রিগনিক্স এ আছে Regorafenib। রিগনিক্স এর কাজঃ

Colorectal Cancer: রিগনিক্স is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild- type, an anti-EGFR therapy.

Gastrointestinal Stromal Tumors: রিগনিক্স is indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.

Hepatocellular Carcinoma: রিগনিক্স is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

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ব্র্যান্ড নাম রিগনিক্স
জেনেরিকঃ Regorafenib
পরিমাপঃ 40 mg
ধরণঃ ট্যাবলেট
চিকিৎসাগত শ্রেণিঃ Targeted Cancer Therapy
উৎপাদনকারীঃ Beacon Pharmaceuticals Ltd
দামঃ 0.00
সর্বশেষ সম্পাদনাঃ 2020-11-19 18:15:00
পরিচিতি

রিগনিক্স is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, metastasis and tumor immunity. In in vitro biochemical or cellular assays, regorafenib or its major human active metabolites M-2 and M-5 inhibited the activity of RET, VEGFR1, VEGFR2, VEGFR3, KIT, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, TrkA, Eph2A, RAF-1, BRAF, BRAF V600E, SAPK2, PTK5, Abl and CSF1R at concentrations of regorafenib that have been achieved clinically. In in vivo models, regorafenib demonstrated anti-angiogenic activity in a rat tumor model and inhibition of tumor growth in several mouse xenograft models including some for human colorectal carcinoma, gastrointestinal stromal and hepatocellular carcinoma. রিগনিক্স also demonstrated anti-metastatic activity in a mouse xenograft model and two mouse orthotopic models of human colorectal carcinoma.

খাওয়ার নিয়ম

রিগনিক্স এ আছে Regorafenib 40 mg। রিগনিক্স খাওয়ার নিয়ম নিম্নরূপঃ

Recommended Dose: The recommended dose is 160 mg রিগনিক্স (four 40 mg tablets) taken orally once daily for the first 21 days of each 28-day cycle. Continue treatment until disease progression or unacceptable toxicity.

Take রিগনিক্স at the same time each day. Swallow tablet whole with water after a low-fat meal that contains less than 600 calories and less than 30% fat. Do not take two doses of রিগনিক্স on the same day to make up for a missed dose from the previous day.

Dose Modifications: If dose modifications are required, reduce the dose in 40 mg (one tablet) increments; the lowest recommended daily dose of রিগনিক্স is 80 mg daily.

Interrupt রিগনিক্স for the following:

  • Grade 2 hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia syndrome (PPES)] that is recurrent or does not improve within 7 days despite dose reduction; interrupt therapy for a minimum of 7 days for Grade 3 HFSR
  • Symptomatic Grade 2 hypertension
  • Any Grade 3 or 4 adverse reaction
  • Worsening infection of any grade

Reduce the dose of রিগনিক্স to 120 mg:

  • For the first occurrence of Grade 2 HFSR of any duration
  • After recovery of any Grade 3 or 4 adverse reaction except infection
  • For Grade 3 aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevation, only resume if the potential benefit outweighs the risk of hepatotoxicity

Reduce the dose of রিগনিক্স to 80 mg:

  • For re-occurrence of Grade 2 HFSR at the 120 mg dose
  • After recovery of any Grade 3 or 4 adverse reaction at the 120 mg dose (except hepatotoxicity or infection)

Discontinue রিগনিক্স permanently for the following:

  • Failure to tolerate 80 mg dose
  • Any occurrence of AST or ALT more than 20 times the upper limit of normal (ULN)
  • Any occurrence of AST or ALT more than 3 times ULN with concurrent bilirubin more than 2 times ULN
  • Re-occurrence of AST or ALT more than 5 times ULN despite dose reduction to 120 mg
  • For any Grade 4 adverse reaction; only resume if the potential benefit outweighs the risks

Advise patients to swallow the রিগনিক্স tablet whole with water at the same time each day following a low-fat meal. Inform patients that the low-fat meal should contain less than 600 calories and less than 30% fat

Advise patients to store medicine in the original container. Do not place medication in daily or weekly pill boxes. Discard any remaining tablets 7 weeks after opening the bottle. Tightly close bottle after each opening and keep the desiccant in the bottle

পার্শ্বপ্রতিক্রিয়া

Common side effects are Hepatotoxicity, Infections, Hemorrhage, Gastrointestinal Perforation or Fistula, Dermatological Toxicity, Hypertension, Cardiac Ischemia and Infarction, Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

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সতর্কতা

Severe hepatic impairment. Pregnancy and lactation.

প্রতিক্রিয়া

Effect Of Strong CYP3A4 Inducers On রিগনিক্স: Co-administration of a strong CYP3A4 inducer with রিগনিক্স decreased the plasma concentrations of regorafenib, increased the plasma concentrations of the active metabolite M-5, and resulted in no change in the plasma concentrations of the active metabolite M-2, and may lead to decreased efficacy. Avoid concomitant use of রিগনিক্স with strong CYP3A4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort).

Effect Of Strong CYP3A4 Inhibitors On রিগনিক্স: Co-administration of a strong CYP3A4 inhibitor with রিগনিক্স increased the plasma concentrations of regorafenib and decreased the plasma concentrations of the active metabolites M-2 and M-5, and may lead to increased toxicity. Avoid concomitant use of রিগনিক্স with strong CYP3A4 inhibitors (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole).

Effect Of রিগনিক্স On Breast Cancer Resistance Protein (BCRP) Substrates: Co-administration of রিগনিক্স with a BCRP substrate increased the plasma concentrations of the BCRP substrate. Monitor patients closely for signs and symptoms of exposure related toxicity to the BCRP substrate (e.g. methotrexate, fluvastatin, atorvastatin). Consult the concomitant BCRP substrate product information when considering administration of such products together with রিগনিক্স.

গর্ভকালীন কিংবা দুগ্ধদানকালীন অবস্থায় ব্যবহার

Pregnancy: Based on animal studies and its mechanism of action, রিগনিক্স can cause fetal harm when administered to a pregnant woman. There are no available data on রিগনিক্স use in pregnant women. Administration of regorafenib was embryolethal and teratogenic in rats and rabbits at exposures lower than human exposures at the recommended dose, with increased incidences of cardiovascular, genitourinary, and skeletal malformations. Advise pregnant women of the potential hazard to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 % and 15 to 20%, respectively.

Lactation: There are no data on the presence of regorafenib or its metabolites in human milk, the effects of regorafenib on the breastfed infant, or on milk production. In rats, regorafenib and its metabolites are excreted in milk. Because of the potential for serious adverse reactions in breastfed infants from রিগনিক্স, do not breastfeed during treatment with রিগনিক্স and for 2 weeks after the final dose.

প্রতিনির্দেশনা

None

বিশেষ সতর্কতা

Pediatric Use: The safety and efficacy of রিগনিক্স in pediatric patients less than 18 years of age have not been established.

Geriatric Use: Of the 1142 রিগনিক্স-treated patients enrolled in randomized, placebo-controlled trials, 40% were 65 years of age and over, while 10% were 75 and over. No overall differences in efficacy were observed between these patients and younger patients. There was an increased incidence of Grade 3 hypertension (18% versus 9%) in the placebo-controlled trials among রিগনিক্স-treated patients 65 years of age and older as compared to younger patients. In addition, one Grade 4 hypertension event has been reported in the 65 years and older age group and none in the younger age group.

Hepatic Impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Closely monitor patients with hepatic impairment for adverse reactions. রিগনিক্স is not recommended for use in patients with severe hepatic impairment as রিগনিক্স has not been studied in this population.

Renal Impairment: No dose adjustment is recommended for patients with renal impairment. The pharmacokinetics of regorafenib have not been studied in patients who are on dialysis and there is no recommended dose for this patient population

মাত্রাতিরিক্ত সেবনের প্রতিক্রিয়া

The highest dose of রিগনিক্স studied clinically is 220 mg per day. The most frequently observed adverse drug reactions at this dose were dermatological events, dysphonia, diarrhea, mucosal inflammation, dry mouth, decreased appetite, hypertension, and fatigue. There is no known antidote for রিগনিক্স overdose. In the event of suspected overdose, interrupt রিগনিক্স, institute supportive care, and observe until clinical stabilization.

অন্যান্য ঔষধের সাথে প্রতিক্রিয়া

 

সংরক্ষণ

Store রিগনিক্স at 25°C; excursions are permitted from 15 to 30°C. Store tablets in the original bottle and do not remove the desiccant. Keep the bottle tightly closed after first opening. Discard any unused tablets 7 weeks after opening the bottle. Dispose of unused tablets in accordance with local requirements.

রিগনিক্স ট্যাবলেট এর দাম 0.00

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