Understanding
Quadramet®
International Myeloma Foundation
12650 Riverside Drive, Suite 206
North Hol ywood, CA 91607 USA
Telephone:
800-452-CURE (2873)
(USA & Canada)
818-487-7455
Fax: 818-487-7454
TheIMF@myeloma.org
www.myeloma.org
07/06
Table of Contents
Introduction
5
WhatisQuadramet®?
7
HowdoesQuadramet®differ
fromanalgesics?
9
HowdoesQuadramet®differ
frombisphosphonates?
10
WhocanbenefitfromQuadramet®therapy?10
HowdoesQuadramet®work?
11
Whatarethepossible
sideeffectsofQuadramet®?
12
WhoshouldnotreceiveQuadramet®?
16
HowisQuadramet®given?
16
CanQuadramet®betaken
withothercancertreatments?
17
Wil Insurancecoverthecost
ofQuadramet®?
17
Afinalnote
18
AbouttheIMF
19
Glossary
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©2006, International Myeloma Foundation, North Hollywood, California
Introduction
Quadramet® belongs to a class of drugs
cal ed radiopharmaceuticals and is used
to treat bone pain that often results when
cancer has spread to the bone. Quadramet®
is currently approved by the United States
Food and Drug Administration (FDA) to
relieve pain in patients who have confirmed
osteoblastic* metastatic bone lesions that
are evident on a bone scan. To explain,
when cancer spreads (metastasizes) to the
bone, it is often characterized as osteolytic
(the breakdown of bone), osteoblastic (the
formation of bone), or mixed (a mixture of
osteolytic and osteoblastic components).
In general, myeloma results in osteolytic
lesions that are associated with excessive
bone destruction. Other cancers, such as
prostate cancer, are often associated with
excessive bone formation when they metasta-
size. Recent observations, however, indicate
that osteolytic and osteoblastic lesions simply
represent two extremes of a broad spectrum
and most bone metastases exhibit charac-
teristics of both.
Radiopharmaceuticals, like Quadramet®,
are a type of systemic therapy meaning
one dose can target multiple sites of bone
metastasis.
If patients have confirmed osteoblastic
lesions, they may benefit from treatment
with Quadramet®. Ongoing studies in the
*Words and phrases in bold are defined in the Glossary section in this booklet
4
5
United States are currently evaluating the
What is Quadramet®?
specific benefits that Quadramet® can of er
to patients with myeloma.
Quadramet® (Samarium Sm-153 Lexidronam
Injection) belongs to the radiopharmaceuti-
This booklet is intended to provide a basic
cal drug class. Radiopharmaceuticals were
understanding of what you can expect from
first used in the 1950s to provide pain relief
Quadramet® therapy, including:
for cancer that metastasizes to the bone.
n What Quadramet® is and how it works
Phosphorous-32 and strontium-89 were the
to treat pain from cancer that has
first radiopharmaceuticals. Quadramet® is
metastasized to the bone,
indicated for the relief of pain in patients
with confirmed osteoblastic metastatic bone
n How to handle Quadramet® therapy
lesions that are enhanced on a radionuclide
safely,
bone scan.
n What side effects might be expected
Quadramet® received FDA approval in
from Quadramet® therapy, and
1997. Quadramet® combines a radionu-
n How Quadramet® may be used in
clide (an atom characterized by the compo-
combination with other therapies.
sition of its nucleus and, consequently, the
This information may be useful not only to
quantity of protons, neutrons, and energy)
patients, but also to friends, family, loved
with more desirable nuclear properties (eg,
ones, and other caregivers. Information
shorter half-life and lower energy-particle
about Quadramet® is also available at
emissions) and greater selectivity than earlier
www.cytogen.com. A copy of the ful pre-
radiopharmaceuticals.
scribing information for Quadramet® may be
Next-generation radiopharmaceuticals such
obtained in the United States from Cytogen
as Quadramet® of er certain advantages
Corporation by cal ing tol free at 800-833-
in treating pain associated with bone
3533 or by visiting www.cytogen.com.
metastasis:
Please remember that myeloma, like al can-
n A Quadramet® dose is administered in a
cers, is a complicated disease. A doctor or
single injection over a few minutes, usual y
nurse should address any specific questions
as an outpatient procedure.
about treatment.
n Patients who respond might begin to
notice the onset of pain relief one week
after injection with maximal pain relief
general y at 3 to 4 weeks. Not al patients
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7
How does Quadramet® differ
from analgesics?
Analgesics are used to relieve pain. These
drugs include over-the-counter medications
such as aspirin and acetaminophen, as wel
as prescription-only drugs such as morphine
and other opiates. Although these drugs can
ef ectively provide general pain relief, some
of them, especial y morphine and the other
opiates, may cause unpleasant side ef ects,
including constipation, nausea or vomiting,
and drowsiness.
Quadramet® delivers treatment directly to
respond to Quadramet®. Some patients
the site and source of bone pain and has
have reported a transient increase in
a dif erent side ef ect profile. Please see
bone pain within 72 hours of injection
the side ef ects section for a ful listing of
(flare reaction) which is usual y mild and
Quadramet®'s potential side ef ects. Patients
self-limiting.
who experience a reduction in pain from
n In a clinical trial, 62%72% of patients
Quadramet® treatment may be encouraged
receiving the approved dose of Quadramet
by their doctors to reduce their use of opi-
experienced pain relief in the first four
oid analgesics. Most patients who receive
weeks. Two thirds of these responding
Quadramet® also take a variety of other
patients were stil experiencing pain relief
medicines to help treat their pain. These
at 16 weeks.
normal y include both over-the-counter medi-
n If appropriate, radiopharmaceuticals can
cations (such as aspirin and ibuprofen) as
be used in combination with other treat-
wel as stronger prescription drugs (such as
ments. However, because of the unknown
oxycodone and morphine).
potential for additive ef ects on bone mar-
row, Quadramet® should not be given con-
currently with chemotherapy or external
beam radiation unless the clinical benefits
outweigh the risks.
8
9
How does Quadramet® differ
How does Quadramet® work?
from bisphosphonates?
The exact mechanism of action of Quadramet
in relieving the pain of bone metastases is
Quadramet® targets new bone formation
not known.
and bisphosphonates target bone destruc-
tion. Together, Quadramet® and bisphospho-
Quadramet® contains a radioactive ingredi-
nates target the two activities present in bone
ent that is designed to target areas where
metastasis.
cancer is at acking bone. In clinical studies,
more Quadramet® accumulates in osteo-
Who can benefit
blastic lesions than in normal bone, with a
lesion-to-bone ratio of approximately 5:1.
from Quadramet® therapy?
This targeting means that healthy bone and
Quadramet® has demonstrated significant
other normal tissues receive lower exposure
reductions in pain scores in randomized
to radioactivity than do lesions. In addition,
clinical trials. These trials included patients
because Quadramet® is a systemic therapy,
with prostate, breast, and other cancers.
one dose can target multiple sites of bone
Quadramet has been found to be ef ective in
metastases.
patients suf ering bone pain associated with
dif erent stages of cancer, including:
n Patients who have been newly diagnosed
with myeloma or bone metastasis,
n Patients who have not responded to other
treatments, and
n Patients in whom cancer has returned after
initial successful treatment.
Before Quadramet® is administered, consid-
eration should be given to the patient's cur-
rent clinical and hematologic status and to
bone marrow response history to treatment
with myelotoxic agents.
10
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What are the possible side effects
of Quadramet®?
Themostcommonsideef ectwithQuadramet®
is bone marrow toxicity, which causes a
decrease in the number of blood cel s in your
body. Bone marrow toxicity occurred in 47%
of patients in clinical trials.
Bone marrow toxicity may increase your
risk of infections by reducing the number
of white cel s, which guard against infec-
tion; or bleeding by reducing the number of
platelets, which control blood clot ing, so it
is important for your doctor to consider your
hematologic status prior to treatment with
Quadramet®, especial y if you are undergo-
ing other therapies that may also af ect your
blood counts.
Non blood-related adverse events that
occurred in 5% or more patients and that
occurred more commonly in the Quadramet®
who have known hypersensitivity to EDTMP
group than in those patients who were given
(Ethylene Diamine Tetramethylene Phosphate)
a placebo were pain flare (7%), infection
or similar phosphonate compounds; women
(7%), spinal cord compression (6.5%), diar-
of childbearing age should have a nega-
rhea (6%), arrhythmias (5%) and hematuria,
tive pregnancy test before administration
which is blood in the urine (5%). Because
of Quadramet®. If Quadramet® is adminis-
of the unknown potential for additive ef ects
tered to a nursing mother, formula feeding
on bone marrow, Quadramet® should not
should be substituted for breast feeding.
be given concurrently with chemotherapy or
Patients who receive Quadramet® should
external beam radiation unless the clinical
be advised that for several hours fol owing
benefits outweigh the risks. Patients taking
administration, radioactivity wil be present
Quadramet® should have their blood counts
in excreted urine. To help protect themselves
monitored for at least 8 weeks, or until
and others in the environment, precautions
recovery of adequate bone marrow function.
need to be taken for 12 hours fol owing
Quadramet® should not be used in patients
administration.
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Before You receive QuAdrAmet®
After You receive QuAdrAmet®
n Tel your doctor if you are pregnant,
You should take some basic steps after
trying to become pregnant, or nursing.
receiving Quadramet® to protect yourself
Quadramet® can be harmful to fetuses
and others:
and infants and should not be used by
n Remember that for about 12 hours, radio-
pregnant women. Women of childbearing
activity wil be present in your urine.
age should have a negative pregnancy
n
test before administration of Quadramet®.
During the first few hours after your injec-
Men and women should be advised to use
tion, drink extra fluids and urinate as often
an ef ective method of contraception after
as possible.
administration. If Quadramet® is adminis-
n If you are a man, use a toilet if possible,
tered to a nursing mother, formula feeding
rather than a urinal.
should be substituted for breast feeding.
n Flush the toilet several times when you are
n Tel your doctor if you have had an al ergic
finished urinating, clean up any spil ed
reaction to any drugs.
urine immediately, and wash your hands
n Drink at least 2 cups (1 pint) of fluid just
thoroughly.
before you receive Quadramet®.
n If any urine or blood gets on your cloth-
ing, wash those clothes separately or store
them for 1 to 2 weeks before washing.
If you have been receiving chemotherapy
or radiation therapy for your cancer, your
doctor wil decide if and when you should
continue after you receive Quadramet®.
Quadramet® therapy may af ect your blood
cel counts, which may in turn af ect other
treatment decisions. Therefore, for about 8
weeks after treatment, you should tel other
health care professionals you see, including
your dentist and pharmacist, that you have
received Quadramet®.
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15
Who should not receive
Can Quadramet® be taken with
Quadramet®?
other cancer treatments?
Before you receive Quadramet®, your doctor
As mentioned, Quadramet® can be given
should consider your current medical and
with analgesics, including opiates. Moreover,
blood count status, along with your history
patients who experience a reduction in pain
of response to treatment with other drugs
from Quadramet® treatment may be encour-
that suppress bone marrow. Because of the
aged by their doctors to reduce their use of
potential for additive ef ects on bone mar-
opioid analgesics.
row, Quadramet® should not be given at
It is not typical y recommended that
the same time as chemotherapy or external-
Quadramet® be taken at the same time
beam radiation therapy unless your doctor
that patients are receiving chemotherapy or
feels the possible benefits outweigh the risks.
external-beam radiation therapy, but your
Similarly, Quadramet® should not be given
doctor can best assess the possible benefits
to patients whose bone marrow supply has
and risks.
been af ected, either from disease or other
therapy, unless your doctor feels the possible
Will insurance cover the cost of
benefits outweigh the risks. Quadramet®
should not be used in patients who have
Quadramet®?
known hypersensitivity to EDTMP or similar
Insurance coverage varies. Individual insur-
phosphonate compounds. Quadramet® can
ance companies can provide information
be harmful to fetuses and infants and should
regarding their Quadramet® coverage. For
not be used by pregnant or nursing women.
more information, you can also cal the
If Quadramet® is administered to a nursing
Cytogen Benefit Verification line at 1-888-
mother, formula feeding should be substi-
837-4397 (1-888-VERIFYQ).
tuted for breast feeding.
How is Quadramet® given?
Quadramet® is given intravenously over
a 1-minute period through an indwel ing
catheter. In most cases, Quadramet® can be
given on an outpatient basis.
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A final note
About the IMF
Quadramet® is a treatment for relief of
"One person can make a dif erence,
bone pain from metastatic bone disease for
Two can make a miracle."
a number of diseases. As with any drug,
however, it can cause harm if misused. It
Brian D. Novis
IMF Founder
is important that you fol ow al advice from
your health care professionals while you
Myeloma is a lit le-known, complex, and
are taking Quadramet®, and you should
often misdiagnosed bone marrow cancer
promptly contact your doctor or nurse with
that at acks and destroys bone. Myeloma
any questions.
af ects approximately 75,000 to 100,000
people in the United States, with more than
You may have questions or concerns regard-
15,000 new cases diagnosed each year.
ing your Quadramet® treatment once your
While there is presently no known cure for
therapy begins. Some of these concerns
myeloma, doctors have many approaches
may be about Quadramet® itself. Others
to help myeloma patients live bet er and
may be about the outcome of treatment and
longer.
its side ef ects. Stil other concerns may be
more emotional or financial in nature. Many
The International Myeloma Foundation (IMF)
resources are available. You should share
was founded in 1990 by Brian and Susie
your concerns with the members of your
Novis shortly after Brian's myeloma diagno-
treatment team, so that they can help you.
sis at the age of 33. It was Brian's dream that
Communication wil help lead to the active
future patients would have easy access to
management of side ef ects, minimize symp-
medical information and emotional support
toms, and help al eviate fears and concerns
throughout their bat le with myeloma. He
during treatment. Involvement in your per-
established the IMF with the 3 goals of treat-
sonal care wil ultimately lead to confidence
ment, education, and research. He sought
and a sense of control regarding treatment
to provide a broad spectrum of services for
choices.
patients, their families, friends, and health
care providers. Although Brian died 4 years
after his initial diagnosis, his dream didn't.
Today the IMF reaches out to an international
membership of more than 125,000. The IMF
was the first organization dedicated solely to
myeloma, and today it remains the largest.
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The IMF provides programs and services to
mYeLomA todAY NeWSLetter
aid in the research, diagnosis, treatment,
Our quarterly newslet er is available free of
and management of myeloma. The IMF
charge by subscription.
ensures that no one must brave the myeloma
SuPPort
bat le alone.
mYeLomA HotLiNe: 800-452-cure (2873)
We care for patients today, while working
Toll-free throughout the United States and
toward tomorrow's cure.
Canada, the IMF Hotline is staf ed by trained
information specialists and is in frequent inter-
How Can the IMF Help You?
action with members of our Scientific Advisory
Board.
PAtieNt educAtioN
iNformAtioN PAcKAGe
SuPPort GrouPS
Our free IMF InfoPack provides comprehensive
A worldwide network of more than 100 myelo-
information about myeloma, treatment options,
ma support groups hold regular meetings for
disease management, and IMF services. It
members of the myeloma community. The IMF
includes our acclaimed Patient Handbook.
conducts annual retreats for myeloma support
group leaders.
iNterNet AcceSS
Log on to www.myeloma.org for 24-hour
reSeArcH
access to information about myeloma, the IMF,
BANK oN A cure ®
education, and support programs.
This DNA bank wil provide genetic data
oNLiNe mYeLomA forum
research in new drug development.
Join the IMF Internet Discussion Group at
www.myeloma.org/listserve.html to share your
tHe iNterNAtioNAL StAGiNG SYStem (iSS)
thoughts and experiences.
This updated staging system for myeloma wil
enhance physicians' ability to select the most
mYeLomA miNute
appropriate treatment for each patient.
Subscribe to this free weekly email news-
let er for up-to-the-minute information about
reSeArcH GrANtS
myeloma.
Leading the world in col aborative research
and achieving extraordinary results, the IMF
PAtieNt & fAmiLY SemiNArS
Grant Program supports both junior and senior
Meet with leading experts in myeloma treat-
ment to learn more about recent advances in
researchers working on a broad spectrum of
therapy and research.
projects. The IMF has at racted many young
investigators into the field of myeloma, and
mYeLomA mAtriX
they have remained in the field and are actively
On our website and in print, this document is a
pursuing a cure for this disease.
comprehensive guide to drugs in development
for myeloma.
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Glossary
Alkylating agent: An agent that prevents the growth and
Opiate: A pain-relieving drug derived from opium, such
division of new cancer cel s by inhibiting their ability to
as morphine, hydromorphone, codeine, and oxycodone.
replicate DNA.
Osteoblastic: Characterized by the formation of bone.
Analgesic: A drug that relieves pain, including over-the-
Osteolytic: Characterized by the breakdown of bone.
counter medications such as aspirin and acetaminophen
Plasma cell: A type of white blood cel that produces
and prescription-only medications such as morphine and
antibodies.
other opiates.
Platelet: A blood cel that helps with clot ing, which in turn
Bisphosphonate: A drug that restricts the action of bone-
helps repair damaged blood vessels.
destroying cel s.
Protein: A group of compounds that are the main compo-
Blood cell count: The amount of red blood cel s, white
nents of a cel .
blood cel s, and platelets in the body.
Radiation therapy: The careful use of high-energy radiation
Bone marrow: The soft, spongy tissue in the center of
to treat cancer.
bones that produces white blood cel s, red blood cel s,
and platelets.
Radionuclide: An atom characterized by the composition
of its nucleus, and consequently, the quantity of protons,
Bone scan: A technique that creates images of bones on
neutrons, and energy.
a computer screen to indicate areas of injury, disease,
or healing.
Radiopharmaceutical: A drug that contains a radioactive
ingredient.
Cell: The smal est unit of life. Mil ions of microscopic cel s
comprise each bodily organ.
Red blood cell: A blood cel that carries oxygen from the
blood throughout the body.
Chemotherapy: Treatment of disease by means of chemical
substances or drugs.
Side effect: An ef ect caused by treatment with a drug.
The term usual y refers to unwanted ef ects, but some side
External-beam radiation therapy: Radiation therapy that
ef ects may be beneficial.
aims highly focused beams of radiation at the edges of a
cancerous site to destroy any abnormal cel s and prevent
Systemic: Af ecting the entire body.
the growth or regrowth of the tumor.
Targeted radiopharmaceutical: A drug that contains a radio-
Flare: A sudden worsening of disease or pain.
active ingredient that is used to target the cel s that are
af ected by cancer, while minimizing impact on normal
Indwelling catheter: An instrument that is used to inject or
cel s.
withdraw fluids.
White blood cell: A blood cel that helps fight infection
Intravenously: Administered directly to the blood through
and/or disease.
a vein.
Metastasis: The spread of cancer from the primary tumor
to other parts of the body.
Myeloma: A cancer arising from the plasma cel s in the
bone marrow. The plasma cel s in patients with myeloma
form abnormal antibodies, possibly damaging the bone,
bone marrow, and other bodily organs. Also known as
multiple myeloma.
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