Sunitinib Malate Capsules 50mg Technical Specification:

Product Name:Sunitinib Malate Capsules 50mg
Brand Name:Sunitinib
Strength:12.5mg, 25mg, 37.5mg, 50mg
Dosage Form:Hard-Gelatin Capsules
Packing:28s
Route of Administration:For Oral Use
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: Sunitinib is a type of targeted drug called a protein kinase inhibitor. Sunitinib is used to treat gastrointestinal stromal tumors (GIST; a type of tumor that grows in the stomach, intestine (bowel), or esophagus).
Storage:Store at 20°C to 25°C (68° to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Sunitinib Malate Capsules 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Sunitinib Malate Capsules 50mg
    Each hard gelatin capsule contains:
    Sunitinib Malate Equivalent to
    Sunitinib……………….……50 mg
    Excipients………………….q.s
    Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron

THERAPEUTIC INDICATIONS:

Sunitinib is a type of targeted drug called a protein kinase inhibitor. Sunitinib is used to treat gastrointestinal stromal tumors (GIST; a type of tumor that grows in the stomach, intestine (bowel), or esophagus).

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.
Capsule should be swallowed whole and not to be chewed or crushed.
Dispense in a tight, light resistant container
Keep container tightly closed.
Dispense in original container.
Do not use if seal over bottle opening is broken or missing.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

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

Why Taj Pharmaceuticals?

Taj Pharma is your trusted partner for Sunitinib Malate Capsules, offering a compelling combination of quality and reliability in the pharmaceutical industry. Our unwavering commitment to excellence is exemplified through cutting-edge manufacturing facilities and stringent quality control measures, ensuring that each capsule meets the highest industry standards. This dedication to quality has earned us the trust of healthcare professionals and patients worldwide. At Taj Pharma, we understand that timely access to medications is crucial for patients battling cancer. Our robust supply chain and distribution network ensure that Sunitinib Malate Capsules are readily available when and where they are needed most. We prioritize accessibility, making it possible for individuals to receive the treatment they require, regardless of their location.

When you choose Taj Pharma for Sunitinib Malate Capsules, you’re not only selecting a medication; you’re choosing a partner committed to your well-being. We are dedicated to enhancing the quality of life for patients, and our Sunitinib Malate Capsules reflect this commitment. Trust Taj Pharma for unmatched quality, reliability, and accessibility in healthcare.

What is Sunitinib Malate Capsules and its use?

Sunitinib Malate Capsules are a medication used in the treatment of various types of cancer. Sunitinib is the active ingredient, and it is commonly available in capsule form. Here’s an overview of Sunitinib Malate Capsules and their uses:

Sunitinib Malate:

Sunitinib is a tyrosine kinase inhibitor (TKI), a type of targeted therapy that specifically targets and inhibits certain enzymes known as tyrosine kinases. These enzymes play a role in the growth and spread of cancer cells. Sunitinib Malate is the salt form of sunitinib that is used in medication formulations.

Uses:

  • Renal Cell Carcinoma (RCC): Sunitinib is approved for the treatment of advanced or metastatic renal cell carcinoma, which is a type of kidney cancer. It is often used when surgery or other treatments are not suitable.
  • Gastrointestinal Stromal Tumor (GIST): Sunitinib is also indicated for the treatment of gastrointestinal stromal tumors, a type of cancer that starts in the digestive tract, including the stomach and intestines.
  • Pancreatic Neuroendocrine Tumors (pNET): Sunitinib may be used to treat pancreatic neuroendocrine tumors that have progressed or cannot be surgically removed.

Treatment Regimen:

The dosing and duration of Sunitinib treatment can vary based on the type and stage of cancer being treated, as well as the individual patient’s response. Typically, it is taken orally in capsule form, and the treatment plan is determined by a healthcare provider.

Patients prescribed Sunitinib Malate Capsules should have regular follow-up appointments with their healthcare provider to monitor their response to treatment and manage any side effects. Sunitinib should only be used under the supervision and prescription of a qualified healthcare professional, and treatment plans should be tailored to the individual patient’s medical condition and needs.

How does Sunitinib Malate Capsules Work?

Sunitinib Malate Capsules work by inhibiting specific enzymes called tyrosine kinases, which play a crucial role in the growth and spread of cancer cells. Here’s a more detailed explanation of how Sunitinib works:

  • Inhibition of Tyrosine Kinases: Sunitinib is classified as a tyrosine kinase inhibitor (TKI), specifically targeting multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases. These kinases are involved in various signaling pathways that regulate cell growth, division, and angiogenesis (the formation of new blood vessels).
  • Targeting Vascular Endothelial Growth Factor Receptors (VEGFRs): Sunitinib inhibits several receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFRs). VEGFRs are critical in promoting angiogenesis, the process by which new blood vessels form to supply nutrients and oxygen to tumors. By inhibiting VEGFRs, Sunitinib interferes with this process, reducing the tumor’s ability to establish a blood supply.
  • Inhibition of Platelet-Derived Growth Factor Receptors (PDGFRs): Sunitinib also inhibits platelet-derived growth factor receptors (PDGFRs). PDGF plays a role in stimulating the growth of blood vessels and connective tissue. By targeting PDGFRs, Sunitinib further disrupts the tumor’s ability to promote angiogenesis and grow.
  • Blockage of Other Tyrosine Kinases: Sunitinib has activity against other tyrosine kinases, including c-KIT and FLT3, which are associated with specific types of cancer, such as gastrointestinal stromal tumors (GISTs) and acute myeloid leukemia (AML), respectively. Inhibiting these kinases can slow down the growth and spread of cancer cells.
  • Apoptosis Induction: Sunitinib may also induce apoptosis, a process of programmed cell death, in cancer cells. By promoting apoptosis, it helps eliminate abnormal cancer cells from the body.

Overall, Sunitinib’s mechanism of action involves targeting multiple signaling pathways involved in cancer progression, including angiogenesis and cell growth. By inhibiting these pathways and tyrosine kinases, Sunitinib disrupts the ability of cancer cells to divide, receive nutrients, and promote tumor growth.

Benefits and Side effects of Sunitinib Malate Capsules?

Sunitinib Malate Capsules 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 Sunitinib Malate Capsules:

Benefits:

  • Cancer Treatment: Sunitinib is primarily used to treat specific types of cancer, including renal cell carcinoma (RCC), gastrointestinal stromal tumors (GISTs), and pancreatic neuroendocrine tumors (pNETs). It can be effective in slowing down the progression of these cancers and improving symptoms.
  • Inhibition of Tumor Growth: Sunitinib works by inhibiting tyrosine kinases involved in cancer cell growth and angiogenesis (the formation of new blood vessels that support tumor growth). This can lead to tumor shrinkage, stabilization, and a reduction in cancer-related symptoms.
  • Extended Survival: In some cases, Sunitinib treatment has been associated with prolonged overall survival and progression-free survival in patients with advanced or metastatic cancer, offering hope for improved long-term outcomes.

Common Side Effects:

  • Fatigue: Many patients on Sunitinib experience fatigue, which can range from mild to severe. Fatigue may impact daily activities and quality of life.
  • Diarrhea: Diarrhea is a common side effect of Sunitinib. It can vary in severity and may require medication or dietary adjustments.
  • Nausea and Vomiting: Some individuals may experience nausea and vomiting while taking Sunitinib. These symptoms can usually be managed with anti-nausea medications.
  • Hand-Foot Syndrome: Hand-foot syndrome (palmar-plantar erythrodysesthesia) can occur, leading to redness, pain, and peeling of the palms of the hands and soles of the feet.
  • Hypertension (High Blood Pressure): Sunitinib can lead to elevated blood pressure levels. Blood pressure should be monitored regularly during treatment, and medication may be prescribed to manage it.
  • Skin Changes: Skin discoloration, rash, and dryness may occur as side effects of Sunitinib.
  • Loss of Appetite and Weight Loss: Some patients may experience a decreased appetite and weight loss during treatment.
  • Thyroid Abnormalities: Sunitinib can affect thyroid function, leading to hypothyroidism (underactive thyroid) or thyroiditis. Thyroid function should be monitored, and thyroid hormone replacement may be necessary.
  • Liver Function Changes: Sunitinib may cause changes in liver function, which are typically monitored through blood tests.

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 Sunitinib and may adjust the treatment plan or provide supportive care to manage side effects. Patients considering Sunitinib Malate Capsules 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 (FAQs) about Sunitinib Malate Capsules:

  1. What is Sunitinib Malate, and how does it work?

Sunitinib Malate is a medication used to treat certain types of cancer. It works by inhibiting specific enzymes called tyrosine kinases, which play a role in cancer cell growth and angiogenesis.

  1. What types of cancer are treated with Sunitinib Malate Capsules?

Sunitinib is primarily used to treat renal cell carcinoma (kidney cancer), gastrointestinal stromal tumors (GISTs), and pancreatic neuroendocrine tumors (pNETs).

  1. How is Sunitinib Malate taken?

Sunitinib Malate is typically taken orally in the form of capsules. The dosing and schedule are determined by a healthcare provider based on the specific cancer being treated.

  1. What are the potential benefits of Sunitinib treatment?

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

  1. What are the common side effects of Sunitinib Malate Capsules?

Common side effects of Sunitinib may include fatigue, diarrhea, nausea, vomiting, hindfoot syndrome (palmar plantar erythrodysesthesia), hypertension (high blood pressure), and skin changes.

  1. Are there any serious side effects of Sunitinib?

While less common, Sunitinib can be associated with serious side effects such as severe bleeding, heart problems, liver function changes, and thyroid abnormalities.

  1. How often should I have medical check-ups while on Sunitinib treatment?

Regular medical check-ups, blood tests, and imaging scans are typically scheduled to monitor your response to treatment and manage any side effects.

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

Your healthcare provider will determine the most appropriate treatment plan, which may include Sunitinib alone or in combination with other therapies.

  1. Are there dietary restrictions while taking Sunitinib Malate Capsules?

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

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

Inform your healthcare provider about all medications, including over-the-counter drugs and supplements, to ensure there are no potential interactions with Sunitinib.

  1. Is Sunitinib safe during pregnancy or breastfeeding?

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

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

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

Sunitinib Malate 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 Sunitinib Malate 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) Sunitinib Malate Capsules 12.5mg
b) Sunitinib Malate Capsules 25mg
c) Sunitinib Malate Capsules 37.5mg
d) Sunitinib Malate Capsules 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Sunitinib Malate Capsules 12.5mg
Each hard gelatin capsule contains:
Sunitinib Malate Equivalent to
Sunitinib……………….……12.5 mg
Excipients………………….q.s
Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron

b) Sunitinib Malate Capsules 25mg
Each hard gelatin capsule contains:
Sunitinib Malate Equivalent to
Sunitinib……………………25 mg
Excipients………………….q.s
Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron

c) Sunitinib Malate Capsules 37.5mg
Each hard gelatin capsule contains:
Sunitinib Malate Equivalent to
Sunitinib……………………37.5 mg
Excipients………………….q.s
Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron

d) Sunitinib Malate Capsules 50mg
Each hard gelatin capsule contains:
Sunitinib Malate Equivalent to
Sunitinib……………….…...50 mg
Excipients…………………..q.s
Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron

THERAPEUTIC INDICATIONS:

Sunitinib is a type of targeted drug called a protein kinase inhibitor. Sunitinib is used to treat gastrointestinal stromal tumors (GIST; a type of tumor that grows in the stomach, intestine (bowel), or esophagus).

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.
Capsule should be swallowed whole and not to be chewed or crushed.
Dispense in a tight, light resistant container
Keep container tightly closed.
Dispense in original container.
Do not use if seal over bottle opening is broken or missing.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

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