Details for: MITOXANTRONE INJECTION
Company: FRESENIUS KABI CANADA LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02286300 | MITOXANTRONE INJECTION | MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) | 2 MG / ML | SOLUTION | INTRAVENOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
It is used to treat some kinds of cancer:
- metastatic breast cancer;
- relapsed adult leukemia, lymphoma, and hepatoma;
- in combination with other drug(s), for acute non-lymphocytic leukemia (ANLL).
What it does
Mitoxantrone belongs to the general group of medicines known as antineoplastics (anticancer). Mitoxantrone seems to interfere with the growth of cancer cells, which are eventually destroyed.
When it should not be used
- If allergic to Mitoxantrone Injection, USP, or any of its components, or have demonstrated prior hypersensitivity to anthracycline drugs;
- In patients who have received prior substantial anthracycline exposure and have abnormal cardiac function;
- In patients who have NOT recovered from severe suppression of the bone marrow activity due to previous treatment with other cytotoxic agents or radiotherapy;
- In patients with severe liver impairment.
What the medicinal ingredient is
mitoxantrone hydrochloride
What the non-medicinal ingredients are
- Glacial acetic acid
- Sodium acetate
- Sodium chloride
- Water for Injection
What dosage form it comes in
2 mg mitoxantrone/mL aqueous solution for intravenous injection available as 10 mL/vial.
Warnings and precautions
Mitoxantrone Injection, USP must not be given by intrathecal, subcutaneous, intramuscular, or intra-arterial injection.
Secondary acute myelogenous leukemia has been reported in patients treated with anthracyclines.
Heart muscle toxicity (myocardial/cardiac toxicity) may occur.
BEFORE you use Mitoxantrone Injection, USP talk to your doctor or pharmacist if:
- You are allergic to Mitoxantrone Injection, its components, or anthracycline drugs;
- If you have received prior substantial anthracycline exposure;
- You are pregnant, if you plan to become pregnant, or if you are breast-feeding a baby;
- You are recently vaccinated or plan to be vaccinated;
- You have heart problems, liver problems, or multiple sclerosis.
Interactions with this medication
Drugs that may interact with Mitoxantrone Injection, USP include:
- Anthracyclines
- Anthracenediones
- Daunorubicin
- Doxorubicin
- Other cardiotoxic drugs
Proper use of this medication
Mitoxantrone Injection, USP should be administered by individuals experienced in the use of antineoplastic therapy and have the facilities to monitor your blood and heart during and after treatment.
Mitoxantrone Injection should be given slowly into a freely flowing intravenous infusion.
It is recommended that Mitoxantrone Injection not be mixed in the same infusion with other drugs.
Usual Dose
The dose of mitoxantrone will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, body size, and whether or not this drug is being taken in combination with other medication. The proper dose of mitoxantrone will be determined by your doctor.
Overdose
There is no known specific antidote for mitoxantrone.
Side effects and what to do about them
Along with its needed effects, a medicine may cause some unwanted effects that may require medical attention. Discuss these possible effects with your doctor.
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. Talk to your doctor about how to reduce the risk of infection or bleeding.
Mitoxantrone often causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if your stomach is upset. Ask your health care professional for ways to lessen these effects.
Mitoxantrone may cause the urine to turn a blue-green colour. It may also cause the whites of the eyes to turn a blue colour. These effects are normal and last for only 1 or 2 days after each dose is given.
This medicine often causes a temporary loss of hair. After treatment with mitoxantrone has ended, normal hair growth should return.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| body aches or pains | ✔ | ||
| congestion | ✔ | ||
| constipation | ✔ | ||
| diarrhea | ✔ | ||
| dry/sore throat | ✔ | ||
| headache | ✔ | ||
| irregular or longer/heavier menstrual periods | ✔ | ||
| nausea | ✔ | ||
| vomiting | ✔ | ||
| sores in mouth and on lips | ✔ | ||
| stomach pain | ✔ | ||
| 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/lower legs | ✔ | ||
| unusual bleeding/bruising | ✔ | ||
| decrease in urination | ✔ | ||
| seizures | ✔ | ||
| sore, red eyes | ✔ | ||
| yellow eyes or skin | ✔ | ||
| Uncommon | |||
| blue skin at injection site | ✔ | ||
| pain or redness at injection site | ✔ | ||
| skin rash | ✔ | ||
How to store
Mitoxantrone Injection, USP should be stored between 15 °C and 25 °C.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full Product Monograph, prepared for health professionals, can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at: 1-877-821-7724
This leaflet was prepared by:
Fresenius Kabi Canada Ltd.
45 Vogell Rd, Suite 200
Richmond Hill, ON, L4B 3P6
Last revised: September 28, 2016