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• actonel • aredia • boniva • didronel • evista • Forteo • fosamax • miacalcin • zometa • vivelle • reclast •
Aredia (Pamidronate) is
used, along with cancer therapy, in patients with breast
cancer or multiple myeloma whose disease has spread to
the bones. The effect of Aredia appeared to be less in
breast cancer patients receiving hormonal therapy than
in those receiving chemotherapy, though clinical benefit
has been shown.
help in two important ways:
helps reduce the chance of bone complications that
include fractures, surgery to bone, and radiation to
bone. Aredia can be effective in treating your bone
complications, whether or not you have already
can decrease bone pain in some breast cancer and
multiple myeloma patients. Studies have also shown that
some people needed fewer doses or a lower strength of
pain medication; others were able to switch from
narcotics to over-the-counter pain relievers.
Understanding the studies that have shown a reduction in
bone pain and in use of pain medication can be
complicated because many tests were performed. Your
doctor is the best resource for help in understanding
how these study results relate to your cancer.
Aredia is the only
medication designed to specifically delay and reduce the
complications caused by cancer that has spread to the
bone and the pain that comes with it. Aredia was tested
in over 1100 patients with bone metastases. The results
showed that patients who were given Aredia had fewer
bone complications and some had less bone pain. Some
patients who already had bone complications before
starting Aredia had fewer new bone problems during
Some Aredia patients may
experience fever, fatigue, nausea, vomiting, bone pain,
lack of appetite, which pass in a few days, and anemia.
Your doctor can recommend a mild pain reliever that may
help prevent these symptoms or relieve them if they
occur. You should talk to your doctor if you experience
high temperature, redness, swelling, or pain at the site
where Aredia is infused, tiredness, nausea, lack of
appetite, or muscle twitching. Your doctor will be
checking your blood routinely for anemia and other
possible side effects and will be watching your response
to this medication.
treatment for cancer that has spread to your bones,
called bone metastases.
The dual benefits of
Aredia are delay and reduction of bone complications,
such as fractures, and the possibility of reducing bone
pain. The only medication
approved for the treatment of bone metastases, Aredia is
clinically proven to be effective.
Aredia is not
chemotherapy and can be taken along with other cancer
treatments. If you have any
questions about Aredia, ask your doctor
Another way to reduce
the likelihood of having bone complications is to use
intravenous bisphosphonates. Bisphosphonates are drugs
that affect the process by which bone is lost.
Bisphosphonates are administered in addition to other
anti-cancer therapies. Intravenous Aredia® (pamidronate
disodium for injection) is the only bisphosphonate that
is approved for the treatment of osteolytic lesions
caused by breast cancer and multiple myeloma. It is used
along with other cancer therapies.
Pamidronate Appears to Reduce Osteoclast Activity and
Bone Resorption in Thalassaemic Osteoporosis
Pamidronate effectively reduced osteoclast activity and
bone resorption, and lead to increased lumbar bone
mineral density in patients with beta-thalassaemia,
report researchers from Greece.
Although treatment has increased life expectancy in this
population, serious complications including osteoporosis
often occur, caused in part by increased osteoclast
function. Studies have shown varied results with the use
of bisphosphonates to treat osteoporosis in patients
with beta-thalassaemia. Oral alendronate has been
associated with increased bone mineral density (BMD), no
beneficial effect has been noted with clodronate and, to
date, no good evidence is available on the use of
pamidronate in this setting.
To evaluate the effect of pamidronate on
osteoporosis in patients with beta-thalassaemia, Ersi
Voskaridou, MD, Laikon General Hospital, Athens, and
colleagues administered 30 mg/month pamidronate to 18
patients (13 dependent on transfusion; 5 never
transfused or occasionally transfused) or 60 mg/month
pamidronate to 8 patients (4 regularly transfused; 4
occasionally transfused). All patients had beta-thalassaemia
with osteoporosis. A control group of 30 of healthy
blood donors, matched by age and sex to the treatment
groups, was used for comparison. Evaluation of the
effect of pamidronate on bone remodelling, osteoclast
function, and bone mineral density was done using basic
and all bone-related biochemical tests (NTX, TRACP-5b,
bALP, OC, OPG, and sRANKL).
Regardless of transfusion status or dose group, all
treated patients had significantly higher NTX, TRACP-5b,
bALP, and OC values than participants in the control
group (P < .0005, P < .0005, P >
.01, P < .04, respectively). The control group,
on the other hand, had significantly higher OPG values
than did the treatment groups (P < .001).
Variation in the sRANKL levels remained in normal levels
for all groups. Dose did not significantly effect these
values between the treatment groups. In addition, dose
nor transfusion status altered the effect of pamidronate
on BMD of the lumbar spine, with significant increases
in the BMD of the lumbar spine found for all treated
patients (but not for the BMD of the femoral neck or
The comparable beneficial effects of 30 mg and 60
mg/month of pamidronate found in this study, along with
the reported good compliance and drug tolerability, led
the authors to conclude that 30 mg/month regimen of
pamidronate is an effective treatment for osteoporosis
in patients with beta-thalassaemia.
British Journal of Haematology 2003;123:730-737.
"Pamidronate is an effective treatment for osteoporosis
in patients with beta-thalassaemia"
IMPORTANT SAFETY INFORMATION
AREDIA (pamidronate disodium) is
contraindicated in patients with clinically
significant hypersensitivity to bisphosphonates
or any of the excipients in the formulation.
Due to the risk of clinically
significant deterioration in renal function,
which may progress to renal failure, single
doses of AREDIA (pamidronate disodium) should
not exceed 90 mg and the duration of infusion
should be no less than 2 hours. Risk factors for
the deterioration of renal function include
elevated baseline creatinine and multiple cycles
of bisphosphonate treatment.
AREDIA (pamidronate disodium) is not
recommended in patients with severe renal
impairment. Serum creatinine should be measured
before each dose and treatment should be
withheld for renal deterioration. In the
clinical studies, patients with serum creatinine
>3.0 mg/dL were excluded, renal deterioration
was defined as an increase of 0.5 mg/dL for
patients t with normal baseline creatinine and
an increase of 1.0 mg/dL for patients with
abnormal baseline creatinine. Treatment was
resumed only when the creatinine returned to
within 10% of the baseline value.
AREDIA (pamidronate disodium) is excreted
intact primarily via the kidney, and the risk of
renal adverse reactions may be greater in
patients with impaired renal function. Patients
who receive AREDIA (pamidronate disodium) should
have serum creatinine assessed prior to each
treatment. In patients receiving AREDIA (pamidronate
disodium) for bone metastases, who show evidence
of deterioration in renal function, AREDIA (pamidronate
disodium) treatment should be withheld until
renal function returns to baseline.
Pregnancy Category D. AREDIA (pamidronate
disodium) should not be used during pregnancy.
Women of childbearing potential should be
advised to avoid becoming pregnant. If the
patient becomes pregnant while taking this drug,
the patient should be apprised of the potential
harm to the fetus.
Osteonecrosis of the Jaw (ONJ) has been
reported in patients with cancer receiving
treatment including bisphosphonates,
chemotherapy, and/or corticosteroids. The
majority of reported cases have been associated
with dental procedures such as tooth extraction.
A dental examination with appropriate preventive
dentistry should be considered prior to
treatment with bisphosphonates in patients with
concomitant risk factors. While on treatment,
these patients should avoid invasive dental
procedures if possible. No data are available as
to whether discontinuation of bisphosphonate
therapy reduces the risk of ONJ in patients
requiring dental procedures.
The most common adverse events in bone
metastases clinical trials regardless of
causality were as follows: Fluid overload,
generalized pain, hypertension, abdominal pain,
anorexia, constipation, nausea, vomiting,
urinary tract infection, bone pain, fever, back
pain, arthrosis, headache, anemia, hypocalcemia,
arthralgias, myalgias, and dyspnea.