Mitoxantrone

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Generic Name: Mitoxantrone Brand Name(s): Generics only. No brands available.

Uses

What is Mitoxantrone used for?

Mitoxantrone is used to treat leukemia and other cancers. It is also used to treat multiple sclerosis. It belongs to a class of drugs known as anthracenediones and works by slowing or stopping the growth of certain cells (including cancer cells and cells that affect the body’s natural defenses).

How should I take Mitoxantrone?

This medication is given by injection into a vein by a health care professional as directed by your doctor. Dosage is based on your medical condition, body size, and response to treatment.

If this medication touches your skin, immediately wash the area well with soap and water. If this medication gets in your eye, open the eyelid and flush with water for 15 minutes, then seek immediate medical attention.

How do I store Mitoxantrone?

20º to 25ºC (68° to 77°F).  Keep from freezing. If you need to store mitoxantrone at home, talk with your doctor, nurse, or pharmacist about how to store it.

There may be different brands of Mitoxantrone that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Mitoxantrone down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Mitoxantrone?

Before using mitoxantrone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), heart disease (e.g., congestive heart failure, irregular heartbeat), liver disease, radiation treatment, recent/current infection.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist that you are using this medication.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Before you start treatment and during treatment with this medication, your doctor may direct you to have a pregnancy test. If you become pregnant or think you may be pregnant, tell your doctor right away. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control.

This medication passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Mitoxantrone during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Mitoxantrone. Mitoxantrone is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Mitoxantrone?

Nausea, vomiting, diarrhea, headache, or unusual tiredness may occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Severe nausea, vomiting, or diarrhea may rarely cause a loss of too much body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness/lightheadedness, or pale/wrinkled skin.

Temporary hair thinning/loss may occur. Normal hair growth should return after treatment has ended.

This medication may cause your urine to turn blue-green. The white part of your eyes may also turn a bluish color. These effects are temporary, normal, and harmless.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: menstrual changes (e.g., stopped periods), unusual bleeding/bruising (e.g., small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds), numbness/tingling feelings, seizure.

This medication can lower the body’s ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Mitoxantrone?

Some products that may interact with this drug include: other anti-cancer drugs (especially anthracyclines such as doxorubicin).

Mitoxantrone may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Mitoxantrone?

Mitoxantrone may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Mitoxantrone?

Mitoxantrone may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Mitoxantrone.

What is the dose of Mitoxantrone for an adult?

Usual Adult Dose for Acute Nonlymphocytic Leukemia

-INDUCTION THERAPY: 12 mg/m2 IV daily on days 1 to 3 (in combination with cytarabine at 100 mg/m2 given as a continuous 24-hour IV infusion on days 1 to 7)

-SECOND INDUCTION THERAPY (if needed in the event of an incomplete antileukemic response to the first induction): 12 mg/m2 IV daily on days 1 and 2 (in combination with cytarabine given as a continuous 24-hour IV infusion on days 1 to 5)

-CONSOLIDATION THERAPY: 12 mg/m2 given IV daily on days 1 and 2 (in combination with cytarabine given as a continuous 24-hour IV infusion on days 1 to 5). The first course is given approximately 6 weeks after the final induction course and the second is generally administered 4 weeks after the first.

Comments:

-The IV infusion should be given over 5 to 15 minutes.

-Most complete remissions from ANLL occur during initial induction therapy. In the event of an incomplete antileukemic response, a second induction course may be administered.

-Second inductions should be withheld until severe or life-threatening nonhematologic toxicity associated with the first induction dose is cleared.

Use: For the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults (includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias) in combination with other approved drug(s)

Usual Adult Dose for Multiple Sclerosis

12 mg/m2 given as a short (approximately 5 to 15 minute) IV infusion every 3 months

Comments:

-The IV infusion should be given over 5 to 15 minutes.

-Evaluation of left ventricular ejection fraction (LVEF) by echocardiogram or multiple gated acquisition (MUGA) scan is recommended prior to all doses.

-LVEF evaluations are recommended if signs of congestive heart failure develop.

-This drug should not be administered to MS patients who have received a cumulative lifetime dose of 140 mg/m2 or more, or those with either an LVEF less than 50% or a clinically significant reduction in LVEF.

-Complete blood counts, including platelets, should be monitored prior to each dose and if signs of infection develop.

-This drug should not be administered to MS patients with neutrophil counts less than 1500 cells/mm3.

-Liver function tests should also be monitored prior to each dose. Use of this drug in MS abnormal liver function tests is not recommended.

-Women who are capable of becoming pregnant (even if they are using birth control) should have a pregnancy test before each dose.

Use: To reduce neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses)

Usual Adult Dose for Prostate Cancer

12 to 14 mg/m2 given as a short IV infusion every 21 days (in combination with corticosteroids)

Comment:

-The IV infusion should be given over 5 to 15 minutes.

Use: Indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer in combination with corticosteroids

Liver Dose Adjustments

Patients with multiple sclerosis who have liver dysfunction should ordinarily not be treated with mitoxantrone (the drug may be administered with caution to other patients with liver dysfunction).

Dialysis

-This drug is extensively tissue bound and it is unlikely that the therapeutic effect or toxicity would be mitigated by peritoneal or hemodialysis.

Other Comments

Limitations of use:

-This drug is not indicated for the treatment of patients with primary progressive multiple sclerosis.

Patient advice:

-Patients should be informed of the availability of a Medication Guide and instructed to read it prior to initiating treatment and prior to each infusion.

-Patients should be advised that this drug can cause myelosuppression and be informed of signs of myelosuppression.

-Patients should be advised that this drug can cause congestive heart failure that may lead to death, even in people who have never had heart problems before.

-Patients with MS should be advised that they should receive cardiac monitoring prior to each dose and yearly after stopping therapy.

-Patients should be advised that this drug may impart a blue-green color to the urine and/or sclera for 24 hours after administration.

What is the dose of Mitoxantrone for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Mitoxantrone available?

Mitoxantrone is available in the following dosage forms and strengths:

  • Intravenous solution

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Mitoxantrone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: March 29, 2018 | Last Modified: March 29, 2018

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