Novantrone, also known as mitoxantrone hydrochloride, belongs to a group of medicines known as antineoplastics and is indicated for the treatment of pain related to advanced hormone-refractory prostate cancer and, in combination with other drugs, for the initial therapy of acute nonlymphocytic leukemia in adults. Novantrone, originally approved in 1987, seems to interfere with the growth of cancer cells, which are eventually destroyed.
In 2000, the U.S. Food and Drug Administration (FDA) approved Novantrone for treating patients with advanced or chronic multiple sclerosis (MS)
, a disease that attacks the nervous system and can cause weakness, impaired vision, loss of balance, and poor muscle coordination. Novantrone is manufactured for Immunex Corporation, Seattle, Wash., by Lederle Labs.
Side effects of Novantrone include, but may not be limited to, nausea
, hair thinning
, loss of menstrual periods, bladder infections, shortness of breath
, and mouth sores. Patients treated with Novantrone may develop heart problems, including congestive heart failure, that can be very serious and may cause death. The risk of heart disease increases with the cumulative dose, and patients with MS should ordinarily not receive more than 8 to 12 doses administered over two to three years. Damage to the heart may occur during Novantrone therapy or years after therapy ends. The professional labeling and patient information recommend that doctors closely monitor their patients. Patients are advised that regular testing of heart and blood is needed to help avoid serious side effects.
In May 2005, Serono and FDA notified healthcare professionals of revisions to the BOXED WARNING, WARNINGS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Novantrone. The Dear Healthcare Professional letter provides additional information concerning the risks of cardiotoxicity associated with Novantrone and also provides supplemental information regarding secondary acute myelogenous leukemia (AML) reported in MS patients treated with Novantrone.
See your doctor if you have experienced serious side effects associated with Novantrone. In addition, it may be important to contact an attorney
who can help you protect your legal rights. Please keep in mind that there may be time limits
within which you must commence suit.
- Multiple Sclerosis Drugs
- Hair Loss: Overview
- Heart Problems
- Leukemia: Overview
- Lung & Airway Disorders
- Nausea: Overview