Sunitinib Medical Valley: 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. Supplied as 12.5 mg hard capsules by Medical Valley Invest AB.
Sunitinib Medical Valley 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 feed 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 (pNET). The product is marketed in Europe by Medical Valley Invest AB as 12.5 mg hard capsules and is therapeutically equivalent to the reference medicine SUTENT (Pfizer). Because of its significant side-effect profile, Sunitinib Medical Valley is a prescription-only medicine that must be used under close supervision by an oncologist experienced in the use of anticancer therapies.
Quick Facts: Sunitinib Medical Valley
Key Takeaways
- Sunitinib Medical Valley is a multi-targeted tyrosine kinase inhibitor that blocks proteins involved in tumor growth and angiogenesis, including VEGFR1-3, PDGFR-α/β, KIT, FLT3, CSF-1R, and RET receptors.
- It is approved for three cancers: GIST (after imatinib failure or intolerance), metastatic renal cell carcinoma (RCC), and progressive or unresectable pancreatic neuroendocrine tumors (pNET).
- The product is supplied as 12.5 mg hard capsules; doctors build higher daily doses (25, 37.5 or 50 mg) by combining several 12.5 mg capsules, which allows fine-grained dose individualization.
- Regular monitoring of blood pressure, thyroid function, liver enzymes, blood counts, cardiac function and urine protein is essential throughout treatment due to the broad side-effect profile.
- 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 must use reliable contraception and must not breastfeed.
What Is Sunitinib Medical Valley and What Is It Used For?
Sunitinib Medical Valley 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 drugs work by switching off specific enzymes (protein kinases) that play a central role in the signaling pathways that regulate cell growth, cell division, 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 proliferate.
Unlike many targeted therapies that block only one specific target, sunitinib is a broad, multi-targeted inhibitor. It simultaneously blocks several different receptor tyrosine kinases, including platelet-derived growth factor receptors (PDGFR-α and PDGFR-β), 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 pharmacological activity explains its effectiveness across several tumor types that depend on these signaling pathways for survival and growth.
Sunitinib Medical Valley 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 rare type of sarcoma that develops in the wall of the stomach, small intestine, or large bowel. Sunitinib is indicated in adults with unresectable or metastatic GIST after failure of imatinib mesylate treatment, either because of resistance or intolerance. Regulatory 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 advanced kidney cancer that has spread beyond the kidney. Sunitinib has been a long-standing standard-of-care option for first-line treatment of metastatic clear-cell renal cell carcinoma. The landmark phase III trial comparing sunitinib with interferon-alfa demonstrated superior progression-free survival and higher objective response rates, establishing sunitinib as a first-line treatment option. Today it remains an important option, particularly for patients where immune-based combinations are not suitable.
- Pancreatic Neuroendocrine Tumors (pNET): These tumors arise from the hormone-producing cells of the pancreas. Sunitinib Medical Valley is used when the tumor is well-differentiated, unresectable or metastatic, and is progressing in adults. The phase III trial in advanced pNET demonstrated a doubling of progression-free survival compared with placebo, leading to regulatory approval in this indication.
Medical Valley Invest AB is a Swedish-based parallel distributor that repackages and markets originator sunitinib (SUTENT) within the European Economic Area under a parallel import licence. Parallel imports are a well-regulated part of the European pharmaceutical supply chain: the medicinal product itself is the same that is authorized centrally by the EMA, and the pharmaceutical quality, efficacy and safety profile are therefore identical to those of the reference product. The repackaged cartons and patient information leaflets are reviewed by the competent national authority before distribution.
Sunitinib’s ability to block multiple receptor tyrosine kinases at the same time is a key clinical advantage. By targeting both tumor-cell growth signals (through KIT, PDGFR, FLT3, and RET) and the tumor-vessel formation process (through VEGFR1/2/3), sunitinib attacks cancer from two directions simultaneously – directly slowing cancer cell proliferation while also cutting off the blood supply the tumor needs to grow. This dual activity, however, also contributes to its relatively broad side-effect profile, because some of these kinases are also important in normal tissues (for example, VEGFR signalling in blood vessels and PDGFR signalling in the heart).
Sunitinib has a long, well-studied clinical history. After oral administration, it is absorbed with peak plasma concentrations occurring about 6 to 12 hours after the dose. It is extensively metabolized in the liver by the cytochrome P450 enzyme CYP3A4 to its primary active metabolite, SU12662, which has similar potency to sunitinib itself. The terminal elimination half-lives of sunitinib and SU12662 are approximately 40–60 hours and 80–110 hours, respectively – long enough to support once-daily oral dosing. Both parent drug and metabolite are mainly excreted in the feces, with only a small fraction eliminated in urine.
What Should You Know Before Taking Sunitinib Medical Valley?
Contraindications
The primary contraindication for Sunitinib Medical Valley is hypersensitivity (allergy) to sunitinib or any of the other ingredients listed in the capsule. If you have previously experienced an allergic reaction to a sunitinib-containing product, you must not take this medicine. The inactive ingredients include microcrystalline cellulose, mannitol (E421), croscarmellose sodium, povidone (E1201), and magnesium stearate, along with gelatin and several iron oxides in the capsule shell.
Warnings and Precautions
Before starting Sunitinib Medical Valley, your doctor needs to be aware of all your current and past medical conditions, as well as any medicines and supplements you take. 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-interval prolongation, myocardial infarction, stroke, and arterial thromboembolism. Tell your doctor immediately if you experience extreme tiredness, shortness of breath, swelling of the feet and ankles, chest pain, dizziness, fainting, irregular heartbeat, sudden weakness on one side of the body, difficulty speaking, or severe headache.
- High blood pressure (hypertension): Sunitinib frequently raises blood pressure, sometimes severely. Your doctor should measure blood pressure at baseline and monitor it regularly during treatment. If hypertension develops, antihypertensive therapy is started promptly; dose reduction or temporary interruption of sunitinib may also be needed.
- Blood disorders: Treatment with sunitinib can reduce the number of red blood cells, white blood cells, and platelets, potentially causing anemia, infections, and bleeding. Regular complete blood counts are required before each cycle. Report fever, unexplained bruising, bleeding gums or prolonged bleeding to your doctor.
- Heart problems: Sunitinib can cause heart failure, cardiomyopathy, and arrhythmias (including QT prolongation and, rarely, torsades de pointes). Baseline and periodic evaluation of cardiac function – including ECG and ejection fraction via echocardiogram or MUGA scan – may be indicated, particularly in patients with cardiac risk factors.
- Blood clots: Venous and arterial thromboembolic events, including stroke, myocardial infarction, deep vein thrombosis, and pulmonary embolism, have been reported. Seek immediate medical attention if you experience chest pain, arm/back/neck/jaw pain, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, or a severe sudden headache.
- Aneurysms and arterial dissections: Drugs that inhibit VEGF pathways may increase the risk of aneurysms (weakening and bulging of blood vessel walls) or arterial dissection (tearing of blood vessel walls). Tell your doctor if you have a history of aneurysm or dissection, or of uncontrolled hypertension.
- Thrombotic microangiopathy (TMA): Damage to the smallest blood vessels, which can lead to kidney failure, has been reported. Report symptoms of fever, fatigue, unexplained bruising, bleeding, swelling, confusion, vision loss, or seizures to your doctor promptly.
- Thyroid disorders: Sunitinib commonly causes hypothyroidism (underactive thyroid), and less commonly hyperthyroidism or thyroiditis. Thyroid function (TSH) should be measured at baseline and at regular intervals. Symptoms of hypothyroidism include increased tiredness, cold intolerance, weight gain, constipation, and a deeper voice. Levothyroxine replacement is often needed.
- Pancreatic and gallbladder problems: Acute pancreatitis (sometimes fatal) and cholecystitis (gallbladder inflammation) have been reported. Tell your doctor immediately about any severe upper abdominal pain, persistent nausea, vomiting, or fever.
- Liver problems: Hepatotoxicity, including rare cases of fatal liver failure, has occurred. Your doctor should measure liver enzymes (ALT, AST) and bilirubin before starting treatment, at each cycle, and whenever clinically indicated. Report itching, yellowing of the eyes or skin, dark urine, or pain in the upper right abdomen.
- Kidney problems: Your doctor will monitor kidney function (creatinine) and urine protein throughout treatment. Cases of proteinuria, nephrotic syndrome, and acute kidney injury have been reported.
- Surgery and wound healing: Sunitinib can impair wound healing. Treatment should be temporarily stopped before planned major surgery. Your doctor will decide when to restart, typically once the surgical wound has healed adequately.
- Jaw problems (osteonecrosis of the jaw, ONJ): If you experience pain in the mouth, teeth, or jaw, jaw swelling, numbness, loose teeth, or persistent mouth sores, contact your doctor and dentist without delay. The risk of ONJ is higher in patients who have received intravenous bisphosphonates or denosumab, or who have recently undergone invasive dental procedures.
- Serious skin reactions: Severe skin conditions including pyoderma gangrenosum, necrotizing fasciitis (a life-threatening soft-tissue infection), Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have been reported, some fatal. Seek immediate medical attention if you develop a widespread red or target-like rash, blistering, skin peeling, or signs of skin infection (increasing redness, pain, fever).
- Seizures and posterior reversible encephalopathy syndrome (PRES): Rare cases of PRES, previously called reversible posterior leukoencephalopathy syndrome (RPLS), have been reported. Contact your doctor if you experience high blood pressure with headache, vision loss, confusion, or seizures.
- Diabetes and hypoglycemia: Blood sugar may decrease during treatment, sometimes severely. Patients with diabetes may require dose adjustments of their glucose-lowering medications. Report symptoms of low blood sugar (shakiness, sweating, dizziness, confusion).
- Tumor lysis syndrome (TLS): In patients with a high tumor burden, rapid breakdown of cancer cells can release large amounts of potassium, phosphate, and uric acid, potentially causing acute kidney injury and arrhythmias. Close monitoring is indicated in the first treatment cycles.
Children and Adolescents
Sunitinib Medical Valley is not recommended for use in persons under 18 years of age. Safety and efficacy of sunitinib have not been established in the pediatric population, and an increased incidence of cardiovascular and bone-growth related effects has been observed in pediatric studies. Sunitinib should therefore only be considered in children and adolescents when no authorized alternative exists and under specialist supervision.
Pregnancy and Breastfeeding
Sunitinib Medical Valley should not be used during pregnancy unless clearly necessary after a careful benefit-risk evaluation. Animal studies have shown embryolethality and teratogenic effects at clinically relevant doses. Women of childbearing potential must use a reliable method of contraception during treatment and for at least 4 weeks after the last dose. Male patients with female partners of childbearing potential should also use effective contraception during and for at least 4 weeks after treatment. Do not breastfeed while taking sunitinib or for at least 4 weeks after the last dose. Sunitinib can impair fertility in both men and women; discuss fertility preservation options with your oncologist before starting treatment if relevant.
Driving and Operating Machinery
If you experience dizziness, fatigue, or visual disturbances 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, especially during the early weeks of each treatment cycle.
Sodium and Excipient Information
Sunitinib Medical Valley 12.5 mg hard capsules contain less than 1 mmol (23 mg) sodium per capsule and are therefore considered essentially “sodium-free”. This is relevant for patients on a strictly sodium-controlled diet. The capsules also contain mannitol, which can have a mild laxative effect at high doses, though the amount at therapeutic sunitinib doses is unlikely to cause this problem.
How Does Sunitinib Medical Valley Interact with Other Drugs?
Sunitinib is primarily metabolized in the liver by the cytochrome P450 enzyme CYP3A4. This means that other drugs and foods that affect CYP3A4 activity can significantly alter sunitinib blood levels, potentially increasing toxicity or reducing anticancer effectiveness. It is essential to inform your doctor and pharmacist about all medications, over-the-counter products, vitamins, and herbal supplements you are taking before starting sunitinib, and before adding any new medicine during treatment.
Major Interactions (CYP3A4 Inhibitors – Increase Sunitinib Levels)
The following drugs inhibit CYP3A4 and may raise sunitinib concentrations in your blood, which can increase the risk of toxic effects such as severe blood count changes, heart problems, or skin reactions. Your doctor may reduce the sunitinib dose or select an alternative concomitant medicine if co-administration cannot be avoided:
| Drug | Drug Class | Clinical Significance |
|---|---|---|
| Ketoconazole | Azole antifungal | Strong CYP3A4 inhibitor; can substantially increase sunitinib exposure |
| Itraconazole | Azole antifungal | Strong CYP3A4 inhibitor; dose reduction of sunitinib may be needed |
| Voriconazole / Posaconazole | Azole antifungal | Strong CYP3A4 inhibitors; consider an alternative antifungal |
| Ritonavir | HIV protease inhibitor / booster | 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 or switch to azithromycin |
| Grapefruit juice / Seville orange | Food interaction | Intestinal CYP3A4 inhibitor; avoid throughout treatment |
Major Interactions (CYP3A4 Inducers – Decrease Sunitinib Levels)
The following drugs and herbal products induce CYP3A4 and may decrease the concentration of sunitinib in your blood, potentially reducing its anticancer activity. If co-administration is unavoidable, your doctor may need to increase the sunitinib dose under close monitoring:
| Drug | Drug Class | Clinical Significance |
|---|---|---|
| Rifampicin | Antibiotic (tuberculosis) | Strong CYP3A4 inducer; can significantly reduce sunitinib exposure |
| Phenytoin | Antiepileptic | Strong CYP3A4 inducer; may reduce sunitinib efficacy |
| Carbamazepine | Antiepileptic | Strong CYP3A4 inducer; may reduce sunitinib efficacy |
| Phenobarbital | Antiepileptic / barbiturate | Strong CYP3A4 inducer; avoid if possible |
| Dexamethasone | Corticosteroid | Moderate CYP3A4 inducer; monitor sunitinib effectiveness with prolonged use |
| St. John’s Wort (Hypericum perforatum) | Herbal antidepressant | Strong CYP3A4 inducer; must not be taken with sunitinib |
| Enzalutamide | Androgen-receptor inhibitor | Strong CYP3A4 inducer; avoid concomitant use |
Additional Interaction Considerations
Beyond CYP3A4-mediated interactions, several other clinically relevant interactions deserve attention. Sunitinib can modestly prolong the QT interval, so combining it with other QT-prolonging drugs (for example, certain antiarrhythmics such as amiodarone or sotalol, some antipsychotics, and certain fluoroquinolone antibiotics) may increase the risk of serious arrhythmias. Oral anticoagulants such as warfarin and acenocoumarol may interact with sunitinib and with the underlying cancer, increasing the risk of bleeding; INR should be monitored closely and low-molecular-weight heparin is often preferred during active cancer treatment.
Sunitinib is also a mild inhibitor of the multidrug and toxin extrusion (MATE) transporters, which theoretically can increase exposure to certain metformin-containing or other MATE-substrate medicines. In practice, the clinical impact is small, but it is wise to monitor blood glucose and renal function when sunitinib is started or stopped in patients with type 2 diabetes. Always inform your oncology team and pharmacist about any new prescriptions, over-the-counter remedies, or supplements – including vitamins and plant-based products such as ginseng, echinacea, and goldenseal – you plan to use.
What Is the Correct Dosage of Sunitinib Medical Valley?
Always take Sunitinib Medical Valley exactly as your oncologist has told you. The correct dosage depends on the type of cancer being treated, your general health and organ function, how well you tolerate the medicine, and the medicines you are taking concurrently. Because Sunitinib Medical Valley is supplied only as 12.5 mg hard capsules, higher daily doses are reached by combining several capsules (for example, 2 capsules = 25 mg, 3 capsules = 37.5 mg, 4 capsules = 50 mg). This single-strength approach makes it easy to individualize the dose in precise 12.5 mg increments.
Adults
GIST and Metastatic Renal Cell Carcinoma (MRCC)
The recommended starting dose is 50 mg (four × 12.5 mg capsules) 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”). Treatment is continued for as long as the cancer is responding and side effects remain manageable. Dose reductions are made in 12.5 mg increments, so the dose can be stepped down from 50 mg → 37.5 mg → 25 mg daily. The minimum recommended dose is 25 mg daily.
Pancreatic Neuroendocrine Tumors (pNET)
The recommended dose is 37.5 mg (three × 12.5 mg capsules) taken orally once daily on a continuous daily dosing schedule, without a scheduled rest period. Dose adjustments may be made based on individual safety and tolerability. The dose may be increased stepwise up to a maximum of 50 mg daily, or decreased stepwise down to a minimum of 25 mg daily. Increases above 50 mg daily are not recommended.
Sunitinib Medical Valley 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, as the contents are an irritant if released. Try to take your dose at approximately the same time each day – for example, each morning – to help maintain consistent blood levels and to make the regimen easier to remember.
Children and Adolescents
Sunitinib Medical Valley is not recommended for persons under 18 years of age. Data on safety and efficacy in children are limited, and the existing pediatric studies raised concerns about cardiotoxicity and effects on bone growth. Use in children should be confined to specialist clinical settings and, where possible, to clinical trials.
Elderly Patients
No routine dose adjustment is required for elderly patients on the basis of age alone. However, elderly patients (particularly those aged 75 years or more) may be more susceptible to side effects such as fatigue, hypertension, and cytopenias. Careful baseline evaluation and more frequent follow-up are often appropriate.
Dose Adjustments
Your doctor may modify your dose depending on how you tolerate treatment. Common reasons for dose reduction or temporary interruption include grade 3 or 4 hypertension, significant neutropenia or thrombocytopenia, severe hand-foot skin reaction, symptomatic reductions in left ventricular ejection fraction, clinically significant liver enzyme elevations, and proteinuria. In most cases, sunitinib is held until the side effect has resolved or improved to grade 1 or lower, and then restarted at a reduced dose.
For patients taking concurrent strong CYP3A4 inhibitors, a dose reduction should be considered – typically to a minimum of 37.5 mg daily (for GIST/MRCC) or 25 mg daily (for pNET). For patients taking concurrent strong CYP3A4 inducers, a dose increase up to 87.5 mg daily (GIST/MRCC) or 62.5 mg daily (pNET) may be considered, with careful monitoring for both efficacy and toxicity. Whenever possible, however, strong CYP3A4 modulators should simply be replaced by alternatives with less interaction potential.
No specific dose adjustment is required for mild to moderate hepatic impairment (Child-Pugh A or B). Sunitinib has not been studied in patients with severe hepatic impairment (Child-Pugh C), and its use in this population is generally not recommended. No dose adjustment is required for renal impairment, including patients receiving hemodialysis, but urinalysis and serum creatinine should be monitored regularly.
Missed Dose
If you miss a dose of Sunitinib Medical Valley, do not take a double dose to make up for the missed dose. If you remember within a few hours of your usual dosing time, you may take the missed dose. If it is close to the time of the next scheduled dose, skip the missed dose entirely and take your next dose at the usual time. If you are unsure what to do, contact your oncologist or a pharmacist for advice.
Overdose
If you accidentally take more capsules than prescribed, contact your doctor or the nearest emergency department immediately, and take the medicine packaging with you. There is no specific antidote for sunitinib overdose, so management is supportive and may include observation, electrolyte correction, blood count monitoring, and treatment of specific toxicities (for example, hypertension). Symptoms of overdose typically represent an intensification of known side effects such as extreme fatigue, severe hand-foot reaction, or significant blood count drops.
What Are the Side Effects of Sunitinib Medical Valley?
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, dose adjustments, and careful monitoring, but some are potentially serious and require urgent recognition. Report all new symptoms to your oncology team so that they can be addressed promptly. The frequency categories below follow the standard EMA convention.
Contact your doctor immediately, or go to the emergency department, if you experience: extreme tiredness, breathlessness or swollen feet/ankles (heart failure); sudden chest pain, rapid breathing, or coughing up blood (pulmonary embolism or myocardial infarction); sudden weakness on one side of the body or difficulty speaking (stroke); severe abdominal pain with fever (bowel perforation, pancreatitis, or cholecystitis); widespread rash with blistering or skin peeling (severe cutaneous reaction); or severe or unusual bleeding (hemorrhage).
Very Common
May affect more than 1 in 10 people
- Decreased platelet, red blood cell, and white blood cell counts (including neutropenia)
- Shortness of breath (dyspnea), cough
- High blood pressure (hypertension)
- Extreme tiredness, fatigue, weakness (asthenia)
- Peripheral edema (swelling of feet, ankles, or around the eyes)
- Mouth pain and irritation, mouth sores (stomatitis), dry mouth, taste disturbance (dysgeusia)
- Nausea, vomiting, diarrhea, constipation, dyspepsia
- Abdominal pain or distension, decreased appetite (anorexia)
- Hypothyroidism (underactive thyroid), elevated TSH
- Dizziness, headache
- Nosebleeds (epistaxis)
- Back pain, joint pain (arthralgia), pain in arms and legs
- Yellowing or discoloration of the skin, increased skin pigmentation, hair color change
- Hand-foot skin reaction (redness, pain, blistering, or swelling on palms and soles), rash, dry skin
- Fever, 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 (myocardial ischemia), decreased left ventricular ejection fraction
- Chest pain, palpitations
- Pleural effusion (fluid around the lungs)
- Infections, including urinary tract and respiratory infections; sepsis (life-threatening blood infection)
- Hypoglycemia (low blood sugar), elevated uric acid
- Proteinuria (protein in urine), flu-like symptoms
- Elevated liver and pancreatic enzymes (ALT, AST, lipase, amylase)
- Hemorrhoids, rectal pain, bleeding gums, dysphagia (difficulty swallowing)
- Heartburn (GERD), increased gas, weight loss, dehydration
- Muscle and skeletal pain, muscle weakness, muscle cramps
- Nasal dryness and congestion, increased tearing (epiphora)
- Skin itching, skin peeling, blisters, acneiform rash, nail discoloration, hair loss (alopecia)
- Numbness or tingling in hands and feet (paresthesia)
- 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) and transient ischemic attack
- Myocardial infarction (heart attack) and unstable angina
- Changes in the heart’s electrical activity, QT prolongation, torsades de pointes
- Pericardial effusion (fluid around the heart)
- Heart failure
- Liver failure (sometimes fatal)
- Pancreatitis (inflammation of the pancreas)
- Bowel perforation (a hole in the intestine, occasionally due to tumor regression)
- Gallbladder inflammation (cholecystitis), with or without gallstones
- Fistula (abnormal channel between body cavities or to the skin)
- Osteonecrosis of the jaw (ONJ)
- Hyperthyroidism (overactive thyroid)
- Impaired wound healing after surgery
- Elevated creatine phosphokinase (muscle enzyme)
- Severe allergic reactions including anaphylaxis and angioedema
- Colitis (including 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 breakdown
- Rhabdomyolysis (abnormal muscle tissue breakdown that can lead to kidney damage)
- Posterior reversible encephalopathy syndrome (PRES/RPLS) – brain changes causing headache, confusion, seizures, and vision loss
- Pyoderma gangrenosum (painful skin ulcers)
- Hepatitis (liver inflammation)
- Thyroiditis (inflammation of the thyroid gland)
- Thrombotic microangiopathy (TMA) – damage to the smallest blood vessels
- Nephrotic syndrome
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
- Diabetes insipidus
Reporting suspected side effects once a medicine has been authorized is an important way to continuously monitor its benefit-risk balance. Healthcare professionals and patients can report suspected adverse reactions directly to their national pharmacovigilance authority – for example, the EMA / EudraVigilance system in the European Union, the FDA MedWatch program in the United States, or the MHRA Yellow Card scheme in the United Kingdom. Reporting helps identify new signals and keeps the product information up to date.
How Should You Store Sunitinib Medical Valley?
Keep Sunitinib Medical Valley capsules out of the sight and reach of children at all times. Sunitinib is a potent anticancer medicine, and accidental ingestion by a child could cause serious harm. Store the product in a secure cupboard or drawer, not on a kitchen counter or bedside table where children may find it. Consider using a lockable medication storage box if young children live in or visit your home.
There are no special temperature storage conditions for Sunitinib Medical Valley hard capsules. Store in the original packaging to protect from light and moisture. Do not remove capsules from the blister or bottle until immediately before taking them. 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.
Do not use Sunitinib Medical Valley if the packaging appears damaged, shows signs of tampering, or is clearly different in appearance from what you received previously. If you notice any unusual change in the appearance of the capsules (for example, discoloration, cracking, or unusual odor), consult your pharmacist rather than taking the capsule.
Because sunitinib is a cytotoxic anticancer agent, environmental disposal is important. Do not dispose of medicines via wastewater, sinks, or household waste. Return unused or expired capsules to your pharmacy for safe incineration. Many countries have specific take-back schemes for cytotoxic medicines. These measures help protect the environment, drinking water supplies, and prevent accidental exposure to children, other household members, or waste-handling staff.
What Does Sunitinib Medical Valley Contain?
The active substance in Sunitinib Medical Valley is sunitinib. Each hard capsule contains 12.5 mg of sunitinib (equivalent to 16.7 mg sunitinib malate).
Inactive Ingredients (Excipients)
The other ingredients are:
- Capsule contents: Microcrystalline cellulose, mannitol (E421), croscarmellose sodium, povidone (E1201), magnesium stearate
- Capsule shell: Gelatin, titanium dioxide (E171), red iron oxide (E172)
- Printing ink: Shellac, titanium dioxide (E171), propylene glycol, ammonium hydroxide
The capsule does not contain lactose, gluten, or any ingredients of animal origin other than the gelatin in the capsule shell. Patients with specific dietary, religious, or allergy-related concerns about gelatin should discuss alternative brands or formulations with their pharmacist or oncologist.
Capsule Identification
| Strength | Capsule Appearance | Approximate Size | Imprint |
|---|---|---|---|
| 12.5 mg | Orange cap and orange body, containing yellow to orange granules | Approximately 14.3 mm (size 4 hard gelatin capsule) | “12.5 mg” (or equivalent identifier) in white ink |
Sunitinib Medical Valley 12.5 mg hard capsules are supplied as parallel-imported packaging that is repackaged and relabelled for the local market. Typical pack sizes include bottles of 30 capsules and blister packs of 28 capsules. Not all pack sizes may be marketed in every country, and the exact appearance and imprint may vary slightly between batches depending on the original source pack.
Marketing Authorization Holder and Manufacturer
The parallel import marketing authorization holder for Sunitinib Medical Valley is Medical Valley Invest AB, a Swedish pharmaceutical company specialized in parallel distribution within the European Economic Area. The original medicine is manufactured by Pfizer (the originator of sunitinib under the brand name SUTENT) and is centrally authorized by the European Medicines Agency. National competent authorities review and approve the repackaging, labelling, and the patient information leaflet used by the parallel distributor before the product can be placed on the market.
A parallel-imported medicine is an authentic, authorized medicine sourced from one EEA country and supplied to another EEA country, usually under a slightly different trade name or packaging. The underlying medicine is the same as the one authorized in the destination country, and it must meet the same quality, efficacy, and safety standards. Parallel imports are legal throughout the EEA and are supervised by national medicines agencies. They can contribute to patient access and cost savings for healthcare systems while maintaining full regulatory oversight.
Frequently Asked Questions
Yes. Sunitinib Medical Valley contains the same active substance (sunitinib), in the same pharmaceutical form and strength, as the original brand SUTENT manufactured by Pfizer. Medical Valley Invest AB is a parallel distributor that repackages SUTENT for distribution within the European Economic Area under a parallel import licence. Because the medicine itself is the same – only the outer carton and patient leaflet differ – the clinical profile, efficacy and side-effect profile are identical to SUTENT.
Different parallel distributors choose which strengths to repackage for each market, based on local demand and supply-chain considerations. For Sunitinib Medical Valley, only the 12.5 mg hard capsule is currently marketed. Because all clinically relevant doses (25 mg, 37.5 mg, 50 mg) are multiples of 12.5 mg, your oncologist can still build any of the standard daily doses by combining several 12.5 mg capsules. If your prescription requires a different strength and only Sunitinib Medical Valley is available, your pharmacist can confirm how to combine capsules to reach the prescribed total dose.
Yes, Sunitinib Medical Valley can be taken with or without food. Food does not significantly affect the absorption of sunitinib, so you can choose whichever approach makes it easier to remember the daily dose and to tolerate any gastrointestinal side effects. However, you should avoid grapefruit juice, grapefruit, Seville oranges, and pomelo throughout treatment, as these inhibit the CYP3A4 enzyme and can raise sunitinib levels in your blood. Swallow the capsules whole with water; do not open, crush, or chew them.
Sunitinib and its active metabolite have a yellow-orange color that can accumulate in the skin, causing a yellowish tinge. This is a very common side effect and is in itself harmless – it is not the same as jaundice due to liver disease, which also involves yellowing of the whites of the eyes. A true jaundice (yellow sclerae, dark urine, upper-right abdominal pain) always requires prompt medical evaluation. Sunitinib can also cause hair color changes, making hair lighter or gradually depigmented. These skin and hair changes are typically reversible once treatment is stopped.
The duration of sunitinib treatment varies depending on the type of cancer, how well the cancer is responding, and how well you tolerate the medicine. In general, treatment is continued for as long as it provides clinical benefit and the side effects remain manageable. Your oncologist will reassess with scans (CT or MRI) and blood tests approximately every 2–3 months. Some patients take sunitinib for months, others for several years. Treatment is usually stopped at the point of clear disease progression, unacceptable toxicity, or when you and your doctor decide together that another option is preferable.
High blood pressure (hypertension) is a very common side effect of sunitinib and usually appears within the first few cycles of treatment. Your doctor should check your blood pressure at baseline and at regular intervals during treatment. If your blood pressure rises, antihypertensive medication – most often an ACE inhibitor, angiotensin-receptor blocker, or calcium-channel blocker – is started. In some cases, a sunitinib dose reduction or brief treatment interruption may be needed. Do not stop taking sunitinib on your own. Home blood pressure monitoring is often recommended; aim to record readings at roughly the same time each day and bring your log to every clinic visit.
Yes. Thyroid dysfunction is a very common side effect of sunitinib. The most frequent problem is hypothyroidism (underactive thyroid), though some patients develop hyperthyroidism (overactive thyroid) or thyroiditis (inflammation). Thyroid function (TSH with free T4 if needed) should be measured at baseline and monitored at regular intervals, commonly every 2–3 months. Symptoms of hypothyroidism include unusual tiredness, feeling cold, weight gain, constipation, and a deeper voice. If the thyroid becomes underactive, your doctor will prescribe levothyroxine replacement, which is usually well tolerated and allows sunitinib to be continued without dose adjustment.
References
- European Medicines Agency (EMA). SUTENT (sunitinib) – Summary of Product Characteristics (SmPC). Available at: www.ema.europa.eu. Last updated 2025.
- U.S. Food and Drug Administration (FDA). SUTENT (sunitinib malate) – Prescribing Information. Available at: www.fda.gov.
- 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. doi:10.1016/S0140-6736(06)69446-4.
- 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. doi:10.1056/NEJMoa065044.
- 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. doi:10.1056/NEJMoa1003825.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Kidney Cancer, Gastrointestinal Stromal Tumors, and Neuroendocrine and Adrenal Tumors. Version 2025. Available at: www.nccn.org.
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Renal Cell Carcinoma, Gastrointestinal Stromal Tumours, and Gastroenteropancreatic Neuroendocrine Neoplasms. Available at: www.esmo.org.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List (2023). Geneva: WHO; 2023.
- Joint Formulary Committee. British National Formulary (BNF). Sunitinib monograph. London: BMJ Group and Pharmaceutical Press. Available at: bnf.nice.org.uk.
- Schmidinger M. Understanding and managing toxicities of vascular endothelial growth factor (VEGF) inhibitors. EJC Supplements. 2013;11(2):172-191. doi:10.1016/j.ejcsup.2013.07.016.
- Blay JY, Kang YK, Nishida T, von Mehren M. Gastrointestinal stromal tumours. Nature Reviews Disease Primers. 2021;7(1):22. doi:10.1038/s41572-021-00254-5.
- Escudier B, Porta C, Schmidinger M, et al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology. 2024;35(8):692-706.
Editorial Team
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 evaluated against the GRADE evidence framework and cross-checked against the EMA Summary of Product Characteristics, the FDA prescribing information, and NCCN / ESMO clinical practice guidelines before publication.
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