Eribulin mesylate - Eribulin Mesylate -Anti-cancer (Jan 2012)
Drug Name:Eribulin mesylate - Eribulin Mesylate -Anti-cancer (Jan 2012)
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
1 Effects of Other Drugs on HALAVEN
No drug-drug interactions are expected with CYP3A4 inhibitors or P-gp inhibitors.
The effect of ketoconazole, a strong inhibitor of cytochrome P450 3A4 (CYP3A4)
and a P-gp inhibitor, on the pharmacokinetics (PK) of eribulin was studied
in an open-label, two-treatment, two-sequence, two-way crossover trial in
12 patients with advanced solid tumors.
The mean dose-normalized AUC values were similar when eribulin was administered
with or without ketoconazole (ratio of the mean AUC: 0.97; 90% CI: 0.83,
2 Effect of HALAVEN on Other Drugs
Eribulin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1
or CYP3A4 enzymes or induce CYP1A2, CYP2C9, CYP2C19 or CYP3A4 enzymes
at relevant clinical concentrations.
Eribulin is not expected to alter the plasma concentrations of drugs that are substrates
of these enzymes
Indication:
Metastatic Breast Cancer
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Eribulin /meyslate solution 27-01-2012
for Injection 0.88mg/2ml
For the treatment of Patients with Locally Advanced or Metastatic
Breast Cancer who have progressed after alleast two
Chemotherapeutic Regemins for Advanced disease.
Prior therap should have included an anthracycline and a Taxane
unless the paatients were unsuitable for these treatments
Adverse Reaction:
The most common adverse reactions (incidence .25%) were neutropenia, anemia,
asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation
Contra-Indications:
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
.
Neutropenia: Monitor peripheral blood cell counts and adjust dose as
appropriate
.
Peripheral Neuropathy: Monitor for signs of neuropathy. Manage with
dose delay and adjustment
.
Use in Pregnancy: Fetal harm can occur when administered to a
pregnant woman
.
QT Prolongation: Monitor for prolonged QT intervals in patients
with congestive heart failure, bradyarrhythmias, drugs known to prolong
the QT interval, and electrolyte abnormalities
. Avoid in patients with congenital long QT syndrome
Dosages/ Overdosage Etc:
Metastatic Breast Cancer
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Eribulin /meyslate solution 27-012012
for Injection 0.88mg/2ml
For the treatment of Patients with Locally Advanced or Metastatic
Breast Cancer who have progressed after alleast two
Chemotherapeutic Regemins for Advanced disease.
Prior therap should have included an anthracycline and a Taxane
unless the patients were unsuitable for these treatments
INDICATIONS AND USAGE
HALAVEN is a microtubule inhibitor indicated for the
treatment of patients with metastatic breast cancer who have previously
received at least two chemotherapeutic regimens for the treatment of
metastatic disease.
Prior therapy should have included an anthracycline and a taxane in either the
adjuvant or metastatic setting
DOSAGE AND ADMINISTRATION
Administer 1.4 mg/m2 intravenously over 2 to 5 minutes on
Days 1 and 8 of a 21-day cycle
Reduce dose in patients with hepatic impairment and moderate renal impairment
Do not mix with other drugs or administer with dextrose-containing solutions
DOSAGE FORMS AND STRENGTHS
Intravenous administration.
Eribulin mesylate injection, 1 mg per 2 mL (0.5 mg per mL)
Patient Information:
PATIENT COUNSELING INFORMATION
1.Advise patients to contact their health care provider for a fever of 100.5°F or
greater or other signs or symptoms of infection such as chills, cough
, or burning or pain on urination. [see Warnings and Precautions
2.Advise women of childbearing potential to avoid pregnancy and to use
effective contraception during treatment with HALAVEN.
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action
Eribulin inhibits the growth phase of microtubules without affecting the shortening
phase and sequesters tubulin into nonproductive aggregates.
Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading
to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately,
apoptotic cell death after prolonged mitotic blockage
2. Pharmacokinetics
The pharmacokinetics of eribulin is linear with a mean elimination half-life
of approximately 40 hours, a mean volume of distribution of 43 L/m2 to 114 L/m2
and mean clearance of 1.16 L/hr/m2 to 2.42 L/hr/m2 over the dose range
of 0.25 mg/m2 to 4.0 mg/m2
Pregnancy and lactation:
1 Pregnancy Category D
There are no adequate and well-controlled studies with HALAVEN in
pregnant women.
If this drug is used during pregnancy, or if the patient becomes pregnant
while taking this drug, the patient should be apprised of the potential
hazard to the fetus.
2. Nursing Mothers
It is not known whether HALAVEN is excreted into human milk. No studies
in humans or animals were conducted to determine if HALAVEN
is excreted into milk.
Because many drugs are excreted into human milk and because of the
potential for serious adverse reactions in human milk fed infants from
HALAVEN, a decision should be made whether to discontinue
nursing or to discontinue HALAVEN taking into account the importance
of the drug to the mother.
3.Pediatric Use
The safety and effectiveness of HALAVEN in pediatric patients below the age
of 18 years have not been established.
4. Geriatric Use
Of the 827 subjects who received the recommended dose and schedule
of HALAVEN in clinical studies, 15% (121/827) were 65 and older,
and 2% (17/827) patients were 75 and older.
No overall differences in safety were observed between these subjects
and younger subjects.
