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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No studies on the effects of Stivarga on the ability to drive or use machines have been performed. Distributed in the United Kingdom by: To email a medicine you must sign up and log in.

Across all clinical trials, cardiac disorder events all grades have been more often Institute supportive measures immediately. If no improvement occurs despite dose reduction, interrupt therapy for a minimum of 7 days, until toxicity resolves to Grade Adverse drug reactions ADRs reported in clinical trials in patients treated with Stivarga.

Keep the dessicant in the bottle. Close monitoring of the overall safety is recommended in patients with mild or moderate hepatic impairment see also sections 4. Whereas plasma concentrations of M-2 and M-5 after a single dose of regorafenib are much lower than those of parent compound, steady-state plasma concentrations of M-2 and M-5 are comparable to those of regorafenib.

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The Role of Regorafenib in Hepatocellular Carcinoma

Renal impairment 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 with mild or moderate renal impairment, compared to patients with normal renal function.

Respiratory, thoracic and mediastinal disorders.

Thereafter, periodic monitoring should regirafenib continued at least monthly and as clinically indicated. What should you tell your healthcare provider before starting treatment with Stivarga?

Regorafenib (Stivarga)

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. This information is intended for use by health professionals.

The exposure of regorafenib and its metabolites M-2 and M-5 is comparable in insedt with mild hepatic impairment Child-Pugh A and patients with normal hepatic function. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Last updated on eMC: This medicinal product may pose a risk to the environment see section 5.

The Role of Regorafenib in Hepatocellular Carcinoma – Gastroenterology & Hepatology

This is not a complete list of side inwert. Stivarga is not recommended for use in patients with severe hepatic impairment Child-Pugh C as Stivarga has not been studied in this population and exposure might be increased in these patients.

Patients were eligible to participate in the study if they experienced radiological disease progression during treatment with sorafenib and if they had a liver function status of Child-Pugh class A. Monitor liver function weekly until resolution or return to baseline.

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However, the same agent may also be referred to by its chemical name. Not all pack sizes may be marketed.

Regorafenib (Stivarga) | – A Hematology Oncology Wiki

They are classified according to System Organ Class and the most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions. Regorafenib could harm infant growth and development see section 5. Dermatological toxicity Hand-foot skin reaction HFSR or palmar-plantar erythrodysesthesia syndrome and rash represent the most frequently observed dermatological adverse reactions with Stivarga see section 4.

Elimination Following oral administration, mean elimination half-life for regorafenib and its metabolite M-2 in plasma ranges from 20 to 30 hours in different studies. Neoplasms benign, malignant and unspecified including cysts and polyps.

Inset of revision of the text. 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. The decision to re-start Stivarga therapy should be based on careful consideration of the potential benefits and risks regorafenig the individual patient. Packae data indicate that regorafenib has no effect on digoxin pharmacokinetics, therefore can be given concomitantly with p-glycoprotein substrates, such as digoxin, without a clinically meaningful drug interaction.

Major human metabolites M-2 and M-5 exhibited similar efficacies, compared to regorafenib in in vitro and in vivo models. This drug work by blocking the action of enzymes called kinases, which are involved in many cell functions, including cell signaling, growth, and division.

Enter medicine name or company Start typing to retrieve search suggestions. Stivarga has been associated with an increased incidence of arterial hypertension see section 4.