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Thursday
APPROXIMATE COMPLETION DATE: NOVEMBER 2ND
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Researchers report that the safety and tolerability of Novantrone (mitoxantrone) in long-term treatment of worsening multiple sclerosis appears to be consistent with its known safety profile.
The findings were presented here on September 29th at the 22nd Congress of the European Committee for Treatment and research in Multiple Sclerosis (ECTRIMS).
"In a large sample of patients followed prospectively, we found that the risk/benefit ratio is in keeping with prior knowledge about this drug," said lead investigator Edward Fox, MD, PhD, clinical assistant professor, University of Texas Medical Branch, Austin, Texas.
Mitoxantrone is currently being evaluated for long-term safety and tolerability in patients with worsening relapsing-remitting multiple sclerosis, progressive relapsing multiple sclerosis and secondary progressive multiple sclerosis in the ongoing, multicenter, open-label Registry to Evaluate Novantrone Effects in Worsening MS (RENEW)....
Monday
Researchers report that the safety and tolerability of Novantrone (mitoxantrone) in long-term treatment of worsening multiple sclerosis appears to be consistent with its known safety profile.
The findings were presented here on September 29th at the 22nd Congress of the European Committee for Treatment and research in Multiple Sclerosis (ECTRIMS).
"In a large sample of patients followed prospectively, we found that the risk/benefit ratio is in keeping with prior knowledge about this drug," said lead investigator Edward Fox, MD, PhD, clinical assistant professor, University of Texas Medical Branch, Austin, Texas.
Mitoxantrone is currently being evaluated for long-term safety and tolerability in patients with worsening relapsing-remitting multiple sclerosis, progressive relapsing multiple sclerosis and secondary progressive multiple sclerosis in the ongoing, multicenter, open-label Registry to Evaluate Novantrone Effects in Worsening MS (RENEW)....
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Wednesday
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 of more than 12 doses (usually more than140 mg/m2) of Novantrone during their lifetime.
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.
Sunday
The new FDA labeling requires repeat testing of cardiac function prior to each dose, in addition to the baseline testing of cardiac function which was recommended by the original labeling of Novantrone.
Saturday
Heart Risks May Be Higher for Multiple Sclerosis Patients With Heart Problems
The FDA is warning doctors and multiple sclerosis (MS) patients about the risk of heart failure and leukemia from the MS drug Novantrone.
Patients may be more vulnerable if they have a history of heart disease or heart problems. Screening for heart failure should be done prior to starting treatment with Novantrone and prior to all doses administered, says the drug's maker, Serono.
Patients with heart failure should not receive Novantrone, the company says.
A Serono letter to doctors about Novantrone is posted on the FDA's web site. The letter includes a revised warning label, which has what the FDA calls "additional" and "supplemental" information about heart and leukemia risks.
About Novantrone
Novantrone is used to reduce neurological disability and/or the frequency of clinical relapses in patients with several types of MS, says Serono. Those conditions are secondary (chronic) progressive MS, progressive-relapsing MS, or worsening relapsing-remitting MS.
Novantrone is not indicated for patients with primary progressive MS, says Serono.
Heart Risks
"Diminished cardiac function may occur early on in treatment with Novantrone," says Serono's letter, citing postmarketing reports.
"Congestive heart failure, potentially fatal, may occur either during therapy with Novantrone or months to years after termination of therapy," says the revised label. It also says all patients should be carefully assessed for cardiac signs and symptoms -- such as shortness of breath, extreme fatigue with exertion, and leg swelling -- prior to the start of Novantrone therapy.
The label says heart risks may be higher in patients taking Novantrone who have current or past heart disease, those who have had (or are getting) radiation therapy to the chest, those who have previously taken cancer-fighting drugs that can affect the heart -- such as anthracyclines or anthracenediones -- and those who are also taking other drugs that could cause heart damage.
Next: Risk of Treatment-Related LeukemiaCLICK TO READ webmd.com:
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