Patient Medication Information: uses, side effects, how to take - Mitoxantrone Injection USP
ABOUT THIS MEDICATION
What the medication is used for:
Mitoxantrone Injection USP is used to treat:
- metastatic carcinoma of the breast
- relapsed adult leukemia
- lymphoma, and
- hepatoma.
In combination with other drug(s), Mitoxantrone Injection USP used to treat:
- in the initial treatment of acute non-lymphocytic leukemia (ANLL) in adults, including myelogenous, promyelocytic, monocytic and erythroid acute leukemias.
What it does:
Mitoxantrone works by interfering with the process needed for new cell growth.
When it should not be used:
- NOT FOR INTRATHECAL USE.
Do not use Mitoxantrone Injection USP if:
- you are hypersensitive to mitoxantrone hydrochloride, anthracyclines or to any ingredient in the formulary (see What the important nonmedicinal ingredients are).
- you have used significant amounts of anthracyclines previously and you have abnormal heart function just before treatment.
- you have not recovered from severe bone marrow suppression due to treatment by other medications or radiotherapy.
- you have sever liver disease.
What the medicinal ingredient is:
Mitoxantrone hydrochloride
What the important nonmedicinal ingredients are:
Sodium acetate, sodium chloride and acetic acid.
What dosage forms does Mitoxantrone come in:
It is available as a solution containing 2 mg/mL in vials of 10 mL, 12.5 mL and 15 mL.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Mitoxantrone Injection USP should never be given:
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Other Warnings:
- Contact your doctor if an infection develops during treatment. Your doctor may require periodic blood tests during treatment if an infection occurs.
Your doctor may require you to take liver tests prior to mitoxantrone use.
BEFORE you use Mitoxantrone Injection USP talk to your doctor or pharmacist if:
- You have heart or liver problems.
You are pregnant, or planning to become pregnant. You and your doctor will decide if this medication is suitable. Your doctor may request a pregnancy test before you use mitoxantrone and you should avoid getting pregnant while using this medication.
- You are planning a vaccination as it may be ineffective if using mitoxantrone.
INTERACTIONS WITH THIS MEDICATION
There are no known drugs that may interact with Mitoxantrone however, do not mix this product with heparin or any other drugs when administering intravenously.
PROPER USE OF THIS MEDICATION
Mitoxantrone should be administered by individuals experienced in the use of antineoplastic therapy.
Mitoxantrone Injection USP can only be given by slow infusion into a vein. Please consult with your doctor as your dose will vary according to your condition.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, Mitoxantrone Injection USP may have, in addition to its beneficial effects, some unwanted effects.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Uncommon | Allergic reaction | √ | ||
Phlebitis (inflammation of the vein) -symptoms may include: Paresthesia (Tingling or burning sensation at injection) | √ | √ | ||
Suppression of bone marrow function -symptoms may include: Anemia-patients may experience fatigue/ weakness Thrombocyto-penia-patients may experience longer bleeding time | √ | |||
| Tissue necrosis (tissue cell death) | √ | |||
More Common Reactions
Gastrointestinal: Nausea, vomiting and stomatitis (sores in the mouth). In the majority of cases these are mild and transient (not permanent).
Dermatological: Hair loss, most frequently of minimal severity and reversible once the treatment stops.
Hematological (blood):
Myelosuppression (suppression of bone marrow activities), especially leucopenia (blood cells which helps in infection to destroy bacteria). Thrombocytopenia (cells which helps to form blood clots) and anemia are less common.
Renal (kidney): Blue-green urine may be seen for 24 hours after administration.
Less Common Reactions
Gastrointestinal: Diarrhea, anorexia, gastrointestinal bleeding, abdominal pain, altered taste.
Respiratory: Dyspnea (difficulty in breathing) interstitial pneumonitis (swelling of the lining of the lung).
Local: Phlebitis (inflammation of the vein). Tissue necrosis (tissue cell death) following extravasation (bleeding outside of the blood vessels) has been reported rarely.
General: Allergic reactions, fever, fatigue and weakness, drowsiness, confusion, anxiety and mild burning sensations. Tumor lysis syndrome (a condition in which there are sudden, rapid death of cells) has been observed rarely during single-agent chemotherapy with Mitoxantrone, as well as during combination chemotherapy.
Dermatological: Rash, loosening of the nail at the border and abnormal colouring.
Hepatic (liver): Increased liver enzyme levels and elevated bilirubin levels have been reported occasionally.
Renal (kidney): Elevated serum creatinine and blood urea nitrogen levels have been reported occasionally.
This is not a complete list of side effects. For any unexpected effects while taking Mitoxantrone Injection USP, contact your doctor or pharmacist.
HOW TO STORE IT
Store unopened vials of Mitoxantrone Injection USP, between 15 °C and 25 °C. Protect from light and freezing. Keep out of reach of children.
Reporting Suspected Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Pfizer Canada Inc. at: 1-800-463-6001.