Patient Information
Indication: VELCADE® is approved for the treatment of multiple
VELCADE® is intended for use under the guidance and
myeloma patients who have received at least two prior therapies and
supervision of a health care professional. Please discuss
have demonstrated disease progression on the last therapy. The
the possibility of the following side effects with your
effectiveness of VELCADE is based on response rates. There are no
doctor:
controlled trials demonstrating a clinical benefit, such as improvement
in survival. VELCADE is contraindicated in patients with hypersensitivity
to bortezomib, boron, or mannitol.
Effects on Ability to Drive or Operate Machinery or
Precautions: Risks associated with VELCADE therapy include new or
Impairment of Mental Ability:
worsening peripheral neuropathy, orthostatic hypotension, congestive
VELCADE may be associated with fatigue, dizziness, light-
heart failure, gastrointestinal adverse events, thrombocytopenia, and
headedness, fainting or blurred vision. Please exercise
tumor lysis syndrome. Patients should be monitored for symptoms of
caution or avoid operating machinery, including
peripheral neuropathy including neuropathic pain; patients
automobiles, following use of VELCADE.
experiencing new or worsening peripheral neuropathy may require a
change in dose and schedule of VELCADE. Caution should be used
when treating patients with a history of syncope, patients receiving
Pregnancy/Nursing:
medications known to be associated with hypotension, and patients
Please use effective contraceptive measures to prevent
who are dehydrated. Patients with existing heart disease or risk factors
pregnancy and avoid breast feeding during treatment with
for heart disease should be closely monitored. Platelet counts should
VELCADE.
be monitored prior to each dose of VELCADE. VELCADE treatment
should be held for platelet counts < 25,000/uL; transfusions may be
used. Complete blood counts should be frequently monitored during
Dehydration/Hypotension:
VELCADE treatment. Gastrointestinal and intracerebral hemorrhage
Following the use of VELCADE therapy, you may
has been reported. Patients with high tumor burden should be
experience vomiting and/or diarrhea. Drink plenty of
monitored closely and appropriate precautions taken to prevent tumor
fluids. Speak with your doctor if these symptoms occur
lysis syndrome. Patients with renal and hepatic impairment should be
closely monitored for toxicities. Patients who are concomitantly
about what you should do to control or manage these
receiving VELCADE and drugs that are inhibitors or inducers of
symptoms.
cytochrome P450 3A4 should be closely monitored for toxicities or
questions and answers
reduced efficacy. In patients concomitantly receiving VELCADE and
If you experience symptoms of dizziness or light-
oral hypoglycemics, close monitoring of blood glucose levels and
headedness, consult a healthcare professional. Seek
adjustment of antidiabetic medications may be required.
for patients about
immediate medical attention if you experience fainting
Pregnancy Category D: Women of childbearing potential should
spells.
avoid becoming pregnant while being treated with VELCADE.
Safety Data: In 228 patients who were treated with VELCADE 1.3
Concomitant Medications:
mg/m2/dose in phase II studies, the most commonly reported adverse
Please speak with your doctor about any other medication
events were asthenic conditions (65%), nausea (64%), diarrhea (51%),
you are currently taking.Your doctor will want to be aware
decreased appetite including anorexia (43%), constipation (43%),
of any other medications.
thrombocytopenia (43%), peripheral neuropathy (37%), pyrexia (36%),
vomiting (36%), and anemia (32%). Fourteen percent of patients
experienced at least one episode of Grade 4 toxicity, with the most
Peripheral Neuropathy:
common toxicities being thrombocytopenia (3%) and neutropenia (3%).
Contact your doctor if you experience new or worsening
A total of 113 (50%) of the 228 patients experienced Serious Adverse
symptoms of peripheral neuropathy such as numbness,
Events (SAEs) during studies. The most commonly reported SAEs
pain, or a burning feeling in the feet or hands.
included pyrexia (7%), pneumonia (7%), diarrhea (6%), vomiting (5%),
dehydration (5%), and nausea (4%).
For more information call 1-866-VELCADE.
Please see accompanying full Prescribing Information.
Millennium Pharmaceuticals, Inc.,
Cambridge, MA 02139
Please see accompanying full Prescribing Information.
Copyright © 2004, Millennium Pharmaceuticals, Inc.
All rights reserved.
Printed in USA
V0055R2
5/04
11
understa
underst nding
a
yo
y ur treat
trea ment
t
with
velc
vel ad
c
eTM
ade®( (bortezomib
bortezomib) )FOR
INJECTION
VELCADE is indicated for the treatment of multiple
myeloma
m
patients who have received
recei
at least two prior
therapies and have demonstrated disease progression on
the last therapy.
therapy The effecti
ef
veness
fecti
of VELCADE is based on
response rates.There are no controlled trials demonstrating
a clinical benefit, such
suc as improvement
impro
in survival.
survi
Your
Y
doctor may have recommended treatment with
VELCADE.This brochure
broc
has been designed to help
answer your questions, as well as those of your family
members and caregivers.
The information in this brochure
broc
is not intended to
replace the advice of your doctor.
doctor He or she is a
valuable resource for answering your questions.
Remember
R
,
emember the more you know about your treatment
plan, the better
bet
prepared you will be to take an active
part
par in decisions about your medical care.
The health information contained in this brochure is provided for
educational purposes only and is not intended to replace discussions
between patients and their health care providers. All decisions regarding
patient care must be made with a health care provider considering all the
unique characteristics of the patient.
2
2
What is multiple myeloma?
Multiple myeloma is a type of cancer of the bone
marrow that affects certain white blood cells called
plasma cells.1 Plasma cells help protect the body from
infection and disease by producing antibodies (proteins
that rid the body of harmful substances, also known as
immunoglobulins).1 When cancer involves plasma cells,
the body keeps producing more and more of these cells.
The cancerous plasma cells are called myeloma cells.1
Myeloma cells tend to collect in the bone marrow,
sometimes forming a single mass, or tumor, called a
plasmacytoma.1 In most cases, however, the myeloma
cells collect in many bones, often forming multiple
tumors--which is why the disease is called multiple
myeloma.1These myeloma cells produce changes in the
body that can cause serious medical problems, such as
bone damage and pain; increased calcium in the blood; a
weakened immune system; a reduction in red blood cells
(causing anemia); and even kidney problems.1
Please see accompanying full Prescribing Information.
3
How does VELCADE®(bortezomib) FOR
INJECTION
work?
VELCADE is the first in a new class of drugs called
proteasome inhibitors that act in a different way from other
anti-cancer therapies.The diagram below, based on
laboratory studies, shows how VELCADE may work.
MECHANISM OF ACTION OF VELCADE
Proteasome
Proteins
Broken down
VELCADE
(signals) in
proteins
the cell to be
broken down
Proteasomes are enzyme complexes
1
present in all cells that break down
intracellular proteins in a regulated
manner in both healthy and
cancerous cells2-5
2 Cancer cells depend
upon proteins regulated
Inhibition of the proteasome by
3
by the proteasome to
VELCADE prevents the breakdown of
multiply, spread, and
intracellular proteins, affecting
survive2
multiple signaling cascades within cells
This disruption of signaling
4
cascades in cancer cells can
lead to cell death and
inhibit tumor growth
4
How and when
is VELCADE®administered?
VELCADE may be given at a clinic or in your doctor's
office. It is injected into a vein in a brief, 3- to 5-second
procedure.
VELCADE is given twice weekly for 2 weeks followed
by a 10-day rest period. Doses are typically given on
Monday andThursday orTuesday and Friday.The
2-week dosing period plus the 10-day rest period is
called a treatment cycle.Your doctor will advise you on
how long you should receive treatment. In clinical trials,
patients who responded to VELCADE were treated for 8
or more cycles.
Standard dosing schedule
Day 1
Day 4
Day 8
Day 11
10-DAY
REPEAT
REST
CYCLE
VELCADE
VELCADE
VELCADE
VELCADE PERIOD
What can I expect from
treatment with VELCADE?
In clinical trials, on average, most patients who
responded to VELCADE had improvement in their
disease about 6 weeks after treatment was started. It is
important to remember that no two patients respond to
any drug therapy, including VELCADE, in the same way.
Therefore, your results may vary from those seen in
clinical trials.
You may also experience side effects during treatment
with VELCADE (see pages 6 and 7).
Please see accompanying full Prescribing Information.
5
What are the possible side
effects of VELCADE®(bortezomib) FOR
?
INJECTION
In clinical trials, the most common side effects
associated with VELCADE were asthenic conditions
(fatigue, malaise, weakness), nausea, diarrhea,
decreased appetite, constipation, low platelet count,
peripheral neuropathy (numbness, tingling and/or pain
in the hands, arms, feet, or legs), fever, vomiting, and
anemia.The most commonly reported serious side
effects were fever, pneumonia, diarrhea, vomiting,
dehydration, and nausea.
Talk with your doctor if you experience any
uncomfortable side effects during your treatment with
VELCADE. He or she may prescribe other medications to
help minimize or avoid the side effect. If the side effect is
severe, your doctor may lower your dose of VELCADE or
stop treatment temporarily or permanently.
understanding the
side effects of velcade
Asthenic conditions (fatigue, malaise, weakness) may be
experienced early in treatment. Most patients who have
fatigue with VELCADE are able to continue therapy. If
you experience fatigue, you should be cautious when
operating machinery, including driving a car.
Gastrointestinal side effects (e.g., nausea, diarrhea,
constipation, and vomiting) are generally mild to
moderate and can often be managed with appropriate
medications. Ask your doctor about medications that can
be taken before your next dose of VELCADE that may
help prevent these side effects from occurring.
Increasing your fluid intake is recommended to prevent
dehydration.
6
Low platelet counts may temporarily occur during
treatment with VELCADE®. Platelets are blood cells that
help blood to clot. Platelet counts generally return
toward their starting level during the rest period of the
treatment cycle.Your physican may decide that a
transfusion of platelets is needed to bring the platelets
back to an acceptable level.
Peripheral neuropathy may occur throughout therapy
with VELCADE. It is usually felt as a mild tingling or
numbness in the hands, arms, feet, or legs, but can
progress to discomfort, pain, or a burning sensation.
Signs of neuropathy should be reported to your doctor
immediately; the dose of VELCADE may need to be
lowered, or treatment stopped, until your symptoms get
better. When your symptoms improve, your doctor may
decide to restart VELCADE at a lower dose.Your doctor
may also suggest medications or therapies to improve
neuropathy symptoms.
Fever may occur after VELCADE is administered,
even after you go home from your doctor visit.
If your temperature goes up, contact your doctor.
Low blood pressure may occur during treatment with
VELCADE. If you experience a reduction in blood
pressure, your doctor may adjust your medications or
recommend increasing your fluid intake.
Please see accompanying full Prescribing Information.
7
Are there any precautions that
a patient needs to know about
when treated with
velCADE®(bortezomib) FOR
?
INJECTION
Be cautious when operating machinery, including
driving a car, while on VELCADE
Use effective contraceptive measures to prevent
pregnancy and avoid breast feeding during treatment
with VELCADE
Make sure your doctor is aware of any preexisting
heart disease
Avoid dehydration during treatment with VELCADE
by drinking plenty of fluids; contact your doctor if you
have fainting spells or feel dizzy or light headed
Contact your doctor immediately if you experience
new or worsening numbness, tingling, pain or
burning in your hands, arms, feet, or legs
Contact your doctor immediately if you experience
shortness of breath or swelling in your legs
Make sure your doctor is informed of other
medications you are currently taking that may be
associated with peripheral neuropathy or lowered
blood pressure
If you are taking medication for diabetes, your blood
sugar levels may increase or decrease on VELCADE;
your doctor may monitor blood sugar levels and
adjust your antidiabetic medication if necessary
Where can I get more
information about VELCADE?
You can call 1-866-VELCADE toll-free to talk with a health
care professional about VELCADE. Information about
insurance coverage and the VELCADE Reimbursement
Assistance Program is also available at this number.
8
Where can I get more
information about
multiple myeloma and
patient support services?
You can learn more about multiple myeloma and patient
support services by calling these organizations or by
visiting their informative web sites.
American Cancer Society
1-800-227-2345
www.cancer.org
Association of Cancer Online Resources
www.acor.org
Cancer Care, Inc.
1-800-813-4673
www.cancercare.org
International Myeloma Foundation
1-800-452-2873
www.myeloma.org
Multiple Myeloma Research Foundation
1-203-972-1250
www.multiplemyeloma.org
National Cancer Institute
1-800-4-CANCER
(1-800-422-6237)
www.nci.nih.gov
References: 1. National Cancer Institute. What you need to know aboutTM
multiple myeloma. Available at: http://www.cancer.gov. Accessed March 26, 2003.
2. Adams J, et al. Proteasome inhibitors: a novel class of potent and effective
antitumor agents. Cancer Res. 1999;59:26152622. 3. Adams J, et al. Proteasome
inhibition: a new strategy in cancer treatment. Invest New Drugs. 2000;18:109121.
4. Glickman MH, et al.The ubiquitin-proteasome proteolytic pathway: destruction for
the sake of construction. Physiol Rev. 2002;82:373428. 5. HideshimaT, et al.The
proteasome inhibitor PS-341 inhibits growth, induces apoptosis, and overcomes drug
resistance in human multiple myeloma cells. Cancer Res. 2001;61(7):3071-3076.
Please see accompanying full Prescribing Information.
9
Patient Dosing calendar
Complete in consultation with your health care provider
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Notes:
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