visit our Novantrone Forum here.
Novantrone is a potent, well-tolerated
anti-cancer agent. Novantrone's chemical structure is similar to
chemotherapy agents known as anthracyclines (e.g., doxorubicin and
idarubicin), but lacks an amino sugar component that is thought to
contribute to the cardiotoxicity characteristic of anthracyclines.
Novantrone was first licensed in 1987
for use in acute myelogenous leukemia. A supplemental application,
submitted just six months ago, was given priority- review status by the
FDA under the user-fee guidelines, meaning the FDA agreed to review the
application within six months, compared to the normal 12-month review.
In addition, the Novantrone application was one of the first
filed with the FDA after President Clinton announced his initiative to
speed cancer drug approvals for life threatening diseases for which
there is no currently approved therapy.
NOVANTRONE is a medicine to treat MS patients with secondary (chronic)
progressive, progressive relapsing, or worsening relapsing-remitting
MS. It is not for treating primary progressive MS. Patients treated with
NOVANTRONE may have fewer relapses and keep their mobility longer.
NOVANTRONE is given through a needle placed in a vein in your hand or
arm. The dose takes about 5 to 15 minutes to deliver. NOVANTRONE
treatment is usually given once every 3 months for about 2 to 3 years (8
to 12 doses). However, this may differ for different patients.
Most side effects of NOVANTRONE are not severe and can normally be
treated by your doctor. The most common side effects of NOVANTRONE in
patients with MS are nausea, hair thinning, loss of menstrual periods,
bladder infections, and mouth sores. The nausea is usually mild and
generally lasts for less than 24 hours. A small number of patients
treated with NOVANTRONE develop heart problems. Tell your doctor if you
have trouble breathing, swelling of your legs or ankles, or uneven or
fast heartbeat. These problems generally happen in people who get a
total lifetime dose of more than 12 doses (usually more than140
mg/m2) of NOVANTRONE.
NOVANTRONE may cause your white blood cell count to go down, which
increases your chance of getting an infection. This risk is greatest
within one month after each dose. In addition, NOVANTRONE may cause your
platelet count to go down, which increases your chance of bleeding. Call
your doctor right away if you begin to have fever, chills, sore throat,
cough, pain with urination, urination more often, or if you notice any
unusual bleeding or bruising. NOVANTRONE is dark blue in color, so it
may turn your urine a blue-green color for a few days after each dose.
The white part of your eyes may also have a slight blue color.
- Novantrone is indicated for reducing neurologic disability and/or
the frequency of clinical relapses in patients with secondary
(chronic) progressive, progressive relapsing, or worsening
relapsing-remitting multiple sclerosis.
- Novantrone is used for treatment of pain from advanced hormone
- Novantrone in combination with other approved drug(s) is indicated
in the initial therapy of acute nonlymphocytic leukemia in adults.
Along with its needed effects, a medicine may cause some unwanted
effects. Although not all of these side effects may occur, if they do
occur they may need medical attention.
Also, because of the way cancer medicines act on the body, there is a
chance that they might cause other unwanted effects that may not occur
until months or years after the medicine is used. These delayed effects
may include certain types of cancer, such as leukemia. Discuss these
possible effects with your doctor.
Check with your doctor or nurse immediately if any of the following
side effects occur:
- Black, tarry stools; cough or shortness of breath
Check with your health care professional as soon as possible if any of
the following side effects occur:
- Blood in urine or stools; fast or irregular heartbeat; fever or
chills; lower back or side pain; painful or difficult urination;
pinpoint red spots on skin; swelling of feet and lower legs; unusual
bleeding or bruising
- Sores in mouth and on lips; stomach pain
- Decrease in urination; seizures; sore, red eyes; yellow eyes or
Other side effects may occur that usually do not need medical attention.
These side effects may go away during treatment as your body adjusts to
the medicine. Also, your health care professional may be able to tell
you about ways to prevent or reduce some of these side effects. Check
with your health care professional if any of the following side effects
continue or are bothersome:
- Blue skin at place of injection; pain or redness at place of
injection; skin rash
Mitoxantrone may cause the urine to turn a blue-green color. It may also
cause the whites of the eyes to turn a blue color. These effects are
normal and last for only 1 or 2 days after each dose is given.
- Diarrhea; headache; nausea and vomiting
This medicine often causes a temporary loss of hair. After treatment
with mitoxantrone has ended, normal hair growth should return.
Other side effects not listed above may also occur in some patients.
If you notice any other effects, check with your health care
- It is very important that your doctor check your progress at
regular visits to make sure that this medicine is working properly
and to check for unwanted effects.
- While you are being treated with mitoxantrone, and after you stop
treatment with it, do not have any immunizations (vaccinations)
without your doctor's approval . Mitoxantrone may lower your body's
resistance and there is a chance you might get the infection the
immunization is meant to prevent. In addition, other persons living
in your household should not take oral polio vaccine since there is
a chance they could pass the polio virus on to you. Also, avoid
persons who have taken oral polio vaccine. Do not get close to them
and do not stay in the same room with them for very long. If you
cannot take these precautions, you should consider wearing a
protective face mask that covers the nose and mouth.
- Mitoxantrone can temporarily lower the number of white blood cells
in your blood, increasing the chance of getting an infection. It can
also lower the number of platelets, which are necessary for proper
- Tell your doctor if you are pregnant, breast feeding, or if you
intend to have children during treatment with this medicine.
Library of Medicine, MEDLINEplus Health Information