Sorafenib Tablets 200mg (Sorataj) Technical Specification:

Product Name:Sorafenib Tablets 200mg
Brand Name:Sorataj
Strength:200mg
Dosage Form:Film-coated Tablet
Packing:30s, 60s, 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: Sorafenib is used to treat late-stage kidney cancer (advanced renal cell carcinoma), liver cancer (hepatocellular carcinoma) that cannot be treated by surgery, and differentiated thyroid cancer that has come back or spread to other parts of your body.
Storage:Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Sorafenib Tablets 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Sorafenib Tablets 200mg
    Each film-coated tablet contains:
    Sorafenib Tosylate Equivalent to
    Sorafenib………………………200 mg
    Excipients……………………..q.s.
    Colours: Titanium Dioxide USP, Ferric Oxide Red.

THERAPEUTIC INDICATIONS:

Sorafenib is used to treat late-stage kidney cancer (advanced renal cell carcinoma), liver cancer (hepatocellular carcinoma) that cannot be treated by surgery, and differentiated thyroid cancer that has come back or spread to other parts of your body.

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.|
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Protect from light.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.

Why Taj Pharmaceuticals?

Taj Pharma is your reliable source for Sorafenib Tablets, offering a combination of quality, affordability, and accessibility that sets us apart in the pharmaceutical industry. Our commitment to excellence begins with our state-of-the-art manufacturing facilities, adhering to stringent quality control measures to ensure every tablet meets the highest standards. This dedication to quality has earned us the trust of healthcare professionals and patients worldwide. One of our core principles is affordability. We believe that life-saving medications should be within reach of everyone who needs them. At Taj Pharma, we work diligently to keep our prices competitive without compromising on the quality of Sorafenib Tablets. This commitment has made us a preferred choice for those seeking cost-effective solutions to their healthcare needs. Accessibility is another key pillar of our mission. We strive to make Sorafenib Tablets available to patients across the globe. Through a vast distribution network, we ensure that our medications reach even the most remote areas, supporting individuals in their fight against cancer.

When you choose Taj Pharma for Sorafenib Tablets, you’re not just selecting a medication; you’re choosing a partner in your healthcare journey. We are dedicated to improving the lives of patients, and our Sorafenib Tablets exemplify this commitment. Trust Taj Pharma for quality, affordability, and accessibility in healthcare.

Sorafenib is a medication that is commonly available in tablet form and is used primarily for the treatment of certain types of cancer. It belongs to a class of drugs known as kinase inhibitors and is specifically categorized as a multikinase inhibitor. Sorafenib works by inhibiting the action of various proteins and enzymes involved in cancer cell growth and the development of blood vessels that support tumor growth. Here are some key points about Sorafenib and its uses:

  • Indications: Sorafenib is primarily used for the treatment of two main types of cancer:
    Hepatocellular Carcinoma (HCC): It is used to treat advanced liver cancer when it cannot be removed surgically.|
    Renal Cell Carcinoma (RCC): Sorafenib is also used to treat advanced kidney cancer when other treatments have been unsuccessful.
  • Mode of Action: Sorafenib inhibits multiple kinase enzymes and receptors that are involved in signaling pathways promoting cancer cell growth and tumor angiogenesis (the formation of new blood vessels that supply tumors with nutrients). By doing so, it helps slow down the growth and spread of cancer cells.
  • Treatment Regimen: The dosing and duration of Sorafenib treatment can vary depending on the type and stage of cancer being treated. It is usually taken orally in the form of tablets and is typically taken once or twice a day.
  • Side Effects: Like most medications, Sorafenib can cause side effects. Common side effects may include fatigue, diarrhea, hand-foot skin reaction (redness, pain, and swelling of the palms and soles), hypertension (high blood pressure), and rash. Serious side effects are less common but can include bleeding, severe skin reactions, and changes in liver function.
  • Consultation with a Healthcare Professional: Sorafenib is a prescription medication, and its use should be supervised by a qualified healthcare provider. Patients should discuss potential benefits, risks, and side effects with their healthcare team before starting treatment.
  • Monitoring: Patients undergoing Sorafenib treatment often require regular medical monitoring, including blood tests and imaging scans, to assess the medication’s effectiveness and manage any potential side effects.

Sorafenib may not be suitable for all patients, and its use should be determined by a healthcare professional after a thorough evaluation of the individual’s medical condition and needs. Additionally, the information provided here is general in nature, and specific treatment protocols may vary. Patients should follow their healthcare provider’s guidance and treatment plan.

How does Sorafenib Tablets Work?

Sorafenib is a targeted therapy medication that works by inhibiting specific proteins and enzymes involved in cancer cell growth and the formation of blood vessels that support tumor growth. Here’s a more detailed explanation of how Sorafenib tablets work:

  • Inhibition of Kinases: Sorafenib is classified as a multikinase inhibitor. Kinases are enzymes that play a crucial role in cell signaling pathways, regulating various cellular processes, including cell growth and division. In cancer, some kinases become overactive, leading to uncontrolled cell growth. Sorafenib targets and inhibits the activity of several kinases that are commonly overactive in cancer cells.
  • RAS/RAF/MEK/ERK Pathway: One of the key pathways targeted by Sorafenib is the RAS/RAF/MEK/ERK pathway. This pathway is often dysregulated in cancer, leading to increased cell proliferation and survival. Sorafenib inhibits RAF kinases, which are upstream of MEK and ERK. By doing so, it disrupts this pathway and reduces cancer cell growth.
  • VEGF Receptor Inhibition: Sorafenib also inhibits vascular endothelial growth factor (VEGF) receptors. VEGF is a protein that promotes the formation of new blood vessels, a process known as angiogenesis. In cancer, angiogenesis is essential for tumors to receive a blood supply and nutrients. By inhibiting VEGF receptors, Sorafenib interferes with angiogenesis, reducing the tumor’s ability to establish a blood supply.
  • PDGF Receptor Inhibition: Sorafenib can also inhibit platelet-derived growth factor (PDGF) receptors. PDGF plays a role in stimulating the growth of blood vessels and connective tissue. Inhibiting PDGF receptors can further disrupt the tumor’s ability to promote angiogenesis and support its growth.
  • Apoptosis Induction: Sorafenib may also induce apoptosis, which is programmed cell death. By promoting apoptosis in cancer cells, Sorafenib helps to eliminate these abnormal cells from the body.

By targeting multiple pathways involved in cancer growth and angiogenesis, Sorafenib interferes with the ability of cancer cells to divide and receive the nutrients they need to grow. This can slow down the progression of certain types of cancer, such as hepatocellular carcinoma (liver cancer) and renal cell carcinoma (kidney cancer), for which Sorafenib is commonly prescribed.

Sorafenib is a highly specialized medication and should only be used under the guidance and supervision of a qualified healthcare provider. The specific mechanisms of action and effects of Sorafenib may vary depending on the type and stage of cancer being treated. Patients should consult with their healthcare team to understand how Sorafenib will be used in their individual treatment plan.

Sorafenib tablets offer potential benefits for individuals with certain types of cancer, but they may also be associated with side effects. Here are the benefits and common side effects of Sorafenib:

Benefits:

  • Cancer Treatment: Sorafenib is primarily used to treat two main types of cancer: hepatocellular carcinoma (HCC or liver cancer) and renal cell carcinoma (RCC or kidney cancer). It can be effective in slowing down the progression of these cancers, especially in advanced stages when surgery or other treatments are not suitable.
  • Tumor Growth Inhibition: Sorafenib works by inhibiting the growth of cancer cells and interfering with the formation of blood vessels that supply nutrients to tumors. This can lead to tumor shrinkage or stabilization, helping to control the disease’s progression.
  • Prolonged Survival: In some cases, Sorafenib treatment has been associated with an extension of overall survival and progression-free survival in patients with advanced liver or kidney cancer, providing an opportunity for a better quality of life.

Common Side Effects:

  • Fatigue: Many patients on Sorafenib experience fatigue, which can range from mild to severe. It may impact daily activities and quality of life.
  • Diarrhea: Diarrhea is a common side effect of Sorafenib. It can vary in severity and may require medication or dietary adjustments.
  • Hand-Foot Skin Reaction: This condition, also known as palmar-plantar erythrodysesthesia (PPE), causes redness, pain, swelling, and sometimes blisters on the palms of the hands and soles of the feet.
  • Hypertension (High Blood Pressure): Sorafenib can lead to elevated blood pressure levels, which may require medication to manage.
  • Rash: Some patients may develop a rash, which can range from mild to severe. It is important to notify your healthcare provider if you experience a rash.
  • Nausea and Vomiting: Nausea and vomiting can occur as side effects of Sorafenib, although they are generally manageable with medication.
  • Hair Thinning or Changes: Some individuals may experience changes in hair texture or mild hair thinning during treatment.
  • Loss of Appetite and Weight Loss: A decreased appetite and weight loss can occur in some patients.
  • Liver Function Changes: Sorafenib may cause changes in liver function, which is usually monitored through blood tests.
  • Bleeding: Although less common, Sorafenib may increase the risk of bleeding or bruising. Any unusual bleeding or bruising should be promptly reported to a healthcare provider.

It’s important to note that not all patients will experience these side effects, and their severity can vary from person to person. Healthcare providers closely monitor patients on Sorafenib and may adjust the treatment plan or provide supportive care to manage side effects. Patients considering Sorafenib treatment should discuss the potential benefits and risks with their healthcare team. It’s essential to communicate any side effects or concerns to your healthcare provider promptly to ensure the best possible management of your treatment.

Frequently asked questions about Sorafenib Tablets:

  1. What is Sorafenib, and how does it work?

Sorafenib is a medication used to treat certain types of cancer. It works by inhibiting specific proteins and enzymes involved in cancer cell growth and angiogenesis (the formation of new blood vessels that support tumor growth).

  1. What types of cancer are treated with Sorafenib?

Sorafenib is primarily used to treat hepatocellular carcinoma (liver cancer) and renal cell carcinoma (kidney cancer).

  1. How is Sorafenib taken?

Sorafenib is typically taken orally in the form of tablets. The dosing and schedule will be determined by your healthcare provider based on your specific condition.

  1. What are the potential benefits of Sorafenib treatment?

Sorafenib can slow down the growth and progression of cancer, potentially leading to tumor shrinkage, stabilization, and improved survival in some cases.

  1. What are the common side effects of Sorafenib?

Common side effects of Sorafenib include fatigue, diarrhea, handfoot skin reaction (redness and pain in the palms and soles), hypertension (high blood pressure), rash, and nausea.

  1. Are there any serious side effects of Sorafenib?

While less common, Sorafenib can be associated with serious side effects, including bleeding, severe skin reactions, and changes in liver function. It’s crucial to report any unusual symptoms to your healthcare provider promptly.

  1. How often will I need medical monitoring during Sorafenib treatment?

Your healthcare provider will schedule regular checkups, blood tests, and imaging scans to monitor the effectiveness of Sorafenib and manage any side effects.

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

Your healthcare provider will determine the most appropriate treatment plan for your specific cancer, which may include Sorafenib alone or in combination with other therapies.

  1. Are there any dietary restrictions while taking Sorafenib?

Some dietary changes may be recommended to manage side effects, such as diarrhea. It’s essential to follow your healthcare provider’s guidance.

  1. Can I continue taking other medications or supplements while on Sorafenib?

You should inform your healthcare provider about all medications, including overthecounter drugs and supplements, to ensure there are no potential interactions with Sorafenib.

  1. Is Sorafenib safe during pregnancy or breastfeeding?

Sorafenib can harm a developing fetus, so it is generally not recommended during pregnancy. Breastfeeding should also be avoided while taking Sorafenib, as it may pass into breast milk.

  1. What should I do if I miss a dose of Sorafenib?

If you miss a dose, follow your healthcare provider’s instructions for making up the missed dose. Do not double the dose unless instructed to do so.

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

Sorafenib Tablets 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 Sorafenib Tablets, 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:

Sorafenib Tablets 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Sorafenib Tablets 200mg
Each film-coated tablet contains:
Sorafenib Tosylate Equivalent to
Sorafenib………………………200 mg
Excipients……………………..q.s.
Colours: Titanium Dioxide USP, Ferric Oxide Red.

THERAPEUTIC INDICATIONS:

Sorafenib is used to treat late-stage kidney cancer (advanced renal cell carcinoma), liver cancer (hepatocellular carcinoma) that cannot be treated by surgery, and differentiated thyroid cancer that has come back or spread to other parts of your body.

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Protect from light.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.