ASH News Daily 2012 - Sunday, December 9, 2012 - (Page A-11)
APPROVED FOR SUBCUTANEOUS
AND IV ADMINISTRATION*
Survival never gets old
vs MP alone for previously untreated multiple myeloma (median 56.4 vs
43.1 months [HR=0.695; 95% CI, 0.57-0.85; p<0.05]; 60.1-month median follow-up‡
VELCADE®
with MP†
VELCADE®
INDICATION
(bortezomib) Indication and Important Safety Information
VELCADE (bortezomib) is indicated for the treatment of
patients with multiple myeloma.
CONTRAINDICATIONS
VELCADE is contraindicated in patients with hypersensitivity
to bortezomib, boron, or mannitol. VELCADE is contraindicated
for intrathecal administration.
WARNINGS, PRECAUTIONS, AND
DRUG INTERACTIONS
▼ Peripheral neuropathy, including severe cases, may occur –
manage with dose modification or discontinuation. Patients
with preexisting severe neuropathy should be treated with
VELCADE only after careful risk-benefit assessment
▼ Hypotension can occur. Use caution when treating patients
receiving antihypertensives, those with a history of syncope,
and those who are dehydrated
▼ Closely monitor patients with risk factors for, or existing
heart disease
▼ Acute diffuse infiltrative pulmonary disease has
been reported
▼ Nausea, diarrhea, constipation, and vomiting have
occurred and may require use of antiemetic and
antidiarrheal medications or fluid replacement
▼ Thrombocytopenia or neutropenia can occur; complete
blood counts should be regularly monitored
throughout treatment
▼ Tumor Lysis Syndrome, Reversible Posterior
Leukoencephalopathy Syndrome, and Acute
Hepatic Failure have been reported
▼ Women should avoid becoming pregnant while being
treated with VELCADE. Pregnant women should be
apprised of the potential harm to the fetus
▼ Closely monitor patients receiving VELCADE in combination
with strong CYP3A4 inhibitors. Concomitant use of strong
CYP3A4 inducers is not recommended
ADVERSE REACTIONS
Most commonly reported adverse reactions (incidence ≥30%)
in clinical studies include asthenic conditions, diarrhea,
nausea, constipation, peripheral neuropathy, vomiting,
pyrexia, thrombocytopenia, psychiatric disorders, anorexia
and decreased appetite, neutropenia, neuralgia, leukopenia,
and anemia. Other adverse reactions, including serious
adverse reactions, have been reported
Please see Brief Summary for VELCADE on next page.
* The reconstituted concentration for subcutaneous administration (2.5 mg/mL) is
greater than the reconstituted concentration for IV administration (1 mg/mL).
†Melphalan+prednisone.
‡
VISTA: a randomized, open-label, international phase 3 trial (N=682) evaluating
the efficacy and safety of VELCADE administered intravenously in combination with
MP vs MP in previously untreated multiple myeloma (MM). The primary endpoint
was TTP. Secondary endpoints were CR, ORR, PFS, and overall survival. At a
pre-specified interim analysis (median follow-up 16.3 months), VELCADE+MP
resulted in significantly superior results for TTP (median 20.7 months with
VELCADE+MP vs 15.0 months with MP [p=0.000002]), PFS, overall survival,
and ORR. Further enrollment was halted and patients receiving MP were offered
VELCADE in addition. Updated analyses were performed.
(bortezomib) delivered >13-month overall survival advantage in combination
)
Living Proof
10/5/12 11:44 AM
Table of Contents for the Digital Edition of ASH News Daily 2012 - Sunday, December 9, 2012
ASH News Daily 2012 - Sunday, December 9, 2012
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