Introduction
Resinib Capsule 50 mg is an oral medication used primarily in the treatment of certain types of cancer. It is a tyrosine kinase inhibitor that targets multiple receptor kinases involved in cancer growth and angiogenesis. Resinib Capsule 50 mg is marketed under the brand name Sutent and is used for various indications including renal cell carcinoma and gastrointestinal stromal tumors (GISTs).
Uses
Resinib Capsule 50 mg is used for the treatment of:
- Renal cell carcinoma (RCC) in patients with advanced or metastatic disease.
- Gastrointestinal stromal tumors (GISTs) in patients who are resistant or intolerant to imatinib.
- Pancreatic neuroendocrine tumors (pNETs) in cases where the disease is locally advanced or metastatic.
| Brand Name | Resinib |
|---|---|
| Type | Capsule |
| Weight | 50 mg |
| Generic | Sunitinib |
| Manufacturer | Jenphar Bangladesh Ltd. |
| Available in | English বাংলা |
Mechanism of Action
Resinib Capsule 50 mg works by inhibiting several receptor tyrosine kinases, including those involved in tumor growth and angiogenesis. Key targets include vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), and c-KIT. By blocking these receptors, sunitinib interferes with tumor blood supply and cell signaling pathways critical for tumor progression and metastasis.
How Long Does It Take to Work?
The onset of therapeutic effect with sunitinib can vary. Some patients may begin to see improvements within 1 to 2 months of starting treatment, but it can take several months to observe the full clinical benefits. The response time depends on the type of cancer being treated and individual patient factors.
Absorption
Resinib Capsule 50 mg is well absorbed after oral administration, with peak plasma concentrations typically occurring within 6 to 12 hours. The drug is absorbed with a bioavailability of approximately 40%. Food does not significantly affect the absorption of sunitinib.
Route of Elimination
Resinib Capsule 50 mg is primarily metabolized in the liver by cytochrome P450 enzymes, particularly CYP3A4. The drug and its metabolites are excreted mainly through the feces, with a smaller amount eliminated in the urine.
Dosage
Recommended Dose for GIST and Advanced RCC: The recommended dose of Sutinib for gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (RCC) is one 50 mg oral dose taken once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2). It may be taken with or without food.Recommended Dose for Adjuvant Treatment of RCC: The recommended dose of Sutinib for the adjuvant treatment of RCC is 50 mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2), for nine 6-week cycles. It may be taken with or without food.
Recommended Dose for pNET: The recommended dose of Sutinib for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily continuously without a scheduled off-treatment period. It may be taken with or without food.
The standard dosage of sunitinib is:
- For renal cell carcinoma: 50 mg once daily for 4 weeks, followed by a 2-week rest period (cycle of 6 weeks).
- For gastrointestinal stromal tumors: 50 mg once daily continuously.
- For pancreatic neuroendocrine tumors: 37.5 mg once daily continuously.
Administration
Resinib Capsule 50 mg is administered orally in the form of capsules. It should be taken with a full glass of water and can be taken with or without food. The capsules should be swallowed whole and not crushed or chewed.
Side Effects
Common side effects of sunitinib include:
- Fatigue
- Nausea
- Diarrhea
- Hypertension
- Skin rash
- Cardiac issues such as heart failure
- Severe liver toxicity
- Hemorrhage
- Thyroid dysfunction
Toxicity
Toxicity can manifest as severe adverse effects, including but not limited to severe hypertension, liver dysfunction, and heart failure. Monitoring of liver function tests, blood pressure, and cardiac function is necessary during treatment. Management of toxicity may involve dose reductions or discontinuation of the medication.
Precautions
Precautions include:
- Regular monitoring of blood pressure, liver function, and thyroid function is recommended.
- Use with caution in patients with pre-existing cardiac conditions or hepatic impairment.
- Consider dose adjustments for patients with significant side effects or those at risk of adverse reactions.
Interaction
Resinib Capsule 50 mg may interact with other drugs, including:
- Strong CYP3A4 inhibitors (e.g., ketoconazole) which can increase sunitinib levels.
- Strong CYP3A4 inducers (e.g., rifampin) which can decrease sunitinib levels.
- Other medications that affect blood pressure or liver function.
Disease Interaction
Resinib Capsule 50 mg should be used with caution in patients with:
- Severe liver impairment due to altered drug metabolism.
- Pre-existing cardiac conditions, as it may exacerbate heart failure or other cardiac issues.
- Uncontrolled hypertension, as sunitinib can increase blood pressure.
Drug Interaction
Potential drug interactions include:
- Drugs that are substrates or inhibitors of CYP3A4.
- Antihypertensive medications that may require adjustment due to sunitinib-induced hypertension.
- Other antineoplastic agents, as combination therapy may affect tolerability.
Food Interactions
There are no significant food interactions with sunitinib. The drug can be taken with or without food. However, it is advisable to maintain consistency in diet to avoid variability in drug absorption.
Pregnancy Use
Resinib Capsule 50 mg is classified as Category D in pregnancy, indicating that there is evidence of risk to the fetus based on human studies. It should be used during pregnancy only if the potential benefits outweigh the risks. Women of childbearing potential should use effective contraception during treatment.
Lactation Use
It is not known whether sunitinib is excreted in human breast milk. Due to potential risks to a nursing infant, breastfeeding is generally not recommended during treatment with sunitinib. Consultation with a healthcare provider is advised for lactating women.
Acute Overdose
In case of acute overdose, symptoms may include severe adverse effects related to the drug’s known side effects. Treatment involves supportive care and symptomatic management. The specific antidote for overdose is not available, and medical consultation is necessary.
Contraindication
Resinib Capsule 50 mg is contraindicated in:
- Patients with severe hypersensitivity to sunitinib or any of its components.
- Pregnant women, unless the potential benefits justify the risk to the fetus.
Use Direction
Resinib Capsule 50 mg should be used according to the prescribing information. The usual dose is 50 mg once daily for 4 weeks, followed by a 2-week break, for renal cell carcinoma. For GISTs and pancreatic neuroendocrine tumors, the dose may be adjusted based on individual tolerability and clinical response.
Storage Conditions
Store sunitinib capsules at room temperature, between 20°C and 25°C (68°F and 77°F). Keep the medication in its original container, tightly closed, and away from moisture and heat. Do not use after the expiration date printed on the label.
Volume of Distribution
The volume of distribution of sunitinib is approximately 3,800 L, indicating extensive distribution into body tissues and fluids.
Half Life
The terminal half-life of sunitinib is approximately 40 to 60 hours. This long half-life supports once-daily dosing and allows for effective suppression of tumor growth with intermittent dosing schedules.
Clearance
The clearance of sunitinib is primarily hepatic, with the drug being metabolized by the liver. The renal clearance of unchanged drug is minimal. The overall clearance can be affected by liver function and other concomitant medications.
See in details version Resinib Capsule 50 mg also Resinib Capsule 50 mg in bangla
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