Mitoxantrone

Mitoxantrone a synthetic antineoplastic anthracenedione used alone or with other medicines to treat people with:

• secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (MS)
• pain related to advanced hormone-refractory prostate cancer
• acute nonlymphocytic leukemia (ANLL)

Mitoxantrone

Mitoxantrone ball-and-stick

What are the uses of this medicine?

Mitoxantrone is used alone or with other medicines to treat people with:

• secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (MS)
• pain related to advanced hormone-refractory prostate cancer
• acute nonlymphocytic leukemia (ANLL)

Limitation of Use:

• Mitoxantrone is not for people with primary progressive MS.

How does this medicine work?

Mitoxantrone mechanism

• Mitoxantrone (mye tox’ an trone) is an antineoplastic antibiotic that is a synthetic derivative of doxorubicin and is considered an anthracenedione.
• It is believed to act by intercalating into helical double-stranded DNA causing cross links and strand breaks, thus blocking both DNA and RNA synthesis.
• Mitoxantrone has potent antitumor effects in vitro and has been evaluated in leukemia, lymphoma and several solid tumors in humans.
• Mitoxantrone also has immunosuppressive activity, inhibiting B cell, T cell and macrophage proliferation and decreasing tumor necrosis factor alpha and interleukin-2 secretion.
• These actions led to its evaluation in patients with progressive forms of multiple sclerosis where it was shown to have activity in decreasing the rates of relapse and development of new lesions.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to Mitoxantrone or any of the ingredients in mitoXATRONE.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist if you are taking or have ever received certain cancer chemotherapy medications such as daunorubicin (Cerubidine), doxorubicin (Doxil), epirubicin (Ellence), or idarubicin (Idamycin).

Especially tell your doctor if you take or have taken:

• medicines for cancer treatment called anthracyclines or anthracenediones
• medicines that may affect your heart

Is this medicine FDA approved?

• Mitoxantrone was approved for use in the United States in 1987 and current indications include acute non-lymphocytic leukemia and advanced prostate cancer.
• Mitoxantrone is also approved for use in relapsing and progressive multiple sclerosis.

How should this medicine be used?

Recommended dosage: Multiple Sclerosis

• The recommended dosage of Mitoxantrone injection (concentrate) is 12 mg/m2 given as a short (approximately 5 to 15 minutes) intravenous infusion every 3 months.

Hormone-Refractory Prostate Cancer:

• The recommended dosage of Mitoxantrone injection (concentrate) is 12 to 14 mg/m2 given as a short intravenous infusion every 21 days.

Combination Initial Therapy for acute nonlymphocytic leukemia (ANLL) in Adults:

• For induction, the recommended dosage is 12 mg/m2 of Mitoxantrone injection (concentrate) daily on Days 1 to 3 given as an intravenous infusion, and 100 mg/m2 of cytarabine for 7 days given as a continuous 24 hour infusion on Days 1 to 7.

Administration:

• Mitoxantrone is given by slow infusion through a needle placed in a vein (intravenous infusion) in your arm.
• Your doctor will tell you how often you will receive Mitoxantrone.
• If you receive Mitoxantrone to treat MS, your doctor should check how well your heart is working before each Mitoxantrone dose. Talk to your doctor if you have not had your heart tests done before your Mitoxantrone dose.
• Your doctor will do blood tests during your treatment with Mitoxantrone to check your blood cell counts.
• If you are a woman of childbearing age taking Mitoxantrone to treat MS, your doctor should do a pregnancy test before each Mitoxantrone dose, even if you are using birth control.
• If you receive Mitoxantrone to treat MS, there is a limit to the total amount of Mitoxantrone you can receive during your lifetime. There is a higher risk of heart failure with increasing total lifetime doses of Mitoxantrone.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Mitoxantrone injection USP

This medicine is available in fallowing brand namesː

• Mitoxantrone is available in several generic formulations as a solution for injection (usually 2 mg/mL).

What side effects can this medication cause?

The most common side effects of this medicine include:

• blue-green colored urine for about 24 hours after receiving Mitoxantrone. This color change is harmless.
• bluish coloring of the whites of your eyes for about 24 hours after receiving Mitoxantrone. This color change is harmless.
• nausea
• constipation
• diarrhea
• stomach pain
• hair loss
• fever and chills due to infections
• cough and sore throat due to upper respiratory tract infection
• mouth sores due to mouth infection
• loss of your menstrual period

Mitoxantrone may cause serious side effects, including:

• myelosuppression
• congestive heart failure
• skin problems at your injection site
• febrile neutropenia
• secondary leukemia in patients with multiple sclerosis

What special precautions should I follow?

• Mitoxantrone injection (concentrate) should be administered under the supervision of a physician experienced in the use of cytotoxic chemotherapy agents.
• Mitoxantrone injection (concentrate) should be given slowly into a freely flowing intravenous infusion. It must never be given subcutaneously, intramuscularly, or intra-arterially. Severe local tissue damage may occur if there is extravasation during administration.
• Except for the treatment of acute nonlymphocytic leukemia, Mitoxantrone injection (concentrate) therapy generally should not be given to patients with baseline neutrophil counts of less than 1,500 cells/mm3.
• Congestive heart failure (CHF), potentially fatal, may occur either during therapy with Mitoxantrone injection (concentrate) or months to years after termination of therapy. Such patients should have regular cardiac monitoring of LVEF from the initiation of therapy.
• Mitoxantrone injection (concentrate) therapy in patients with MS and in patients with cancer increases the risk of developing secondary acute myeloid leukemia.
• Mitoxantrone therapy is often accompanied by mild to moderate elevations in serum aminotransferase levels, but in typical doses it rarely causes clinically apparent, acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• severe leukopenia with infection

Management of overdosage:

• There is no known specific antidote for Mitoxantrone injection.
• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• Mitoxantrone injection may cause fetal harm when administered to a pregnant woman.
• Women of childbearing potential should be advised to avoid becoming pregnant.

Can this medicine be used in children?

• It is not known if mitroxantrone is safe and effective in children.

What are the active and inactive ingredients in this medicine?

• Active ingredient: Mitoxantrone hydrochloride USP
• Inactive ingredients: sodium chloride, sodium acetate anhydrous, glacial acetic acid and water for injection

Who manufactures and distributes this medicine?

• Teva Parenteral Medicines, Inc.
• Irvine, CA

What should I know about storage and disposal of this medication?

• Mitoxantrone injection USP (concentrate) should be stored at 20° to 25°C (68° to 77°F).
• DO NOT FREEZE.

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• Dailymed label info on Mitoxantrone
• FDA Mitoxantrone

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