JEVTANA*
Manufacturer DetailsSANOFI AVENTIS U.S. INC.
Compositions:
Cabazitaxel -mg,
Cabazitaxel -mg,
| Strength | Rate | Packing Style |
|---|---|---|
| mg | 0.00 | unit |
List of Related Indications:
- Treatment of patients with Hormone Refractory Metastatic Prostrate Cancer previuosly treated with Docetaxel containg regimen
List Of Drugs:
- Cabazitaxel- Jevtana- @- Anti-cancer (June 2010)
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Use with caution in patients taking concomitant medicines that induce or inhibit CYP3A.
Indication:
Proprietary Name- Jevtana
Established Name - Cabazitaxel
Applicant- Sandoz Aventis U.S. Inc
Indication-
Indicated for patients with hormone Refractory Metastatic Prostrate
Cancer previously treated with a Docetaxel treatment Regimen
Approved by FDA on 7-6-2010 (Ref- FDA approved List- 2010)
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Cabazitaxel injection 60mg/1.5ml 16-11-2011
In combination with prednisolone for treatment of patients with
hormone refractory metastatic prostrate cancer previously treated
with a Docetaxel- containing treatment regimen
Adverse Reaction:
Most common all grades adverse reactions (.10%) are
neutropenia,anemia, leukopenia, thrombocytopenia, diarrhea, fatigue,
nausea, vomiting,constipation, asthenia, abdominal pain, hematuria,
back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia,
cough, arthralgia,and alopecia.
Contra-Indications:
CONTRAINDICATIONS
.
Neutrophil counts of .1,500/mm3 .
History of severe hypersensitivity to JEVTANA or polysorbate 80
WARNING
Neutropenic deaths have been reported. Obtain frequent blood counts to
monitor for neutropenia.
Do not give JEVTANA if neutrophil counts are .1,500 cells/mm3.
.
Severe hypersensitivity can occur and may include generalized rash/erythema,
hypotension and bronchospasm.
Discontinue JEVTANA immediately if severe reactions occur and administer
appropriate therapy.
PRECAUTIONS
Neutropenia, febrile neutropenia: Neutropenic deaths have been reported.
Monitor blood counts frequently to determine if initiation of G-CSF and/or
dosage modification is needed.
Primary prophylaxis with G-CSF should be considered in patients
with high-risk clinical features.
.
Hypersensitivity: Severe hypersensitivity reactions can occur.
Premedicate with corticosteroids and H2 antagonists.
Discontinue infusion immediately if hypersensitivity is observed and treat
as indicated.
.
Gastrointestinal symptoms (nausea, vomiting, diarrhea): Mortality related
to diarrhea has been reported.
Rehydrate and treat with anti-emetics and anti-diarrheals as needed.
If experiencing Grade . 3 diarrhea, dosage should be modified.
.
Renal failure, including cases with fatal outcomes, has been reported.
Identify cause and manage aggressively.
.
Elderly patients: 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
.
Hepatic impairment: Patients with impaired hepatic function were excluded
from the randomized clinical trial. Hepatic impairment is likely to increase
the cabazitaxel concentrations.
JEVTANA should not be given to patients with hepatic impairment.
.
JEVTANA can cause fetal harm when administered to a
pregnant woman.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
JEVTANA is a microtubule inhibitor indicated in combination with prednisone
for treatment of patients with hormone-refractory metastatic prostate cancer
previously treated with a docetaxel-containing treatment regimen.
DOSAGE AND ADMINISTRATION-
Recommended dose: JEVTANA 25 mg/m2 administered every three weeks
as a one-hour intravenous infusion in combination with oral prednisone
10 mg administered daily throughout JEVTANA treatment.
JEVTANA requires two dilutions prior to administration
Use the entire contents of the accompanying diluent to achieve a concentration
of 10 mg/mL JEVTANA.
PVC equipment should not be used
Premedication Regimen: Administer intravenously 30 minutes before
each dose of JEVTANA:
- Antihistamine (dexchloropheniramine 5 mg or diphenhydramine 25 mg
or equivalent antihistamine)
- Corticosteroid (dexamethasone 8 mg or equivalent steroid)
- H2 antagonist (ranitidine 50 mg or equivalent H2 antagonist)
- Antiemetic prophylaxis (oral or intravenous) is recommended as needed.
DOSAGE FORMS AND STRENGTHS
Single use vial 60 mg/1.5 mL, supplied with diluent (5.7 mL) for JEVTANA
Patient Information:
.1.Educate patients about the risk of potential hypersensitivity associated
with JEVTANA. Confirm patients do not have a history of severe
hypersensitivity reactions to cabazitaxel or to other drugs formulated
with polysorbate 80. Instruct patients to immediately report signs of a hypersensitivity
reaction.
2.Explain the importance of routine blood cell counts. Instruct patients to monitor
their temperature frequently and immediately report any occurrence of fever
to the treating oncologist.
3.Explain that it is important to take the oral prednisone as prescribed.
Instruct patients to report if they were not compliant with oral corticosteroid regimen.
4.Explain to patients that severe and fatal infections, dehydration, and renal failure
have been associated with cabazitaxel exposure.
5.Patients should immediately report fever, significant vomiting or diarrhea,
decreased urinary output, and hematuria to the treating oncologist.
6.Inform patients about the risk of drug interactions and the importance of
providing a list of prescription and non-prescription drugs to the treating
oncologist
Inform elderly patients that certain side effects may be more frequent or severe.
Pharmacology/ Pharmacokinetics:
1 Mechanism of Action
Cabazitaxel is a microtubule inhibitor. Cabazitaxel binds to tubulin and promotes
its assembly into microtubules while simultaneously inhibiting disassembly.
This leads to the stabilization of microtubules, which results in the inhibition of
mitotic and interphase cellular functions
2. Pharmacokinetics
A population pharmacokinetic analysis was conducted in 170 patients with solid
tumors at doses ranging from 10 to 30 mg/m2 weekly or every three weeks.
Absorption
Based on the population pharmacokinetic analysis, after an intravenous
dose of cabazitaxel 25 mg/m2 every three weeks, the mean Cmax in patients
with metastatic prostate cancer was 226 ng/mL (CV 107%) and was reached
at the end of the one-hour infusion (Tmax). The mean AUC in patients with
metastatic prostate cancer was 991 ng•h/mL (CV 34%).
Pregnancy and lactation:
1. Pregnancy
Pregnancy category D.
JEVTANA can cause fetal harm when administered to a pregnant woman.
In non-clinical studies in rats and rabbits, cabazitaxel was embryotoxic,
fetotoxic, and abortifacient at exposures significantly lower than those
expected at the recommended human dose level.
2. Nursing Mothers
Cabazitaxel or cabazitaxel metabolites are excreted in maternal milk of lactating rats.
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk and because of the potential
for serious adverse reactions in nursing infants from JEVTANA, a decision
should be made whether to discontinue nursing or to discontinue the drug,
taking into account the importance of the drug to the mother.
3.Pediatric Use
The safety and effectiveness of JEVTANA in pediatric patients have not been established.
4. Geriatric Use
Based on a population pharmacokinetic analysis, no significant difference was observed
in the pharmacokinetics of cabazitaxel between patients < 65 years and older .
