What is ZOMETA?
ZOMETA is not chemotherapy.
ZOMETA belongs to a class of drugs called bisphosphonates
that are used to reduce or delay complications from
bone
metastases or bone lesions from multiple myeloma.
These drugs reduce the “wearing away” of
bone and slow the abnormal buildup of unstable bone.
What is the indication for ZOMETA?
ZOMETA (zoledronic acid) injection is indicated for the treatment
of patients with multiple myeloma and patients with documented bone
metastases from solid tumors, in conjunction with standard antineoplastic
therapy. Prostate cancer should have progressed after treatment
with at least one hormonal therapy.
ZOMETA (zoledronic acid) injection is indicated for the treatment
of hypercalcemia of malignancy. Vigorous saline hydration, an integral
part of hypercalcemia therapy, should be initiated promptly and
an attempt should be made to restore the urine output to about 2L/
day throughout treatment. Mild or asymptomatic hypercalcemia may
be treated with conservative measures (i.e., saline hydration, with
or without loop diuretics). Patients should be hydrated adequately
throughout the treatment, but overhydration, especially in those
patients who have cardiac failure, must be avoided. Diuretic therapy
should not be employed prior to correction of hypovolemia. The safety
and efficacy of ZOMETA in the treatment of hypercalcemia associated
with hyperparathyroidism or with other non-tumor-related conditions
has not been established.
How is ZOMETA given?
ZOMETA is given by intravenous infusion. It can be administered
in your doctor’s office, a clinic, or hospital as outpatient
therapy. The infusion takes at least 15 minutes. ZOMETA is
administered every 3 to 4 weeks. Before ZOMETA was available, IV
bisphosphonate therapy took at least 2 hours to administer.
How effective is ZOMETA?
ZOMETA was tested in three large studies involving over 3,000
patients. These patients all had bone metastases from
solid tumors (breast, prostate, lung, kidney cancer,
genitourinary cancer, bladder cancer, colorectal cancer,
other gastrointestinal cancers, liver cancer, head and
neck cancer, malignant melanoma, sarcoma, and others)
or multiple myeloma. They were all receiving chemotherapy
or hormonal therapy. In these studies, patients who
were given ZOMETA had fewer bone complications,
a longer time until bone complications occurred, and
a lower risk of developing bone complications, than
patients who did not take ZOMETA.
What are the side effects from ZOMETA?
The most common side effects are flu-like symptoms that are usually
mild and transient. These symptoms include fatigue, nausea, vomiting,
bone pain, or lack of appetite; they may start after the 1st infusion
and can last 3 to 5 days. These flu-like symptoms usually occur
with the 1st, and perhaps 2nd dose. Patients who experience these
symptoms usually do not experience them with the 3rd or 4th dose.
If necessary, your doctor can prescribe a mild pain reliever to
make you more comfortable. Before each infusion, your doctor will
do blood tests to monitor your kidney function and will closely
watch your response to ZOMETA.
It is important to keep up with your fluid intake while
on ZOMETA therapy. Signs and symptoms of low fluid
intake dehydration include thirst, sagging skin, low
urine output, and dry mouth. Be sure to drink plenty
of water or other fluids.
Click here for important
safety information.
What is osteonecrosis of the jaw?
Osteonecrosis
(pronounced OSS-tee-oh-ne-KROH-sis) of the jaw is an uncommon condition that
involves the loss, or breakdown, of the jaw bone. 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, if possible,
invasive dental procedures. No data are available as to whether
discontinuation of bisphosphonate therapy reduces the risk of ONJ in
patients requiring dental procedures.
Who should not take ZOMETA?
A doctor should make the decisions regarding which medicine is best
for each patient. ZOMETA should be used with caution
in patients with aspirin-sensitive asthma. In addition,
there are some patients who should not receive ZOMETA
- ZOMETA is contraindicated in patients with clinically significant
hypersensitivity to zoledronic acid or other bisphosphonates,
or any of the excipients in the formulation of ZOMETA
- ZOMETA should not be administered to women who are pregnant
due to potential harm to the fetus
- Patients with severe kidney problems should not receive ZOMETA.
In some cases, ZOMETA and other bisphosphonates have been
known to cause kidney damage. If you have any kidney problems,
your doctor may reduce your dose or determine that ZOMETA
should not be given
How long will I be taking ZOMETA?
Your doctor will make the decision as to how long
you should continue ZOMETA. ZOMETA has been
given to patients in studies for up to 24 months.
With treatment of ZOMETA it is important to take
a multivitamin that contains 400 IU of Vitamin D and
an oral calcium supplement of at least 500 mg daily.
Do I continue my regular cancer therapy while receiving ZOMETA?
ZOMETA is not chemotherapy. It is a treatment
for bone metastases. It is used along with other treatments
for cancer, such as chemotherapy, hormonal therapy,
or radiation
therapy. ZOMETA may be given on the same schedule
as your other therapy or at a different time. Your doctor
will decide which cancer medications you will continue
to take.
Can children use ZOMETA?
Safety and efficacy have not been established in children.
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