Ibrutinib Capsules 140mg Technical Specification:

Product Name:Ibrutinib Capsules 140mg
Brand Name:Imbrutaj
Strength:70mg, 140mg
Dosage Form:Hard-Gelatin Capsules
Packing:30s, 90s, 120s
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: This medication is used to treat certain cancer such as mantle cell or marginal zone lymphoma, chronic lymphocytic leukemia/ small lymphocytic lymphoma, Waldenstrom’s macroglobulinemia. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.
Storage:Store at 20°C – 25°C (68° F – 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep in a cool & dry place. Protect from light & moisture

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Ibrutinib Capsules 140mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ibrutinib Capsules 140mg
    Each hard gelatin capsule contains:
    Ibrutinib………….……140mg
    Excipients…………….q.s.
    Approved colours used in capsule shell

THERAPEUTIC INDICATIONS:

This medication is used to treat certain cancer such as mantle cell or marginal zone lymphoma, chronic lymphocytic leukemia/ small lymphocytic lymphoma, Waldenstrom’s macroglobulinemia. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.

WARNING: Cytotoxic Agent: To be sold by retail on the prescription of a Medical Practitioner only.

WARNING: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a cancer specialist only.

Do not open the capsules. Swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

About the IMBRUTAJ tablets

It contains 28 tablets (a 4-week supply)

Each tablet is identical

Blister packs are available in different tablet strengths. Contact your doctor for dosing instructions.

Keep out of reach and sight of children.

STORAGE & DOSAGE:

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

Keep in a cool & dry place

Protect from light & moisture

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

Usual Dosage: Take one IMBRUTAJ tablet by mouth, at about the same time each day, with a glass of water.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a pharmaceutical company known for its commitment to producing high-quality medications, including Ibrutinib Capsules. These capsules are used in the treatment of certain types of cancers, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström’s macroglobulinemia. There are several compelling reasons why Taj Pharmaceuticals stands out as a choice for Ibrutinib Capsules. First and foremost, Taj Pharmaceuticals places a strong emphasis on maintaining rigorous quality assurance standards. The company adheres to strict quality control processes to ensure that each Ibrutinib capsule meets the required specifications. This dedication to quality is crucial in ensuring that the medication is safe and effective for patients battling cancer. Taj Pharmaceuticals boasts a wealth of experience and expertise in the pharmaceutical industry. With a history of producing a wide range of pharmaceuticals, the company brings a level of knowledge and proficiency that contributes to the quality of Ibrutinib Capsules. Their commitment to research and development further supports the development of effective cancer treatments. Regulatory compliance is another hallmark of Taj Pharmaceuticals. They adhere to all necessary regulatory guidelines and standards, both at the national and international levels. This compliance ensures that Ibrutinib Capsules meet the stringent requirements set forth by regulatory authorities, providing healthcare providers and patients alike with confidence in the product’s safety and efficacy. Affordability is a critical consideration in cancer treatment, given the often substantial costs associated with medications. Taj Pharmaceuticals aims to make essential medications, including Ibrutinib Capsules, accessible and affordable to a broader population. This commitment to affordability can significantly impact the lives of patients facing cancer diagnoses. Taj Pharmaceuticals’ global reach is another notable factor.

Their extensive distribution network enables patients in various regions around the world to access Ibrutinib Capsules, ensuring that individuals in need have the opportunity to receive this vital cancer treatment. Research and innovation play a pivotal role in Taj Pharmaceuticals’ operations. They invest in research and development efforts to enhance existing medications and develop new treatment options. This dedication to innovation can lead to advancements in cancer care, potentially offering patients more effective therapies and improved outcomes. In addition to their commitment to quality and innovation, some pharmaceutical companies, including Taj Pharmaceuticals, offer patient support programs and resources. These programs can provide valuable information, financial assistance, and access to healthcare services, further demonstrating their dedication to patients’ well-being. Ultimately, the choice of a pharmaceutical company for a specific medication, such as Ibrutinib Capsules, should consider various factors, including quality, safety, regulatory compliance, affordability, and the specific needs of the patient. Consulting with healthcare professionals is essential in making informed treatment decisions for individuals battling cancer.

What is Ibrutinib Capsules and its uses:

Ibrutinib Capsules are a medication used in the treatment of various types of cancer, primarily hematologic malignancies. Ibrutinib is the active pharmaceutical ingredient in these capsules, and it belongs to a class of drugs known as Bruton’s tyrosine kinase (BTK) inhibitors. Here is an overview of Ibrutinib Capsules and their uses:

Ibrutinib Capsules: Ibrutinib Capsules contain Ibrutinib as the active ingredient. These capsules are administered orally, typically in the form of a daily oral medication.

Uses of Ibrutinib Capsules:

  • Chronic Lymphocytic Leukemia (CLL): Ibrutinib Capsules are approved for the treatment of CLL, a type of cancer that affects the blood and bone marrow. It is used as a first-line treatment or in cases where other treatments have not been effective.
  • Mantle Cell Lymphoma (MCL): Ibrutinib is also indicated for the treatment of MCL, a rare and aggressive form of non-Hodgkin’s lymphoma. It is often used in patients who have received at least one prior therapy.
  • Waldenström’s Macroglobulinemia: Ibrutinib is approved for the treatment of Waldenström’s macroglobulinemia, a rare type of non-Hodgkin’s lymphoma that affects the bone marrow and blood.
  • Marginal Zone Lymphoma: In some cases, Ibrutinib may be used to treat marginal zone lymphoma, another type of non-Hodgkin’s lymphoma.

How does Ibrutinib Capsules work?

Ibrutinib Capsules work by inhibiting a specific protein called Bruton’s tyrosine kinase (BTK), which plays a crucial role in the growth and survival of certain cancer cells, particularly those associated with hematologic malignancies. Here’s how Ibrutinib functions at the molecular level:

  • Targeting BTK: Ibrutinib is a Bruton’s tyrosine kinase inhibitor. BTK is a protein kinase that is part of the B-cell receptor signaling pathway. In normal B-cells (a type of immune cell), BTK helps regulate cell growth and immune responses. However, in certain cancerous B-cells, such as those seen in chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and other hematologic malignancies, BTK is overactive and promotes uncontrolled cell growth.
  • Blocking Signaling Pathways: Ibrutinib works by binding to BTK and irreversibly inhibiting its activity. By doing so, it disrupts the signaling pathways that are crucial for the survival, proliferation, and migration of cancer cells. These pathways are responsible for transmitting signals that drive cancer cell growth and prevent cell death.
  • Apoptosis Induction: By inhibiting BTK, Ibrutinib triggers a process known as apoptosis in cancer cells. Apoptosis is a natural mechanism by which damaged or abnormal cells self-destruct. In cancer, this process is often disrupted, leading to the uncontrolled growth of malignant cells. Ibrutinib helps restore the ability of cancer cells to undergo programmed cell death, thereby reducing the tumor burden.
  • Immune Modulation: Additionally, Ibrutinib may have immunomodulatory effects. It can impact the tumor microenvironment, potentially enhancing the body’s immune response against cancer cells. This is particularly relevant in certain lymphomas where the tumor microenvironment plays a significant role in tumor growth.

Overall, Ibrutinib’s mechanism of action is highly targeted, disrupting the signaling pathways that drive cancer cell growth while sparing healthy cells. This targeted approach has made Ibrutinib a valuable therapeutic option for patients with specific hematologic malignancies, leading to improved outcomes and extended survival rates. However, it’s important to note that the use of Ibrutinib should be closely monitored by healthcare professionals to manage potential side effects and optimize treatment efficacy.

Benefits of Ibrutinib Capsules:

  • Effective Treatment: Ibrutinib has demonstrated significant efficacy in the treatment of various hematologic malignancies, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström’s macroglobulinemia, among others. It is often used when other treatments have not been effective or as a first-line therapy.
  • Extended Survival: Ibrutinib has been associated with improved overall survival rates in patients with certain types of cancer, particularly CLL and MCL. It offers a chance for patients to achieve remission and manage their cancer over an extended period.
  • Oral Administration: Ibrutinib is available in capsule form for oral administration, making it a convenient treatment option for patients who may prefer oral medications over intravenous therapies.
  • Targeted Therapy: Ibrutinib is a targeted therapy that specifically inhibits the activity of Bruton’s tyrosine kinase (BTK) in cancer cells. This targeted approach minimizes damage to healthy cells and reduces the risk of many of the common side effects associated with traditional chemotherapy.
  • 5. Improvement in Symptoms: Many patients experience a significant improvement in cancer-related symptoms, such as enlarged lymph nodes, fatigue, and night sweats, while taking Ibrutinib.

Common Side Effects of Ibrutinib Capsules:

While Ibrutinib is effective in treating hematologic malignancies, it may be associated with certain side effects. Common side effects include:

  • Bleeding: Ibrutinib can increase the risk of bleeding, including bruising, nosebleeds, and gastrointestinal bleeding. Patients taking blood thinners or antiplatelet drugs may be at higher risk.
  • Infections: Ibrutinib may weaken the immune system, making patients more susceptible to infections. This can include bacterial, viral, and fungal infections.
  • Diarrhea: Gastrointestinal side effects, such as diarrhea, are common with Ibrutinib. Diarrhea can sometimes be severe and lead to dehydration.
  • Fatigue: Many patients report fatigue as a side effect of Ibrutinib treatment. It can affect daily activities and quality of life.
  • Muscle and Joint Pain: Some patients may experience muscle and joint pain while taking Ibrutinib.

It’s important to note that not all patients will experience these side effects, and the severity can vary. Healthcare providers closely monitor patients on Ibrutinib to manage and mitigate side effects. In some cases, dose adjustments or temporary discontinuation may be necessary to address side effects while maintaining treatment effectiveness. Patients should discuss the benefits and potential side effects of Ibrutinib with their healthcare provider to make informed decisions about their cancer treatment plan.

Frequently Asked Questions About Ibrutinib Capsules:

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

  1. What is Ibrutinib, and what types of cancer is it used to treat?

Ibrutinib is a medication used to treat certain types of cancer, primarily hematologic malignancies. It is approved for chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Wald Enstrom’s macroglobulinemia, and marginal zone lymphoma.

  1. How does Ibrutinib work to treat cancer?

Ibrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor. It works by blocking the activity of BTK, a protein involved in the growth and survival of cancer cells, particularly Bcell cancers like CLL and MCL.

  1. What is the recommended dosage and treatment duration for Ibrutinib?

The dosage and duration of Ibrutinib treatment can vary based on the type of cancer being treated and individual patient factors. Your healthcare provider will determine the appropriate dose and treatment duration for your specific case.

  1. Are there any common side effects associated with Ibrutinib?

Yes, Ibrutinib can have common side effects, including bleeding, infections, diarrhea, fatigue, muscle and joint pain, high blood pressure, irregular heartbeat, skin rash, nausea, and headache. It’s essential to discuss potential side effects with your healthcare provider.

  1. Can Ibrutinib be used in combination with other cancer treatments?

Ibrutinib may be used alone or in combination with other cancer therapies, depending on the type and stage of cancer. Your healthcare provider will determine the most appropriate treatment plan for you.

  1. How is Ibrutinib taken?

Ibrutinib is typically taken orally in the form of capsules. It’s essential to follow your healthcare provider’s instructions on how to take the medication, including whether it should be taken with or without food.

  1. What should I do if I experience side effects while taking Ibrutinib?

If you experience side effects while taking Ibrutinib, it’s crucial to promptly notify your healthcare provider. They can provide guidance on managing side effects, adjusting the dose if necessary, or considering other treatment options.

  1. Is Ibrutinib safe during pregnancy and breastfeeding?

Ibrutinib may harm an unborn baby, so it should not be used during pregnancy. It is also not recommended during breastfeeding, as it can pass into breast milk. Patients should discuss family planning and potential risks with their healthcare provider.

  1. Are there any drug interactions I should be aware of while taking Ibrutinib?

Ibrutinib can interact with other medications, including blood thinners and certain antifungal drugs. It’s essential to inform your healthcare provider about all medications and supplements you are taking to prevent potential interactions.

  1. How often will I need to see my healthcare provider while on Ibrutinib treatment?

Regular monitoring by your healthcare provider is crucial while taking Ibrutinib. They will assess your response to treatment, manage side effects, and ensure your safety throughout the course of therapy.

Patients should always consult with their healthcare provider for personalized information and guidance regarding Ibrutinib treatment and any specific questions or concerns they may have.

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

Ibrutinib 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 Ibrutinib 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

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Ibrutinib Capsules 70mg
b) Ibrutinib Capsules 140mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Ibrutinib Capsules 70mg
Each hard gelatin capsule contains:
Ibrutinib………….……70mg
Excipients…………….q.s.
Approved colours used in capsule shell

b) Ibrutinib Capsules 140mg
Each hard gelatin capsule contains:
Ibrutinib………….……140mg
Excipients…………….q.s.
Approved colours used in capsule shell


THERAPEUTIC INDICATIONS:

This medication is used to treat certain cancer such as mantle cell or marginal zone lymphoma, chronic lymphocytic leukemia/ small lymphocytic lymphoma, Waldenstrom’s macroglobulinemia). Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of a Medical Practitioner only.
WARNING: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a cancer specialist only.
Do not open the capsules. Swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.
About the IMBRUTAJ tablets
It contains 28 tablets (a 4-week supply)
Each tablet is identical
Blister packs are available in different tablet strengths. Contact your doctor for dosing instructions.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store at 20°C - 25°C (68° F - 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Keep in a cool & dry place
Protect from light & moisture
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Usual Dosage: Take one IMBRUTAJ tablet by mouth, at about the same time each day, with a glass of water.