Is NOVANTRONE your best option to treat your rapidly progressing MS?

WHAT IS NOVATRONE?

Novantrone (Mitoxantrone) was approved over 15 years ago as a treatment for certain types of cancer. It is a chemotherapy that has been shown to be effective in slowing the progression of Secondary Progressive MS (SPMS) and Progressive Relapsing MS (PRMS). In the year 2000 the Food and Drug Administration Agency (FDA) approved Novantrone as the only treatment for worsening MS

If you are one of those MSers whose illness is rapidly progressing and worsening regardless of the therapies you have tried before, Novantrone can help you slow and reduce the progression of disability and help preserve some level of independence.

WHAT DOES “WORSENING MS” MEANS?

Let’s start by saying that worsening MS is not a clinical category or type of multiple sclerosis (MS). The term “worsening MS” can be difficult to describe since it's different for everyone. In fact, all four types of MS can worsen.

A better way to explain the term is to say that the term “worsening MS” confirms a change in the pattern of your disease. The recommendation for you is that instead of endless worrying, you should be aware of changes in your symptoms or the pattern of your relapses and remissions, only your doctor can determine if you have worsening MS.

THINGS THAT SHOULD MAKE YOUR BELLS GO “OFF” AND DISCUSS WITH YOUR DOCTOR ARE:

1. If you have more problems with coordination or more difficulty getting around.
2. If you notice new numbness in your arms and hands or spasticity in your legs.
3. If you feel weaker or more fatigued.
4. If you notice having more frequent difficulty thinking of the name of someone you've known for years or needing extra concentration to remember what you planned to do next.
5. If you are Starting to slur words or stutter when tired or stressed.

WHAT COULD BE SOME INDICATORS OF WORSENING MS?

The following list is going to give you an idea of common indicators of probable worsening MS

• more frequent relapses or more than two in the first year of your MS diagnosis
• relapses that last longer than you usually experience
• much longer recovery from relapses than you usually experience
• relapses that result in a continuing measurable loss of abilities (either physical or mental)
• increase in the number and/or size of lesions in the brain or spine as measured on an MRI

If your recovery from a relapse is not as fast or as complete as in the past, contact your doctor for a thorough evaluation. It may be time for a new approach to treatment that could reduce the progression of your disease.

Any progressing of disability you might be experiencing is certainly a clear indicator of worsening MS. Especially if you start noticing:

1. Less sense of touch - harder to pick up small objects or less sensitivity to hot and cold
2. Persistent pain or numbness in limbs - tingling, numbness, or pain in arms or legs
3. Greater loss of coordination - stumbling, tripping, stiffness, problems with bladder control
4. Increased difficulty getting around - grabbing walls for support, needing cane
5. Greater difficulty with everyday activities - problems dressing, bathing, washing hair, or preparing food
6. Weakness spreading - from one leg to both legs
7. increased problems with vision - blurriness, more difficulty driving at night, "double vision," "blind spots"

Some of these problems, such as increased difficulty driving at night, can also occur with normal aging. So, it's important for your doctor to determine if your symptoms are due to worsening MS or unrelated health problems.

What patients should know about this drug when used for MS treatment? <

This drug is a well-established drug with more than a decade of use. Side effects and risks are well-known and your doctor will routinely carry out tests to monitor for symptoms that could be a factor in the continued use of the medication. A couple of interesting points:

1. The recommended treatment schedule is far less intensive than for cancer treatment.
2. Side effects like nausea and hair loss, typically associated with cancer-fighting drugs, are generally mild and manageable.

THINGS FOR YOUR CONSIDERATION

If your doctor’s diagnosis confirms you have a progressive form of MS, starting with one of the CRAB (COPAXONE, REBIF, AVONEX, BETASERON) drugs is probably not the best option for you. If you already started using one of these drugs but discover that your MS has continued to progress, it may be time to switch to Novantrone.

The drug TYSABRI might still be an option and there are factors to consider when deciding between TYSABRI and Novantrone.

When considering Novantrone, we can’t overlook the fact that we are talking about a chemotherapy drug that has been approved by the Food and Drug Administration (FDA) for use in MS. The drug works by suppressing the immune system to lessen its attack on the body but just the idea that it is a chemotherapy cancer-fighting drug, scares a lot of folks.

The American Academy of Neurology published guidelines back in 2003 recommending that “because of its toxicity and the somewhat limited evidence of benefit, Novantrone (mitoxantrone) should be reserved for patients with rapidly advancing disease who have failed other therapies.” What you should know is that a lot of people have experienced relief from rapidly progressing symptoms – even regaining some lost function for awhile – after taking a full course of this drug.

As you probably already know when it comes to MS, there are no clear cut answers and there are quite a few things to consider and tough decisions to make. For example, young women of childbearing age must really think well their decision to use this drug since it can make women sterile (unable to have children). The best advice for you would be to make sure that all of your questions are answered, your fears are addressed and any expectations you have are realistic.

MORE ON EFFECTIVENSS AND HISTORY OF THE DRUG

The drug was approved by the Food and Drug Administration (FDA) for use in “advanced multiple sclerosis” back in 2000.

A couple of meta-analyses - a statistical technique which combines the results of several studies that ask the same or similar research questions - of the use of this drug showed that using this drug for MS treatment is an effective way to reduce MS relapses and disability progression.

Note that these studies are all very difficult to compare, and that this drug does have potentially serious side effects. In the pivotal phase III 2-year study, compared to a placebo, the drug was shown to reduce the number of relapses, lengthen time between relapses, demonstrate a 61% reduction in the decline of study participants’ ability to walk, and there was significantly less neurological disability in the treatment group compared to placebo group

REPORTED POTENTIAL SIDE EFFECTS

1. HEART PROBLEMS

The possibility of suffering irreversible damage to the heart is the scariest side effect of this drug and the main reason for having a strict limit of 10 or 11 total number of doses in a patient’s lifetime.

2. FEMALE INFERTILITY

The majority of women stop having their periods while taking this drug. Between 5 to 30% of women completing a full course of treatment never start their periods again and are sterile (cannot get pregnant). Recent studies demonstrate that the chance of female sterility can be lessened by the use of hormone treatment during treatment with Novantrone and this should be discussed with your doctor.

3. LEUKEMIA

A few cases of leukemia, called Acute Myelogenous Leukemia (AML), a type of cancer, have been reported in people taking this drug for MS. AML can be fatal. A 2009 Italian study of 2,854 people has shown the rate of developing leukemia to be 7.4 leukemia cases for every 1,000 patients (about 10 times higher than previously estimated). Twenty-one people in the group developed leukemia and 8 of them died.

4. CHEMOTHERAPY SIDE EFFECTS

Novantrone is a chemotherapy (antineoplastic) drug, and comes with all of the potential side effects of such a drug, including nausea, hair loss (usually moderate to mild in these doses), sores in the mouth, and falling white blood cell count (leading to increased risk of infection – usually in the lungs or bladder).

Since this drug suppresses your immune system, your risk of infection will rise after treatment. Don’t forget to avoid contact with people who are sick.

You should call your doctor right away if you have any of the following symptoms:

• Fever
• Chills
• Sore throat or cough
• Sores on lips or in mouth
• Shortness of breath
• Stomach pain
• Vomiting
• Diarrhea
• Painful or difficult urination
• Uneven or rapid heartbeat
• Swollen feet or ankles
• Unusual bleeding or bruising
• Pain, swelling, redness, or irritation at the injection site

AS YOUR BODY ADJUSTS TO THE NOVANTRONE, THE FOLLOWING SIDE EFFECTS SHOULD DISAPPEAR

1. A blue-green color of urine for 24 hours after receiving an infusion.
2. Mild or moderate nausea.
3. Menstrual irregularities in women.
4. Hair loss that may be mild to moderate (hair will usually grow back after treatment is discontinued).

BEFORE STARTING YOUR TREATMENT WITH NOVANTRONE TELL YOUR DOCTOR IF YOU HAVE ANY OF THE FOLLOWING CONDITIONS:

• Dental disease
• Gout
• Heart disease*
• Infection (especially a viral infection such as chicken pox or herpes)
• Liver disease
• Recent radiation therapy*

Allergies

• Pregnant or trying to get pregnant
• Breastfeeding
• Unusual or unexpected bleeding
• Have received chemotherapy*

* Patients who have or have had heart disease or cancer treatment should not take Novantrone. Serious side affects could result. Your doctor should thoroughly check for warning signs before beginning your treatment with Novantrone.

ADDITIONAL PRECAUTIONS YOU SHOULD BE AWARE OF

Blue? A kind of funky side effect of Novantrone is that it may turn the whites of your eyes slightly blue for a couple of days after treatment. Your urine will probably also be a startling blue-green color for about 24 hours following your infusion.

Drug Cocktail: Your infusion will probably contain up to 1 mg of Solu-Medrol and some anti-nausea medication, such as Zophran

SAFETY MEASURES WHEN USING THIS DRUG

Blood will be drawn before and after each dose. Prior to starting the treatment, you should be carefully evaluated for any signs and symptoms of heart disease. A baseline evaluation of left ventricular ejection fraction (LVEF) should be performed before every dose.

Treatment should be discontinued if LVEF changes significantly or is ever under 50%. The Food and Drug Administration (FDA) also now recommends that even after completing the course of treatmen, people continue to receive yearly LVEF to detect late-occurring cardiac damage.

CONTRAINDICATIONS/PRECAUTIONS

This medication should not be used (or used with great caution) in a person with:

• current or prior history of heart disease or that are currently using other medications that can damage the heart
• abnormal liver function tests or a history of liver problems
• low white or red blood cell counts
• blood clotting problems or unusual bleeding
• cancer or another condition that involves use of other chemotherapies or radiation (especially to the chest area) – this may include past cancer treatment
• infections

VACCINES

Your immune system will be suppressed during your treatment. During treatment with this medication (and for at least a month after a dose but always check with your doctor about this) do not have any immunizations with live virus vaccines without your doctor’s approval (neither you nor anyone in your household should take the oral polio vaccine). Avoid anyone with infections during this time, as well.

POTENTIAL INTERACTIONS

Some types of antibiotics and other medications should also be avoided, including: Amphotericin B by injection; antithyroid agents; azathioprine; chloramphenicol; colchicine; flucytosine; ganciclovir; plicamycin; probenecid; ulfinpyrazone; zidovudine. Make sure you discuss this issue with your neurologist.

YOUR COST

The drug has a cost around US$3,000 a year for the medication only. There will be additional charges for the infusion center.

To find out more about financial assistance, contact a representative of Serono’s patient support program, MS Lifelines at 1-877-447-3243


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