Sunitinib Glenmark
Protein kinase inhibitor for advanced cancers including GIST, kidney cancer, and pancreatic neuroendocrine tumors
Sunitinib Glenmark is a targeted cancer therapy containing the active substance sunitinib, a multi-kinase inhibitor. It works by blocking the activity of several protein kinases involved in tumor growth, abnormal blood vessel formation (angiogenesis), and cancer cell spread. Sunitinib Glenmark is used to treat gastrointestinal stromal tumors (GIST), metastatic renal cell carcinoma (kidney cancer), and pancreatic neuroendocrine tumors (pNET). This medication requires a prescription and must be taken under close medical supervision with regular monitoring of blood counts, thyroid function, blood pressure, and heart function.
Quick Facts
Key Takeaways
- Sunitinib Glenmark is a multi-targeted kinase inhibitor used for GIST (after imatinib failure), metastatic renal cell carcinoma, and advanced pancreatic neuroendocrine tumors.
- The standard GIST/RCC dose is 50 mg daily for 28 days followed by 14 days off; for pNET the dose is 37.5 mg daily without interruption.
- Common side effects include fatigue, diarrhea, skin discoloration, high blood pressure, and decreased blood cell counts — all requiring regular monitoring.
- Strong CYP3A4 inhibitors (ketoconazole, ritonavir) and inducers (rifampicin, phenytoin, St. John’s Wort) significantly affect sunitinib blood levels.
- Grapefruit juice must be avoided; regular thyroid, heart, liver, kidney, and blood pressure monitoring is essential throughout treatment.
What Is Sunitinib Glenmark and What Is It Used For?
Sunitinib Glenmark contains the active substance sunitinib, which belongs to a class of medications known as protein kinase inhibitors (also called tyrosine kinase inhibitors or TKIs). These drugs work by targeting specific proteins on and inside cancer cells that are responsible for driving tumor growth, promoting the formation of new blood vessels that supply the tumor (a process called angiogenesis), and enabling cancer cells to spread to other parts of the body (metastasis).
Sunitinib simultaneously inhibits multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, VEGFR-3), platelet-derived growth factor receptors (PDGFR-alpha and PDGFR-beta), stem cell factor receptor (KIT), FMS-like tyrosine kinase-3 (FLT3), colony-stimulating factor 1 receptor (CSF-1R), and the glial cell line-derived neurotrophic factor receptor (RET). By blocking these pathways simultaneously, sunitinib starves tumors of their blood supply while directly inhibiting cancer cell proliferation.
Sunitinib Glenmark is approved for the treatment of the following cancer types:
Gastrointestinal Stromal Tumors (GIST)
GIST is a type of cancer that develops in the wall of the gastrointestinal tract, most commonly in the stomach or small intestine. These tumors arise from specialized cells called interstitial cells of Cajal. Sunitinib Glenmark is used as a second-line treatment for GIST when imatinib (another tyrosine kinase inhibitor) is no longer effective due to disease progression or resistance, or when the patient cannot tolerate imatinib due to side effects. Clinical trials have demonstrated that sunitinib significantly prolongs time to tumor progression compared with placebo in imatinib-resistant or intolerant GIST patients.
Metastatic Renal Cell Carcinoma (mRCC)
Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for approximately 90% of all kidney malignancies. When the cancer has spread beyond the kidney to other parts of the body — such as the lungs, bones, liver, or brain — it is classified as metastatic. Sunitinib Glenmark is approved as a first-line treatment for metastatic renal cell carcinoma. Landmark clinical trials established sunitinib as a standard of care in this setting, demonstrating a median progression-free survival of approximately 11 months compared with 5 months for interferon-alfa therapy.
Pancreatic Neuroendocrine Tumors (pNET)
Pancreatic neuroendocrine tumors originate from the hormone-producing cells of the pancreas. These are relatively rare tumors that can produce excess hormones (functional tumors) or remain non-functional. Sunitinib Glenmark is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease. Clinical evidence has shown that sunitinib approximately doubles progression-free survival compared with placebo in this patient population.
Sunitinib Glenmark is a generic version of sunitinib. The active substance sunitinib may also be available under other brand names. Always follow your prescribing physician’s instructions regarding your specific medication and dosing schedule.
What Should You Know Before Taking Sunitinib Glenmark?
Contraindications
Do not take Sunitinib Glenmark if you are allergic (hypersensitive) to sunitinib or any of the other ingredients in this medicine. Known hypersensitivity to the active substance or excipients is the primary absolute contraindication. If you have previously experienced an allergic reaction to sunitinib or another tyrosine kinase inhibitor, inform your oncologist before starting treatment.
Warnings and Precautions
Sunitinib is a potent medication that requires careful monitoring throughout treatment. Speak with your doctor or pharmacist before taking Sunitinib Glenmark, particularly if any of the following conditions apply to you:
Contact your doctor or go to the emergency department immediately if you experience: severe chest pain or pressure, sudden shortness of breath, blood in your urine or stool, sudden severe headache, signs of stroke (facial drooping, arm weakness, speech difficulty), or severe abdominal pain.
Cardiovascular risks: Sunitinib may cause high blood pressure (hypertension), heart failure, reduced heart pumping function, and abnormal heart rhythms (QT prolongation). Your doctor should monitor your blood pressure regularly during treatment and may prescribe antihypertensive medication if needed. Report any symptoms of heart problems immediately, including unusual fatigue, shortness of breath, swollen feet or ankles, dizziness, fainting, or irregular heartbeat. Baseline and periodic electrocardiograms (ECGs) may be performed to monitor heart rhythm.
Blood disorders: Treatment with sunitinib can lead to decreased blood cell counts, including low platelets (thrombocytopenia), low red blood cells (anemia), and low white blood cells (neutropenia). This increases the risk of bleeding, infection, and fatigue. Complete blood counts should be checked before each treatment cycle. If you take blood-thinning medications such as warfarin or acenocoumarol, the risk of bleeding may be increased. Report any unusual bruising or bleeding to your doctor.
Thromboembolic events: Sunitinib may increase the risk of blood clots in veins and arteries, including stroke, heart attack, deep vein thrombosis, and pulmonary embolism. Patients with a history of thromboembolic events should be closely monitored. Contact your doctor immediately if you experience chest pain, arm or jaw pain, sudden numbness or weakness on one side of the body, difficulty speaking, or sudden severe headache.
Aneurysm and artery dissection: The use of VEGF pathway inhibitors including sunitinib may promote the formation of aneurysms (enlargement and weakening of a blood vessel wall) and artery dissections (tears in the artery wall). This risk should be considered before starting treatment, especially in patients with risk factors such as hypertension or a history of aneurysm.
Thrombotic microangiopathy (TMA): Sunitinib has been associated with damage to the smallest blood vessels, a condition known as thrombotic microangiopathy. Symptoms may include fever, fatigue, bruising, bleeding, swelling, confusion, vision loss, and seizures. Report these symptoms immediately.
Thyroid dysfunction: Sunitinib commonly affects thyroid function, most frequently causing hypothyroidism (underactive thyroid). Symptoms include increased fatigue, cold intolerance, weight gain, constipation, and a deepening voice. Thyroid function tests should be performed before treatment initiation and regularly monitored throughout therapy. Thyroid hormone replacement therapy may be required. In rare cases, hyperthyroidism (overactive thyroid) may also occur.
Hepatotoxicity: Sunitinib may cause liver damage. Symptoms of liver problems include itching, yellowing of the eyes or skin (jaundice), dark urine, and pain in the upper right abdomen. Liver function blood tests should be performed before starting treatment and monitored periodically during therapy. Severe liver failure has been reported rarely and can be fatal.
Pancreatic and gallbladder disorders: Inflammation of the pancreas (pancreatitis) and gallbladder (cholecystitis) have been reported with sunitinib. Seek medical attention if you develop severe upper abdominal pain, nausea, vomiting, or fever.
Kidney function: Your doctor will monitor your kidney function during treatment. Protein in the urine (proteinuria) and, rarely, kidney failure have been reported.
Wound healing: Sunitinib may impair wound healing. Treatment is typically interrupted before planned surgical procedures. Your doctor will determine when it is safe to resume treatment after surgery.
Jaw osteonecrosis: Cases of osteonecrosis of the jaw (bone damage in the jaw) have been reported, particularly in patients also receiving intravenous bisphosphonates. Dental examinations are recommended before starting treatment. Inform your dentist that you are taking sunitinib.
Skin reactions: Severe skin reactions including pyoderma gangrenosum (painful skin ulcers), necrotizing fasciitis (a rapidly spreading and potentially life-threatening soft tissue infection), Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have been reported. Seek immediate medical attention if you develop widespread skin rash, blistering, or skin peeling.
Seizures: Reversible posterior leukoencephalopathy syndrome (RPLS) has been reported, which may present with seizures, headache, visual disturbances, confusion, and high blood pressure.
Diabetes: Blood glucose levels should be monitored regularly in patients with diabetes, as sunitinib may cause hypoglycemia (low blood sugar). Adjustments to diabetes medication may be necessary.
Children and Adolescents
Sunitinib Glenmark is not recommended for use in individuals under 18 years of age. There is insufficient clinical data to establish the safety and efficacy of sunitinib in the pediatric population.
Pregnancy and Breastfeeding
Sunitinib may cause harm to an unborn baby. If you are pregnant, think you may be pregnant, or are planning to become pregnant, do not take this medication without consulting your doctor. Women of childbearing potential should use effective contraception during treatment and for a period after the last dose as directed by their physician.
Breastfeeding is not recommended during treatment with sunitinib, as the drug may pass into breast milk and harm the nursing infant. Discuss alternative feeding options with your healthcare provider.
Driving and Operating Machinery
Sunitinib may cause dizziness and unusual tiredness. If you experience these effects, exercise caution when driving or operating machinery. You are responsible for assessing whether you are fit to perform tasks requiring alertness.
Sunitinib Glenmark capsules contain less than 1 mmol (23 mg) sodium per capsule, meaning they are essentially sodium-free.
How Does Sunitinib Glenmark Interact with Other Drugs?
Always inform your doctor or pharmacist about all medications you are taking, including prescription drugs, over-the-counter medicines, and herbal supplements. Sunitinib is primarily metabolized by the cytochrome P450 enzyme CYP3A4 in the liver. Drugs that inhibit or induce this enzyme can significantly alter sunitinib blood levels, potentially increasing toxicity or reducing effectiveness.
Major Interactions (CYP3A4 Inhibitors)
Strong CYP3A4 inhibitors can significantly increase sunitinib plasma concentrations, leading to a higher risk of serious side effects. Co-administration with strong CYP3A4 inhibitors should be avoided if possible. If concurrent use is unavoidable, your doctor may reduce the sunitinib dose.
Major Interactions (CYP3A4 Inducers)
Strong CYP3A4 inducers can significantly decrease sunitinib plasma concentrations, potentially reducing the drug’s anticancer effectiveness. If concurrent use with strong CYP3A4 inducers cannot be avoided, your doctor may increase the sunitinib dose with careful monitoring.
| Drug / Substance | Interaction Type | Effect | Clinical Recommendation |
|---|---|---|---|
| Ketoconazole | Strong CYP3A4 inhibitor | Increases sunitinib levels | Avoid or reduce sunitinib dose |
| Itraconazole | Strong CYP3A4 inhibitor | Increases sunitinib levels | Avoid or reduce sunitinib dose |
| Ritonavir | Strong CYP3A4 inhibitor | Increases sunitinib levels | Avoid or reduce sunitinib dose |
| Erythromycin | Moderate CYP3A4 inhibitor | May increase sunitinib levels | Use with caution; monitor |
| Clarithromycin | Moderate CYP3A4 inhibitor | May increase sunitinib levels | Use with caution; monitor |
| Rifampicin | Strong CYP3A4 inducer | Decreases sunitinib levels | Avoid or increase sunitinib dose |
| Phenytoin | Strong CYP3A4 inducer | Decreases sunitinib levels | Avoid or increase sunitinib dose |
| Carbamazepine | Strong CYP3A4 inducer | Decreases sunitinib levels | Avoid or increase sunitinib dose |
| Phenobarbital | Strong CYP3A4 inducer | Decreases sunitinib levels | Avoid or increase sunitinib dose |
| Dexamethasone | CYP3A4 inducer | May decrease sunitinib levels | Use with caution; monitor |
| St. John’s Wort | Strong CYP3A4 inducer | Decreases sunitinib levels | Avoid during treatment |
| Grapefruit juice | CYP3A4 inhibitor | Increases sunitinib levels | Avoid during treatment |
Anticoagulants
Patients taking blood-thinning medications (anticoagulants) such as warfarin or acenocoumarol concurrently with sunitinib may have an increased risk of bleeding. Your doctor should monitor coagulation parameters more frequently if you require both medications. Signs of bleeding — such as unusual bruising, blood in urine or stool, or prolonged bleeding from cuts — should be reported immediately.
Avoid drinking grapefruit juice while taking Sunitinib Glenmark. Grapefruit inhibits the CYP3A4 enzyme that metabolizes sunitinib, which can lead to increased drug levels in the blood and a higher risk of side effects.
What Is the Correct Dosage of Sunitinib Glenmark?
Always take Sunitinib Glenmark exactly as your doctor has instructed. Do not change your dose or stop taking this medication without consulting your doctor. The appropriate dose depends on the type of cancer being treated, your response to treatment, and any side effects you may experience.
Adults
GIST and Metastatic Renal Cell Carcinoma (mRCC)
The recommended dose is 50 mg taken orally once daily for 28 consecutive days (4 weeks), followed by a 14-day rest period (2 weeks) without medication. This constitutes one complete 6-week treatment cycle. Treatment cycles are repeated as long as the patient benefits from therapy and side effects remain manageable. Your doctor may adjust the dose in 12.5 mg increments (minimum 25 mg, maximum 75 mg) based on your individual tolerability and response.
Pancreatic Neuroendocrine Tumors (pNET)
The recommended dose is 37.5 mg taken orally once daily on a continuous basis (no scheduled rest period). Your doctor may adjust the dose based on tolerability. Dose reductions should occur in 12.5 mg increments.
Sunitinib Glenmark can be taken with or without food. Swallow the capsule whole with a glass of water. Do not open, crush, or chew the capsule.
Children and Adolescents
Sunitinib Glenmark is not recommended for patients under 18 years of age due to insufficient data on safety and efficacy in this population.
Elderly Patients
No specific dose adjustment is required for elderly patients. However, older patients may be more susceptible to certain side effects and should be monitored closely. Your oncologist will determine the appropriate dose based on your overall health status and any co-existing medical conditions.
Missed Dose
If you forget to take a dose, do not take a double dose to make up for the missed one. Simply skip the forgotten dose and take the next dose at your usual time. If you are unsure about what to do, contact your doctor or pharmacist for guidance.
Overdose
If you accidentally take more capsules than prescribed, contact your doctor or go to the nearest emergency department immediately. You may require medical monitoring. There is no specific antidote for sunitinib overdose; treatment is supportive and symptomatic. Bring your medication packaging with you so the medical team can identify what you have taken.
| Indication | Recommended Dose | Schedule | Dose Adjustments |
|---|---|---|---|
| GIST | 50 mg once daily | 28 days on / 14 days off | ±12.5 mg (range: 25–75 mg) |
| mRCC | 50 mg once daily | 28 days on / 14 days off | ±12.5 mg (range: 25–75 mg) |
| pNET | 37.5 mg once daily | Continuous (no rest period) | ±12.5 mg based on tolerability |
What Are the Side Effects of Sunitinib Glenmark?
Like all medicines, Sunitinib Glenmark can cause side effects, although not everyone experiences them. Some side effects can be serious and require immediate medical attention. The frequency and severity of side effects vary among patients and may be managed through dose adjustments and supportive treatments.
Contact your doctor immediately if you experience: extreme fatigue with shortness of breath and swollen ankles (heart failure); coughing blood or sudden breathlessness (pulmonary embolism); changes in urination (kidney problems); severe bleeding from any site; severe abdominal pain with fever (possible bowel perforation or pancreatitis); widespread blistering or skin peeling.
Very Common
May affect more than 1 in 10 people
- Decreased blood cell counts (platelets, red cells, white cells including neutrophils)
- Fatigue and weakness
- High blood pressure (hypertension)
- Diarrhea, nausea, vomiting, constipation
- Mouth sores, mouth pain, taste changes, dry mouth
- Decreased appetite and abdominal pain or swelling
- Skin discoloration (yellowing), increased pigmentation, hair color changes
- Hand-foot skin reaction (rash on palms and soles), dry skin, rash
- Shortness of breath and cough
- Hypothyroidism (underactive thyroid)
- Headache and dizziness
- Nosebleeds (epistaxis)
- Joint pain, back pain, and limb pain
- Swelling (edema), including around the eyes
- Fever, difficulty sleeping
Common
May affect up to 1 in 10 people
- Blood clots in blood vessels
- Reduced blood supply to the heart (coronary artery disease), chest pain
- Decreased heart pumping function (ejection fraction decline)
- Fluid accumulation around the lungs (pleural effusion)
- Infections, including severe infections (sepsis)
- Low blood sugar (hypoglycemia)
- Protein in the urine (proteinuria)
- Abnormal blood values (liver and pancreatic enzymes, uric acid)
- Hemorrhoids, rectal pain, gum bleeding, difficulty swallowing
- Heartburn, gas, inflammation of the GI tract lining
- Weight loss, dehydration
- Muscle pain, muscle weakness, muscle spasm
- Nasal dryness, nasal congestion
- Increased tearing, skin itching, blisters, acne, nail discoloration, hair loss
- Abnormal sensation in limbs, numbness or tingling
- Depression, hot flashes, chills, discolored urine
- Flu-like symptoms
Uncommon
May affect up to 1 in 100 people
- Life-threatening soft tissue infections (necrotizing fasciitis)
- Stroke, heart attack
- Changes in heart electrical activity, abnormal heart rhythm
- Fluid around the heart (pericardial effusion)
- Liver failure
- Pancreatitis (inflammation of the pancreas)
- Bowel perforation (tumor breakdown causing a hole in the intestine)
- Gallbladder inflammation (cholecystitis)
- Fistula (abnormal channel between body cavities or to the skin)
- Jaw osteonecrosis (bone damage in the jaw)
- Hyperthyroidism (overactive thyroid)
- Impaired wound healing after surgery
- Elevated muscle enzyme (creatine phosphokinase)
- Severe allergic reactions including anaphylaxis
- Inflammation of the colon (colitis, ischemic colitis)
Rare
May affect up to 1 in 1,000 people
- Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)
- Tumor lysis syndrome (TLS) — metabolic complications from rapid cancer cell death, which may cause nausea, irregular heartbeat, seizures, cloudy urine, and fatigue
- Rhabdomyolysis (abnormal muscle tissue breakdown potentially leading to kidney damage)
- Reversible posterior leukoencephalopathy syndrome (RPLS) — brain changes causing headache, confusion, seizures, and vision loss
- Pyoderma gangrenosum (painful skin ulcers)
- Hepatitis (liver inflammation)
- Thyroiditis (thyroid inflammation)
- Thrombotic microangiopathy (TMA) — damage to the smallest blood vessels
Frequency Not Known
Reported in an unknown number of users
- Aneurysm and arterial dissection (enlargement, weakening, or tearing of a blood vessel wall)
- Hyperammonemic encephalopathy — brain toxicity caused by high ammonia levels, presenting as lack of energy, confusion, drowsiness, or loss of consciousness
Managing Side Effects
Many side effects of sunitinib can be managed with appropriate supportive care. Dose adjustments (reductions or temporary interruptions) are a common strategy for managing intolerable side effects. Anti-diarrheal medications, anti-nausea drugs, topical creams for hand-foot syndrome, and antihypertensive medications are frequently used alongside sunitinib therapy. Do not attempt to manage severe side effects on your own — always consult your oncology team.
Regular monitoring is essential throughout treatment. Your healthcare team will typically check complete blood counts, liver function, thyroid function, blood pressure, and heart function at regular intervals. These monitoring schedules are designed to detect problems early so they can be addressed before becoming serious.
How Should You Store Sunitinib Glenmark?
Keep Sunitinib Glenmark out of the sight and reach of children. This is especially important as the capsules could be extremely harmful if accidentally ingested by a child.
Do not use this medicine after the expiry date stated on the carton, bottle, or blister pack after “EXP.” The expiry date refers to the last day of the stated month. No special storage conditions are required for this medication — store at room temperature.
Do not use Sunitinib Glenmark if the packaging appears damaged or shows signs of tampering. Inspect the blister pack or bottle before each use.
Do not dispose of medications via wastewater or household waste. Return unused or expired capsules to your pharmacist for proper disposal. These measures help to protect the environment, as sunitinib is a cytotoxic agent that should not enter the general waste stream.
What Does Sunitinib Glenmark Contain?
Active Substance
The active substance is sunitinib. Sunitinib Glenmark is available in three strengths:
- 12.5 mg hard capsules: Each capsule contains 12.5 mg sunitinib
- 25 mg hard capsules: Each capsule contains 25 mg sunitinib
- 50 mg hard capsules: Each capsule contains 50 mg sunitinib
Inactive Ingredients (Excipients)
The other ingredients are:
- Capsule contents: Microcrystalline cellulose (E460), mannitol (E421), croscarmellose sodium, povidone (E1201), magnesium stearate (E470b)
- Capsule shell: Red iron oxide (E172), titanium dioxide (E171), gelatin; the 25 mg and 50 mg capsules also contain black iron oxide (E172) and yellow iron oxide (E172)
- Printing ink (white): Shellac, titanium dioxide (E171), propylene glycol (E1520)
Appearance and Package Sizes
12.5 mg capsules: Size 4 gelatin capsules (approximately 14.3 mm long) with orange cap and body, marked “12.5 mg” in white ink on the body, containing yellow to orange granules.
25 mg capsules: Size 3 gelatin capsules (approximately 15.9 mm long) with caramel-colored cap and body, marked “25 mg” in white ink on the body, containing yellow to orange granules.
50 mg capsules: Size 1 gelatin capsules (approximately 19.4 mm long) with caramel-colored cap and body, marked “50 mg” in white ink on the body, containing yellow to orange granules.
Sunitinib Glenmark is available in perforated unit-dose blisters of 28 × 1 or 30 × 1 hard capsules, and in plastic bottles containing 30 hard capsules. Not all pack sizes may be marketed in all countries.
Glenmark Arzneimittel GmbH, Industriestr. 31, 82194 Gröbenzell, Germany. Manufactured by Remedica Ltd., Limassol, Cyprus; and Glenmark Pharmaceuticals s.r.o., Vysoké Mýto, Czech Republic.
Frequently Asked Questions About Sunitinib Glenmark
Sunitinib Glenmark is a targeted cancer therapy used to treat three types of cancer: gastrointestinal stromal tumors (GIST) when imatinib is no longer effective or cannot be tolerated, metastatic renal cell carcinoma (advanced kidney cancer that has spread), and progressive well-differentiated pancreatic neuroendocrine tumors (pNET) that are locally advanced or metastatic. It works by inhibiting multiple protein kinases involved in tumor growth and blood vessel formation.
The most common side effects (affecting more than 1 in 10 people) include fatigue, diarrhea, nausea and vomiting, mouth sores and taste changes, decreased appetite, skin discoloration and hand-foot skin reaction, high blood pressure, decreased blood cell counts, hypothyroidism, headache, dizziness, nosebleeds, and joint or muscle pain. Many of these side effects can be managed with supportive care and dose adjustments. Your oncology team will monitor you closely throughout treatment.
No, you should avoid grapefruit juice while taking Sunitinib Glenmark. Grapefruit juice contains compounds that inhibit the CYP3A4 enzyme in the liver, which is responsible for breaking down sunitinib. Consuming grapefruit juice can lead to higher-than-intended levels of sunitinib in your blood, potentially increasing the risk and severity of side effects. This applies to grapefruit in all forms, including fresh fruit, juice, and grapefruit-containing beverages.
If you miss a dose of Sunitinib Glenmark, do not take a double dose to compensate. Simply skip the missed dose and take your next scheduled dose at the usual time. Taking a double dose could increase the risk of side effects. If you frequently forget doses or are unsure about your dosing schedule, speak with your doctor or pharmacist for advice on how to stay on track with your treatment.
Yes, sunitinib has significant drug interactions. Strong CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir can increase sunitinib blood levels and toxicity. Strong CYP3A4 inducers like rifampicin, phenytoin, carbamazepine, phenobarbital, and St. John’s Wort can reduce sunitinib’s effectiveness. Anticoagulants such as warfarin may increase bleeding risk. Always inform your doctor about all medications, supplements, and herbal products you are taking before starting sunitinib treatment.
Sunitinib Glenmark is a generic version of sunitinib. It contains the same active substance (sunitinib) and is approved for the same indications. Generic medicines must meet the same rigorous quality, safety, and efficacy standards as the original branded product. The European Medicines Agency (EMA) requires that generic drugs demonstrate bioequivalence to the reference product, meaning they deliver the same amount of active substance to the body in the same timeframe.
References
- European Medicines Agency (EMA). Sunitinib — Summary of Product Characteristics. EMA/CHMP. Last updated 2025.
- Demetri GD, van Oosterom AT, Garrett CR, et al. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006;368(9544):1329-1338.
- Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007;356(2):115-124.
- Raymond E, Dahan L, Raoul JL, et al. Sunitinib malate for the treatment of pancreatic neuroendocrine tumours. N Engl J Med. 2011;364(6):501-513.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Gastrointestinal Stromal Tumors (GISTs). Version 1.2025.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. Version 2.2025.
- European Society for Medical Oncology (ESMO). Renal Cell Carcinoma: ESMO Clinical Practice Guidelines. Ann Oncol. 2024.
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List. Geneva: WHO; 2023.
- British National Formulary (BNF). Sunitinib. National Institute for Health and Care Excellence (NICE). 2025.
- U.S. Food and Drug Administration (FDA). Sunitinib malate prescribing information. Reference ID: updated 2024.
Medical Editorial Team
This article was written by the iMedic Medical Editorial Team, specialists in oncology and clinical pharmacology, and reviewed by the iMedic Medical Review Board. Our content follows international clinical guidelines including those from the EMA, FDA, NCCN, ESMO, and WHO. All information is evidence-based and regularly updated to reflect the latest medical knowledge.