`
`Dosing and Administration | JEVTANA® (cabazitaxel) Injection
`
`For U.S. Healthcare Professionals Only
`For Patients Full Prescribing Information including Boxed WARNING
`
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`Dosing
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`Preparation and
`Administration
`
`Important Safety Information
`for JEVTANA (cabazitaxel)
`®
`Injection
`
`WARNING: NEUTROPENIA
`AND HYPERSENSITIVITY
`Neutropenic deaths have been
`reported. In order to monitor the
`occurrence of neutropenia,
`frequent blood cell counts
`should be performed on all
`patients receiving JEVTANA .
`®
`JEVTANA should not be given
`®
`to patients with neutrophil
`counts of ≤1,500 cells/mm
`3
`Severe hypersensitivity reactions
`can occur and may include
`generalized rash/erythema,
`hypotension and bronchospasm.
`Severe hypersensitivity reactions
`require immediate
`discontinuation of the
`JEVTANA infusion and
`®
`administration of appropriate
`therapy. Patients should receive
`premedication
`JEVTANA must not be given to
`®
`patients who have a history of
`severe hypersensitivity reactions
`to JEVTANA or to other drugs
`®
`formulated with polysorbate 80
`Continue »
`
`®
`JEVTANA is a microtubule
`inhibitor indicated in combination
`with prednisone for the treatment
`of patients with hormonerefractory
`metastatic prostate cancer
`(mHRPC) previously treated with a
`docetaxelcontaining treatment
`regimen.
`
`Dosing and Administration
`
`1
`
`Dosing schedule
`For patients with hormonerefractory metastatic prostate cancer previously treated
`with a docetaxelcontaining regimen:
`
`JEVTANA 25 mg/m as a 1hour IV infusion
`®
`2
`every 3 weeks
`+ oral predisone 10 mg daily throughout treatment
`
`Dose modifications
`
`1
`
`Toxicity
`
`Dose modification
`
`Prolonged grade ≥3
`neutropenia (>1 week) despite
`a
`appropriate medication
`including GCSF
`
`Febrile neutropenia or
`neutropenic infection
`
`Grade ≥3 diarrhea or persisting
`diarrhea despite appropriate
`medication, fluid and electrolyte
`replacement
`
`Grade 2 peripheral neuropathy
`
`Delay treatment until neutrophil count is
`>1,500 cells/mm , then reduce dosage of JEVTANA to
`3
`®
`20 mg/m . Use GCSF for secondary prophylaxis.
`2
`
`Delay treatment until improvement or resolution, and
`until neutrophil count is >1,500 cells/mm , then reduce
`3
`dosage of JEVTANA to 20 mg/m . Use GCSF for
`2
`secondary prophylaxis.
`
`Delay treatment until improvement or resolution, then
`reduce dosage of JEVTANA to 20 mg/m .
`®
`2
`
`Delay treatment until improvement or resolution, then
`reduce dosage of JEVTANA to 20 mg/m .
`2
`
`Grade ≥3 peripheral neuropathy Discontinue JEVTANA.
`
`a
`9
` Absolute neutrophil count <1.0 x 10 /L.
`GCSF=granulocyte colonystimulating factor.
`
`®
`Discontinue JEVTANA treatment if a patient continues to experience any of these
`2
`reactions at 20 mg/m
`®
`Dose reductions were reported in 12% of JEVTANA treated patients and 4% of
`mitoxantronetreated patients
`®
`Dose delays were reported in 28% of JEVTANA treated patients and 15% of
`mitoxantronetreated patients
`
`Important Safety Information for JEVTANA
`
`®1
`
`Patients should be observed closely for hypersensitivity reactions, especially
`during the first and second infusions
`Severe hypersensitivity can occur and may include generalized rash/erythema,
`hypotension and bronchospasm. Discontinue JEVTANA immediately if severe
`®
`reactions occur and administer appropriate therapy
`Contraindicated if history of severe hypersensitivity reactions to JEVTANA or to
`®
`drugs formulated with polysorbate 80
`Nausea, vomiting and severe diarrhea, at times, may occur. Death related to
`diarrhea and electrolyte imbalance occurred in the randomized clinical trial.
`Intensive measures may be required for severe diarrhea and electrolyte imbalance
`Women of childbearing potential should be advised to avoid becoming pregnant
`during treatment with JEVTANA
`®
`
`Important Safety Information for JEVTANA (cabazitaxel) Injection
`®
`
`http://www.jevtana.com/hcp/dosing/default.aspx
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`Dosing and Administration | JEVTANA® (cabazitaxel) Injection
`
`WARNING: NEUTROPENIA AND HYPERSENSITIVITY
`Neutropenic deaths have been reported. In order to monitor the
`occurrence of neutropenia, frequent blood cell counts should be
`performed on all patients receiving JEVTANA . JEVTANA should not
`®
`®
`be given to patients with neutrophil counts of ≤1,500 cells/mm
`3
`Severe hypersensitivity reactions can occur and may include
`generalized rash/erythema, hypotension and bronchospasm. Severe
`hypersensitivity reactions require immediate discontinuation of the
`JEVTANA infusion and administration of appropriate therapy. Patients
`should receive premedication
`JEVTANA must not be given to patients who have a history of severe
`hypersensitivity reactions to JEVTANA or to other drugs formulated
`®
`with polysorbate 80
`
`® ®
`
`CONTRAINDICATIONS
`®
`JEVTANA should not be used in patients with neutrophil counts of ≤1,500/mm
`®
`JEVTANA is contraindicated in patients who have a history of severe
`®
`hypersensitivity reactions to JEVTANA or to other drugs formulated with
`polysorbate 80
`
`3
`
`WARNINGS AND PRECAUTIONS
`Neutropenic deaths have been reported
`Monitoring of complete blood counts is essential on a weekly basis during cycle
`1 and before each treatment cycle thereafter so that the dose can be adjusted, if
`needed
`Monitor blood counts frequently to determine if initiation of GCSF and/or dosage
`modification is needed
`Primary prophylaxis with GCSF should be considered in patients with highrisk
`clinical features
`
`Severe hypersensitivity reactions can occur
`Premedicate with antihistamines, corticosteroids and H antagonists
`2
`Patients should be observed closely for hypersensitivity reactions, especially
`during the first and second infusions
`Discontinue infusion immediately if hypersensitivity is observed and treat as
`indicated
`
`Mortality related to diarrhea has been reported
`Rehydrate and treat with antiemetics and antidiarrheals as needed
`If experiencing grade ≥3 diarrhea, dosage should be modified
`
`Nausea, vomiting and severe diarrhea, at times, may occur. Death related to
`diarrhea and electrolyte imbalance occurred in the randomized clinical trial.
`Intensive measures may be required for severe diarrhea and electrolyte imbalance
`Gastrointestinal (GI) hemorrhage and perforation, ileus, enterocolitis, neutropenic
`enterocolitis, including fatal outcome, have been reported
`Risk may be increased with neutropenia, age, steroid use, concomitant use of
`NSAIDs, antiplatelet therapy or anticoagulants, and prior history of pelvic
`radiotherapy, adhesions, ulceration and GI bleeding
`Abdominal pain and tenderness, fever, persistent constipation, diarrhea, with or
`without neutropenia, may be early manifestations of serious GI toxicity and
`should be evaluated and treated promptly
`®
`JEVTANA treatment delay or discontinuation may be necessary
`
`Renal failure, including cases with fatal outcomes, has been reported. Identify
`cause and manage aggressively
`Patients ≥65 years of age were more likely to experience fatal outcomes not related
`to disease progression and certain adverse reactions, including neutropenia and
`febrile neutropenia. Monitor closely
`Patients with impaired hepatic function were excluded from the randomized clinical
`trial
`®
`Hepatic impairment is likely to increase the JEVTANA concentrations
`®
`JEVTANA should not be given to patients with hepatic impairment
`®
`JEVTANA can cause fetal harm when administered to a pregnant woman
`There are no adequate and wellcontrolled studies in pregnant women using
`®
`JEVTANA
`Women of childbearing potential should be advised to avoid becoming pregnant
`®
`during treatment with JEVTANA
`
`ADVERSE REACTIONS
`Deaths due to causes other than disease progression within 30 days of last study
`®
`drug dose were reported in 18 (5%) JEVTANA treated patients. The most common
`®
`fatal adverse reactions in JEVTANA treated patients were infections (n=5) and
`renal failure (n=4)
`
`http://www.jevtana.com/hcp/dosing/default.aspx
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`Dosing and Administration | JEVTANA® (cabazitaxel) Injection
`The most common (≥10%) grade 14 adverse reactions were anemia, leukopenia,
`neutropenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation,
`asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy,
`pyrexia, dyspnea, dysgeusia, cough, arthralgia, and alopecia
`The most common (≥5%) grade 34 adverse reactions in patients who received
`®
`JEVTANA were neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea,
`fatigue, and asthenia
`
`Please see full prescribing information including boxed WARNING.
`
`Reference
`1. JEVTANA Prescribing Information. Bridgewater, NJ: sanofiaventis U.S. LLC; November 2014.
`®
`
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`US.CAB.15.02.004 Last Update: February 2015
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