Please 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.

Generic Name
Mitoxantrone for Injection

Manufacturer
Immunex Corporation

Common Uses

• 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 refractory prostate cancer.
• Novantrone in combination with other approved drug(s) is indicated in the initial therapy of acute nonlymphocytic leukemia in adults.

How Taken
Intravenous injection

Adverse Effects
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:
More common

• Black, tarry stools; cough or shortness of breath

• 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 skin

• Blue skin at place of injection; pain or redness at place of injection; skin rash

• 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 professional.

Warnings

• 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 blood clotting.
• Tell your doctor if you are pregnant, breast feeding, or if you intend to have children during treatment with this medicine.

Source: National Library of Medicine, MEDLINEplus Health Information