Resihance

Resihance (Regorafenib) is antineoplastic drug. It is a new option for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, anti-VEGF drugs, and anti-EGFR therapy - in the case of wild-type KRAS and for the treatment of patients with inoperable or metastatic gastrointestinal stromal tumors (GIST) that previously received treatment with itiminib mesylate and sunnytinib malate.

Also, the drug is used to treat patients with hepatocellular carcinoma (HCC) who have previously received treatment with sorafenib.

Resihance (Regorafenib) is an oral, potent inhibitor of a large number of protein kinases, including the kinases involved in angiogenesis (VEGFR1, -2, -3, TIE2), tumor oncogenesis (KIT, RET, RAF-1, BRAF, BRAFV600E), tumor metastases (VEGRF3, PDGFR, FGFR) and immunity to tumors (CSF1R). In particular, regoraphineb suppresses mutated kinase KIT, the major oncogenic factor in the development of gastrointestinal stromal tumors, and thus blocks the proliferation of tumor cells.

During preclinical studies, regoraphenib demonstrated strong antitumor activity in a relatively wide range of tumor models, including models of colorectal tumors and gastrointestinal stromal tumors, due to its antiangiogenic and antiproliferative properties. In addition, regoraphainib has shown an antimetastatic effect in vivo. The major metabolites detected in the human body (M-2 and M-5), in vitro and in vivo, have shown efficacy similar to that of regoraphenib.

Treatment should be carried out by doctors who have experience in the management of anticancer therapy. Always follow your doctor`s instructions when using Resihance (Regorafenib) to get the safest and most effective results from treatment.

The recommended dose is 160 mg of regoraphenib (4 tablets of 40 mg) that is used once a day for 3 weeks followed by a break in treatment for duration of 1 week. The specified 4-week period is considered a treatment course.

If you miss a dose, take it as soon as recalls it. The patient should not take a double dose within one day to compensate for the missed dose.

In the case of vomiting after the use of regoraphenib, the patient should not take extra pills. It is recommended to continue treatment as long as the clinical benefit of the use of the medicinal product remains, or until there is a phenomenon of clinically unacceptable toxicity.

The most commonly reported adverse reactions (≥ 30%) observed in patients taking Resihance (Regorafenib) are pain, asthenia / fatigue, diarrhea, appetite loss, arterial hypertension and infections.

The most serious adverse reactions in patients treated with Resihance (Regorafenib) are severe liver damage, bleeding, perforation of the gastrointestinal tract, and infection.

Women of reproductive age should be informed that regoraphionib can adversely affect the fetus. Women of reproductive age and men should use effective contraceptive methods during treatment and 8 weeks after the completion of treatment.

There is no data available on the use of Resihance (Regorafenib) in pregnant women. In the case of a pregnancy, regoraphineb may have a detrimental effect on the fetus. In animal studies, reproductive toxicity was detected. Resihance (Regorafenib) should not be used during pregnancy, except in cases of urgent need after careful evaluation of the maternal benefit/risk for the fetus.

It has been established that regoraphineb and its metabolites fall into animal milk. The risk for a breastfed baby can not be ruled out. Regoraphineb may interfere with the growth and development of the baby. Breastfeeding should be stopped during treatment with Stevar®.

No data are available on the effects of Resihance (Regorafenib) on fertility in humans. Animal studies indicate that regoraphionib can adversely affect fertility in males and females.

No studies have been conducted on the ability of the Resihance (Regorafenib) drug to influence the reaction rate when driving with motor vehicles or other mechanisms. If during treatment with Resihance (Regorafenib) patient’s symptoms which impair their ability to concentrate attention and adversely affect the speed of the reaction are noted, it is recommended to avoid motor vehicle or machinery management.