Sunitinib Eugia Pharma: Uses, Dosage & Side Effects
A multi-targeted protein kinase inhibitor used to treat gastrointestinal stromal tumors (GIST), metastatic renal cell carcinoma, and pancreatic neuroendocrine tumors
Sunitinib Eugia Pharma contains the active substance sunitinib, a multi-targeted receptor tyrosine kinase (RTK) inhibitor that blocks several proteins involved in cancer cell growth and the formation of new blood vessels that supply tumors. It is approved for the treatment of gastrointestinal stromal tumors (GIST) after failure of imatinib, metastatic renal cell carcinoma (advanced kidney cancer), and progressive pancreatic neuroendocrine tumors. Sunitinib Eugia Pharma is a generic version of the original brand SUTENT and is taken orally as a hard capsule. This medication requires a prescription and must be used under close medical supervision due to its significant side effect profile.
Quick Facts: Sunitinib Eugia Pharma
Key Takeaways
- Sunitinib Eugia Pharma is a multi-targeted tyrosine kinase inhibitor that blocks proteins involved in tumor growth and angiogenesis, including VEGFR, PDGFR, KIT, FLT3, CSF-1R, and RET receptors.
- It is approved for three cancer types: GIST (after imatinib failure), metastatic renal cell carcinoma, and progressive or unresectable pancreatic neuroendocrine tumors (pNET).
- Regular monitoring of blood pressure, thyroid function, blood counts, and liver function is essential throughout treatment, as sunitinib can cause significant cardiovascular, endocrine, and hematologic side effects.
- Strong CYP3A4 inhibitors (ketoconazole, grapefruit juice) and inducers (rifampicin, St. John’s Wort) can significantly alter sunitinib blood levels and should be avoided or managed with dose adjustments.
- Women of childbearing potential must use reliable contraception during treatment; sunitinib should not be used during pregnancy or breastfeeding due to potential harm to the developing child.
What Is Sunitinib Eugia Pharma and What Is It Used For?
Sunitinib Eugia Pharma contains the active substance sunitinib, which belongs to a class of anticancer drugs known as protein kinase inhibitors (also called tyrosine kinase inhibitors or TKIs). These medicines work by blocking the activity of specific enzymes (protein kinases) that play a crucial role in the signaling pathways regulating cell growth, proliferation, and the formation of new blood vessels (angiogenesis). By inhibiting these pathways, sunitinib effectively starves tumors of their blood supply while directly interfering with the signals that tell cancer cells to grow and divide.
Unlike many targeted therapies that block a single target, sunitinib is a multi-targeted inhibitor. It simultaneously blocks several different receptor tyrosine kinases, including platelet-derived growth factor receptors (PDGFR-alpha and PDGFR-beta), vascular endothelial growth factor receptors (VEGFR1, VEGFR2, and VEGFR3), the stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor type 1 (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET). This broad spectrum of activity makes sunitinib effective against multiple types of cancer that depend on these signaling pathways for their growth and survival.
Sunitinib Eugia Pharma is approved by the European Medicines Agency (EMA) and regulatory authorities worldwide for the treatment of the following cancers:
- Gastrointestinal Stromal Tumors (GIST): GIST is a type of cancer that develops in the wall of the stomach or intestines. Sunitinib Eugia Pharma is used when imatinib (another targeted cancer drug that is typically the first-line treatment for GIST) has stopped working or when the patient cannot tolerate imatinib. The approval was based on a pivotal phase III trial that demonstrated a significant improvement in time to tumor progression compared with placebo in imatinib-resistant or imatinib-intolerant GIST patients.
- Metastatic Renal Cell Carcinoma (MRCC): This is a type of kidney cancer that has spread to other parts of the body. Sunitinib is used as a treatment for advanced renal cell carcinoma and has been one of the standard-of-care options in this setting for many years. The landmark phase III trial comparing sunitinib with interferon-alpha demonstrated superior progression-free survival and objective response rates, establishing sunitinib as a first-line treatment option for metastatic clear cell renal cell carcinoma.
- Pancreatic Neuroendocrine Tumors (pNET): These are tumors that arise from the hormone-producing cells of the pancreas. Sunitinib Eugia Pharma is used when the tumor is progressing (getting worse) or cannot be removed by surgery. The phase III trial in advanced pNET demonstrated a doubling of progression-free survival compared with placebo, leading to regulatory approval in this indication.
Sunitinib Eugia Pharma is a generic version of the original brand SUTENT (manufactured by Pfizer). As a generic medicine, it has been demonstrated to be bioequivalent to the reference product, meaning it contains the same active substance in the same amounts and works in the same way in the body. Regulatory authorities approved Sunitinib Eugia Pharma after rigorous evaluation of pharmaceutical quality, bioequivalence, and manufacturing standards. Other generic versions of sunitinib that may be available internationally include Sunitinib Accord, Sunitinib Zentiva, Sunitinib Sandoz, Sunitinib STADA, Sunitinib Teva, Sunitinib Glenmark, and Sunitinib Avansor, all of which contain the same active substance.
Sunitinib’s ability to block multiple receptor tyrosine kinases simultaneously is a key advantage. By targeting both tumor cell growth signals (through KIT, PDGFR, FLT3, and RET) and the blood vessel formation process (through VEGFR1/2/3), sunitinib attacks the tumor from two directions: directly slowing cancer cell proliferation while also cutting off the blood supply that the tumor needs to grow. However, this broad activity also contributes to its side effect profile, because some of these targets also play important physiological roles in normal tissues such as endothelium, cardiac muscle, thyroid gland, and skin.
After oral administration, sunitinib is absorbed from the gastrointestinal tract with peak plasma concentrations reached approximately 6 to 12 hours after a single dose. It is extensively metabolized in the liver by the cytochrome P450 isoenzyme CYP3A4 to its primary active metabolite desethyl sunitinib (SU12662), which has similar pharmacological activity. The terminal elimination half-life of sunitinib is approximately 40 to 60 hours and that of SU12662 is approximately 80 to 110 hours, supporting once-daily dosing. Steady-state concentrations are typically reached within 10 to 14 days of continuous administration. Sunitinib is primarily eliminated via the feces.
What Should You Know Before Taking Sunitinib Eugia Pharma?
Before starting Sunitinib Eugia Pharma, your doctor will review your full medical history, current medications, and perform baseline laboratory investigations. Because sunitinib affects a wide range of physiological systems, careful pre-treatment assessment and ongoing monitoring are essential for safe use. Tell your oncologist and pharmacist about every medicine, supplement, vitamin, and herbal product you are taking, including those you take only occasionally.
Contraindications
The primary contraindication for Sunitinib Eugia Pharma is hypersensitivity (allergy) to sunitinib or any of the other ingredients listed in section 6 of the product information. If you have previously experienced an allergic reaction to sunitinib-containing products, you must not take this medication. Symptoms of an allergic reaction include rash, itching, hives, swelling of the face, lips, tongue, or throat, and difficulty breathing. Severe allergic reactions are medical emergencies.
Warnings and Precautions
Before starting Sunitinib Eugia Pharma, your doctor needs to be aware of all your current and past medical conditions. Sunitinib has a broad range of potential effects on the body, and certain pre-existing conditions may require closer monitoring, dose adjustments, or may make sunitinib unsuitable for you. Discuss the following with your healthcare provider:
Sunitinib can cause serious cardiovascular events including heart failure, cardiomyopathy, reduced left ventricular ejection fraction, QT prolongation, and myocardial infarction. Tell your doctor immediately if you experience extreme tiredness, shortness of breath, swollen feet and ankles, chest pain, dizziness, fainting, or abnormal heartbeats during treatment. Baseline and periodic assessments of left ventricular ejection fraction should be considered.
- High blood pressure: Sunitinib frequently raises blood pressure, sometimes to severe levels. Your doctor should monitor blood pressure regularly throughout treatment and may prescribe antihypertensive medication if needed. In some cases, dose reduction or temporary interruption of sunitinib may be necessary. Home blood pressure monitoring is often recommended.
- Blood disorders: Treatment with sunitinib can increase the risk of bleeding or change the number of blood cells, potentially causing anemia, thrombocytopenia (low platelet count), or neutropenia (low neutrophil count). If you take blood thinners such as warfarin or acenocoumarol, your bleeding risk may be further increased. Report any unusual bruising, prolonged bleeding, blood in urine or stool, or black tarry stools to your doctor immediately.
- Heart problems: Sunitinib can cause heart failure, cardiomyopathy, and abnormal heart rhythms (arrhythmias). Your doctor may perform electrocardiograms (ECG) and echocardiograms to monitor heart function. Report any symptoms of tiredness, breathlessness, swelling, dizziness, fainting, or palpitations immediately. Patients with a history of cardiovascular disease require particularly close monitoring.
- QT prolongation: Sunitinib has been associated with prolongation of the QT interval on ECG, which can lead to serious ventricular arrhythmias including torsades de pointes. Electrolyte abnormalities (low potassium, magnesium, or calcium) increase this risk and should be corrected before starting treatment.
- Blood clots: Venous and arterial thromboembolic events, including stroke, heart attack, and pulmonary embolism, have been reported. Seek immediate medical attention if you experience chest pain, arm, back, neck or jaw pain, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, or severe headache.
- Aneurysms and arterial dissection: Sunitinib may increase the risk of aneurysms (abnormal enlargement and weakening of blood vessel walls) or arterial dissections (tears in blood vessel walls), particularly in patients with uncontrolled hypertension. Tell your doctor if you have a history of these conditions.
- Thrombotic microangiopathy (TMA): Damage to the smallest blood vessels has been reported with sunitinib. Report symptoms of fever, fatigue, bruising, bleeding, swelling, confusion, vision loss, or seizures to your doctor. Laboratory findings include hemolytic anemia, thrombocytopenia, and acute kidney injury.
- Thyroid disorders: Sunitinib commonly causes hypothyroidism (underactive thyroid). Thyroid function should be tested before and regularly during treatment. Symptoms include increased tiredness, feeling colder than usual, constipation, weight gain, or a deeper voice. Thyroid hormone replacement (levothyroxine) may be needed. Hyperthyroidism and thyroiditis have also been reported.
- Pancreatic and gallbladder problems: Pancreatitis and cholecystitis (gallbladder inflammation, with or without gallstones) have been reported. Tell your doctor about any abdominal pain, nausea, vomiting, or fever. Serum amylase and lipase may be monitored.
- Liver problems: Hepatotoxicity, including fatal liver failure, has occurred with sunitinib. Your doctor should monitor liver function tests (ALT, AST, bilirubin) before and during treatment. Report itching, yellowing of the eyes or skin (jaundice), dark urine, or pain in the upper right abdomen.
- Kidney problems: Your doctor will monitor kidney function throughout treatment. Cases of proteinuria and nephrotic syndrome have been reported. Urine dipstick for protein may be performed at baseline and periodically.
- Surgery: Sunitinib can impair wound healing by inhibiting the formation of new blood vessels. Treatment is usually stopped at least 2 to 4 weeks before planned surgery, and your doctor will determine when it is safe to restart, typically after the wound has healed adequately.
- Jaw problems (osteonecrosis): If you experience pain in the mouth, teeth, or jaw, swelling, numbness, or loose teeth, contact your doctor and dentist immediately. This is especially important if you are receiving or have received intravenous bisphosphonates. A dental examination before starting sunitinib is recommended.
- Skin reactions: Serious skin conditions including pyoderma gangrenosum (painful skin ulcers), necrotizing fasciitis (life-threatening soft tissue infection), Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have been reported. Seek immediate medical attention if you develop red target-like patches, widespread blistering, peeling, or signs of skin infection.
- Hand-foot syndrome: Palmar-plantar erythrodysesthesia, with redness, pain, blistering, or peeling of the palms and soles, is a very common and often dose-limiting skin reaction. Preventive moisturizing, avoidance of friction and heat, and supportive skin care can reduce severity.
- Seizures and RPLS: Reversible posterior leukoencephalopathy syndrome (RPLS) has been reported in patients with severe hypertension. Contact your doctor if you experience headache, confusion, vision changes, or seizures.
- Diabetes and hypoglycemia: Blood sugar levels should be monitored regularly in patients with diabetes, as dose adjustments of diabetes medications may be necessary. Hypoglycemia (low blood sugar) has been reported even in non-diabetic patients, with symptoms of sweating, trembling, and confusion.
- Infections: Serious infections including sepsis and necrotizing fasciitis may occur, sometimes fatally. Report any signs of infection such as fever, chills, cough, or skin redness promptly.
Children and Adolescents
Sunitinib Eugia Pharma is not recommended for use in persons under 18 years of age. The safety and efficacy of sunitinib have not been established in the pediatric population, and there are insufficient clinical data to support its use in children and adolescents. In addition, there is a risk of serious effects on growth, development of internal organs, and endocrine function in the pediatric population.
Pregnancy and Breastfeeding
Sunitinib Eugia Pharma should not be used during pregnancy unless clearly necessary and only if the potential benefit to the mother justifies the risk to the fetus. Women of childbearing potential must use a reliable method of contraception during treatment and for at least 4 weeks after the last dose. Men with partners of childbearing potential should also use effective contraception. Do not breastfeed while taking sunitinib or for a period after the last dose. Animal studies have shown potential harm to the developing fetus, including malformations and fetal loss. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Sunitinib and its metabolites may also impair fertility. Men and women of reproductive age should be informed about potential effects on fertility before starting treatment, and family planning options such as sperm or egg cryopreservation may be considered.
Driving and Operating Machinery
If you experience dizziness, unusual tiredness, or blurred vision while taking sunitinib, exercise caution when driving or operating machinery. These are common side effects that may impair your ability to perform these activities safely. Do not drive or use tools or machines if your symptoms affect your ability to do so safely.
Sodium Content
Sunitinib Eugia Pharma contains less than 1 mmol (23 mg) sodium per capsule, derived from the excipient croscarmellose sodium, and is therefore considered essentially sodium-free. This is relevant for patients on a controlled sodium diet, including those with heart failure or severe kidney disease.
How Does Sunitinib Eugia Pharma Interact with Other Drugs?
Sunitinib is primarily metabolized in the liver by the cytochrome P450 enzyme CYP3A4. This means that other drugs, foods, or herbal products that affect CYP3A4 activity can significantly alter sunitinib blood levels, potentially increasing toxicity or reducing anticancer effectiveness. It is critical to inform your doctor about all medications, dietary supplements, and herbal products you are taking before starting sunitinib and to check with your pharmacist before starting any new medication during treatment.
Major Interactions (CYP3A4 Inhibitors – Increase Sunitinib Levels)
The following drugs inhibit CYP3A4 and may increase the concentration of sunitinib in your blood, potentially leading to increased side effects. Your doctor may need to reduce the sunitinib dose if co-administration cannot be avoided:
| Drug | Drug Class | Clinical Significance |
|---|---|---|
| Ketoconazole | Antifungal | Strong CYP3A4 inhibitor; can significantly increase sunitinib exposure. Avoid or reduce dose. |
| Itraconazole | Antifungal | Strong CYP3A4 inhibitor; dose reduction of sunitinib may be needed. |
| Voriconazole, Posaconazole | Antifungal | Strong CYP3A4 inhibitors; potential for significantly elevated sunitinib levels. |
| Ritonavir | HIV Protease Inhibitor | Strong CYP3A4 inhibitor; significant interaction expected. |
| Erythromycin | Macrolide Antibiotic | Moderate CYP3A4 inhibitor; may increase sunitinib levels. |
| Clarithromycin | Macrolide Antibiotic | Strong CYP3A4 inhibitor; monitor for increased toxicity. |
| Diltiazem, Verapamil | Calcium Channel Blockers | Moderate CYP3A4 inhibitors; may raise sunitinib levels. |
| Grapefruit juice | Food interaction | CYP3A4 inhibitor; must be avoided during treatment. |
Major Interactions (CYP3A4 Inducers – Decrease Sunitinib Levels)
The following drugs induce CYP3A4 and may decrease the concentration of sunitinib in your blood, potentially reducing its anticancer effectiveness. Your doctor may need to increase the sunitinib dose if co-administration cannot be avoided:
| Drug | Drug Class | Clinical Significance |
|---|---|---|
| Rifampicin | Antibiotic (Tuberculosis) | Strong CYP3A4 inducer; can significantly reduce sunitinib exposure. Avoid co-use if possible. |
| Phenytoin | Antiepileptic | Strong CYP3A4 inducer; may reduce sunitinib efficacy. |
| Carbamazepine | Antiepileptic | Strong CYP3A4 inducer; may reduce sunitinib efficacy. |
| Phenobarbital, Primidone | Antiepileptic / Barbiturate | Strong CYP3A4 inducers; avoid if possible. |
| Efavirenz | HIV Antiretroviral | Moderate to strong CYP3A4 inducer; monitor clinical response. |
| Dexamethasone | Corticosteroid | Moderate CYP3A4 inducer; monitor sunitinib effectiveness. |
| St. John’s Wort (Hypericum perforatum) | Herbal supplement | Strong CYP3A4 inducer; must not be taken with sunitinib. |
Additional Interaction Considerations
Beyond CYP3A4-mediated interactions, sunitinib may also interact with anticoagulants (blood thinners) such as warfarin and acenocoumarol, increasing the risk of bleeding. If you are taking anticoagulants, your doctor will monitor you closely for signs of bleeding throughout your treatment and may adjust the anticoagulant dose based on INR results.
Caution is also advised when sunitinib is combined with other medicines known to prolong the QT interval, such as certain antiarrhythmics (amiodarone, sotalol), certain antipsychotics (haloperidol, quetiapine), fluoroquinolone antibiotics (moxifloxacin), or certain antiemetics (ondansetron in high doses). Electrocardiographic monitoring and electrolyte checks may be appropriate in such situations.
Concomitant use with other anticancer therapies, radiotherapy, or drugs affecting bone marrow function (such as ganciclovir, valganciclovir, co-trimoxazole, interferon-alpha, or methotrexate) may increase the risk of bone marrow suppression. Blood counts should be monitored more frequently in these circumstances. Always inform your doctor and pharmacist about every medicine you are taking, including over-the-counter products, vitamins, and herbal or traditional remedies.
What Is the Correct Dosage of Sunitinib Eugia Pharma?
Always take Sunitinib Eugia Pharma exactly as your doctor has told you. Treatment should be initiated and supervised by a physician experienced in the use of anticancer agents. The dosage depends on the type of cancer being treated, and your doctor may adjust the dose based on how well you tolerate the medication and how your cancer responds to treatment. The range of capsule strengths (12.5 mg, 25 mg, 37.5 mg, and 50 mg) allows for flexible dose adjustments in 12.5 mg increments.
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 (2-week) rest period without medication. This constitutes one complete 6-week treatment cycle (Schedule 4/2). Your doctor will continue treatment cycles for as long as the cancer is responding and you are tolerating the medication. Dose reductions are made in 12.5 mg increments; the minimum recommended dose is 25 mg per day.
Pancreatic Neuroendocrine Tumors (pNET)
The recommended dose is 37.5 mg taken orally once daily on a continuous daily dosing schedule (no scheduled rest period). Dose adjustments may be made based on individual patient safety and tolerability. The dose may be increased to a maximum of 50 mg daily or decreased to a minimum of 25 mg daily. Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
Sunitinib Eugia Pharma capsules may be taken with or without food. Swallow the capsules whole with a glass of water. Do not open, crush, or chew the capsules. Try to take your dose at approximately the same time each day to maintain consistent blood levels. If you vomit shortly after taking a dose, do not take an additional dose – simply take the next scheduled dose at the usual time.
Children and Adolescents
Sunitinib Eugia Pharma is not recommended for persons under 18 years of age. There are insufficient data on safety and efficacy in the pediatric population, and there is a theoretical risk of effects on growth and organ development in growing children.
Elderly Patients
No specific dose adjustment is required for elderly patients (≥65 years) in clinical studies. However, elderly patients may be more susceptible to certain side effects, particularly fatigue, cardiovascular events, and hand-foot skin reaction, and careful monitoring is recommended. Your doctor will determine the appropriate dose based on your overall health status, renal and hepatic function, concomitant medications, and ability to tolerate the medication.
Patients with Liver Impairment
No starting dose adjustment is recommended for patients with mild or moderate hepatic impairment (Child-Pugh class A and B). Sunitinib has not been studied in patients with severe hepatic impairment (Child-Pugh class C) and is therefore not recommended in this population. Patients with liver metastases or pre-existing liver disease should be monitored closely with liver function tests.
Patients with Kidney Impairment
No starting dose adjustment is required in patients with mild, moderate, or severe renal impairment or in patients with end-stage renal disease on hemodialysis. However, given limited clinical experience, subsequent dose adjustments should be based on individual safety and tolerability. Periodic urinalysis to detect proteinuria is recommended.
Dose Adjustments
Your doctor may increase or decrease your dose depending on how well you tolerate treatment. Dose modifications are typically made in 12.5 mg steps. Common reasons for dose reduction include severe side effects such as significant blood pressure elevation, severe fatigue, clinically significant blood count changes, grade 3 or 4 hand-foot skin reaction, significant liver enzyme elevation, or clinically important cardiac effects. If side effects become severe, your doctor may temporarily stop treatment (dose interruption) and restart at a lower dose once the side effects have resolved or improved to an acceptable level.
For patients taking concurrent strong CYP3A4 inhibitors, a dose reduction to a minimum of 37.5 mg daily (for GIST/MRCC) or 25 mg daily (for pNET) should be considered. For patients taking concurrent strong CYP3A4 inducers, a dose increase to a maximum of 87.5 mg daily (for GIST/MRCC) or 62.5 mg daily (for pNET) may be considered under careful monitoring for efficacy and toxicity.
Missed Dose
If you miss a dose of Sunitinib Eugia Pharma, do not take a double dose to make up for the missed one. Simply take your next scheduled dose at the usual time. Taking a double dose could increase the risk of side effects. If you are unsure about what to do, contact your doctor or pharmacist for advice. Keep a written or electronic log of your doses to help you stay on schedule.
Overdose
If you accidentally take more capsules than prescribed, contact your doctor or local poison control center immediately, or go to the nearest emergency department. You may need medical observation in a hospital setting. There is no specific antidote for sunitinib overdose, and treatment is supportive (general supportive measures, management of cardiovascular and hepatic toxicity, and correction of fluid and electrolyte abnormalities). Symptoms of overdose may include an intensification of known side effects such as severe fatigue, diarrhea, vomiting, mouth sores, or hand-foot skin reaction.
What Are the Side Effects of Sunitinib Eugia Pharma?
Sunitinib has a broad range of potential side effects due to its multi-targeted mechanism of action. Many side effects are manageable with supportive care and dose adjustments, and most improve during the 14-day rest period in the 4/2 schedule. It is important to report all new symptoms to your healthcare team promptly so they can be addressed. Some side effects require immediate medical attention, and you should not hesitate to seek urgent care if you are concerned.
Contact your doctor or emergency services immediately if you experience: extreme tiredness, breathlessness, or swollen feet/ankles (possible heart failure); cough, chest pain, sudden shortness of breath, or coughing up blood (possible pulmonary embolism); changes in urination, swelling, or foamy urine (possible kidney problems); severe or unusual bleeding, including blood in urine or stool; severe abdominal pain with fever (possible bowel perforation or pancreatitis); widespread skin blistering or peeling; signs of severe infection including high fever and chills; or chest pain radiating to arm or jaw.
Very Common
May affect more than 1 in 10 people
- Decreased platelet, red blood cell, and white blood cell counts (including neutropenia and lymphopenia)
- Shortness of breath (dyspnea)
- High blood pressure (hypertension)
- Extreme tiredness, fatigue, weakness (asthenia)
- Swelling due to fluid retention under the skin and around the eyes (edema)
- Mouth pain or irritation, mouth sores (stomatitis, mucositis), dry mouth, taste disturbance (dysgeusia)
- Nausea, vomiting, diarrhea, constipation
- Abdominal pain or swelling (dyspepsia, flatulence), decreased appetite
- Hypothyroidism (underactive thyroid) and related symptoms
- Dizziness, headache
- Nosebleeds (epistaxis), cough
- Back pain, joint pain (arthralgia), pain in arms and legs
- Yellowing or discoloration of skin, increased skin pigmentation
- Hair color change or lightening, hand-foot skin reaction, rash, dry skin
- Fever (pyrexia), difficulty sleeping (insomnia)
Common
May affect up to 1 in 10 people
- Blood clots in blood vessels (venous thromboembolism)
- Reduced blood supply to the heart (coronary artery disease, myocardial ischemia)
- Chest pain, decreased cardiac output, left ventricular dysfunction
- Fluid around the lungs (pleural effusion)
- Infections including urinary tract, respiratory, and skin; sepsis (life-threatening blood infection)
- Low blood sugar (hypoglycemia, see warnings section)
- Protein in urine (proteinuria), flu-like symptoms
- Abnormal blood tests (elevated liver and pancreatic enzymes), elevated uric acid
- Hemorrhoids, rectal pain, bleeding gums, difficulty swallowing (dysphagia)
- Heartburn (gastroesophageal reflux), increased gas, weight loss
- Muscle and skeletal pain, muscle weakness, muscle cramps
- Nasal dryness, nasal congestion, increased tearing (lacrimation)
- Skin itching (pruritus), skin peeling (exfoliation), blisters, acne, nail discoloration, hair loss (alopecia)
- Numbness or tingling in hands and feet (peripheral neuropathy)
- Dehydration, hot flushes, discolored urine
- Depression, chills
Uncommon
May affect up to 1 in 100 people
- Necrotizing fasciitis (life-threatening soft tissue infection)
- Stroke (cerebrovascular accident), transient ischemic attack, heart attack (myocardial infarction)
- Changes in heart’s electrical activity (QT prolongation), abnormal heart rhythm
- Fluid around the heart (pericardial effusion)
- Liver failure, hepatitis
- Pancreatitis (inflammation of the pancreas)
- Bowel perforation (tumor breakdown or direct toxicity leading to a hole in the intestine)
- Gallbladder inflammation (cholecystitis), with or without gallstones
- Fistula formation (abnormal channel between body cavities or to the skin)
- Osteonecrosis of the jaw (bone damage in the jaw)
- Hyperthyroidism (overactive thyroid)
- Impaired wound healing after surgery or injury
- Elevated creatine phosphokinase (muscle enzyme)
- Severe allergic reactions including anaphylaxis and angioedema
- Colitis (inflammation of the colon), including ischemic colitis
Rare
May affect up to 1 in 1,000 people
- Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme
- Tumor lysis syndrome (TLS) – metabolic complications from rapid cancer cell breakdown
- Rhabdomyolysis (abnormal muscle tissue breakdown that can lead to kidney damage)
- Reversible posterior leukoencephalopathy syndrome (RPLS) – brain changes causing headache, confusion, seizures, and vision loss
- Pyoderma gangrenosum (painful skin ulcers)
- Thyroiditis (thyroid gland inflammation)
- Thrombotic microangiopathy (TMA) – damage to the smallest blood vessels leading to hemolysis and organ injury
- Nephrotic syndrome (heavy proteinuria)
Not Known
Frequency cannot be estimated from available data
- Aneurysms and arterial dissections (enlargement, weakening, or tearing of blood vessel walls)
- Hyperammonemic encephalopathy (brain toxicity due to high ammonia levels) – symptoms include lack of energy, confusion, drowsiness, or loss of consciousness
- Cardiac failure with fatal outcome
It is important to report suspected side effects after the medicine has been authorized. This allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals and patients can report suspected adverse reactions to their national pharmacovigilance authority (for example, the EMA in Europe, the FDA MedWatch program in the United States, or the MHRA Yellow Card Scheme in the United Kingdom). By reporting side effects, you can help provide more information on the safety of this medicine.
How Should You Store Sunitinib Eugia Pharma?
Keep Sunitinib Eugia Pharma capsules out of the sight and reach of children at all times. This medication is a potent anticancer agent and accidental ingestion by a child could cause serious harm. Store the capsules in their original packaging until use to protect them from light and moisture.
There are no special storage temperature conditions required for Sunitinib Eugia Pharma; it can be stored at room temperature. Do not use this medicine after the expiry date (EXP) stated on the carton, bottle, or blister pack. The expiry date refers to the last day of the stated month. Using expired medication may reduce its effectiveness and potentially increase risks.
Do not use Sunitinib Eugia Pharma if the packaging appears damaged or shows signs of tampering. Inspect the capsules before taking them. If you notice any changes in the appearance of the capsules (cracks, broken shells, leakage, discoloration), consult your pharmacist and do not take the capsule.
Do not dispose of medicines via wastewater or household waste. Return unused, expired, or damaged capsules to your pharmacy for safe disposal, or follow local guidelines for cytotoxic drug disposal. These measures help protect the environment and prevent accidental exposure to other people, children, or animals. Cytotoxic agents like sunitinib require special disposal procedures; some regions require double-bagging or return to the oncology pharmacy.
Caregivers handling the capsules should avoid direct skin contact with the capsule contents. If a capsule is broken and the contents are spilled, wear gloves, clean the area with a damp cloth, and dispose of the cloth as medical waste. Wash hands thoroughly after handling capsules.
What Does Sunitinib Eugia Pharma Contain?
The active substance in Sunitinib Eugia Pharma is sunitinib, supplied as sunitinib malate. Each hard capsule contains an amount equivalent to 12.5 mg, 25 mg, 37.5 mg, or 50 mg of sunitinib base. Sunitinib malate is used because it has improved pharmaceutical stability and solubility compared with the free base form.
Inactive Ingredients
The other ingredients (excipients) typically include:
- Capsule contents: Microcrystalline cellulose (bulking agent), mannitol (E421) (diluent), croscarmellose sodium (E468) (disintegrant), povidone (E1201) (binder), magnesium stearate (E572) (lubricant)
- Capsule shell: Gelatin, titanium dioxide (E171) (opacifier), black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172) (various combinations used as colorants to distinguish strengths)
- Printing ink: Shellac, titanium dioxide (E171), propylene glycol, ammonium hydroxide, black iron oxide (E172)
The capsule contents are formulated as yellow to orange granules, which reflects the intrinsic color of sunitinib. This color can also manifest as a yellowish tint in patients’ skin during treatment, which is a common cosmetic side effect that resolves after treatment discontinuation.
Capsule Identification
| Strength | Capsule Appearance | Approximate Size | Imprint |
|---|---|---|---|
| 12.5 mg | Orange cap and orange body | 14.3 mm (Size 4) | Strength and batch marking |
| 25 mg | Caramel/brown cap and orange body | 15.9 mm (Size 3) | Strength and batch marking |
| 37.5 mg | Yellow cap and yellow body | 18.0 mm (Size 2) | Strength and batch marking |
| 50 mg | Caramel/brown cap and caramel/brown body | 19.4 mm (Size 1) | Strength and batch marking |
Sunitinib Eugia Pharma is typically available in bottles or blister packs of 28 or 30 capsules. Not all pack sizes may be marketed in all countries, and availability may vary depending on local regulatory approval and distribution.
Marketing Authorization Holder and Manufacturer
Sunitinib Eugia Pharma is manufactured and distributed by Eugia Pharma Specialities Ltd., a subsidiary of the global Aurobindo Pharma group that focuses on oncology, hormonal, and specialty products. Eugia Pharma operates manufacturing facilities approved by multiple stringent regulatory authorities including the EMA, FDA, MHRA, and Health Canada. The specific marketing authorization holder and manufacturing address details are printed on the product packaging and in the patient information leaflet supplied with the medicine.
Frequently Asked Questions
Sunitinib Eugia Pharma is a generic version of SUTENT (the original brand by Pfizer). Both contain the same active ingredient – sunitinib – in the same dosages. Sunitinib Eugia Pharma has been demonstrated to be bioequivalent to SUTENT, meaning it is absorbed into the body at the same rate and to the same extent and therefore produces the same clinical effect. Regulatory agencies approved Sunitinib Eugia Pharma after evaluating its pharmaceutical quality and bioequivalence data. Generic medicines typically cost less than the originator brand, which can improve patient access to effective cancer treatment.
Yes, Sunitinib Eugia Pharma can be taken with or without food. Food does not significantly affect the absorption of sunitinib, so you can choose what works best for your routine. However, you must avoid grapefruit juice and grapefruit, as they can increase sunitinib levels in your blood and raise the risk of side effects. Swallow the capsules whole with water – do not open, crush, or chew them, as this could expose you and others to the cytotoxic contents.
Sunitinib and its active metabolite have an intrinsic yellow-orange color that can accumulate in the skin, causing a yellowish discoloration that typically appears within the first cycle of treatment. This is a very common side effect and is generally harmless. The discoloration may also affect your hair, making it lighter or changing its color temporarily. These changes are reversible and usually resolve within several weeks after treatment is stopped. Other skin effects such as dryness, hand-foot skin reaction, and changes in pigmentation are also common and should be discussed with your healthcare team so you can receive appropriate skin care recommendations.
The duration of sunitinib treatment varies depending on the type of cancer, how well the cancer responds, and how well you tolerate the medication. Treatment is typically continued for as long as it is providing clinical benefit and side effects remain manageable. Your oncologist will assess your response with regular clinical evaluations, imaging scans (usually every 8 to 12 weeks), and blood tests. Some patients may take sunitinib for months or even years. Your oncologist will decide when to stop treatment based on disease progression, unacceptable toxicity, or your personal preferences and goals of care.
High blood pressure (hypertension) is a very common side effect of sunitinib because the medication blocks the VEGF pathway, which is important for normal blood vessel function. Your doctor should check your blood pressure before starting treatment and regularly during treatment. If your blood pressure rises, your doctor may prescribe antihypertensive medication such as an ACE inhibitor, angiotensin receptor blocker, calcium channel blocker, or beta-blocker. In some cases, a sunitinib dose reduction or temporary treatment interruption may be needed. Do not stop taking sunitinib without consulting your doctor. Home blood pressure monitoring (daily during the treatment phase) is often recommended so you and your care team can track changes between clinic visits.
Yes, thyroid dysfunction is a very common side effect of sunitinib treatment. The most frequent thyroid effect is hypothyroidism (underactive thyroid), though some patients develop hyperthyroidism (overactive thyroid) or thyroiditis (inflammation of the thyroid gland). Your thyroid function should be tested before starting sunitinib (baseline TSH, free T4) and monitored every 2 to 3 months during treatment. Symptoms of hypothyroidism include unusual tiredness, feeling cold, constipation, weight gain, and changes in voice. If your thyroid becomes underactive, your doctor will prescribe thyroid hormone replacement therapy (levothyroxine), which effectively manages the condition and can usually continue even during ongoing sunitinib treatment.
Hand-foot syndrome (palmar-plantar erythrodysesthesia) affects many patients on sunitinib and can cause redness, pain, blistering, and peeling of the palms and soles. Preventive measures include using thick moisturizing creams (urea-based creams are often recommended), avoiding hot water, wearing cushioned shoes and cotton socks, and minimizing friction and pressure on hands and feet during the first weeks of each cycle. Keep hands and feet cool and avoid vigorous exercise, manual labor, or activities that cause repetitive friction. If symptoms become severe (grade 2 or 3), tell your oncologist, who may recommend a dose reduction, dose interruption, or topical treatments such as corticosteroid creams.
References
- European Medicines Agency (EMA). Sunitinib – Summary of Product Characteristics (SmPC). Available at: www.ema.europa.eu. 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. The Lancet. 2006;368(9544):1329-1338.
- Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. New England Journal of Medicine. 2007;356(2):115-124.
- Raymond E, Dahan L, Raoul JL, et al. Sunitinib malate for the treatment of pancreatic neuroendocrine tumours. New England Journal of Medicine. 2011;364(6):501-513.
- U.S. Food and Drug Administration (FDA). SUTENT (sunitinib malate) – Prescribing Information. Available at: www.fda.gov.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Kidney Cancer, Gastrointestinal Stromal Tumors, Neuroendocrine and Adrenal Tumors. Version 2025.
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Renal Cell Carcinoma, Gastrointestinal Stromal Tumours, Neuroendocrine Neoplasms. Available at: www.esmo.org.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List (2023). Geneva: WHO; 2023.
- Schmidinger M. Understanding and managing toxicities of vascular endothelial growth factor (VEGF) inhibitors. EJC Supplements. 2013;11(2):172-191.
- Blay JY, Kang YK, Nishida T, von Mehren M. Gastrointestinal stromal tumours. Nature Reviews Disease Primers. 2021;7(1):22.
- British National Formulary (BNF). Sunitinib monograph. London: BMJ Group and Pharmaceutical Press; updated 2025.
- Houk BE, Bello CL, Poland B, et al. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemotherapy and Pharmacology. 2010;66(2):357-371.
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This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in oncology, hematology, and clinical pharmacology. All content is reviewed against the current EMA Summary of Product Characteristics, FDA label, NCCN, and ESMO guidelines.
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