GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Lenalidomide Capsules 5mg
b) Lenalidomide Capsules 10mg
c) Lenalidomide Capsules 15mg
d) Lenalidomide Capsules 25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Lenalidomide Capsules 5mg
Each capsule contains:
Lenalidomide….………….5mg
Excipients……………….….q.s.
Colours: Approved colours used in capsule shell


b) Lenalidomide Capsules 10mg
Each capsule contains:
Lenalidomide………….….10mg
Excipients……………….….q.s.
Colours: Approved colours used in capsule shell

c) Lenalidomide Capsules 15mg
Each capsule contains:
Lenalidomide……………..15mg
Excipients……………….….q.s.
Colours: Approved colours used in capsule shell

d) Lenalidomide Capsules 25mg
Each capsule contains:
Lenalidomide……….…….25mg
Excipients……………….….q.s.
Colours: Approved colours used in capsule shell

THERAPEUTIC INDICATIONS:

Lenalidomide is a medication used to treat multiple myeloma, smoldering myeloma, and myelodysplastic syndromes.

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.
CAUTION: This is potent Cytotoxic agent. Use only after reading the directions on the pack insert.
Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
WARNING: Lenalidomide should never be taken by pregnant women or women capable of becoming pregnant as even a single dose can cause severe birth defects or death to an unborn baby.
PHARMACIST: Dispense the accompanying medication guide to each patient.
Do not open the capsules. Swallow whole.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 30°C.
Do not refrigerate.
Dispense in tight container.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.

Lenalidomide Capsules 5mg Technical Specification:

Product Name:Lenalidomide Capsules 5mg
Brand Name:Myelosar
Strength:5mg, 10mg, 15mg, 25mg
Dosage Form:Hard-Gelatin Capsules
Packing:10s, 21s, 28s, 30s
Route of Administration:For Oral Use 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: Lenalidomide is a medication used to treat multiple myeloma, smoldering myeloma, and myelodysplastic syndromes.
Storage:Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Lenalidomide Capsules 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Lenalidomide Capsules 5mg
    Each capsule contains:
    Lenalidomide….………….5mg
    Excipients……………….….q.s.
    Colours: Approved colours used in capsule shell

THERAPEUTIC INDICATIONS:

Lenalidomide is a medication used to treat multiple myeloma, smoldering myeloma, and myelodysplastic syndromes.

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.
CAUTION: This is potent Cytotoxic agent. Use only after reading the directions on the pack insert.
Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
WARNING: Lenalidomide should never be taken by pregnant women or women capable of becoming pregnant as even a single dose can cause severe birth defects or death to an unborn baby.
PHARMACIST: Dispense the accompanying medication guide to each patient.
Do not open the capsules. Swallow whole.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.
Dispense in a tight container.
Dosage: As directed by the Oncologist.
For Oral use. Read the package insert before use.

Why Taj Pharmaceuticals? 

Taj Pharmaceuticals emerges as a trusted source for Lenalidomide Capsules 5mg, driven by a combination of factors that highlight their pharmaceutical prowess. With a rich legacy in the industry, Taj Pharmaceuticals brings to the table decades of experience and a deep understanding of medications, particularly Lenalidomide, ensuring that its products are of the highest quality and efficacy. Quality assurance is a hallmark of Taj Pharmaceuticals. They are unwavering in their commitment to upholding the most stringent standards of quality and safety in pharmaceutical products. Lenalidomide Capsules, among their offerings, undergo meticulous manufacturing processes and rigorous quality control measures.

Taj Pharmaceuticals operates on a global scale, functioning as an exporter from India. This role is pivotal in making essential medications accessible to healthcare providers and patients across the world. Their extensive distribution network ensures that these medications are readily available in diverse regions, contributing to improved healthcare on an international scale. At the core of their mission is a patient-centric approach. Taj Pharmaceuticals prioritizes patient well-being, aiming to enhance health and elevate the overall quality of life through the provision of reliable medications such as Lenalidomide Capsules. The company’s reputation as a dependable pharmaceutical provider is reinforced by a proven track record. This track record has solidified their position as a trusted partner for healthcare professionals and institutions, underlining their unwavering dedication to maintaining quality and safety in medical treatments. Taj Pharmaceuticals often offers a diverse range of formulations for medications, acknowledging and catering to the diverse needs and preferences of patients. This versatility further enhances their standing as a trusted pharmaceutical resource in the healthcare landscape.

What are Lenalidomide Capsules and its uses:

Lenalidomide Capsules is a medication primarily used to treat specific blood disorders and certain types of cancer. It is an immunomodulatory drug that can be a valuable part of treatment for various medical conditions. Here’s an overview of Lenalidomide Capsules and their common uses:

  • Medication Type: Lenalidomide is classified as an immunomodulatory drug (IMiD). It affects the body’s immune system and has anti-inflammatory and anticancer properties.
  • Mechanism of Action: Lenalidomide has multiple mechanisms of action, including immune system modulation, anti-inflammatory effects, and antiangiogenesis (inhibition of blood vessel formation). These actions contribute to its therapeutic benefits.

Common Uses of Lenalidomide Capsules:

  • Multiple Myeloma: Lenalidomide is often prescribed as part of a combination therapy for the treatment of multiple myeloma, a type of blood cancer that affects plasma cells in the bone marrow. It can help slow the progression of the disease and improve overall survival.
  • Myelodysplastic Syndromes (MDS): Lenalidomide is used to treat specific subtypes of myelodysplastic syndromes, a group of bone marrow disorders. It can reduce the need for blood transfusions and improve the quality of life in some patients with MDS.
  • Mantle Cell Lymphoma: In certain cases of mantle cell lymphoma, Lenalidomide may be prescribed as part of treatment to slow down the progression of the disease.
  • Other Hematological Disorders: Lenalidomide is being studied for its potential use in other hematological disorders, such as chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma.
  • Solid Tumors: Some clinical trials are exploring Lenalidomide’s effectiveness in the treatment of solid tumors, although it is not currently approved for this use.

It’s important to note that the use of Lenalidomide Capsules is determined by a healthcare provider based on the specific medical condition, the type and stage of cancer, and the individual patient’s needs. Patients should follow their healthcare provider’s instructions regarding the dosage and duration of treatment with this medication to ensure its effectiveness and safety. Lenalidomide is a powerful medication with potentially serious side effects, so its use should be closely monitored by a healthcare team experienced in its administration. Additionally, individuals should inform their healthcare provider of any allergies or other medications they are taking to avoid potential interactions or adverse reactions.

How Do Lenalidomide Capsules Work?

Lenalidomide Capsules work through several mechanisms, making them effective in the treatment of various medical conditions, particularly blood disorders and certain types of cancer. Here’s how Lenalidomide works:

  • Immunomodulation: Lenalidomide is classified as an immunomodulatory drug (IMiD). It has a significant impact on the immune system. One of its primary effects is enhancing the body’s immune response against cancer cells and abnormal cells, such as those found in myelodysplastic syndromes (MDS) and multiple myeloma.
  • Anti-Inflammatory Properties: Lenalidomide possesses anti-inflammatory properties, which can help reduce inflammation and its associated symptoms. This anti-inflammatory action can be particularly beneficial in conditions where inflammation plays a role in disease progression.
  • Anti-Angiogenesis: Lenalidomide has anti-angiogenic properties, meaning it inhibits the formation of new blood vessels (angiogenesis). In cancer, tumors require a blood supply to grow and spread. By blocking angiogenesis, Lenalidomide can help limit the blood supply to cancerous tissues, hindering their growth.
  • Immunomodulation of Bone Marrow: In conditions like multiple myeloma and MDS, Lenalidomide has been shown to modify the bone marrow microenvironment. This alteration can help promote healthy blood cell production and inhibit the proliferation of abnormal cells.
  • Inhibition of Abnormal Cell Growth: In myelodysplastic syndromes, Lenalidomide has been shown to reduce the percentage of abnormal blood cells and may improve the production of healthy blood cells.
  • Enhanced Immune Surveillance: Lenalidomide may enhance the immune system’s ability to recognize and eliminate cancer cells, contributing to improved outcomes in cancer treatment.

It’s important to note that the exact mechanisms of Lenalidomide’s actions can vary depending on the medical condition being treated. The drug’s immunomodulatory properties, anti-inflammatory effects, and anti-angiogenic actions collectively make it a valuable therapeutic option in a range of hematological disorders and certain solid tumors. Lenalidomide is typically used as part of combination therapies tailored to specific conditions, and its use should be closely monitored by healthcare professionals experienced in its administration. The drug’s diverse mechanisms of action make it a versatile tool in the treatment of various medical conditions, particularly those involving the blood and the immune system.

Benefits of Lenalidomide Capsules:

  • Effective Treatment for Multiple Myeloma: Lenalidomide is a cornerstone of treatment for multiple myeloma, a type of blood cancer. It is often used in combination with other medications and has been shown to significantly improve progression-free survival and overall survival in patients with multiple myeloma.
  • Treatment of Myelodysplastic Syndromes (MDS): Lenalidomide is an important therapeutic option for certain subtypes of myelodysplastic syndromes. It can reduce the need for red blood cell transfusions in some patients, leading to improved quality of life.
  • Reduction in Risk of Disease Progression: In addition to multiple myeloma and MDS, Lenalidomide has shown promise in other hematological disorders and solid tumors. It can help slow the progression of disease and delay the need for more aggressive treatments.
  • Improved Immune Response: Lenalidomide’s immunomodulatory properties enhance the body’s immune response against cancer cells, contributing to its effectiveness in cancer treatment.
  • Potential for Reduced Inflammation: The drug’s anti-inflammatory effects can help alleviate symptoms related to inflammation, such as pain and discomfort.

Common Side Effects of Lenalidomide Capsules:

  • Fatigue: Many patients experience fatigue, which can range from mild to severe. It’s important to rest and conserve energy during treatment.
  • Hematological Effects: Lenalidomide can affect blood cell counts, leading to conditions such as neutropenia (low white blood cell count), anemia (low red blood cell count), and thrombocytopenia (low platelet count). Regular blood tests are needed to monitor these effects.
  • Gastrointestinal Symptoms: Nausea, vomiting, diarrhea, and constipation are common gastrointestinal side effects. These symptoms are often manageable with medications and dietary adjustments.
  • Skin Rash: Some individuals may develop a skin rash, which can range from mild to severe. Inform your healthcare provider if this occurs.
  • Peripheral Neuropathy: This condition can cause numbness, tingling, or pain in the extremities (hands and feet). It’s important to report any signs of peripheral neuropathy to your healthcare provider.
  • Risk of Blood Clots: Lenalidomide is associated with an increased risk of blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE). Your healthcare provider may prescribe blood-thinning medications to reduce this risk.
  • Birth Defects: Lenalidomide can cause severe birth defects if taken during pregnancy. Effective contraception is crucial for both men and women during treatment and for a period afterward.
  • Other Side Effects: Less common side effects may include dizziness, headache, and muscle cramps.

It’s important to remember that the benefits of Lenalidomide treatment often outweigh the potential side effects. Healthcare providers closely monitor patients receiving Lenalidomide and may adjust treatment or provide supportive care to manage side effects effectively. Patients should communicate openly with their healthcare team about any side effects or concerns during treatment. Lenalidomide is a powerful medication used to treat serious medical conditions, and its use should be guided by healthcare professionals experienced in its administration.

Frequently Asked Questions About Lenalidomide Capsules:

Certainly, here are some frequently asked questions (FAQs) about Lenalidomide Capsules:

  • What is Lenalidomide, and what is it used for?

Lenalidomide is a medication used in the treatment of various medical conditions, including multiple myeloma, myelodysplastic syndromes (MDS), and certain solid tumors. It is known for its immunomodulatory and anti-inflammatory properties.

  • How does Lenalidomide work in the treatment of multiple myeloma?

Lenalidomide is believed to have several mechanisms of action, including enhancing the immune system’s response against cancer cells and inhibiting the formation of new blood vessels that supply tumors. It is typically used in combination with other medications to target multiple myeloma.

  • What are the potential side effects of Lenalidomide Capsules?

Common side effects of Lenalidomide may include fatigue, hematological effects (such as low blood cell counts), gastrointestinal symptoms, skin rash, peripheral neuropathy, and an increased risk of blood clots. Serious side effects, including severe birth defects if taken during pregnancy, can occur.

  • How is Lenalidomide administered?

Lenalidomide is usually taken orally in capsule form. The dosage and administration schedule are determined by a healthcare provider based on the specific medical condition being treated.

  • Are there any specific precautions or monitoring requirements during Lenalidomide treatment?

Yes, patients receiving Lenalidomide require regular blood tests to monitor blood cell counts and may need blood-thinning medications to reduce the risk of blood clots. Effective contraception is crucial during treatment to prevent pregnancy related complications.

  • Can Lenalidomide be used in other medical conditions apart from multiple myeloma and MDS?

Lenalidomide is being studied for its potential use in other hematological disorders and solid tumors, but its use is currently approved for specific conditions. Consult with a healthcare provider for the most up-to-date information on its approved uses.

  • How long does Lenalidomide treatment typically last?

The duration of Lenalidomide treatment varies depending on the medical condition, treatment response, and individual patient factors. Treatment plans are determined by healthcare providers and may involve cycles of therapy.

  • What should I do if I experience side effects while taking Lenalidomide?

It’s essential to promptly report any side effects or concerns to your healthcare provider. They can provide guidance on managing side effects and may adjust your treatment plan if necessary.

  • Is Lenalidomide safe during pregnancy?

No, Lenalidomide is known to cause severe birth defects if taken during pregnancy. Effective contraception should be used by both men and women during treatment and for a specific time afterward to prevent pregnancy-related complications.

Patients should consult with their healthcare provider for personalized information and guidance regarding the use of Lenalidomide Capsules. Treatment decisions should be based on individual circumstances and medical guidelines.

As Lenalidomide Capsules Exporters; We can cater to export business queries from the following geographies. We are exporting our Lenalidomide Capsules 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

Lenalidomide Capsules 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 Lenalidomide Capsules, 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