REGORAFENIB PACKAGE INSERT PDF

Heathcare Professional site for STIVARGA (regorafenib) Tablets. Hepatotoxicity: Severe drug-induced liver injury with fatal outcome occurred in. 30 May STIVARGA (regorafenib) should be prescribed by a qualified healthcare This leaflet is Part III of a three-part “Product Monograph”. The recommended dose of regorafenib is mg (4 tablets of 40 mg) taken .. The most serious adverse drug reactions in patients receiving Stivarga are ( polypropylene) screw cap with sealing insert and a molecular sieve desiccant.

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Each film-coated tablet pavkage 40 mg of regorafenib. Available clinical data and physiology-based pharmacokinetic modelling indicate similar steady-state exposure of regorafenib and its metabolites M-2 and M-5 in patients packgae mild or moderate renal impairment, compared to patients with normal renal function. In the placebo-controlled phase III trials, the overall incidence of hypertension was higher in patients treated with Stivarga, compared to patients receiving placebo The study was halted when patient response rates were lower than those seen across a similar trial involving the drug.

Increase in amylase Increase in lipase Abnormal International normalised ratio.

Regorafenib (Stivarga) | – A Hematology Oncology Wiki

Maintain adequate rest and nutrition. The safety profile of pxckage in these studies was consistent with the safety results of a phase III B study conducted in patients with metastatic colorectal cancer whose disease had progressed after treatment with standard therapies.

In the event of suspected overdose, Stivarga should be discontinued immediately, with best supportive care initiated by a medical professional, and the patient should be observed until clinical stabilisation. No studies on the effects of Reborafenib on the ability to drive or use machines have been performed.

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The Role of Regorafenib in Hepatocellular Carcinoma

Management of tyrosine kinase inhibitor-induced hand-foot skin reaction: In clinical trials, a higher incidence of severe liver function test abnormalities and hepatic dysfunction was observed in Asian in particular Japanese patients treated with Stivarga, compared with Caucasians see section 4.

Co-administration of a strong UGT1A9 inhibitor e. Pack of 84 3 bottles of 28 film-coated tablets.

Severe liver function test abnormalities Grade 3 to 4 and hepatic dysfunction with clinical manifestations including fatal outcomes have been reported in a small proportion of patients see section 4.

Finally, there was a small increase in diarrhea with regorafenib, although not as much as with sorafenib. In vitro protein binding of regorafenib to human plasma proteins is high Recommended dose modification and measures.

The decision to resume treatment with Stivarga following major surgical intervention should be based on clinical judgment of adequate wound healing. Light pink film-coated tablets, oval shaped with a length of 16 mm and a width of 7 mm marked with ‘BAYER’ on one side and ’40’ on the other side.

Stivarga 40 mg film-coated tablets

General disorders and administration site conditions. Stivarga has been associated with an increased incidence of myocardial ischaemia and infarction see section 4. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer.

Dose modifications are to be applied in 40 mg one tablet steps.

You have symptoms of skin problems. As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information.

Grade 3 1st occurrence Institute supportive measures immediately. Discontinuation of Stivarga is recommended in patients developing gastrointestinal perforation or fistula. Regorafenib treatment consisted of cycles of 3 weeks on the agent and then 1 week off of it, unlike sorafenib dosing, which is continuous.

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A slightly increased incidence of thickening of the atrioventricular iinsert of the heart was seen in the 26 week repeat-dose toxicity study in rats.

Keep the bottle tightly closed. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

We are providing this information regorafdnib as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice.

This information is intended for use by health professionals.

Therefore, it is important to follow up with patients on regorafenib earlier than with those regorafdnib sorafenib or other multikinase inhibitors. Excipients with known effect Each daily dose of mg contains 2.

Therefore, it is recommended to monitor patients closely for signs and symptoms of increased exposure to BCRP substrates. In the placebo-controlled phase III trials, packge overall incidence of haemorrhage was Stivarga has been associated with an increased incidence of electrolyte abnormalities including hypophosphatemia, hypocalcaemia, hyponatraemia and hypokalaemia and metabolic abnormalities including increases in thyroid stimulating hormone, lipase and amylase.