Jevtana60 mg/1.5 ml

In combination with prednisone or prednisolone, for patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. Due to high incidence of neutropenia, granulocyte-colony stimulating factor (G-CSF) should be administered within 24-72 hr since 1st cycle of Jevtana 60 mg/1.5 ml administration.

Cytotoxic Chemotherapy

Jevtana 60 mg/1.5 ml is a microtubule inhibitor. Jevtana 60 mg/1.5 ml binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the interference of mitotic and interphase cellular functions. The cell is then unable to progress further into the cell cycle, being stalled at metaphase, thus triggering apoptosis of the cancer cell.

25 mg/m2 administered as a 1 hr IV infusion every 3 wk in combination with oral prednisone or prednisolone 10 mg administered daily throughout treatment.

25 mg/m2 administered as a 1 hr IV infusion every 3 wk in combination with oral prednisone or prednisolone 10 mg administered daily throughout treatment.

May increase plasma conc with strong CYP3A4 inhibitors. May lead to decreased plasma conc with strong CYP3A4 inducers. Vaccination with a live attenuated vaccine should be avoided.

Neutrophil counts <1,500/mm3; platelets >100,000/mm3, haemoglobin >10 g/dL, creatinine <1.5 x ULN, hepatic impairment (bilirubin ≥1 x ULN, or AST &/or ALT ≥1.5 × ULN); concomitant vaccination with yellow fever vaccine.

Most commonly in all grades, anemia, leukopenia, neutropenia, thrombocytopenia, diarrhea. Most commonly in ≥3 grade, neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea.

Pregnancy category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Hypersensitivity reaction; risk of neutropenia; risk of nausea, vomiting, diarrhea, dehydration, peripheral neuropathy; renal failure, cardiac arrhythmias; liver impairment; anemia. Pregnancy & lactation. Elderly.

Store between 15-30° C. Do not refrigerate.

Children: The safety and the efficacy of Jevtana 60 mg/1.5 ml in children have not been established.Elderly: No specific dose adjustment for the use of Jevtana 60 mg/1.5 ml in elderly patients is recommended (see Pharmacology: Pharmacokinetics under Actions, Precautions and Adverse Reactions).Hepatic Impairment: Jevtana 60 mg/1.5 ml is extensively metabolized by the liver. Patients with mild hepatic impairment [total bilirubin >1 to ≤1.5 x Upper Limit of Normal (ULN) or AST >1.5 x ULN], should have Jevtana 60 mg/1.5 ml dose reduced to 20 mg/m2. Administration of Jevtana 60 mg/1.5 ml to patients with mild hepatic impairment should be undertaken with caution and close monitoring of safety. Limited efficacy data for Jevtana 60 mg/1.5 ml at 15 mg/m2, the maximum tolerated dose in patients with moderate hepatic impairment (total bilirubin >1.5 to ≤3.0 x ULN), are available to recommend this dose in this population. Jevtana 60 mg/1.5 ml should not be given to patients with severe hepatic impairment (total bilirubin >3 x ULN).Renal Impairment: Jevtana 60 mg/1.5 ml is minimally excreted through the kidney. No dose adjustment is necessary in patients with renal impairment not requiring hemodialysis. Patients presenting end-stage renal disease (CLCR <15 mL/min/1.73 m2), by their condition and the limited amount of available data, therefore these patients should be treated with caution and monitored carefully during treatment.Concomitant Drug Use: Concomitant drugs that are strong CYP3A inducers or strong CYP3A inhibitors should be avoided (see Pharmacology: Pharmacokinetics under Actions and Interactions). However, if patients require co-administration of a strong CYP3A inhibitor, a 25% Jevtana 60 mg/1.5 ml dose reduction should be considered (see Pharmacology: Pharmacokinetics under Actions and Interactions).

Cytotoxic Chemotherapy

Jevtana 60 mg/1.5 ml is a microtubule inhibitor. Jevtana 60 mg/1.5 ml binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the interference of mitotic and interphase cellular functions. The cell is then unable to progress further into the cell cycle, being stalled at metaphase, thus triggering apoptosis of the cancer cell.

Pregnancy category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Children: The safety and the efficacy of Jevtana 60 mg/1.5 ml in children have not been established.Elderly: No specific dose adjustment for the use of Jevtana 60 mg/1.5 ml in elderly patients is recommended (see Pharmacology: Pharmacokinetics under Actions, Precautions and Adverse Reactions).Hepatic Impairment: Jevtana 60 mg/1.5 ml is extensively metabolized by the liver. Patients with mild hepatic impairment [total bilirubin >1 to ≤1.5 x Upper Limit of Normal (ULN) or AST >1.5 x ULN], should have Jevtana 60 mg/1.5 ml dose reduced to 20 mg/m2. Administration of Jevtana 60 mg/1.5 ml to patients with mild hepatic impairment should be undertaken with caution and close monitoring of safety. Limited efficacy data for Jevtana 60 mg/1.5 ml at 15 mg/m2, the maximum tolerated dose in patients with moderate hepatic impairment (total bilirubin >1.5 to ≤3.0 x ULN), are available to recommend this dose in this population. Jevtana 60 mg/1.5 ml should not be given to patients with severe hepatic impairment (total bilirubin >3 x ULN).Renal Impairment: Jevtana 60 mg/1.5 ml is minimally excreted through the kidney. No dose adjustment is necessary in patients with renal impairment not requiring hemodialysis. Patients presenting end-stage renal disease (CLCR <15 mL/min/1.73 m2), by their condition and the limited amount of available data, therefore these patients should be treated with caution and monitored carefully during treatment.Concomitant Drug Use: Concomitant drugs that are strong CYP3A inducers or strong CYP3A inhibitors should be avoided (see Pharmacology: Pharmacokinetics under Actions and Interactions). However, if patients require co-administration of a strong CYP3A inhibitor, a 25% Jevtana 60 mg/1.5 ml dose reduction should be considered (see Pharmacology: Pharmacokinetics under Actions and Interactions).