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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Elimination Following packafe administration, mean elimination half-life for regorafenib and its metabolite M-2 in plasma ranges from 20 to 30 hours in different studies. Hand-foot skin reaction HFSR or palmar-plantar erythrodysesthesia syndrome regorafeinb rash represent the most frequently observed dermatological adverse reactions with Stivarga see section 4.

Finding the maximum dose that the patient can tolerate will keep the patient on therapy longer than trying to force the patient to take a very high dose that he or she cannot tolerate. Therefore, it is important to follow up with patients on regorafenib earlier than with those on sorafenib or other multikinase inhibitors. Cancer Management and Research, originally published November 19, A package insert is required by the FDA and contains a summary of pakcage essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.

M-5 may be reduced to M-4 in the gastrointestinal tract by microbial flora, allowing reabsorption of M-4 enterohepatic circulation. In the placebo-controlled phase III trials, the overall incidence of hypertension was higher in patients treated with Onsert, compared to patients receiving placebo There are no data for patients with Child-Pugh C severe hepatic impairment. Genotoxicity and carcinogenicity There was no indication for a genotoxic potential of regorafenib tested in standard assays in vitro and in vivo in mice.

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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.

Co-administration of a strong UGT1A9 inhibitor e. The primary reegorafenib endpoint was Overall Survival OS. Across all clinical trials, cardiac disorder events all grades have been more often Regorafenib could harm infant growth and development see section 5.

Patients with performance status PS 2 or higher were excluded from clinical studies. In clinical studies, no relevant differences in exposure, safety or efficacy were observed between male and female patients.

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

Occasionally, medications, such as armodafinil, are used to help fatigue, although they are rarely necessary and can increase the risk of hypertension. In cases of worsening infection events, interruption of Stivarga treatment should be considered.

This drug work by blocking the action apckage enzymes called kinases, which are involved in many cell functions, including cell signaling, growth, and division. Sorafenib stabilizes the disease, and the response with sorafenib is considered to be stable disease.

Plasma concentration-time profiles for regorafenib as well as for the major circulating metabolites showed multiple peaks across the hour dosing interval, which are attributed to enterohepatic circulation.

Demographics and baseline disease characteristics were comparable between the Stivarga- and placebo-treated groups and are shown below for all randomised patients:. Strong inducers of CYP3A4 should be avoided, or selection of an alternate concomitant medicinal product, with no or minimal potential to induce CYP3A4 pacckage be considered.

Dose interruption or reduction, or permanent discontinuation of Stivarga should be insdrt in case of persistent or recurrent significant abnormalities see section 4.

I usually have patients start using a moisturizer even before they start the drug and then use the moisturizer twice a day. They also can use caffeine if desired and may need to plan naps. Gegorafenib did not affect the regorafenib pharmacokinetics over the studied age range 29 — 85 years. There is limited data on regorafenib in the black patient population.

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Absorption Regorafenib reaches mean peak plasma levels of about 2.

Regorafenib has been used and approved for colon cancer for some time. The 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. The incidence of Grade 3 hand-foot skin reaction in Asians was Hypersensitivity to the active substance or to any of the excipients listed in section 6. It is also difficult to determine when to move from locoregional therapy or chemoembolization, for example, to systemic therapy.

The Role of Regorafenib in Hepatocellular Carcinoma

This 4-week period is considered a treatment cycle. Close monitoring of overall safety is recommended in these patients see sections 4.

Have reografenib to have surgery. The recommended dose of regorafenib is mg 4 tablets of 40 mg taken once daily for 3 regorqfenib followed by 1 week off therapy. If the potential benefit outweighs the risk of hepatotoxicity, re-start Stivarga treatment, reduce dose by 40 mg one tabletand monitor liver function weekly for at least 4 weeks.

Stivarga 40 mg film-coated tablets. Pregnancy There are no data on the use of regorafenib in pregnant women. John’s wort may also increase metabolism of regorafenib. Drug and supportive care agents may be referred to by different names. The safety of regorafenib was evaluated in patients enrolled in randomized, placebo-controlled trials.

Studies on the carcinogenic potential of regorafenib have not been performed. You have symptoms of bleeding problems. Drug Dictionary Use our drug profile search engine to review information about current FDA approved drugs.