Eribulin Mesylate Solution for Injection 0.44mg/ml (Rayldeima) Technical Specification:

Product Name:Eribulin Mesylate Solution for Injection 0.44mg/ml
Brand Name:Rayldeima
Strength:0.5mg/ml, 0.44mg/ml
Dosage Form: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: Eribulin is an anticancer medication used to treat breast cancer and liposarcoma.
Storage:Store at 25°C (77° F); excursions permitted between 15°C to 30°C (59° to 86° F). Do not freeze or refrigerate.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Eribulin Mesylate Solution for Injection 0.44mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Eribulin Mesylate Solution for Injection 0.44mg/ml
    Each 2 ml vial contains:
    Eribulin (as mesylate) ………….0.88mg
    Ethanol anhydrous……………….4.5% to 5.5%

THERAPEUTIC INDICATION:

Eribulin is an anticancer medication used to treat breast cancer and liposarcoma.

PACKING:

  • 5mg/ml
  • 44mg/ml

DIRECTION OF USE:

For Intravenous infusion only.

See the package insert for dosage and administration.

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.

WARNING: To be supplied against demand from Cancer Hospital, Institutions.

Do not accept if vial seal is broken.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard Unused portion.

Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted between 15°C to 30°C (59° to 86° F). Do not freeze or refrigerate.

Dosage: As directed by an Oncologist.

Why Taj Pharmaceuticals?

Taj Pharma is the preferred choice for Eribulin Mesylate Solution for Injection due to its unwavering commitment to pharmaceutical excellence, patient-centered care, and affordability. With a strong focus on quality assurance, Taj Pharma ensures that every vial of Eribulin Mesylate Solution meets the highest industry standards, guaranteeing purity, safety, and effectiveness. Their dedicated customer support team is available to assist patients, providing information and addressing concerns, ensuring a seamless experience from order to delivery. Taj Pharma’s commitment to accessibility and competitive pricing ensures that vital healthcare remains affordable for all, making them a trusted partner for those seeking Eribulin Mesylate Solution for their medical needs. Choose Taj Pharma as your reliable source for Eribulin Mesylate Solution for Injection, and let us support you on your path to better health.

What is Eribulin Mesylate Solution for Injection and its use?

Eribulin Mesylate Solution for Injection is a medication used in the treatment of certain types of cancer. It is specifically indicated for the treatment of:

  • Metastatic Breast Cancer: Eribulin is used to treat metastatic breast cancer in patients who have previously received at least two other types of chemotherapy. It is typically considered when the cancer has continued to progress despite prior treatments.
  • Metastatic Liposarcoma: Eribulin is also approved for the treatment of metastatic liposarcoma, a rare type of soft tissue sarcoma. It is used in patients who have previously received chemotherapy containing anthracycline.

Eribulin Mesylate Solution for Injection interferes with the microtubule structures within cells, disrupting cell division and growth. By stabilizing microtubules, eribulin inhibits cancer cell replication and may induce cell death, making it an effective treatment option for metastatic breast cancer and metastatic liposarcoma that have not responded to other therapies. However, its use can be associated with side effects, and treatment requires close medical monitoring and management.

How does Eribulin Mesylate Solution for Injection Work?

Eribulin Mesylate Solution for Injection works as an anticancer medication through its unique mechanism of action, particularly in the treatment of metastatic breast cancer and metastatic liposarcoma. Here’s how Eribulin works:

  • Microtubule Inhibition: Inside cells, there are structures called microtubules that are crucial for various cellular processes, including cell division (mitosis). Microtubules act as “skeletons” within the cell, providing structural support and forming tracks along which cellular components move during division.
  • Microtubule Stabilization: Eribulin works by inhibiting microtubule dynamics. Instead of allowing microtubules to grow and shrink as they typically do during cell division, eribulin stabilizes them. This stabilization prevents microtubules from functioning properly.
  • Disruption of Cell Division: Microtubule stabilization interferes with the normal process of cell division (mitosis). Cancer cells, which divide rapidly and rely heavily on this process for their growth, are particularly sensitive to this disruption. As a result, their ability to replicate is hampered.
  • Induction of Apoptosis: Eribulin can also induce apoptosis, which is programmed cell death. This process helps eliminate cancer cells from the body.

Eribulin Mesylate Solution for Injection disrupts microtubule dynamics within cells, leading to the inhibition of cancer cell division and growth. By stabilizing microtubules, eribulin interferes with mitosis, ultimately slowing down or stopping the replication of cancer cells. Additionally, its ability to induce apoptosis contributes to the elimination of cancer cells. This mechanism of action makes eribulin an effective treatment for certain advanced cancers, especially when other treatments have not been successful. However, it’s important to note that its use can be associated with side effects, and patients should receive this treatment under the supervision of a healthcare professional.

Benefits of Eribulin Mesylate Solution for Injection:

  • Treatment of Advanced Breast Cancer: Eribulin is a valuable treatment option for individuals with metastatic breast cancer who have already received multiple lines of chemotherapy. It offers a chance to slow down the progression of the disease and improve overall survival.
  • Treatment of Metastatic Liposarcoma: Eribulin is also approved for the treatment of metastatic liposarcoma, providing an option for patients with this rare type of soft tissue sarcoma when other treatments have been exhausted.
  • Unique Mechanism of Action: Eribulin’s mechanism of action, which involves stabilizing microtubules, sets it apart from other chemotherapy drugs. This unique approach may make it effective when other treatments have failed.
  • Potential Survival Benefit: Clinical trials have shown that Eribulin treatment can extend overall survival in certain patient populations, offering hope and additional time for those with advanced cancer.

Common Side Effects of Eribulin Mesylate Solution for Injection:

  • Neutropenia: A decrease in white blood cell count (neutropenia) is a common side effect of Eribulin. This can increase the risk of infections, so regular blood tests are necessary to monitor white blood cell levels.
  • Anemia: Eribulin 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.
  • 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 Eribulin, but hair typically grows back after treatment is completed.

Less Common but Serious Side Effects:

  • Allergic Reactions: In rare cases, Eribulin 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.
  • Liver Function: Eribulin may affect liver function, so regular monitoring of liver enzymes 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: Eribulin can suppress the bone marrow’s ability to produce blood cells, leading to an increased risk of infections, anemia, and bleeding.

The benefits of Eribulin Mesylate Solution often outweigh the potential side effects for individuals with advanced cancer that has not responded to other therapies. However, treatment with Eribulin 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 Eribulin Mesylate Solution for Injection:

  1. What is Eribulin Mesylate Solution for Injection used to treat?

Eribulin is used to treat metastatic breast cancer in patients who have received multiple prior chemotherapy treatments. It is also used to treat metastatic liposarcoma when other treatments have not been effective.

  1. How is Eribulin Mesylate Solution for Injection administered?

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

  1. Are there alternative treatments for metastatic breast cancer and liposarcoma besides Eribulin?

Yes, there are alternative treatments, including other chemotherapy drugs, targeted therapies, immunotherapies, and supportive care measures. 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 Eribulin Mesylate Solution for 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 Eribulin infusions?

The frequency of Eribulin infusions depends on your treatment plan, which is determined by your oncologist. Typically, infusions are given on a specific schedule.

  1. Is Eribulin suitable for all breast cancer patients with metastasis?

Eribulin is specifically indicated for metastatic breast cancer in patients who have previously received multiple lines of chemotherapy. 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 Eribulin 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 Eribulin treatment?

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

  1. Are there any special precautions I should take during Eribulin 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 Eribulin safe for use in elderly patients?

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

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

Eribulin Mesylate Solution 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  Eribulin Mesylate Solution 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) Eribulin Mesylate Solution for Injection 0.5mg/ml
b) Eribulin Mesylate Solution for Injection 0.44mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Eribulin Mesylate Solution for Injection 0.5mg/ml
Each 2 ml vial contains:
Eribulin Mesylate ……….………1mg
Equivalent to Eribulin………….0.88mg
Ethanol……………………………….5% v/v
Water for Injection USP……...q.s.

b) Eribulin Mesylate Solution for Injection 0.44mg/ml
Each 2 ml vial contains:
Eribulin (as mesylate) ………….0.88mg
Ethanol anhydrous……………….4.5% to 5.5%


THERAPEUTIC INDICATION:

Eribulin is an anticancer medication used to treat breast cancer and liposarcoma.

PACKING:

1) 0.5mg/ml
2) 0.44mg/ml

DIRECTION OF USE:

For Intravenous infusion only.
See the package insert for dosage and administration.

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.
WARNING: To be supplied against demand from Cancer Hospital, Institutions.
Do not accept if vial seal is broken.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted between 15°C to 30°C (59° to 86° F). Do not freeze or refrigerate.
Dosage: As directed by an Oncologist.