|
|||
|
|||
|
|||
| Advanced GIST |
|
||
| NB: The benefits of sunitinib on disease control as measured by time to tumor progression were observed irrespective of age, weight, race, pain score, performance status, time since initial diagnosis, duration or dose of initial imatinib treatment, or study location. The treatment effect was significant in the entire study population and in the subgroups defined by baseline factors, irrespective of whether the modified intent-to-treat (ITT) or per-protocol populations were analyzed. | |||
| Pancreatic Neuroendocrine Tumour (pNET) | |||
| Sutent improves outcome by doubling the PFS | |||
 | |||
| Raymond E et al. 5 | |||
| A total of 171 patients with pathologically confirmed, well- differentiated pancreatic neuroendocrine tumours that were advanced and/or metastatic were enrolled in this multinational, randomized, double- blind, placebo- controlled phase III trial. Patients were assigned in a 1:1 ration to receive best supportive care plus Sutent plus a dose of 37.5 mg per day or matching placebo. | |||
| |||
| Sutent significantly reduces the risk of death by almost 60% (HR= 0.41)5 | |||
 | |||
|
||
| ADVERSE REACTIONS: GI disorders (eg, diarrhea, nausea, stomatitis, constipation, vomiting, dyspepsia, abdominal pain, dry mouth, reflux esophagitis, flatulence, oral pain, glossodynia); hypertension, peripheral edema; dry skin, hair or skin depigmentation, blister or rash on the palms of the hands and soles of the feet; altered taste, headache, dizziness; myalgia/limb pain; anorexia, asthenia; back pain, arthralgia, pain in extremity/limb discomfort; cough, dyspnea; anorexia, dehydration; bleeding; insomnia, depression | ||
| INTERACTIONS: Ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole; grapefruit; dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's wort | ||
|
||
| Recommended dose of Sutent for GIST and RCC is 50 mg daily on a schedule of 4 consecutive weeks followed by 2 weeks off. The recommended dose of Sutent for pNET is 37.5 mg taken orally one daily continuously. Dose interruption and/or dose modification in 12.5-mg increments or decrements is recommended based on individual safety and tolerability. the maximum dose administrated in the Phase III pNET study was 50 mg daily. |
|
||
| 12.5 mg, 50 mg. |
|
||
| Capsules: 12.5 mg x 28's. 50 mg x 28's. |
|
||
| CONTRAINDICATIONS: None1 | ||
| SPECIAL PRECAUTIONS: Left ventricular dysfunction; hemorrhagic events; hypertension; QT interval prolongation and torsade de pointes; thyroid dysfunction; adrenal toxicity; pulmonary hemorrhage; perform complete blood count with platelet count and serum chemistries including phosphate at the beginning of each treatment cycle; children | ||
| HEPATOTOXICITY: Sutent has been associated with heaptotoxity, which may result in liver failure or death. Liver failure has been observed in clinical trials (7/2281[0.3%]) and post – marketing experience. Monitor liver function tests (ALT, AST bilirubin) before initiation of treatment, during each cycle of treatment, and as clinically indicated. Sutent should be interrupted for Grade 3 or 4 drug- related hepatic adverse events and discountinued if there is no resolution. Do not restart Sutent if patients subsequently experience severe changes in liver function tests or have other signs and symptoms of liver failure. | ||
| ADVERSE REACTIONS: The most common adverse reactions (≥20%) in patients with GIST, RCC or pNET are fatigue, asthenia, fever, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspepsia, abdominal pain, constipation, hypertension, peripheral edema, rash, hand-foot syndrome, skin discoloration, dry skin, hair color changes, altered taste, headache, back pain, arthralgia, extremity pain, cough, dyspnea, anorexia, and bleeding. The potentially serious adverse reactions of hepatotoxicity, left ventricular dysfunction, QT interval prolongation, hemorrhage, hypertension, thyroid dysfunction, and adrenal function. | ||
| POST-MARKETING ADVERSE REACTIONS: Cases of serious infection (with or without neutropenia) have been reported; myopathy and/or rhabdomyolysis, some with acute renal failure; patients with signs or symptoms of muscle toxicity should be managed as per standard medical practice; thrombotic microangiopathy; following resolution, treatment may be resumed at the discretion of the treating physician; cases of proteinuria and rare cases of nephrotic syndrome; baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria; discontinue in patients with nephrotic syndrome | ||
| PREGNANCY and LACTATION: If Sutent® is used during pregnancy, or if the patient becomes pregnant while receiving this treatment, apprise patient of the potential hazard to the fetus. Women of child-bearing potential should be advised to avoid becoming pregnant while receiving treatment with Sutent®. Due to its potential for serious adverse reactions in nursing infants, a decision should be made as to whether to discontinue nursing or discontinue the drug, duly considering the importance of the drug to the mother. | ||
Please review the full product information or package insert before prescribing. | ||
|
||
|
||
Please review the full product information or package insert before prescribing. |
||
SUT11008P |
