric Approach: We prioritize patient well-being above all else. Our dedicated customer support team is here to assist you throughout your journey, providing information, answering your questions, and ensuring a seamless experience from order to delivery. Your health and comfort are our utmost concern.
  • Affordable Access: We understand the financial challenges that come with critical medical treatments. Taj Pharma is committed to offering competitive pricing on Cabazitaxel Injection, making it accessible to patients without compromising on quality. We believe that every patient should have access to the best possible care.

When it comes to Cabazitaxel Injection, Taj Pharma combines pharmaceutical excellence with a patient-centric approach and affordability. Trust us as your reliable source for this essential medication, and let us support you on your path to better health.

Cabazitaxel Injection is a medication used in the treatment of advanced or metastatic prostate cancer. It is specifically indicated for use in prostate cancer that has progressed despite treatment with other medications, including docetaxel, another chemotherapy drug commonly used for prostate cancer. Here’s an overview of its use:

Indications and Uses:

Cabazitaxel Injection is primarily used in the treatment of castration-resistant prostate cancer (CRPC) that has spread to other parts of the body and is no longer responding to hormonal therapies like androgen deprivation therapy (ADT). It is often used when the cancer has progressed despite treatment with docetaxel.

The use of Cabazitaxel Injection is determined by oncologists and healthcare professionals based on the specific stage and characteristics of the prostate cancer, as well as the patient’s overall health and treatment history. It is typically administered as an intravenous (IV) infusion and is an important option for patients with advanced prostate cancer that has become resistant to other treatments. Cabazitaxel Injection can have side effects, and its use requires careful medical supervision to manage potential adverse effects and optimize treatment outcomes. Patients receiving this medication should have regular check-ups and discussions with their healthcare team to assess their progress and any necessary adjustments to their treatment plan.

How does Cabazitaxel Injection Work?

Cabazitaxel Injection works by interfering with the growth and division of cancer cells, specifically in the treatment of advanced or metastatic prostate cancer. Its mechanism of action is similar to that of other taxane chemotherapy drugs. Here’s how Cabazitaxel works:

  • Microtubule Stabilization: Inside cells, there are structures called microtubules that play a crucial role in cell division (mitosis). Microtubules are like the cell’s “skeleton,” providing structural support and serving as tracks along which cellular components move during cell division.
  • Binding to Tubulin: Cabazitaxel binds to the protein tubulin, which is a major component of microtubules. By attaching to tubulin, Cabazitaxel stabilizes microtubules, preventing them from disassembling and reassembling as they normally do during cell division.
  • Inhibition of Mitosis: When microtubules are stabilized by Cabazitaxel, they cannot properly organize and separate chromosomes during cell division. This disruption leads to the arrest of the cell cycle and prevents cancer cells from dividing.
  • Apoptosis Induction: Cabazitaxel also has the ability to induce apoptosis, which is programmed cell death. This process helps eliminate cancer cells from the body.

In summary, Cabazitaxel Injection disrupts the microtubule dynamics necessary for cancer cell division and growth. By stabilizing microtubules and preventing their proper functioning, Cabazitaxel inhibits mitosis, leading to the inhibition of cancer cell replication and, in some cases, the induction of cell death. This mechanism of action makes Cabazitaxel an effective treatment option for advanced prostate cancer that is resistant to other therapies.

However, it’s important to note that Cabazitaxel treatment can also affect normal, healthy cells in the body, leading to potential side effects. Therefore, its use requires careful medical monitoring and management to balance the benefits of treatment with the potential risks.

Benefits of Cabazitaxel Injection:

  • Treatment of Advanced Prostate Cancer: Cabazitaxel Injection is a valuable treatment option for individuals with advanced or metastatic prostate cancer that has progressed despite other therapies, including docetaxel. It can help slow down the progression of the disease and improve overall survival rates.
  • Potential for Extended Survival: Clinical trials have shown that Cabazitaxel, when used in the appropriate patient population, can extend overall survival compared to other treatments. This offers hope and additional time for those with advanced prostate cancer.

Common Side Effects of Cabazitaxel Injection:

  • Neutropenia: A decrease in white blood cell count (neutropenia) is a common side effect of Cabazitaxel. This can increase the risk of infections, so regular blood tests are necessary to monitor white blood cell levels.
  • Anemia: Cabazitaxel can lead to a decrease in red blood cell count (anemia), which may result in fatigue, weakness, and shortness of breath.
  • Thrombocytopenia: A drop in platelet count (thrombocytopenia) can occur, which may increase the risk of bleeding or bruising.
  • Nausea and Vomiting: Gastrointestinal symptoms, including nausea and vomiting, can occur. Medications may be prescribed to manage these symptoms.
  • Diarrhea: Some individuals may experience diarrhea, which can be mild to moderate in severity.
  • Fatigue: Fatigue and weakness are common side effects of chemotherapy, including Cabazitaxel.
  • Peripheral Neuropathy: Peripheral neuropathy may cause tingling, numbness, or pain in the hands and feet.
  • Hair Loss: Hair loss (alopecia) is a possible side effect of Cabazitaxel, but hair typically grows back after treatment is completed.

Less Common but Serious Side Effects:

  • Allergic Reactions: In rare cases, Cabazitaxel can cause severe allergic reactions. Signs of an allergic reaction may include hives, difficulty breathing, swelling of the face or throat, and severe dizziness. Seek immediate medical attention if these symptoms occur.
  • Kidney and Liver Function: Cabazitaxel may affect kidney and liver function, so regular monitoring of these organ systems is necessary during treatment.
  • Gastrointestinal Issues: Severe diarrhea and gastrointestinal perforation are rare but serious side effects that require prompt medical attention.
  • Bone Marrow Suppression: Cabazitaxel can suppress the bone marrow’s ability to produce blood cells, leading to an increased risk of infections, anemia, and bleeding.

The benefits of Cabazitaxel treatment often outweigh the potential side effects for individuals with advanced prostate cancer that has not responded to other treatments. However, treatment with Cabazitaxel requires close medical monitoring and management to address side effects and ensure the best possible outcome for the patient. Patients should discuss potential risks and benefits with their healthcare provider.

Frequently asked questions (FAQs) about Cabazitaxel Injection:

  1. What is Cabazitaxel Injection used to treat?

Cabazitaxel Injection is used to treat advanced or metastatic prostate cancer that has progressed despite other treatments, including docetaxel chemotherapy.

  1. How is Cabazitaxel Injection administered?

Cabazitaxel is administered through intravenous (IV) infusion by healthcare professionals in a clinical setting. The dosage and infusion schedule are determined by the treating oncologist.

  1. Are there alternative treatments for advanced prostate cancer besides Cabazitaxel?

Yes, there are alternative treatments, including other chemotherapy drugs, targeted therapies, immunotherapies, and hormonal therapies. The choice of treatment depends on various factors, such as the patient’s health, previous treatments, and the stage of the cancer.

  1. What are the common side effects of Cabazitaxel Injection?

Common side effects may include neutropenia (low white blood cell count), anemia, thrombocytopenia (low platelet count), nausea, vomiting, diarrhea, fatigue, peripheral neuropathy, and hair loss.

  1. How often will I need to receive Cabazitaxel infusions?

The frequency of Cabazitaxel infusions depends on your treatment plan, which is determined by your oncologist. Typically, infusions are given every three weeks.

  1. Is Cabazitaxel suitable for all prostate cancer patients with disease progression?

Cabazitaxel is specifically indicated for patients with advanced prostate cancer that has progressed despite previous treatments, including docetaxel. Its use is determined by the oncologist based on individual patient characteristics and treatment history.

  1. What should I do if I experience severe side effects while on Cabazitaxel treatment?

It’s essential to report any severe side effects to your healthcare provider immediately. They can provide guidance on managing side effects and may adjust your treatment plan as needed

  1. Can I continue with my daily activities during Cabazitaxel treatment?

Fatigue is a common side effect of chemotherapy, including Cabazitaxel. It’s important to listen to your body and get adequate rest. Your ability to perform daily activities may vary depending on how you feel during treatment.

  1. Are there any special precautions I should take during Cabazitaxel treatment?

Due to the risk of neutropenia and infections, it’s important to take precautions to minimize the risk of infection. This may include practicing good hand hygiene and avoiding crowded or sick individuals.

  1. Is Cabazitaxel safe for use in elderly patients?

Cabazitaxel can be used in elderly patients with advanced prostate cancer; however, the treatment plan may be adjusted based on the patient’s overall health and tolerance to the medication.

As Cabazitaxel Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Cabazitaxel Injection product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Cabazitaxel Injection Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of  Cabazitaxel Injection, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

Cabazitaxel Injection 60mg/1.5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Cabazitaxel Injection 60mg/1.5ml
Each vial OF 1.5ml of concentrate contains:
Cabazitaxel………………………...60mg
Excipients…………………………...q.s.

Diluent for Cabazitaxel Injection
Each vial contains:
5.7ml of 13% (w/w) ethanol in water for Injection.

THERAPEUTIC INDICATION:

Cabazitaxel injection is given together with a steroid medicine to treat men with metastatic (cancer that has already spread) castration-resistant prostate cancer (prostate cancer that cannot be treated by surgery or medicines that lower testosterone). Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of cancer cells.

PACKING:

60mg/1.5ml

DIRECTION OF USE:

For Intravenous Infusion only after Second Dilution
When diluted with the Diluent, the first diluted solution contains 10mg/vial of cabazitaxel.
Two-step dilution required:
First Dilution: Add entire contents of the diluent (approximately 5.7 ml) to cabazitaxel to obtain a concentration of 10mg/ml.
Second Dilution: Withdraw the exact volume required from the 10mg/ml solution and dilute into 0.9% Sodium chloride or 5% dextrose solution to prepare the final infusion solution.
See package insert for full dilution information.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
DO NOT USE PVC INFUSION CONTAINERS OR POLYURETHANE INFUSIONS SETS FOR PREPRATION AND ADMINISTRATION OF CABAZITAXEL SOLUTION.
For Intravenous Infusion only after Second Dilution
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
Cytotoxic Agent: Wear gloves at all times when handling containers.
Keep out of reach of children

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Do not refrigerate.
Dosage: As directed by the Oncologist.