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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In the pivotal placebo-controlled phase III study, patients received prior therapy with sorafenib. As medicinal products with anti-angiogenic properties may suppress or interfere with wound healing, temporary interruption of Stivarga is recommended for precautionary reasons in patients undergoing major surgical procedures.

Each daily dose of mg contains 1. More research is also needed on dose reduction and how much patients experiencing AEs need to take to see a benefit. Hyperbilirubinaemia Increase in transaminases. However, the same agent may also be referred to by its chemical name.

The Role of Regorafenib in Hepatocellular Carcinoma

If you are interested in helping the Publications Committee with creating. Our drug dictionary is organized by alphabet, including both generic and trade names.

Regorafenib reaches mean peak plasma levels of about 2. CA Cancer J Clin.

With sorafenib, AEs occur 2 to 6 weeks after the initiation of therapy. Richard Pazdur to inform oncologists and professionals in oncology-related fields regorafwnib a timely manner. Blood pressure should be controlled prior to initiation of treatment with Stivarga.

Date of revision of the text. I usually see patients back in the packgae 1 to 2 weeks after starting therapy. Specific studies on fertility have not been performed. The difference in patient reaction may be attributed to the fact that patients in the RESORCE trial were already known to tolerate a tyrosine kinase inhibitor sorafenib.

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No improvement within 7 days or 2nd occurrence. You have symptoms of lung problems.

Show table of contents Hide table of contents 1. No packave are available. Dr Frenette serves on the speakers bureau, is a consultant, and has been on an advisory board for Bayer Pharmaceuticals. Sorafenib and regorafenib block similar kinases, but regorafenib has more activity against the vascular endothelial growth factor receptors. The clinical efficacy and safety of Stivarga have been evaluated in an international, multi-centre, randomised, double-blind, placebo-controlled phase III study GRID in patients with gastrointestinal stromal tumours GIST previously treated with 2 tyrosine kinase inhibitors imatinib and sunitinib.

Keep the dessicant in the bottle. No QTc prolonging effects were observed after administration of mg regorafenib at steady state in a dedicated QT study in male and female cancer patients. Posterior reversible encephalopathy syndrome PRES.

M-5 is finally excreted via M-4 as M-6 carboxylic acid in faeces. In clinical studies, no relevant differences in exposure, safety or efficacy were observed between elderly aged 65 years and above and younger patients see also section 5. The adverse drug reactions insett in clinical trials in patients treated with Stivarga are shown in Table 3.

Drug Monographs Colorectal and other GI cancers.

In case of hypertensive crisis, Stivarga should be discontinued. It is recommended to monitor blood pressure and to treat hypertension in accordance with standard medical practice. Have high blood pressure. Grade 2 1st occurrence Decrease dose by 40 mg one tablet and immediately institute supportive measures.

Fortunately, most patients with end-stage liver disease have a relatively low blood pressure to begin with, so hypertension is generally relatively easy to control. Full prescribing information is available at: Also important is finding out whether using this drug in combination with other systemic therapies or locoregional therapies can result in better outcomes for the patient.

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This molecule is also important in angiogenesis, potentially allowing regorafenib to be a stronger inhibitor of angiogenesis than sorafenib. Administration of regorafenib mg for 14 days prior to administration of a single dose of rosuvastatin 5 mga BCRP substrate, resulted in a 3.

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Regorafenib is the first second-line treatment that has been shown to have any activity in HCC that has failed to respond to sorafenib. In addition, progression-free survival was 3. Pack of 84 3 bottles of 28 film-coated tablets. Metabolites M-2 and M-5 are weak substrates regoarfenib P-gp. Continue typing to refine. For recommended measures and dose modifications in case of worsening of liver function tests considered related to treatment with Stivarga see Table 2 see also section 4.

Recommended dose modifications and measures for HFSR Skin toxicity grade Occurrence Recommended dose modification and measures Grade 1 Any Maintain dose level and immediately institute supportive measures for symptomatic relief. Breast-feeding It is unknown whether regorafenib or its metabolites are excreted in human milk.

Finally, there was a small increase in diarrhea with regorafenib, although not as much as with sorafenib. Neoplasms benign, malignant and unspecified including cysts and pacakge. Marketing authorisation number s 9.

Stivarga 40 mg film-coated tablets – Summary of Product Characteristics (SmPC) – (eMC)

Patients continued therapy until disease progression or unacceptable toxicity. Stivarga should be prescribed by physicians experienced in the administration of anticancer therapy. The primary efficacy endpoint was OS. Inssrt information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor.