Capsule Lenvacent 4 mg (12's box)
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\nLenvacent 4: Each capsule contains Lenvatinib mesylate INN equivalent to Lenvatinib 4 mg.
\nLenvacent 10: Each capsule contains Lenvatinib mesylate INN equivalent to Lenvatinib 10 mg.
\n \nDescription
\nLenvatinib is a kinase inhibitor that inhibits the kinase activities of vascular endothelial
\n \ngrowth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4).
\n \nLenvatinib inhibits other kinases that have been implicated in pathogenic angiogenesis,
\n \ntumor growth, and cancer progression in addition to their normal cellular functions,
\n \nincluding fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; platelet derived
\n \ngrowth factor receptor alpha (PDGFR?), KIT, and RET. Lenvatinib also exhibited
\n \nantiproliferative activity in hepatocellular carcinoma cell lines dependent on activated
\n \nFGFR signaling with a concurrent inhibition of FGF-receptor substrate 2? (FRS2?)
\n \nphosphorylation. The combination of lenvatinib and everolimus showed increased
\n \nantiangiogenic and antitumor activity as demonstrated by decreases in human
\n \nendothelial cell proliferation, tube formation, and VEGF signaling in vitro, and by
\n \ndecreases in tumor volume in mouse xenograft models of human renal cell cancer that
\n \nwere greater than those with either drug alone.
\n \nIndications
\nLenvatinib is a kinase inhibitor that is indicated:
\n \n? For the treatment of patients with locally recurrent or metastatic, progressive,
\n \nradioactive iodine-refractory differentiated thyroid cancer (DTC).
\n \n? In combination with everolimus, for the treatment of patients with advanced renal cell
\n \ncarcinoma (RCC) following one prior anti-angiogenic therapy.
\n \n? For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
\n \nDosage & Administration
\n? DTC: The recommended dosage is 24 mg orally once daily.
\n? RCC: The recommended dosage is 18 mg orally once daily with everolimus 5 mg
\norally once daily.
\n? HCC: The recommended dosage is based on actual body weight:
\n12 mg orally once daily for patients greater than or equal to 60 kg
\n8 mg orally once daily for patients less than 60 kg.
\n? Modify the recommended daily dose for certain patients with renal or hepatic impairment.
\n \nSide Effects
\nIn DTC, the most common adverse reactions (incidence ?30%) for lenvatinib are
\nhypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, decreased
\nweight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar
\nerythrodysesthesia syndrome, abdominal pain, and dysphonia.
\nIn RCC, the most common adverse reactions (incidence ?30%) for lenvatinib and
\neverolimus are diarrhea, fatigue, arthralgia/myalgia, decreased appetite, vomiting,
\nnausea, stomatitis/oral inflammation, hypertension, peripheral edema, cough, abdominal
\npain, dyspnea, rash, decreased weight, hemorrhagic events, and proteinuria.
\nIn HCC, the most common adverse reactions (incidence ?20%) for lenvatinib are
\nhypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased
\nweight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria,
\ndysphonia, hemorrhagic events, hypothyroidism, and nausea.
\n \nPrecautions
\n? Hypertension: Blood pressure should be controlled and monitered prior to treatment
\nand during treatment. Lenvatinib should be withheld for Grade 3 hypertension despite
\noptimal antihypertensive therapy. For Grade 4 hypertension Lenvatinib should be
\ndiscontinued.
\n? Cardiac Dysfunction: Patients should be monitored for clinical symptoms or signs of
\ncardiac dysfunction. Lenvatinib should be withheld or discontinued for Grade 3 cardiac
\ndysfunction. For Grade 4 cardiac dysfunction Lenvatinib should be discontinued.
\n? Arterial Thromboembolic Events: Lenvatinib should be discontinued following an
\narterial thromboembolic event.
\n? Hepatotoxicity: Liver function should be monitored prior to treatment and periodically
\nduring treatment. Lenvatinib should be withheld or discontinued for Grade 3 or 4
\nhepatotoxicity. For hepatic failure Lenvatinib should be discontinued.
\n? Renal Failure or Impairment: Lenvatinib should be withheld or discontinued for Grade
\n3 or 4 renal failure or impairment.
\n? Proteinuria: Proteinuria should be monitored prior to treatment and periodically during
\ntreatment. Lenvatinib should be withheld for 2 or more grams of proteinuria per 24 hours.
\nFor nephrotic syndrome Lenvatinib should be discontinued.
\n? Diarrhea: May be severe and recurrent. Promptly management for severe diarrhea
\nshould be initiated. Lenvatinib should be withheld or discontinued based on severity.
\n? Fistula Formation and Gastrointestinal Perforation: Lenvatinib should be discontinued
\nin patients who develop Grade 3 or 4 fistula or any Grade gastrointestinal perforation.
\n? QT Interval Prolongation: Electrolyte abnormalities should be monitored and
\ncorrected. Lenvatinib should be withheld for QT interval greater than 500 ms or for 60 ms
\nor greater increase in baseline QT interval.
\n? Hypocalcemia: Blood calcium levels should be monitored at least monthly and
\ncalcium should be replaced as necessary. Lenvatinib should be withheld or discontinued
\nbased on severity.
\n? Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Lenvatinib should be
\nwithheld for RPLS until fully resolved or should be discontinued.
\n? Hemorrhagic Events: Lenvatinib should be withheld or discontinued based on
\nseverity.
\n? Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Dysfunction:
\nThyroid function should be monitored prior to treatment and monthly during treatment.
\n? Wound Healing Complications: Lenvatinib should be withheld before surgery.
\nLenvatinib should be discontinued in patients with wound healing complications.
\n? Embryo-Fetal Toxicity: Lenvatinib can cause fetal harm. Patients should be advised of
\npotential risk to a fetus and use of effective contraception.
\n \nUse in Pregnancy & Lactation
\nThere are no available human data informing the drug-associated risk. Pregnant women
\nshould be advised of the potential risk to a fetus.
\nIt is not known whether lenvatinib is present in human milk. Because of the potential for
\nserious adverse reactions in breastfed infants, women should be advised to discontinue
\nbreastfeeding during treatment with lenvatinib and for at least 1 week after the last dose.
\n \nDrug Interaction
\nDrugs That Prolong the QT Interval: Lenvatinib has been reported to prolong the QT/QTc
\ninterval. Coadministration of Lenvatinib shoud be avoided with medicinal products with a
\nknown potential to prolong the QT/QTc interval
\n \nStorage
\nDo not store above 30 0C. Keep away from light and out of the reach of children
\n \nCommercial Pack
\nLenvacent 4: Each box contains 3 blister strips of 4 capsules.
\nLenvacent 10: Each box contains 3 blister strips of 4 capsules
\n \nOthers
\nPediatric Use
\nThe safety and effectiveness of lenvatinib in pediatric patients have not been established.
\nGeriatric Use
\nNo overall differences in safety or effectiveness were observed between these subjects
\nand younger subjects.
\nHepatic Impairment
\nDose adjustment is not recommended for patients with HCC and mild hepatic impairment
\n(Child-Pugh A). There is no recommended dose for patients with HCC with moderate or
\nsevere hepatic impairment.
\nDose adjustment is not recommended for patients with DTC or RCC and mild or
\nmoderate hepatic impairment (Child-Pugh A or B). Lenvatinib concentrations may
\nincrease in patients with DTC or RCC and severe hepatic impairment (Child-Pugh C).
\nThe dose should be reduced for patients with DTC or RCC and severe hepatic
\nimpairment.
\nRenal Impairment
\nDose adjustment is not recommended for patients with mild (CLcr 60-89 mL/min) or
\nmoderate (CLcr 30-59 mL/min) renal impairment. Lenvatinib concentrations may increase
\nin patients with DTC or RCC and severe (CLcr 15-29 mL/min) renal impairment. The
\ndose should be reduced for patients with RCC or DTC and severe renal impairment.
\nThere is no recommended dose of Lenvatinib for patients with HCC and severe renal
\nimpairment. Lenvatinib has not been studied in patients with end stage renal disease.
\n
