Bortezomib for Injection 2mg Technical Specification:

Product Name:Bortezomib for Injection 2mg
Brand Name:Norvelzo
Strength:1mg, 2mg, 2.5mg, 3.5mg
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE USE VIAL
Route of Administration:1mg, 2mg, 2.5mg – for Intravenous use.
3.5mg – For Intravenous or Subcutaneous use.
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: Bortezomib used to treat multiple myeloma and mantle cell lymphoma.
Storage:Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Bortezomib for Injection 2mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Bortezomib for Injection 2mg
    Each vial contains:
    Bortezomib……………………2mg
    Excipients………………………q.s.

THERAPEUTIC INDICATION:

Bortezomib used to treat multiple myeloma and mantle cell lymphoma.

DIRECTION OF USE:

1mg, 2mg, 2.5mg – for Intravenous use.

3.5mg – For Intravenous or Subcutaneous use.

Reconstitution for 2mg: Reconstitute with 2 ml of 0.9% Sodium Chloride Injection

CAUTION & WARNING:

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

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

Cytotoxic special handling procedures see insert

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

The vial stopper is not made with natural rubber latex.

Discard Unused portion.

Keep out of the reach of the children. 

STORAGE & DOSAGE:

Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].

Dosage: As directed by an Oncologist.

Why Taj Pharmaceuticals?

“Elevate your healthcare with Taj Pharma’s Bortezomib for Injection. Our commitment to excellence is evident in every vial we produce. Experience unmatched quality, affordability, and global availability when you choose Taj Pharma for your Bortezomib needs. At Taj Pharma, we prioritize your well-being by adhering to the highest standards of pharmaceutical manufacturing. Our Bortezomib for Injection is meticulously crafted to ensure safety and efficacy, giving you peace of mind throughout your treatment journey.

What sets Taj Pharma apart is our dedication to affordability. We believe that access to essential medications should not be a financial burden. With Taj Pharma, you can trust that you’re getting top-notch quality at a price that’s accessible to all. With a global reach, Taj Pharma ensures that patients around the world can benefit from our Bortezomib for Injection. Whether you’re in need of this critical medication in your local healthcare facility or halfway across the globe, Taj Pharma has you covered. Make the choice for excellence in healthcare – choose Taj Pharma for Bortezomib for Injection. Your health, our priority.”

What is Bortezomib for Injection and its use?

Bortezomib for Injection is a medication used in the treatment of certain types of cancer, primarily multiple myeloma and mantle cell lymphoma. It is a type of drug known as a proteasome inhibitor, which means it works by blocking the action of proteasomes, cellular structures responsible for breaking down proteins. By inhibiting proteasomes, bortezomib disrupts the normal protein degradation process in cancer cells, leading to their accumulation of toxic proteins and ultimately causing cell death.

Uses:

  • Multiple Myeloma: Bortezomib is commonly used in the treatment of multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. It helps to slow down the growth and spread of myeloma cells and can be used in combination with other medications in various stages of treatment.
  • Mantle Cell Lymphoma: Bortezomib is also used in the treatment of mantle cell lymphoma, a type of non-Hodgkin lymphoma. It can be administered as part of combination therapy to target and control cancerous cells.

The use of bortezomib is typically determined by an oncologist, and the treatment plan may involve various cycles of intravenous (IV) injections or subcutaneous injections, depending on the specific cancer and its stage. Bortezomib can be a valuable component of cancer therapy, and its use is usually guided by the individual patient’s condition and response to treatment. It’s important to consult with a healthcare professional for a thorough evaluation and personalized treatment plan if you or a loved one is facing a cancer diagnosis.

How does Bortezomib for Injection work?

Bortezomib for Injection works by targeting and inhibiting proteasomes, which are cellular structures responsible for breaking down proteins in cells. This inhibition of proteasomes has several effects on cancer cells, ultimately leading to their death. Here’s how bortezomib works:

  • Protein Degradation Inhibition: Proteasomes play a crucial role in the degradation of proteins within cells. They break down proteins that are damaged or no longer needed, which is essential for maintaining cellular health. Bortezomib specifically targets and inhibits the proteasomes in cancer cells, disrupting the normal protein degradation process.
  • Accumulation of Toxic Proteins: When proteasomes are inhibited by bortezomib, cancer cells cannot break down and dispose of damaged or misfolded proteins properly. As a result, these proteins accumulate within the cancer cell, leading to an overload of toxic substances.
  • Disruption of Cell Functions: The accumulation of toxic proteins interferes with various cellular functions in cancer cells. This disruption can trigger a series of events, including interference with cell cycle regulation, DNA repair mechanisms, and signalling pathways that are essential for cell survival and growth.
  • Induction of Apoptosis: Ultimately, the cellular stress caused by the accumulation of toxic proteins and the disruption of critical cellular functions lead to a process called apoptosis. Apoptosis is programmed cell death, and when it is triggered, the cancer cell undergoes a series of changes that result in its self-destruction.
  • Anticancer Effects: Bortezomib’s ability to induce apoptosis and inhibit cancer cell proliferation makes it an effective treatment for certain types of cancer, such as multiple myeloma and mantle cell lymphoma. By specifically targeting cancer cells and sparing healthy cells to a certain extent, bortezomib helps control the growth and spread of cancerous cells.

It’s important to note that bortezomib is typically used in combination with other cancer treatments in various regimens. The specific treatment plan and dosages are determined by healthcare professionals based on the type and stage of cancer, as well as the patient’s individual health and response to treatment.

Benefits and Side Effects of Bortezomib for Injection

Benefits:

  • Effective Cancer Treatment: Bortezomib is highly effective in the treatment of multiple myeloma and mantle cell lymphoma. It is often used as part of combination therapy to target cancer cells and slow down their growth.
  • Prolonged Survival: Bortezomib has been shown to improve survival rates in patients with multiple myeloma and mantle cell lymphoma when used as part of a comprehensive treatment plan.
  • Symptom Management: Bortezomib can help alleviate symptoms associated with these cancers, such as bone pain, anaemia, and kidney problems often seen in multiple myeloma patients.
  • Potential for Stem Cell Transplantation: In some cases, bortezomib may be used as part of a treatment regimen to prepare patients for stem cell transplantation, which can offer a chance for a cure in select cases.

Common Side Effects:

  • Low Blood Cell Counts: Bortezomib can lead to low levels of red blood cells (anaemia), white blood cells (neutropenia), and platelets (thrombocytopenia), which can increase the risk of infections and bleeding.
  • Peripheral Neuropathy: This is a common side effect characterized by tingling, numbness, or pain in the hands and feet. It can be managed with dose adjustments or medication.
  • Gastrointestinal Issues: Nausea, vomiting, diarrhoea, and constipation are possible side effects. These symptoms can usually be managed with supportive medications.
  • Fatigue: Many patients experience fatigue or weakness during treatment with bortezomib.
  • Fever and Infection: Infections can occur due to reduced white blood cell counts, leading to fever and a higher risk of bacterial or viral infections.
  • Skin Rash: Some individuals may develop skin rashes or itching.
  • Low Appetite: Loss of appetite and weight loss can occur during treatment.
  • Headache: Headaches are a less common side effect.
  • Liver Enzyme Changes: Bortezomib can affect liver function, leading to changes in liver enzyme levels. Regular monitoring is important.

It’s essential for patients to be closely monitored by healthcare professionals during treatment with bortezomib to manage and mitigate potential side effects. Treatment plans can be adjusted as needed to balance the benefits of cancer control with the side effects.

Frequently asked questions about Bortezomib for Injection

  • What is Bortezomib for Injection used for?

Bortezomib for Injection is primarily used in the treatment of multiple myeloma and mantle cell lymphoma, two types of cancer that affect the blood and lymphatic system.

  • How does Bortezomib for Injection work?

Bortezomib inhibits proteasomes in cancer cells, leading to the accumulation of toxic proteins and ultimately causing cancer cell death through a process called apoptosis.

  • What is the recommended dosage and treatment schedule for Bortezomib?

The dosage and treatment schedule for Bortezomib can vary based on the type of cancer being treated, the patient’s overall health, and the specific treatment plan determined by the healthcare provider.

  • What are the potential side effects of Bortezomib for Injection?

Common side effects include low blood cell counts, peripheral neuropathy, gastrointestinal issues, fatigue, fever, and infection. However, side effects can vary from person to person.

  • How is peripheral neuropathy managed during Bortezomib treatment?

Peripheral neuropathy, characterized by tingling or numbness in the hands and feet, can be managed with dose adjustments, medication, or other supportive measures. Patients should report any neuropathy symptoms to their healthcare provider promptly.

  • Is Bortezomib for Injection a curative treatment for multiple myeloma or mantle cell lymphoma?

Bortezomib can be highly effective in controlling the growth of cancer cells and improving survival rates, but it may not be a curative treatment on its own. It is often used in combination with other therapies.

  • Can Bortezomib for Injection be used in children?

Bortezomib is generally not recommended for use in children or adolescents unless specifically prescribed by a paediatric oncologist for a rare condition.

  • Are there any drug interactions with Bortezomib?

It’s essential to inform your healthcare provider about all medications and supplements you are taking as some drugs may interact with Bortezomib and affect its effectiveness or increase the risk of side effects.

  • How is Bortezomib administered?

Bortezomib can be administered via intravenous (IV) injection or subcutaneous injection. The specific method and dosing schedule will be determined by the healthcare team.

  • Is Bortezomib covered by insurance?

Coverage for Bortezomib may vary depending on the insurance plan and individual circumstances. Patients should check with their insurance provider and healthcare team for information on coverage and financial assistance programs.

  • What should I do if I miss a dose of Bortezomib?

It’s crucial to follow the prescribed treatment schedule. If a dose is missed, patients should contact their healthcare provider for guidance on when to take the next dose.

Patients should always consult their healthcare provider or oncologist for personalized information and guidance regarding Bortezomib for Injection and its use in their specific situation.

As Bortezomib for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Bortezomib for 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

Bortezomib for 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 Bortezomib for 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:

a) Bortezomib for Injection 1mg
b) Bortezomib for Injection 2mg
c) Bortezomib for Injection 2.5mg
d) Bortezomib for Injection 3.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Bortezomib for Injection 1mg
Each vial contains:
Bortezomib……………………1mg
Excipients……………………...q.s.

b) Bortezomib for Injection 2mg
Each vial contains:
Bortezomib……………………2mg
Excipients………………………q.s.


c) Bortezomib for Injection 2.5mg
Each vial contains:
Bortezomib……………………2.5mg
Excipients………………………q.s.

d) Bortezomib for Injection 3.5mg
Each vial contains:
Bortezomib……………………3.5mg
Excipients……………………...q.s.

THERAPEUTIC INDICATION:

Bortezomib used to treat multiple myeloma and mantle cell lymphoma.

DIRECTION OF USE:

1mg, 2mg, 2.5mg – for Intravenous use.
3.5mg - For Intravenous or Subcutaneous use.
Reconstitution for 2mg: Reconstitute with 2 ml of 0.9% Sodium Chloride Injection

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
The vial stopper is not made with natural rubber latex.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].
Dosage: As directed by an Oncologist.