Patient Medication Information: uses, side effects, how to take - Idarubicin Hydrochloride Injection (Fresenius Kabi Canada)
What the medication is used for:
Idarubicin Hydrochloride Injection alone or in combination with other anticancer drugs is used in the treatment of:
- acute non-lymphocytic leukemia (ANLL) as a first- line in adult patients;
- acute lymphocytic leukemia (ALL) as a second-line in adults and children.
What it does:
Idarubicin Hydrochloride Injection is a cancer drug (chemotherapy drug) which works by killing rapidly dividing cells, such as cancer cells. This action can affect normal cells as well.
In people with leukemia, the bone marrow produces abnormal white blood cells. The abnormal white cells are cancer cells (leukemia cells).
When it should not be used:
Do not use the drugs if you:
- are allergic to idarubicin or any of the ingredients of the drug or its container (see What the important non-medicinal ingredients are);
- are allergic to other anthracyclines or anthracenediones such as epirubicin, daunorubicin, mitoxantrone or mitomycin;
- have persistent low blood count (myelosuppression);
- have severe liver, renal or heart disease;
- have recent heart attack;
- have severe irregular heartbeat;
- have history of severe cardiac disease;
- have uncontrolled infections;
- have been treated with a maximum cumulative dose of idarubicin, doxorubicin, daunorubicin, epirubicin or other anthracyclines or anthracenediones.
What the medicinal ingredient is:
Idarubicin hydrochloride, USP is the active ingredient.
What the important non-medicinal ingredients are:
Glycerin, USP Hydrochloric acid, NF Water for Injection, USP
What dosage forms it comes in:
Idarubicin Hydrochloride Injection, 1 mg / mL is a clear red-orange sterile solution to be given intravenously.
BEFORE you use Idarubicin Hydrochloride Injection, talk to your doctor if you:
- have low blood cell counts;
- have heart disease, recent heart attack or irregular heartbeat;
- have an infection;
- have had radiotherapy to chest area;
- are taking calcium channel blockers, such as amlodipine, diltiazem, verapamil;
are pregnant or planning to become pregnant;
- are breast-feeding or planning to breast-feed
- have been previously treated with Idarubicin Hydrochloride Injection or other anti-cancer drugs, including anthracyclines (cardiotoxic drugs).
As Idarubicin Hydrochloride Injection may be harmful to an unborn child, women should be advised to avoid becoming pregnant. Effective contraceptive methods should be used.
Tell your doctor right away if you become pregnant during treatment. If you have been nursing, you should stop before starting treatment with Idarubicin Hydrochloride Injection. Ask your baby’s doctor to recommend a formula that would be best for your baby.
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
Idarubicin Hydrochloride Injection should be given under the supervision of a doctor experienced with the use of anticancer drugs. Idarubicin Hydrochloride Injection should not be given to patients with the following conditions:
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As Idarubicin Hydrochloride Injection may cause fertility impairment and damage chromosomes in sperm, men undergoing treatment with Idarubicin Hydrochloride Injection should use effective contraceptive methods.
Tell your doctor or pharmacist if you have or recently have taken any other medicines including medicines bought without prescription.
Drugs that may interact with Idarubicin Hydrochloride Injection include:
cytarabine, other anthracyclines, anthracenediones and calcium channel blockers such amlodipine, diltiazem or verapamil.
Other drugs that may be used in therapy with Idarubicin Hydrochloride Injection may increase the chance of toxic effects
include: cyclophosphamide, fludarabine, etoposide, paclitaxel.
Talk to your doctor before you receive a vaccine while treated with Idarubicin Hydrochloride Injection, as the combination may result in a serious infection in patients with a compromised immunity (i.e., patients taking oral corticosteroids, transplanted patients, elderly patients).
PROPER USE OF THIS MEDICATION
How is Idarubicin Hydrochloride Injection given?
You may receive Idarubicin Hydrochloride Injection through a vein in the arm (“intravenously” or “IV”) by your doctor or nurse,
usually in the hospital, outpatient department or clinic.
If you are getting many injections, for your convenience, your doctor may insert a catheter (thin tube) or port into a large
vein in your body that is placed there as long as it is needed. Medicines get injected through the catheter or port rather than directly into a vein.
How much time does it take to get a treatment with
Idarubicin Hydrochloride Injection?
It usually takes about 5-10 minutes to inject Idarubicin Hydrochloride Injection. However, you may get other medicines before or after Idarubicin Hydrochloride Injection, so your entire treatment may last an hour or longer.
How long will I need treatment?
Your doctor will determine the length of your treatment based on your treatment goals, the medicines you receive, and how your body responds to those medicines.
Your treatment cycle will depend on your medical condition and the other chemotherapy medicines you are getting. Idarubicin Hydrochloride Injection is usually given once a day for 3 consecutive days.
Overdose
If you think you are given more Idarubicin Hydrochloride Injection than you should, contact your doctor, nurse, or poison control centre immediately. |
Missed dose
If you miss your scheduled treatment with the drug, contact your doctor as soon as possible to schedule your next treatment.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, Idarubicin Hydrochloride Injection can have side effects.
Common side effects include:
- Hair loss, which is temporary and usually starts to grow back within 2 or 3 months after you have finished your treatments;
- Infection, as a result of low white blood cell count. The signs of infection include fever over 38 °C (100 °F), chills or sweating, sore throat or coughing, redness or swelling around a cut, wound or a catheter site, a burning feeling when you urinate, unusual vaginal itching or discharge;
- Nausea and vomiting;
- Fatigue, or feeling tired;
- Mouth sores;
- Anemia, or low red blood cell count;
- Red coloration of your urine for 1 to 2 days after administration during active therapy;
- Diarrhea with dehydration and symptoms such as skin flushed, dry and pale, less urination;
- Sensitivity of irradiated skin;
- Hot flashes;
- Skin and nail changes or colouration, tingling sensation;
- Rash/itch/redness skin allergy.
Rare side effects include:
- Severe adverse events such as local tissue damages due to leakage of Idarubicin Hydrochloride Injection from your vein into surrounding tissues with intravenous injection might be observed;
- Serious heart problems in a small percentage of patients;
- Urticaria (hives).
INTERACTIONS WITH THIS MEDICATION
This is not a complete list of side effects. For any unexpected effects while taking Idarubicin Hydrochloride Injection, contact your doctor or pharmacist
HOW
HOW TO STORE IT
Idarubicin Hydrochloride Injection should be stored at
2 °C to 8 °C and protected from light.
Keep out of the reach of children.
Reporting 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 obtained by contacting the sponsor, Fresenius Kabi Canada Ltd. at: 1-877-821-7724
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Last Revised: June 19, 2019
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom/effect | Talk with your doctor or pharmacist | |
| Only if severe | In all cases | |
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