Sunitinib 12.5 mg/25 mg/37.5 mg/50 mg Capsules

Gastrointestinal stromal tumour (GIST)
SUNITINIB CIPLA is indicated for the treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance.
Metastatic renal cell carcinoma (MRCC)
SUNITINIB CIPLA is indicated for the treatment of treatment-nau00efve advanced and/or metastatic renal cell carcinoma. SUNITINIB CIPLA is also indicated for the treatment of metastatic renal cell carcinoma (MRCC) after failure of cytokine-based therapy (interferon u03b1, interleukin-2). Efficacy is based on time to tumour progression and an increase in survival in GIST and on objective response rates for MRCC. Efficacy and safety has not been demonstrated for more than 12 months.
Pancreatic neuroendocrine tumours (pNET)
SUNITINIB CIPLA is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.

Therapy with should be initiated by a medical practitioner experienced in the treatment of renal cell carcinoma or GIST.
Posology
For GIST and MRCC, the recommended dose of SUNITINIB CIPLA is one 50 mg dose orally, taken daily for 4 consecutive weeks, followed by a 2-week rest period (Schedule 4/2) to comprise a complete cycle of 6 weeks.
For pancreatic neuroendocrine tumours (pNET), the recommended dose of SUNITINIB CIPLA is 37,5 mg taken orally once daily without a scheduled rest period.
Dose modifications
Safety and tolerability
For GIST and MRCC, dose modifications in 12,5 mg increments may be applied based on individual safety and tolerability. Daily dose should not exceed 75 mg nor be decreased below 25 mg. For pNET, dose modification in 12,5 mg steps may be applied based on individual safety and tolerability. The maximum dose administered in the Phase 3 pNET study was 50 mg daily. Dose interruptions may be required based on individual safety and tolerability.
CYP3A4 inhibitors/inducers
In patients receiving SUNITINIB CIPLA with a potent CYP3A4 inducer such as rifampicin, the dosage of SUNITINIB CIPLA may need to be increased in 12,5 mg increments (up to 87,5 mg per day for GIST and MRCC or 62,5 mg per day for pNET). Clinical response and tolerability should be carefully monitored.
In patients receiving SUNITINIB CIPLA with a CYP3A4 inhibitor such as ketoconazole, the doses of SUNITINIB CIPLA may need to be reduced to a minimum of 37,5 mg daily for GIST and MRCC or 25 mg daily for pNET, based on tolerability and/or clinical response. Selection of an alternate concomitant medication with no, or minimal potential to induce or inhibit CYP3A4 should be considered.
Population pharmacokinetic analyses of demographic data indicate that no dose adjustments are necessary for age, body weight, creatinine clearance, race, gender or ECOG (Eastern Cooperative Oncology Group) score.
Special populations
Elderly patients
No significant differences in safety or efficacy were observed between younger and older patients.
Hepatic insufficiency
No dosage adjustment is necessary when administering SUNITINIB CIPLA to patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. SUNITINIB CIPLA was not studied in patients with severe (Child-Pugh Class C) hepatic impairment.
Renal insufficiency
No starting dose adjustment is required when administering SUNITINIB CIPLA to patients with renal impairment (mild-severe) or with end-stage renal disease (ESRD) on haemodialysis. Subsequent dose adjustments should be based on individual safety and tolerability.
Paediatric population
The safety and efficacy of SUNITINIB CIPLA in paediatric patients have not been established.
Method of administration
For oral use. If a dose is missed, the patient should not be given an additional dose. The patient should take the usual prescribed dose on the following day.

• SUNITINIB CIPLA is contraindicated in patients with hypersensitivity to sunitinib malate or to any of the other excipients of SUNITINIB CIPLA (listed in section 6.1).
• Pregnancy and lactation (see section 4.6).

Skin and tissues
Patients should be advised that depigmentation of the hair or skin may also occur during treatment with SUNITINIB CIPLA. Other possible dermatologic effects may include dryness, thickness or cracking of the skin, blisters or occasional rash on the palms of the hands and soles of the feet.
Mouth pain/irritation and dysgeusia (taste disturbance) were reported in studies. These events were not cumulative and were typically reversible and generally did not result in treatment discontinuation.
Severe cutaneous reactions have been reported, including cases of erythema multiforme (EM) and cases suggestive of Stevens-Johnson syndrome (SJS), some of which were fatal. If signs or symptoms of SJS or EM (e.g., progressive skin rash often with blisters or mucosal lesions) are present, SUNITINIB CIPLA should be discontinued. If the diagnosis of SJS is confirmed, treatment must not be re-started. In some cases of suspected EM, patients tolerated the reintroduction of SUNITINIB CIPLA at a lower dose after resolution of the reaction; some of these patients also received concomitant treatment with corticosteroids or antihistamines.
Haemorrhage
Haemorrhagic events reported through post-marketing experience, some of which were fatal, have included gastrointestinal (GI), respiratory, tumour, urinary tract and brain haemorrhage. In clinical trials, tumour haemorrhage occurred in patients with GIST. These events may occur suddenly, and in the case of pulmonary tumours, may present as severe or life-threatening haemoptysis or pulmonary haemorrhage. Tumour haemorrhage has not been observed in patients with MRCC or other solid tumours. Cases of pulmonary haemorrhage, some with a fatal outcome, have been observed in clinical trials and have been reported in post-marketing experience in patients treated with sunitinib as in SUNITINIB CIPLA for MRCC, GIST, and metastatic non-small cell lung cancer (NSCLC). SUNITINIB CIPLA is not approved for use in patients with NSCLC. Bleeding in patients receiving sunitinib for treatment-nau00efve MRCC, cytokine-refractory MRCC, and pNET has been reported in clinical studies. Routine assessment of these events should include complete blood counts and physical examination. Treatment-related epistaxis was reported in patients with solid tumours in clinical trial. Epistaxis was the frequent treatment-related haemorrhagic adverse event, having been reported for approximately half of the patients with solid tumours who experienced haemorrhagic events.
Gastrointestinal events
Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation have occurred in patients with intra-abdominal malignancies treated with sunitinib. Nausea, diarrhoea, stomatitis, dyspepsia and vomiting were frequently reported treatment-related gastrointestinal events. Supportive care for gastrointestinal adverse events requiring treatment may include medication with an anti-emetic or anti-diarrhoeal medication.
Pancreatitis
Pancreatitis has been reported in clinical trials of sunitinib. Increases in serum lipase and amylase were observed in patients with various solid tumours who received sunitinib. Increases in lipase levels were transient and were generally not accompanied by signs or symptoms of pancreatitis in subjects with various solid tumours. If symptoms of pancreatitis are present, patients should have proper medical follow-up.
Hepatotoxicity
Hepatotoxicity has been observed in patients treated with sunitinib. Liver function tests (alanine transaminase [ALT], aspartate transaminase [AST], bilirubin levels) should be monitored before initiation of treatment, during each cycle of treatment, and additionally as clinically indicated. SUNITINIB CIPLA treatment should be interrupted for Grade 3 or 4 hepatic-related adverse events and discontinued if there is no resolution of the adverse events.
Haematological
Decreased absolute neutrophil counts occurred frequently and decreased platelet counts were reported less frequently in clinical trials. Such events were not cumulative, were typically reversible and generally did not result in treatment discontinuation. In addition, some cases of fatal haemorrhage associated with thrombocytopenia were reported through post-marketing experience. Complete blood counts should be performed at the beginning of each treatment cycle for patients receiving treatment with SUNITINIB CIPLA.
Cardiovascular
Cardiovascular events, including heart failure, cardiomyopathy, myocardial ischaemia, angina pectoris and myocardial infarction, some of which were fatal, have been reported in clinical trials and through post-marketing experience. In the treatment-nau00efve MRCC study, patients on sunitinib had a left ventricular ejection fraction (LVEF) value below the lower limit of normal. Cardiac failure that may be fatal, congestive cardiac failure or left ventricular failure were reported in clinical trials. The relationship between receptor tyrosinase kinase (RTK) inhibition and cardiac function remains unclear but seems to be a class effect. Data from non-clinical (in vitro and in vivo) studies, at doses higher than the recommended human dose, indicate that sunitinib has the potential to inhibit the cardiac action potential repolarisation process (e.g., prolongation of QT interval). Increases in the QTc interval and changes from baseline that occurred were recognised as potentially significant.
QT interval prolongation
At approximately twice the therapeutic concentrations, sunitinib as in SUNITINIB CIPLA has been shown to prolong the QTcF (Fredericiau2019s correction) interval. QT interval prolongation may lead to an increased risk for ventricular dysrhythmias including torsade de pointes. SUNITINIB CIPLA should be used with caution in patients with a known history of QT interval prolongation, patients who are taking antidysrhythmics or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances.
Hypertension
Patients treated with SUNITINIB CIPLA should have regular blood pressure assessments. Hypertension was a frequent adverse event reported in clinical trials in patients with solid tumours, including primarily GIST and cytokine-refractory RCC. Patients should be screened for hypertension and controlled as appropriate. Temporary suspension of SUNITINIB CIPLA therapy is recommended in patients with severe hypertension that is not controlled with medical management. Treatment may be resumed once hypertension is appropriately controlled.
Thyroid dysfunction
Baseline laboratory measurement of thyroid function is recommended and patients with hypothyroidism or hyperthyroidism should be treated as per standard medical treatment prior to the start of SUNITINIB CIPLA treatment. All patients should be observed closely for signs and symptoms of thyroid dysfunction whilst on SUNITINIB CIPLA treatment. Patients with signs and/or symptoms suggestive of thyroid dysfunction should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice. In studies, acquired hypothyroidism was noted in GIST patients. Hypothyroidism was reported as an adverse event in patients on sunitinib in the treatment-nau00efve MRCC study and in subjects across 2 cytokine-refractory MRCC studies. Cases of hyperthyroidism, some followed by hypothyroidism, have been reported in clinical trials and through post-marketing experience.
Seizures
In clinical studies of sunitinib, seizures have been observed in subjects with radiological evidence of brain metastases. Patients with seizures and signs/symptoms consistent with reversible posterior leukoencephalopathy syndrome (RPLS), such as hypertension, headache, decreased alertness, altered mental functioning, and visual loss, including cortical blindness, should be controlled with medical management including control of hypertension. Temporary suspension of SUNITINIB CIPLA therapy is recommended in patients with seizures or RPLS. Following resolution, treatment may be resumed at the discretion of the treating medical practitioner.
Surgical procedures
Cases of impaired wound healing have been reported during sunitinib therapy. Temporary interruption of SUNITINIB CIPLA therapy is recommended for precautionary reasons in patients undergoing major surgical procedures. There is limited clinical experience regarding the timing of re-initiation of therapy following major surgical intervention. Therefore, the decision to resume SUNITINIB CIPLA therapy following a major surgical intervention should be based upon clinical judgement of recovery from surgery.
Osteonecrosis of the jaw (ONJ)
ONJ has been less frequently observed in clinical trials and has been reported in post-marketing experience in patients treated with sunitinib. The majority of cases occurred in patients who had received prior or concomitant treatment with intravenous (IV) bisphosphonates, for which ONJ is an identified risk. Caution should therefore be exercised when SUNITINIB CIPLA and IV bisphosphonates are used either simultaneously or sequentially. Invasive dental procedures are also an identified risk factor for ONJ. Prior to treatment with SUNITINIB CIPLA, a dental examination and appropriate preventative dentistry should be considered. In patients being treated with SUNITINIB CIPLA, who have previously received or are receiving IV bisphosphonates, invasive dental procedures should be avoided, if possible.
Venous thromboembolic event
Some patients on sunitinib in a GIST study experienced venous thromboembolic events and treatment-nau00efve MRCC had venous thrombolic events reported such as pulmonary embolism.
Pulmonary embolism
Pulmonary embolism was reported in patients with solid tumours who received sunitinib. None of these events resulted in a patient discontinuing treatment with sunitinib; however, a dose reduction or temporary delay in treatment occurred in a few cases. There were no further occurrences of pulmonary embolism in these patients after treatment was resumed.
Tumour lysis syndrome (TLS)
Cases of TLS, some fatal, have been observed in clinical trials and have been reported in post-marketing experience in patients treated with sunitinib. Patients generally at risk of TLS are those with high tumour burden prior to treatment. These patients should be monitored closely and treated as clinically indicated.
Necrotising fasciitis
Cases of necrotising fasciitis, including of the perineum, sometimes fatal, have been reported. SUNITINIB CIPLA therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
Thrombotic microangiopathy
Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and haemolytic uraemic syndrome (HUS), frequently leading to renal failure or a fatal outcome, has been reported in clinical trials and in post-marketing experience of sunitinib as monotherapy and in combination with bevacizumab. Discontinue SUNITINIB CIPLA in patients developing TMA.
Proteinuria
Cases of proteinuria and nephrotic syndrome have been reported. Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria. The safety of continued sunitinib treatment in patients with moderate to severe proteinuria has not been systematically evaluated. Discontinue SUNITINIB CIPLA in patients with nephrotic syndrome.
Hypoglycaemia
Decreases in blood glucose, in some cases clinically symptomatic, have been reported during sunitinib treatment. Blood glucose levels in diabetic patients should be checked regularly in order to assess if antidiabetic medicine dosage needs to be adjusted to minimise the risk of hypoglycaemia.
Cerebrovascular events
Cerebrovascular adverse events identified as class related adverse events have occurred in patients treated with TKI containing medicines. These class-related cerebrovascular adverse events, shared to a variable degree by all TKIs, are cerebrovascular accident (CA), transient ischaemic attack (TIA), ischaemic stroke (IS), and cerebral infarction (CI). These cerebrovascular events may occur in patients on treatment with TKIs with or without risk factors for these events and may occur at any time during treatment with TKIs. Patients on treatment with TKI containing medicine should be carefully monitored, and relevant risk factors managed to reduce the risk for these class related cerebrovascular adverse events. Treatment with TKI containing medicines should be discontinued, and alternative treatment options be considered in patients who develop these class-related cerebrovascular adverse events.
Arterial thromboembolic events
Cases of arterial thromboembolic events (ATE), sometimes fatal, have been reported in patients treated with sunitinib. The most frequent events included cerebrovascular accident, transient ischaemic attack, and cerebral infarction. Risk factors associated with ATE, in addition to the underlying malignant disease and age u2265 65 years, included hypertension, diabetes mellitus, and prior thromboembolic disease.
Aneurysms and artery dissections
The use of vascular endothelial growth factor (VEGF) pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections. Before initiating sunitinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.

When sunitinib as in SUNITINIB CIPLA is co-administered with other medicines, there is a potential for medicine interaction. In vitro studies indicate that sunitinib neither induces nor inhibits major CYP enzymes, including CYP3A4. The dose of SUNITINIB CIPLA may need to be reduced based on tolerability when co-administered with CYP3A4 inhibitors. The dose of SUNITINIB CIPLA may need to be increased when it is co-administered with potent CYP3A4 inducers.
Medicines that may increase SUNITINIB CIPLA plasma concentrations
Concurrent administration of SUNITINIB CIPLA with the CYP3A4 inhibitor, ketoconazole, increases sunitinib C max and AUC 0 - u221e values, respectively, after a single dose of sunitinib in clinical studies. Administration of SUNITINIB CIPLA with other inhibitors of the CYP3A4 family (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) may increase SUNITINIB CIPLA concentrations. Concomitant administration with inhibitors should therefore be avoided, or the selection of an alternate concomitant medication with no or minimal potential to inhibit CYP3A4, should be considered. If this is not possible, the dosage of SUNITINIB CIPLA may need to be reduced (see section 4.2, Dose modifications).
Medicines that may decrease SUNITINIB CIPLA plasma concentrations
Concomitant use of sunitinib as in SUNITINIB CIPLA with the CYP3A4 inducer, rifampicin, resulted in reduction in sunitinib C max and AUC 0 - u221e values, respectively, after a single dose of sunitinib in healthy volunteers. Administration of SUNITINIB CIPLA with strong inducers of the CYP3A4 family (e.g., dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbitone or Hypericum perforatum known also as St. Johnu2019s Wort) may decrease SUNITINIB CIPLA concentrations. To maintain SUNITINIB CIPLA target concentrations, dose adjustment of SUNITINIB CIPLA, or selection of co-medications with less enzyme induction potential, should be considered.

Women of childbearing potential / Contraception in males and females
Teratogenicity has been observed in animal studies. Women of childbearing potential should use effective contraceptive measures during SUNITINIB CIPLA treatment and 4 weeks after the last dose of SUNITINIB CIPLA.
Pregnancy
SUNITINIB CIPLA is contraindicated in pregnancy as safety has not been demonstrated.
Breastfeeding
SUNITINIB CIPLA is secreted in breast milk. Women using SUNITINIB CIPLA should not breastfeed their infants, because of the potential for serious adverse reactions in nursing infants.
Fertility
Based on the findings of pre-clinical studies, fertility in males and females may be compromised by treatment with SUNITINIB CIPLA.

No studies on the effects on the ability to drive or operate machinery have been performed. Patients should be advised that they may experience dizziness during treatment with SUNITINIB CIPLA.

Summary of the safety profile
The most important serious adverse events associated with sunitinib treatment of solid tumour patients were pulmonary embolism, thrombocytopenia, tumour haemorrhage, febrile neutropenia, and hypertension. Frequent adverse events included: fatigue; gastrointestinal disorders, such as diarrhoea, nausea, stomatitis, dyspepsia and vomiting; skin discolouration; rash; hand-foot syndrome (palmarplantar erythrodysaesthesia); dry skin; hair colour changes; mucosal inflammation; asthenia; dysgeusia; anorexia and hypertension. Fatigue, hypertension and neutropenia were the frequent adverse events of Grade 3 maximum severity; and increased lipase was the frequently occurring adverse event of Grade 4 maximum severity in patients with solid tumours.
Infections and infestations
Frequent: Infections*, viral infections a, respiratory infections b,**, abscess c,**, fungal infections d, urinary tract infection, skin infections e, sepsis f,**.
Less frequent: Necrotising fasciitis**, bacterial infections g.
Blood and lymphatic system disorders
Frequent: Neutropenia, leukopenia, thrombocytopenia, anaemia, lymphopenia.
Less frequent: Pancytopenia, thrombotic microangiopathy h **.
Immune system disorders
Less frequent: Hypersensitivity, angioedema.
Endocrine disorders
Frequent: Hypothyroidism. Less frequent: Hyperthyroidism, thyroiditis.
Metabolism and nutrition disorders
Frequent: Decreased appetite i, dehydration, hypoglycaemia. Less frequent: Tumour lysis syndrome**.
Psychiatric disorders
Frequent: Insomnia, depression.
Nervous system disorders
Frequent: Dysgeusia j, headache, dizziness, paraesthesia, peripheral neuropathy, hypoaesthesia, hyperaesthesia. Less frequent: Cerebral haemorrhage**, cerebrovascular accident**, transient ischaemic attack, cerebral infarction, reversible posterior encephalopathy syndrome**, ageusia.
Eye disorders
Frequent: Periorbital oedema, eyelid oedema, increased lacrimation.
Cardiac disorders
Frequent: Myocardial ischaemia k, **, decreased ejection fraction l. Less frequent: Myocardial infarction m, **, cardiac failure**, congestive cardiac failure, prolonged electrocardiogram QT, pericardial effusion cardiomyopathy**, left ventricular failure**, torsade de pointes.
Vascular disorders
Frequent: Hypertension, deep vein thrombosis, hot flush, flushing. Less frequent: Tumour haemorrhage**. Frequency unknown: Aneurysms and artery dissections**.
Respiratory, thoracic and mediastinal disorders
Frequent: Dyspnoea, epistaxis, cough, oropharyngeal pain n, haemoptysis o**, pulmonary embolism**, pleural effusion**, exertional dyspnoea, nasal congestion, nasal dryness. Less frequent: Pulmonary haemorrhage**, respiratory failure**.
Gastrointestinal disorders
Frequent: Diarrhoea, nausea, vomiting, abdominal pain p, stomatitis q, constipation, dyspepsia, gastrointestinal haemorrhage**, oesophagitis**, gastro-oesophageal reflux disease, oral pain, glossodynia, abdominal distension, gingival bleeding, dry mouth, flatulence, dysphagia, abdominal discomfort, rectal haemorrhage, mouth ulceration, proctalgia, cheilitis, haemorrhoids, oral discomfort, eructation.
Less frequent: Pancreatitis, gastrointestinal perforation r **, anal fistula, colitis s.
Hepato-biliary disorders
Less frequent: Cholecystitis t **, hepatic failure**, abnormal hepatic function, hepatitis.
Skin and subcutaneous tissue disorders
Frequent: Hand-foot syndrome (Palmar-plantar erythrodysaesthesia syndrome), skin discolouration u, rash v, hair colour changes, dry skin, alopecia, erythema, pruritus, skin exfoliation, blister, skin lesion, skin reaction w, nail disorder x, eczema, acne, skin hyperpigmentation, hyperkeratosis, dermatitis.
Less frequent: Exfoliative dermatitis, erythema multiforme**, Stevens-Johnson Syndrome**, pyoderma gangrenosum, toxic epidermal necrolysis**.
Musculoskeletal and connective tissue disorders
Frequent: Pain in extremity, arthralgia, back pain, musculoskeletal pain, muscle spasms, myalgia, muscular weakness.
Less frequent: Osteonecrosis of jaw, fistula formation**, rhabdomyolysis**, myopathy.
Renal and urinary disorders
Frequent: Renal failure**, acute renal failure**, chromaturia, proteinuria.
Less frequent: Renal impairment, urinary tract, haemorrhage, nephrotic syndrome.
General disorders and administration site conditions
Frequent: Fatigue y, mucosal inflammation, oedema z, pyrexia, chills, influenza like illness, chest pain, pain.
Less frequent: Impaired healing.
Investigations
Frequent: Increased lipase, increased amylase za, increased blood uric acid, decreased white blood cell count, decreased platelet count, decreased haemoglobin, decreased weight, increased aspartate aminotransferase, increased alanine aminotransferase, increased blood creatinine, increased blood pressure.
Less frequent: Increased blood creatine phosphokinase, increased blood thyroid stimulating hormone.
The following terms have been combined: a Nasopharyngitis and oral herpes. b Bronchitis, lower respiratory tract infection, pneumonia, and respiratory tract infection. c Abscess, abscess limb, anal abscess, gingival abscess, liver abscess, pancreatic abscess, perineal abscess, perirectal abscess, rectal abscess, subcutaneous abscess, and tooth abscess. d Oesophageal candidiasis and oral candidiasis. e Cellulitis and skin infection. f Sepsis and sepsis shock. g Abdominal abscess, abdominal sepsis, diverticulitis, and osteomyelitis. h Thrombotic microangiopathy, thrombotic thrombocytopenic purpura, haemolytic uraemic syndrome. i Decreased appetite and anorexia. j Dysgeusia, ageusia, and taste disturbance. k Acute coronary syndrome, angina pectoris, unstable angina, coronary artery occlusion, myocardial ischaemia. l Decreased ejection fraction and abnormal ejection fraction. m Acute myocardial infarction, myocardial infarction, silent myocardial infarction. n Pharyngolaryngeal pain and oropharyngeal pain. o Haemoptysis and pulmonary haemorrhage. p Abdominal pain, lower abdominal pain, upper abdominal pain q Stomatitis and aphthous stomatitis r Gastrointestinal perforation and intestinal perforation s Colitis and colitis ischaemic. t Cholecystitis and acalculous cholecystitis. u Skin discolouration, yellow skin, pigmentation disorder. v Dermatitis psoriasiform, exfoliative rash, rash, erythematous rash, follicular rash, generalised rash, macular rash, maculo-papular rash, rash papular, pruritic rash. w Skin reaction and skin disorder. x Nail disorder and discolouration. y Fatigue and asthenia. z Face oedema, oedema, peripheral oedema. za Amylase, increased amylase. * Infections and infestations are described in the post-marketing experience section. ** Event may be fatal.

There is no specific antidote for overdosage with sunitinib as in SUNITINIB CIPLA. Treatment of overdose is symptomatic and supportive. Cases of overdose have been reported; some cases were associated with adverse reactions consistent with the known adverse effects profile of sunitinib (see section 4.8).