Daunorubicin Hydrochloride for Injection USP 20mg (Oxirvera) Technical Specification:

Product Name:Daunorubicin Hydrochloride for Injection USP 20mg
Brand Name:Oxirvera
Strength:20mg
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE USE VIAL
Route of Administration:For I.V. infusion only.
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: Daunorubicin HCL is used in treatment of acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, and Kaposi’s sarcoma.
Storage:Store between 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Daunorubicin Hydrochloride for Injection USP 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Daunorubicin Hydrochloride for Injection USP 20 mg
    Each vial contains:
    Daunorubicin hydrochloride USP Equivalent to
    Daunorubicin……………………20 mg
    Excipients…………………………q.s.

THERAPEUTIC INDICATION:

Daunorubicin HCL is used in treatment of acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, and Kaposi’s sarcoma.

DIRECTION OF USE:

For Intravenous infusion only.

As sterile, freeze-dried powder for reconstitution with Sodium Chloride Injection USP 10ml. Use immediately after reconstitution.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution. Fatal if given Intrathecally, for Intravenous use only.

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

This is potent Cytotoxic agent, use only after reading the directions on the pack insert.

Discard Unused portion.

Cytotoxic Agent – Special Handling

Keep the pack upright, Handle with care.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard Unused portion.

Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C in a refrigerator.

Do not freeze. Protect from light.

Dosage: As directed by an Oncologist.

Why Taj pharmaceuticals?

At Taj Pharmaceuticals, we are dedicated to advancing cancer care through the production and distribution of high-quality medications like Daunorubicin Hydrochloride for Injection. Cancer is a complex and challenging disease that affects millions of lives worldwide, and we understand the urgency and importance of providing effective treatments. Daunorubicin Hydrochloride is a critical component of chemotherapy regimens used in the treatment of various cancers, particularly hematological malignancies like acute myeloid leukemia (AML) and lymphoma. It works by interfering with the DNA in cancer cells, preventing their growth and division. This powerful medication is administered under the supervision of healthcare professionals who carefully tailor treatment plans to each patient’s unique needs.

Our commitment to pharmaceutical excellence extends to every aspect of our operations. We adhere to stringent quality control standards to ensure that each dose of Daunorubicin Hydrochloride meets the highest safety and efficacy standards. This commitment to quality extends from the research and development of our products to their manufacturing and distribution. Cancer treatment is a challenging journey, and we stand with patients, caregivers, and healthcare providers as partners in the fight against cancer. We are proud to play a role in providing access to vital medications like Daunorubicin Hydrochloride, which can make a meaningful difference in the lives of those affected by cancer. Choose Taj Pharmaceuticals as your trusted source for Daunorubicin Hydrochloride for Injection and experience the assurance of pharmaceutical quality that places your health and well-being at the forefront. Together, we can contribute to advancing cancer care and improving the lives of cancer patients around the world.

What is Daunorubicin Hydrochloride for Injection and its uses:

Daunorubicin Hydrochloride for Injection is a medication used in the treatment of various types of cancer, particularly hematological malignancies and certain solid tumors. It belongs to a class of drugs known as anthracyclines and is a crucial component of chemotherapy regimens. Daunorubicin Hydrochloride is administered intravenously under the supervision of healthcare professionals due to its potent and potentially toxic effects on cancer cells.

Here are the primary uses of Daunorubicin Hydrochloride for Injection:

  • Acute Myeloid Leukemia (AML): Daunorubicin Hydrochloride is commonly used in the treatment of AML, a type of blood cancer that affects the bone marrow and blood cells. It is often part of induction chemotherapy regimens aimed at inducing remission in AML patients.
  • Acute Lymphoblastic Leukemia (ALL): In certain cases, Daunorubicin Hydrochloride may be included in chemotherapy protocols for ALL, a cancer that primarily affects white blood cells (lymphocytes).
  • Hodgkin Lymphoma: Daunorubicin Hydrochloride is used in combination with other chemotherapy agents in the treatment of Hodgkin lymphoma, a cancer of the lymphatic system.
  • Non-Hodgkin Lymphoma (NHL): It may be part of chemotherapy regimens for various types of NHL, which are cancers that originate in lymphocytes.
  • Solid Tumors: While Daunorubicin is primarily associated with hematological malignancies, it is occasionally used in the treatment of certain solid tumors, including breast cancer and sarcomas.
  • Ewing Sarcoma: Daunorubicin Hydrochloride may be used as part of chemotherapy for Ewing sarcoma, a rare type of bone cancer that primarily affects children and young adults.

Daunorubicin Hydrochloride works by interfering with the DNA in cancer cells, preventing their replication and causing cell death. While it is effective against cancer cells, it can also affect normal cells in the body, leading to potential side effects. Therefore, its use is carefully monitored, and the dosage is adjusted based on individual patient factors. It’s important to note that Daunorubicin Hydrochloride is typically administered in a clinical setting by trained healthcare professionals who closely monitor patients for any adverse reactions. The choice of chemotherapy regimen, including the use of Daunorubicin, is determined by the specific type and stage of cancer, as well as the patient’s overall health and response to treatment.

How does Daunorubicin Hydrochloride for Injection Work:

Daunorubicin Hydrochloride for Injection works as an anticancer medication primarily by interfering with the DNA in cancer cells, ultimately leading to their destruction. It belongs to a class of drugs known as anthracyclines, which are potent chemotherapeutic agents. Here’s how Daunorubicin Hydrochloride works:

  • DNA Intercalation: Daunorubicin molecules are capable of inserting themselves between the base pairs of DNA strands within a cancer cell’s nucleus. This process is known as DNA intercalation. By doing so, Daunorubicin disrupts the normal structure and function of the DNA molecule.
  • Inhibition of DNA Replication: Once intercalated, Daunorubicin hinders the cell’s ability to replicate its DNA during cell division. DNA replication is a crucial step in the life cycle of a cell, and interference with this process prevents the cancer cell from creating new genetic material.
  • Inhibition of Topoisomerase II: Daunorubicin also inhibits an enzyme called topoisomerase II, which is essential for DNA repair and replication. By blocking this enzyme, the drug causes breaks in the DNA strands, leading to further DNA damage and preventing the cell from repairing itself.
  • Generation of Free Radicals: Daunorubicin can generate reactive oxygen species (ROS) or free radicals within the cancer cell. These ROS can damage cellular components such as proteins, lipids, and DNA, contributing to cell death.
  • Induction of Apoptosis: The extensive DNA damage and cellular stress caused by Daunorubicin trigger a process called apoptosis, which is a programmed cell death pathway. Apoptosis is a natural mechanism that eliminates damaged or abnormal cells. In the case of cancer cells, this process is initiated to remove them from the body.

It’s important to note that while Daunorubicin is effective against cancer cells, it can also affect normal cells in the body, leading to potential side effects. This is why the use of Daunorubicin is carefully monitored, and the dosage is adjusted based on individual patient factors. Daunorubicin Hydrochloride for Injection is typically administered in a clinical setting by trained healthcare professionals who closely monitor patients for any adverse reactions. The choice of chemotherapy regimen, including the use of Daunorubicin, is determined by the specific type and stage of cancer, as well as the patient’s overall health and response to treatment.

Benefits of Daunorubicin Hydrochloride for Injection:

  • Effective Cancer Treatment: Daunorubicin Hydrochloride is a potent anticancer medication that plays a crucial role in the treatment of various types of cancer, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), Hodgkin lymphoma, non-Hodgkin lymphoma (NHL), and certain solid tumors. It is often a key component of chemotherapy regimens aimed at inducing remission or managing these cancers.
  • Induction of Remission: In AML and ALL, Daunorubicin is frequently used during the induction phase of treatment. It helps reduce the number of cancer cells in the bone marrow and blood, increasing the likelihood of achieving remission.
  • Adjuvant Therapy: In the treatment of certain solid tumors and lymphomas, Daunorubicin is used as adjuvant therapy to prevent cancer recurrence after surgery or radiation therapy.
  • Improved Survival Rates: The inclusion of Daunorubicin in chemotherapy regimens has led to improved survival rates for many cancer patients. It contributes to the control and eradication of cancer cells.

Side Effects of Daunorubicin Hydrochloride for Injection:

  • Cardiotoxicity: One of the most significant concerns with Daunorubicin is its potential to cause cardiotoxicity, which can lead to heart damage. This side effect is dose-dependent and more common with prolonged use. Regular cardiac monitoring is essential during treatment.
  • Bone Marrow Suppression: Daunorubicin can suppress bone marrow function, leading to a decrease in blood cell counts. This can result in anemia (low red blood cells), neutropenia (low white blood cells), and thrombocytopenia (low platelets), increasing the risk of infection, bleeding, and fatigue.
  • Nausea and Vomiting: Gastrointestinal side effects, including nausea and vomiting, are common during Daunorubicin treatment. Antiemetic medications are often prescribed to manage these symptoms.
  • Hair Loss: Some patients may experience hair loss (alopecia) while undergoing chemotherapy with Daunorubicin. Hair typically grows back after treatment is completed.
  • Mouth Sores: Oral mucositis or mouth sores can occur as a side effect of Daunorubicin, making it painful to eat or drink. Proper oral hygiene and mouthwash may help alleviate this symptom.

It’s crucial for patients to discuss potential side effects and risks with their healthcare providers before starting Daunorubicin treatment. The benefits of effectively treating cancer often outweigh the risks, and healthcare providers can provide supportive care and monitor for side effects during treatment. Patient-specific factors, such as overall health and the type and stage of cancer, are considered when determining the appropriate treatment plan.

Frequently Asked Questions About Daunorubicin Hydrochloride for Injection?

Certainly, here are some frequently asked questions (FAQs) about Daunorubicin Hydrochloride for Injection:

  1. What is Daunorubicin Hydrochloride for Injection used for?

Daunorubicin Hydrochloride is primarily used in the treatment of various cancers, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), Hodgkin lymphoma, nonHodgkin lymphoma (NHL), and certain solid tumors.

  1. How is Daunorubicin Hydrochloride administered?

Daunorubicin Hydrochloride is typically administered as an intravenous (IV) infusion by trained healthcare professionals in a clinical setting, such as a hospital or cancer treatment center.

  1. What is the mechanism of action of Daunorubicin Hydrochloride?

Daunorubicin works by intercalating (inserting) itself into the DNA of cancer cells, disrupting DNA replication and causing DNA damage. This leads to the death of cancer cells.

  1. What are the potential side effects of Daunorubicin Hydrochloride for Injection?

Common side effects include cardiotoxicity (heart damage), bone marrow suppression, nausea, vomiting, hair loss, mouth sores, fatigue, and skin changes. However, side effects can vary among individuals.

  1. Is Daunorubicin Hydrochloride safe to use during pregnancy?

Daunorubicin may have harmful effects on the fetus and is generally not recommended during pregnancy. Women of childbearing age should use effective contraception during and after treatment.

  1. What precautions should be taken during Daunorubicin treatment?

Patients receiving Daunorubicin should undergo regular cardiac monitoring to detect any signs of cardiotoxicity. Blood counts should also be monitored to assess bone marrow function. Patients should stay hydrated and receive appropriate supportive care to manage side effects.

  1. Can Daunorubicin Hydrochloride be used in children?

Yes, Daunorubicin is sometimes used in pediatric oncology for the treatment of childhood cancers, including leukemia.

  1. Are there any drug interactions with Daunorubicin Hydrochloride?

Certain medications, especially those that affect the heart, may interact with Daunorubicin. It’s essential to inform your healthcare provider about all medications, supplements, and herbal products you are taking.

  1. Is it safe to breastfeed while receiving Daunorubicin treatment?

Daunorubicin can be excreted in breast milk, and breastfeeding is generally not recommended during treatment. Women should discuss alternative feeding options with their healthcare providers.

  1. How is the dosage of Daunorubicin determined?

The dosage of Daunorubicin is determined based on various factors, including the type of cancer, the patient’s overall health, and the specific chemotherapy regimen being used. It is carefully calculated and adjusted by the healthcare provider.

Patients should always consult their healthcare providers for personalized information and guidance regarding Daunorubicin Hydrochloride for Injection. The treatment plan will be tailored to each patient’s unique circumstances to optimize the benefits and minimize potential risks.

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

Daunorubicin Hydrochloride 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 Daunorubicin Hydrochloride 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

GENERIC NAME OF THE MEDICINAL PRODUCT:

Daunorubicin Hydrochloride for Injection USP 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Daunorubicin Hydrochloride for Injection USP 20 mg
Each vial contains:
Daunorubicin hydrochloride USP Equivalent to
Daunorubicin……………………20 mg
Excipients…………………………q.s.

THERAPEUTIC INDICATION:

Daunorubicin HCL is used in treatment of acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, and Kaposi's sarcoma.

DIRECTION OF USE:

For Intravenous infusion only.
As sterile, freeze-dried powder for reconstitution with Sodium Chloride Injection USP 10ml. Use immediately after reconstitution.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution. Fatal if given Intrathecally, for Intravenous use only.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
This is potent Cytotoxic agent, use only after reading the directions on the pack insert. Discard Unused portion.
Cytotoxic Agent – Special Handling
Keep the pack upright, Handle with care.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C in a refrigerator.
Do not freeze. Protect from light.
Dosage: As directed by an Oncologist.