Introduction to the main contents of the official instructions of regorafenib

Regorafenib (Regorafenib) is an oral small molecule multi-target tyrosine kinase inhibitor mainly used to treat certain types of advanced tumors. According to the official instructions, the indications, usage and dosage, adverse reactions, precautions, etc. of regorafenib are clear, providing an important reference for rational clinical use of the drug.

In terms of indications, regorafenib is approved for the treatment of a variety of solid tumors, including metastatic colorectal cancer (mCRC) after failure of standard therapies, locally advanced or metastatic gastrointestinal stromal tumors ( GIST) after failure of imatinib and sunitinib, and for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) after progression on sorafenib. The treatment goals for different indications are to delay disease progression and improve the patient's survival time and quality of life as much as possible.

Regarding usage and dosage, the official instructions recommend that regorafenib be taken orally, once a day, with a dose of 160mg (i.e. 4 tablets40mg pan>tablets), take it continuously for 21 days, and then stop taking it for 7 days, constituting a complete 28 day treatment cycle. The drug should be taken after meals to reduce adverse gastrointestinal effects and swallowed whole with a glass of water. If the patient experiences serious adverse reactions, the doctor can adjust the dosage according to the specific situation. Common dosage reduction plans include 120mg/day or 80mg/day. In addition, if intolerable toxicity occurs, the doctor may recommend suspending or permanently discontinuing the drug.

In terms of adverse reactions, the official instructions for regorafenib detail a series of side effects that may occur during treatment. The most common adverse reactions include fatigue, decreased appetite, hand-foot syndrome (hand-foot skin reaction), hypertension, diarrhea, and rash. Some patients may experience liver function abnormalities, such as elevated transaminases, which may even lead to severe liver toxicity, so liver function needs to be monitored regularly during treatment. In addition, bleeding events, cardiac-related side effects (such as myocardial ischemia), and increased risk of infection are also issues that require special attention when using regorafenib. In order to reduce risks, patients should closely monitor blood pressure and liver function in the early stages of treatment, and detect and deal with abnormalities in a timely manner.

In terms of precautions and medication warnings, the instructions specifically emphasize that regorafenib should be used under the guidance of an experienced physician. Patients need to regularly review blood pressure, liver and kidney function, electrolyte levels and blood indicators during use. In the event of severe liver injury, persistent hypertension, severe hand-foot syndrome, or other uncontrollable adverse reactions, dose adjustment or discontinuation should be considered. Regorafenib is contraindicated in pregnant and lactating women, and women of childbearing age should not take regorafenib for at least 2 during treatment and after the last dose.Effective contraceptive measures must be taken within 1 month. In addition, regorafenib has potential drug interactions with other drugs. For example, coadministration with strong CYP3A4 enzyme inhibitors or inducers may affect the metabolism of regorafenib. Therefore, special attention must be paid when coadministering drugs.

Overall, regorafenib, as a multi-target anti-cancer drug, provides a new treatment option in the field of advanced tumor treatment. Rational use of regorafenib can delay tumor progression and improve the overall prognosis of patients. However, due to the complex potential side effects, patients need to conduct individualized management under the guidance of professional doctors during medication to ensure that risks are minimized while obtaining therapeutic benefits. Understanding the main contents of the official instructions will help patients and doctors better understand the characteristics of the drug, so as to carry out treatment scientifically and standardizedly.

Reference materials:https://www.stivarga-us.com/