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ONXOL™
Information
In this section you will find answers to many frequently
asked questions about ONXOL™ (paclitaxel) Injection,
a drug used to treat cancer.
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Let’s talk about generic
drugs...
A generic drug contains the same active ingredients,
in the same amounts, as does the branded counterpart.
For most products, they must also prove that the
generic medication produces the same effect on the body
as does the brand-name product.
Who
monitors the quality of generic drugs ?
The Food and Drug Administration, or FDA, approves all
generic products prior to them becoming available. This
is the same U.S. government agency that monitors the
quality of brand-name drugs. The same standards of quality
and consistency that apply to brand-name drugs apply
to generic drugs.
What is ONXOL™ (paclitaxel) Injection?
Paclitaxel is a prescription cancer medicine.
It is injected into a vein and it is used to treat different
types of tumors. The tumors include advanced ovary and
breast cancer.
What
is cancer?
Under normal conditions, the
cells in your body divide and grow in an orderly, controlled
way. Cell division and growth are necessary for the
human body to perform its functions and to repair itself,
when necessary. Cancer cells are different from normal
cells because they are not able to control their own
growth. The reasons for this abnormal growth are not
yet fully understood.
A tumor is a mass of unhealthy cells that are dividing
and growing fast and in an uncontrolled way. When a
tumor invades surrounding healthy body tissue it is
known as a malignant tumor. A malignant tumor can spread
(metastasize) from its original site to other parts
of the body if not found and treated early.
How
does ONXOL™ (paclitaxel) Injection work?
ONXOL™ is a type of
medical treatment called chemotherapy. The purpose of
chemotherapy is to kill cancer cells or prevent their
growth. All cells, whether they are healthy cells or
cancer cells, go through several stages of growth. During
one of the stages, the cell starts to divide. ONXOL™
may stop the cells from dividing and growing, so they
eventually die. In addition, normal cells may also be
affected by ONXOL™ causing some of the side effects.
(See Side Effects).
Who should not take ONXOL™?
Patients who have a history
of hypersensitivity (allergic reactions) to ONXOL™
or other drugs containing polyoxyl 35 castor oil, like
cyclosporine or teniposide, should not be given ONXOL™.
In addition, ONXOL™ should not be given
to patients with dangerously low white blood cell counts.
How
is ONXOL™ given?
ONXOL™ is injected into
a vein (intravenous (IV) infusion). Before you are given
ONXOL™, you will have to take certain medicines
(premedications) to prevent or reduce the chance you
will have a serious allergic reaction. Such reactions
have occurred in a small number of patients while receiving
paclitaxel and have been rarely fatal.
(See Side Effects)
Side
Effects
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L5099, Issue date: 08/00 (L5127 09/01)
This Patient Information Leaflet has been approved by
the U.S. Food and Drug Administration
Please, contact
your doctor, nurse, or other healthcare provider if you
have any other questions about this medicine.
This medicine was prescribed
for your particular condition. This summary does not include
everything there is to know about paclitaxel. Medicines
are sometimes prescribed for purposes other than those
listed in a Patient Information Leaflet. If you have questions
or concerns, or want more information about paclitaxel,
your doctor or pharmacist have the complete prescribing
information upon which this guide is based. You may want
to read it and discuss it with your doctor.
Remember, no written summary can replace careful discussion
with your doctor. |
